FEDERAL COURT OF AUSTRALIA

Novartis AG v Bausch & Lomb (Australia) Pty Ltd [2004] FCA 835

PATENTS – claim for infringement and cross claim for revocation – application for deletion and validating amendments of patent – application opposed at the final hearing as contrary to the public interest to the extent that the amendments are validating amendments in that they seek to cure a lack of fair basis – after the final hearing the parties settled their dispute and requested consent orders dismissing the claim and cross-claim and granting all of the amendments sought – consideration of circumstances in which the Court will exercise its discretion to grant or refuse to grant an application for amendment of a patent – application granted in respect of some amendments and refused in respect of others

PRACTICE AND PROCEDURE – whether a non-party should be permitted to intervene on the amendment application on the ground that there is no longer a proper contradictor in respect of that application

Patents Act 1990 (Cth) ss 40, 102, 105 and 138

Federal Court Rules O 58 r 10

Datadot Technology Ltd v Alpha Microtech Pty Ltd (2003) 59 IPR 402 – cited

Oil Basins Limited v The Commonwealth of Australia (1993) 178 CLR 643 – cited

Arrow Pharmaceuticals Ltd v Merck and Co Inc [2004] FCA 138 – cited

Eli Lilly and Co v Pfizer Research and Development Co NV/SA (2003) 59 IPR 234 – considered

New England Biolabs Inc v Commissioner of Patents (2001) 110 FCR 357 – cited

Wimmera Industrial Minerals Pty Ltd v RGC Mineral Sands Ltd (No 3) (1997) AIPC ¶91-366 (39,772) – considered

RGC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd (1998) 89 FCR 458 – cited

Fina Research SA v Halliburton Energy Services Inc (2003) 127 FCR 561 – cited

ICI Chemicals & Polymers Ltd v Lubrizol Corp (1999) AIPC ¶91-521 (40,012) – considered

ICI Chemicals & Polymers Ltd v Lubrizol Corp (2000) 106 FCR 214 – applied

C. Van der Lely N.V. v Bamfords Limited [1964] RPC 54 – considered

Chiron Corporation v Organon Teknika Limited (No. 5) [1994] FSR 258 – cited

Kirin-Amgen Inc’s Patent [2002] RPC 43 – cited

Smith Kline & French Laboratories Limited v Evans Medical Limited [1989] 1 FSR 561 – applied

Rescare Limited v Anaesthetic Supplies Pty Ltd (unreported, Federal Court of Australia, Gummow J, 4 March 1993) – considered

Gambro Pty Ltd v Fresenius Medical Care South East Asia Pty Ltd (1999) 48 IPR 625 – considered

Hsiung’s Patent [1992] RPC 497 – cited

Neurizon Pty Ltd v Lth Consulting and Marketing Services (No 2) (2003) AIPC ¶91-882 (35,633) – cited

Kimberly-Clark Australia Pty Limited v Airco Trading International Pty Ltd (2001) 207 CLR 1 – applied

Société des Usines Chimiques Rhône-Poulenc v Commissioner of Patents (1958) 100 CLR 5 – applied

F. Hoffman-La Roche & Co. Aktien-Gesellschaft v Commissioner of Patents (1971) 123 CLR 529 – cited

Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 – cited

Leonardis v Sartas No 1 Pty Ltd (1996) 67 FCR 126 – cited

CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 – cited

Lockwood Security Products Pty Ltd  v Doric Products Pty Ltd (2003) 56 IPR 479 – cited

Olin Corporation v Super Cartridge Co. Pty. Ltd. (1977) 180 CLR 236 – applied

Atlantis Corporation Pty Ltd v Schindler (1997) 39 IPR 29 – cited

Chevron Research Company’s Patent [1970] RPC 580 – cited

Bristol Myers Company v Manon Freres Limited [1973] RPC 836 – cited

Matbro Limited v Michigan (Great Britain) Limited [1973] RPC 823 – cited

Bentley Engineering Co. Ltd.’s Patent [1981] RPC 361 – cited

Raleigh Cycle Co. Ld. v H. Miller & Co. Ld.. [1951] AC 278 – cited 

Minerals Separation Ltd v Potter’s Sulphide Ore Treatment Ltd (1909) 8 CLR 779 – cited

Mullard Radio Valve Co. Ltd. v British Belmont Radio Ltd. [1939] RPC 1 – cited

Great Lakes Carbon Corporation’s Patent [1971] RPC 117 – cited

Texas Instruments Ltd v Hyundai Electronics UK Ltd (unreported, UK Patents Court, Pumfrey J, 30 July 1999) – cited

Richardson-Vicks Inc.’s Patent [1995] RPC 568 – cited

Minister of Agriculture’s Patent  [1990] RPC 61 – cited

NOVARTIS AG, COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION, AND CIBA VISION AUSTRALIA PTY LTD (ACN 057 946 540) v BAUSCH & LOMB (AUSTRALIA) PTY LTD (ACN 000 650 251)

V 81 OF 2000

MERKEL J

24 AUGUST 2004

MELBOURNE

THE COURT MAKES THE FOLLOWING ORDERS BY CONSENT:

1.                  The application and the cross claim be dismissed with no order as to costs.

AND THE COURT FURTHER ORDERS:

2.                  Compliance with the requirements of Order 58 rule 10 of the Federal Court Rules be dispensed with in respect of the amendments set out in paragraph  3(g) hereunder.

3.                  The complete specification of Australian Letters Patent No 704749 (“the patent”) be amended as follows:

(a)        On page 4 at lines 11–12, delete the words “lens allows”.

(b)        On page 4 at line 22, replace “mm²/sec” with “cm²/sec”.

(c)        On page 22 at the 7^th last line, delete the word “material”.

(d)        On page 22 at line 25, replace “permeability” with “transmissibility”, and replace “transmissibility” with “permeability”.

(e)        On page 23 at the 11^th last line, replace “material” with “ lens”.

(f)                 On page 99 at line 1, replace “F-13” with “F-12”.

(g)                On pages 102–113 delete claims 1–66 and replace with:

1. An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:

(a)        at least one oxyperm polymerizable material and

(b)        at least one ionoperm polymerizable material,

wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material,

wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and

wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions,

wherein said polymeric material comprises a plurality of co-continuous phases, including at least one oxyperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens and at least one ionoperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens.

2. An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:

(a)        at least one oxyperm polymerizable material and

(b)        at least one ionoperm polymerizable material,

wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material,

wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and

wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions,

wherein said polymeric material comprises a plurality of co-continuous pathways, at least one being an ion or water pathway and at least one other being an oxygen pathway, which pathways extend continuously from the inner surface of the lens to the outer surface of the lens.

3. An ophthalmic lens of claim 2, wherein said co-continuous pathways include a continuous phase of ionoperm polymeric material and a continuous phase of siloxane-containing polymeric material.

4. An ophthalmic lens of claim 2, wherein said pathways have a domain size which is less than a size which undesirably distorts visible light in an amount which is visible to the eye of the wearer.”

4.         Save for the orders set out in paragraph 3 above, the applicants’ motion dated 6 December 2002 for amendment of the patent be dismissed.

5.         The applicants pay any costs of the Commissioner of Patents that were incurred after 2 July 2004 in respect of the applicants’ motion for amendment of the patent.

6.         The motion of Johnson & Johnson Pacific Pty Limited dated 16 July 2004 be dismissed.

7.         Johnson & Johnson Pacific Pty Limited pay the costs of the applicants of and incidental to the motion.

8.         Reserve liberty to apply.

Note:    Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

REASONS FOR JUDGMENT

Introduction

1                     The first and second applicants are the registered proprietors of Australian Letters Patent No 704749 (“the patent”) which relates to an invention entitled “Extended Wear Ophthalmic Lens”. The third applicant is a subsidiary of the first applicant and the exclusive licencee of the patent in Australia.

2                     The applicants (“Novartis”) claimed that the respondent (“Bausch & Lomb”) was infringing the patent by the manufacture and sale of its “PureVision” contact lenses in Australia. Bausch & Lomb denied infringement and cross-claimed to have the patent declared invalid and revoked. Some time after the service of Bausch & Lomb’s cross-claim, Novartis applied by motion to amend the patent under s 105 of the Patents Act 1990 (Cth) (“the Act”). The amendment application, which was opposed by Bausch & Lomb in respect of certain amendments, was heard at the final hearing together with the other issues in the proceeding.

3                     The matter was listed for judgment on 1 July 2004 but the parties requested that the handing down of judgment be deferred until 4.15 pm on 2 July 2004 to enable them to finalise international settlement negotiations in relation to the patent and its international counterparts. On 2 July 2004 the parties announced that the matter had been settled and that they would be seeking orders by consent dismissing the claim and cross claim and granting the amendments sought by Novartis.  As a result, judgment was not handed down and the further hearing of the matter was adjourned to 12 July 2004 to enable the parties to formulate the orders they were seeking and also to enable the Commissioner of Patents (“the Commissioner”), whom I directed to appear pursuant to s 105(3), to consider her position in respect of the amendment application.

4                     When the matter came before the Court on 12 July 2004 Novartis requested orders dismissing the claim and the cross-claim with no order as to costs; a certificate under s 19(1) of the Act that the validity of the patent was questioned; and a direction that the patent be amended in the manner proposed by Novartis. Directions were given for the parties and the Commissioner to file any submissions they wished to make in relation to the orders sought by Novartis. The Commissioner’s submissions stated that because the Commissioner considered that the proposed amendments comply with s 102 of the Act she has no objection to them. The Commissioner also stated that she could not express any view as to the merits, or otherwise, in relation to the proceeding as she has not had the benefit of examining any of the evidence filed by the parties.  However, the Commissioner added that if the Court “is concerned with the validity of the patent in question, or some of the proposed amendments sought, it is appropriate for the Court to direct the Commissioner to re-examine the patent in accordance with section 97(3).”  Section 97(3) empowers the Court to direct the Commissioner to re-examine a patent the validity of which is disputed in a proceeding in the Court. The Commissioner also expressed concerns regarding the appropriateness of a s 19(1) certificate being issued in circumstances where a judicial determination of the merits has not occurred: see Datadot Technology Ltd v Alpha Microtech Pty Ltd (2003) 59 IPR 402.

5                     Novartis filed submissions claiming that, as there was no longer any opposition to the amendments it was seeking and as the “relevant public interests have been properly protected”, the amendments should be allowed.   It submitted that, as the validity of the patent is no longer in dispute, s 97(3) is not applicable to the circumstances of the present case. Novartis did not press its application for a s 19(1) certificate.

Johnson & Johnson’s application to intervene

6                     On 19 July 2004, Johnson & Johnson Pacific Pty Limited (“Johnson & Johnson”) applied to be heard in opposition to Novartis’ amendment application or to be joined as a party for the purpose of opposing that application.  Johnson & Johnson claimed that it had not previously taken any steps to oppose the amendment application because it knew that the amendments were opposed by Bausch & Lomb, which was regarded by it as a suitable contradictor.  Johnson & Johnson claims that, as Bausch & Lomb now consents to the amendment application, it is appropriate for it to be joined as a party to the application, so there is a proper contradictor before the Court.

7                     On 11 September 2003 Johnson & Johnson commenced its own proceeding against Novartis in the New South Wales Registry of the Court for the revocation of the patent.  As the grounds for revocation were substantially the same as those raised by Bausch & Lomb, Johnson & Johnson requested Novartis’ consent for its proceeding to be joined or heard together with the present proceeding, which was fixed for hearing in October 2003.  Novartis refused to consent to that request and Johnson & Johnson did not further pursue the issue, although its  representatives have been present during the hearing in Melbourne and it has received a copy of the transcript and has been granted access to the evidence before the Court. The separate proceeding between Johnson & Johnson and Novartis remains on foot in the New South Wales Registry of the Court, although on 23 March 2004 Wilcox J ordered that the proceeding be stayed pending the giving of judgment in this matter.

8                     However, more relevantly for present purposes, although Johnson & Johnson claims that it was unaware of Novartis’ advertisement of the proposed amendments it is clear that after it became aware of those amendments it took no step to oppose them.  Johnson & Johnson has explained that its election not to intervene came about because it regarded Bausch & Lomb as a suitable contradictor.  However, in making that election it must be taken to have been aware of the possibility that the parties may, as they have in fact done, settle their dispute.

9                     Johnson & Johnson submits that it is in the public interest for there to be a contradictor to Novartis’ amendment application and that as Bausch & Lomb no longer is fulfilling that role, it is appropriate that it do so.  It claims that, as it wishes to do no more than adopt Bausch & Lomb’s submissions in relation to the amendment application, its intervention will not delay, or add any additional expense to, the determination of the matter.

10                  I have concluded that it is appropriate to refuse Johnson & Johnson’s application and shall briefly state my reasons for that conclusion.  Johnson & Johnson must be taken to have elected not to intervene in Novartis’ amendment application and the Court should not permit it to depart from its election absent compelling or persuasive reasons.  There are no compelling, or even persuasive, reasons for permitting Johnson & Johnson’s intervention. 

11                  There is no public interest in Johnson & Johnson filling the role of contradictor in the present matter. Bausch & Lomb fulfilled the role of a contradictor at the hearing and in that role strongly opposed the amendment application.  Although Bausch & Lomb subsequently reversed its position and consented to that application, the submissions made by Bausch & Lomb, and the evidence in support of those submissions, remain before the Court.  Further, following Bausch & Lomb’s consent to the amendment application I directed the Commissioner of Patents to appear, which she has done.  Although the Commissioner did not oppose the amendments, that must be understood in the context of her not having considered or formed a view about the material in support of or against the amendment application.  Nonetheless, the Commissioner has filed submissions in respect of the application and in that role may perhaps have performed a role as a contradictor in a particular way: cf Oil Basins Limited v The Commonwealth of Australia (1993) 178 CLR 643 at 649.  Thus, the present case is not one in which it can be truly said that there has been no contradictor.

12                  Finally, Johnson & Johnson does not seek to do any more than adopt Bausch & Lomb’s submissions which remain before the Court. Thus, it is clear that the Court will not be assisted in any meaningful manner by an intervention by Johnson & Johnson.  Rather, the practical consequence of its application is that if Johnson & Johnson were permitted to intervene at this stage that would enable it to be an appellant or respondent in any appeal from the decision I make.  That, however, is a matter for the Full Court in the light of all the circumstances then existing if, and when, there is such an appeal. Those circumstances would include whether there is a proper contradictor before the Full Court.

13                  For the above reasons Johnson & Johnson’s application to intervene is to be dismissed with costs.

Dismissal of the claim and cross-claim

The infringement and revocation proceedings are adversarial proceedings between Novartis and Bausch & Lomb and there is no reason why the Court should not give effect to the settlement that the parties have reached in relation to those proceedings. Accordingly, it is appropriate to order by consent that the claim for infringement and the cross-claim for revocation be dismissed with no order as to costs.

Amendment

14                  The application for amendment of the patent stands in a position different to that of the infringement and revocation proceedings.  It is well established, and is not in dispute, that the Court has a general discretion under the Act to allow, or to refuse to allow, the amendment of a patent. In exercising the discretion, the Court will be guided by whether it is in the public interest that the amendments sought be allowed or refused. Thus, although the absence of any opposition to an amendment application is a matter that the Court may take into account, it does not relieve the Court of its duty to determine the application on its merits: see Arrow Pharmaceuticals Limited v Merck & Co Inc. [2004] FCA 138 at [7].

15                  The Commissioner did not oppose the amendments, either initially or after the Court directed her to appear.  However, as explained earlier, the Commissioner’s non-opposition needs to be balanced against the fact that she has not had the benefit of examining any of the evidence filed by the parties. 

16                  In regard to the merits of the application, although Bausch & Lomb now consents to the Court allowing the amendments, Bausch & Lomb’s consent cannot alter the evidence it led at trial in support of its now abandoned opposition to the substantive amendments. As a consequence, the evidence upon which the Court is to act in determining Novartis’ amendment application is the evidence adduced by Novartis and Bausch & Lomb in the course of the fully contested final hearing. Notwithstanding Bausch & Lomb’s present position it is appropriate to refer to the submissions it made at the hearing as that will enable a better understanding of the issues that require determination on Novartis’ amendment application.

17                  Before turning to the issues arsing on the amendment application it is necessary to provide some background concerning the invention which is the subject of the patent.

Extended wear contact lenses

18                  The patented invention is an extended wear silicon hydrogel contact lens. Extended wear is generally regarded as involving continuous wear over a period of at least 24 hours.

19                  The development of extended wear contact lenses had been a goal in the contact lens industry since at least the early 1980s. Initially, contact lenses were designed for daily wear with the lens being inserted each morning and removed each night. The lenses had to be stored overnight and cleaned before reinsertion because inadequate care of the lens between each day’s wear could result in eye infections and other complications. This problem, together with the inconvenience of the daily wear regime and the desirability of enabling lens wearers to wake up with corrected vision, led companies in the contact lens industry to work towards the development of a lens which could be worn 24 hours a day, for up to 30 days, without removal.

20                  A basic requirement for an extended wear contact lens is that it be ophthalmically compatible, which means that the lens will not cause significant damage to the eye or user discomfort. In order for a lens to be ophthalmically compatible it must possess the following characteristics:

(a)        High oxygen transmissibility

21                  The oxygen transmissibility of a lens is the rate at which oxygen is able to pass through the lens to reach the cornea. Transmissibility depends, inter alia, on the oxygen permeability of the material used to construct the lens. Oxygen permeability, which is referred to by those skilled in the art as “Dk” and is usually measured in units of “barrers”, is the rate at which oxygen passes through that material. Oxygen transmissibility is referred to as “Dk/t”, with “t” representing the thickness of a lens, and is measured in “barrers/mm”.

22                  High oxygen transmissibility is a pre-requisite for an ophthalmically compatible extended wear contact lens. This is because the cornea has no vascular system and therefore must obtain its oxygen supply directly by means of its contact with the atmosphere. If a lens with insufficient oxygen transmissibility is worn for an extended period the cornea begins to swell and to develop blood vessels, making the cornea susceptible to infections which can interfere with vision. Corneal swelling of about 4%, which usually occurs overnight during sleep when no lens is worn, is not harmful. But overnight use of conventional contact lenses can result in swelling of up to 12%. Thus, if lenses are to be worn for extended periods, including overnight, they must possess an oxygen transmissibility sufficient to ensure ophthalmic compatibility. At 8 December 1995, being the priority date, studies indicated that daily wear lenses must have an oxygen transmissibility of at least around 24 barrers/mm, whereas extended wear lenses required an oxygen transmissibility of at least 87 barrers/mm.

23                  The above oxygen transmissibility values were measured by a technique referred to in the art as the polarographic method. Although there are at least two other methods of measurement of oxygen transmissibility the most commonly used are the polarographic and coulometric methods. The distinction between these two methods is significant, since a lens will show different transmissibility levels when tested coulometrically than it will when tested polarographically. Although there is no known mathematical relationship between coulometrically and polarographically measured transmissibility levels, generally polarographic measurements give higher values than coulometric measurements. The oxygen transmissibility values given in the patent were determined coulometrically. This is said to explain why they are lower than 87 barrers/mm, the polarographic measurement referred to above as the necessary oxygen transmissibility for extended wear lenses.

(b)        On-eye movement

24                  A lens must also move well on the eye. Good on-eye movement prevents adhesion of the lens to the eye, and is necessary to allow tear flow between the lens and the eye and the maintenance of a tear film. As at the priority date of the patent it was believed that the on-eye movement of a lens was related to its water content.

(c)        Other characteristics

25                  The lens must also avoid accumulation of deposits and must not cause any toxic or other acute ocular reactions or adverse symptoms.

26                  Approval for some 30 day extended wear lenses was given by the United States Food and Drug Administration in 1981. However, the approval was later withdrawn when the lenses were found to cause damage to the eye, particularly ulcerative keratitis, a potentially sight-threatening inflammation of the cornea. Scientists theorised that the damage was caused by an inadequate flow of oxygen through the lens, causing the cornea to become oxygen deprived and therefore vulnerable to infections and other complications. Consequently, research began to focus on the development of lenses with higher oxygen transmissibility.

27                  Soft hydrogel lenses, which had been predominantly used for daily wear, were hydrophilic and had good on eye movement, but low oxygen permeability. Soft siloxane lenses, which were also used for daily wear, had high oxygen permeability but were hydrophobic and, as a consequence, tended to adhere to the eye. Rigid gas permeable lenses, which were also used, provided high oxygen transmissibility and good on-eye movement, but caused mechanical trauma to the cornea due to their rigid properties.

28                  Accordingly, the challenge facing those working in the field at the priority date was to develop a lens that was able to combine all of the requisite characteristics, with no adverse side effects. During the 1990s each of Novartis and Bausch & Lomb was seeking to meet that challenge by developing a contact lens which would be ophthalmically compatible for extended wear for up to 30 days.

29                  The invention the subject of the patent is claimed to achieve ophthalmic compatibility for periods of extended wear. The invention was the outcome of the “SEE3” project, a collaboration between Ciba Vision in the United States, Ciba-Geigy’s Central Research Unit in Switzerland, and the Cooperative Research Centre for Eye Research and Technology (“CRCERT”) in Australia. CRCERT was itself a collaboration between various Australian research groups, including the second applicant and the Cornea and Contact Lens Research Unit (“the CCLRU”) at the University of New South Wales. The SEE3 project was headed by Paul Nicolson (“Nicolson”), who was called as a witness for Novartis. Other people who played significant roles in the SEE3 project and/or the patent’s drafting, and who were called as witnesses for Novartis, included the Ciba Vision patent attorneys for the United States and Europe respectively, Scott Meece (“Meece”) and Joerg Dietz (“Dietz”), and Lyn Winterton (“Winterton”) who developed the ionoton measurement for ion permeability.

The Patent

30                  Within the SEE3 project the patent was referred to as the Joint Umbrella Patent, or “JUMP”, since one intention behind it was the creation of a patent that “covered the field of extended wear contact lenses.” The two features of the invention claimed by Novartis to be significant breakthroughs were:

(a)                         the discovery of a correlation between ion permeability (the rate at which sodium ions pass through a lens material) and on-eye movement, leading to the conclusion that extended wear lenses need a high ion permeability in order to avoid adhesion of the lens to the eye; and

(b)                        the discovery that it was possible to achieve both good on-eye movement and sufficient oxygen transmissibility, and thereby ophthalmic compatibility, by the employment of a morphology characterised by separate and co-continuous phases. This means that within the material used to fabricate the lenses separate and continuous pathways exist, each leading from one surface of the lens to the other. One set of pathways (the “oxyperm phase”) is oxygen permeable and the other (the “ionoperm phase”) is ion permeable. The pathways enable sufficient oxygen and ion permeability for the lens to be ophthamically compatible for extended wear.

31                  Novartis’ evidence was to the effect that the use of co-continuous and separate phases was counter-intuitive because the separation of phases had traditionally been avoided in contact lens technology. This was because the presence of separate phases larger than 100 nm in a lens was known to lead to opacity, which is inconsistent with the visual clarity required for a lens. Novartis avoided this problem by reducing the size of the separate phases in its lens materials by employing micro phase, rather than gross phrase, separation.

32                  Similarly, the employment of ion permeability as an indicator of on-eye movement was said by Novartis to be novel because, although it was known previously that the water content of a lens had an impact on its ability to move on the eye, it was not previously known that the permeation of water and sodium ions through the lens was an important factor. In support of its case on novelty Novartis pointed to prior art suggesting that movement of water through the lens should be avoided.

33                  The oxygen and ion permeability values required for ophthalmic compatibility are set out in the specification and in the claims. Those values provide the parameters required for the respective co-continuous oxyperm and ionoperm phases. The parameters taught in the patent were said to establish whether the co-continuous phases had been achieved. Thus Dietz, the attorney responsible for drafting the PCT patent for Novartis, stated that “the ionoton and ionoflux parameters are essential to the ionoperm continuous phase”.

34                  The specification discusses ion permeability at page 14:

“Unexpectedly, it has been determined that the ion permeability through the lens correlates well with on-eye movement. As discussed earlier, it is known that on-eye movement of the lens is required to ensure good tear exchange, and ultimately, to ensure good corneal health. While the invention is not bound by theory presented herein, it may be useful to discuss some theory for a better understanding of ways to practice the invention.

It is theorized that water permeability is an exceptionally important feature for an extended wear lens which includes oxyperm polymers such as those disclosed herein. Siloxane-containing oxyperm materials tend to adhere strongly to the eye, thereby stopping on-eye movement. The ability to pass water through the lens is believed to allow a siloxane-containing polymeric lens to move on the eye, where the movement occurs via forces exerted by water being squeezed out of the lens. The water permeability of the lens is also believed important in replenishing lens water content once pressure is removed. Further, the permeability of ions is believed to be directly proportional to the permeability of water. Thus, ion permeability is a predictor of on-eye movement.

However, regardless of whether the water permeability theory is a correct understanding of the actual on-eye movement phenomenon, it has been unexpectedly found that above a certain threshhold [sic] of ion permeability through a lens, from the inner surface of the lens to the outer, or vice versa, the lens will move on the eye, and below the threshhold [sic] the lens will adhere to the eye. Thus, the present innovative extended-wear contact lenses provide a balance between the relatively high oxygen permeability (and associated high binding capacity) of oxyperm materials with the low binding capacity (high on-eye movement) of ionoperm materials. It is believed that this is accomplished by providing a plurality of continuous ion transmission pathways for ion and water movement through the lens.”

35                  The patent provides two methods for the measurement of ion permeability – the “ionoflux” and “ionoton” measurement techniques. A method, referred to in the patent as the “hydrodell water permeability technique” is also provided for the measurement of water permeability, which is said to be related to ion permeability. As explained above, although ion and water permeability are related they are qualitatively different.

36                  The specification sets out in general terms the principles to be applied in the manufacture of extended wear contact lenses. It provides detailed information about certain specific materials, which were used in the “examples” described in the patent. There are also a number of tables in the body of the specification that record test data and which are relied upon as the source of the quantitative values claimed in the patent as necessary for an ophthalmically compatible contact lens. Three separate tables (Tables E, F and G) show, respectively, the ionoton, ionoflux and hydrodell values for the lenses referred to in the examples and state whether on-eye movement did or did not occur in each case.

37                  Claim 1 is the primary claim. Sixty-five subsequent claims are based on claim  1 and on each other. The claims seek to protect not only the examples disclosed in the specification, but also the broader principles of the invention. It is unnecessary to consider all of the claims because Novartis has abandoned all claims other than claims 8, 11, 12 and 13. Because claims 8, 11, 12 and 13 are dependant upon claim 1 it is necessary to also consider the content of that claim. Claims 1, 8, 11, 12 and 13 are as follows:

“1. An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:

            (a)        at least one oxyperm polymerizable material and

            (b)        at least one ionoperm polymerizable material,

wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids, wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material, wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids, wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and wherein said ophthalmic lens has an oxygen transmissibility of at least 10 weight percent upon full hydration, and wherein said ophthalmic lens has an oxygen transmissibility of at least 70 barrers/mm and an ion permeability characterised either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions.

8. An ophthalmic lens of claim 1, wherein said polymeric material comprises a plurality of co-continuous phases, including at least one oxyperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens and at least one ionoperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens.

11. An ophthalmic lens of claim 1, wherein said polymeric material comprises a plurality of co-continuous pathways, at least one being an ion or water pathway and at least one other being an oxygen pathway, which pathways extend continuously from the inner surface of the lens to the outer surface of the lens.

12. An ophthalmic lens of claim 11, wherein said co-continuous pathways include a continuous phase of ionoperm polymeric material and a continuous phase of siloxane-containing polymeric material.

13. An ophthalmic lens of claim 11, wherein said pathways have a domain size which is less than a size which undesirably distorts visible light in an amount which is visible to the eye of the wearer.”

Amendment of the Patent

38                  It is convenient to provide a brief chronology of the events which led to the application for amendment. The patent is a Patent Cooperation Treaty (“PCT”) patent which was filed in Australia on 22 March 1996. The patent had previously been filed in the European Union (on 4 April 1995), Switzerland (on 19 May 1995), and the United States (on 8 December 1995). According to the evidence of Novartis the United States patent was drafted under the supervision of Meece and was then used as the basis for the PCT patent, the drafting of which was overseen by Dietz.

39                  However, even after the filing of the PCT patent in the various jurisdictions, debate continued among the inventors as to the content of the patent. A series of emails, beginning in 1996 and continuing into 1997, raised questions about problems with the patent as drafted, including errors contained in it. By August 1996 the SEE3 team had begun to consider the filing of a second PCT patent, to be known as “JUMP II”, to ensure adequate protection for the invention and to correct any significant errors. However, notwithstanding the errors in the patent pointed out by some of the inventors, amendment of the patent was not pursued at that stage. The “JUMP II” patent did not proceed.

40                  On 29 February 2000 the first and second applicants commenced the present proceeding against Bausch & Lomb for infringement of the patent. Bausch & Lomb denied infringement and cross claimed for the revocation of the patent. A number of grounds of invalidity were raised, none of which related to the ion permeability values in the patent that are sought to be changed by the amendment application. However by about October 2001, following discovery and the filing of some of Bausch & Lomb’s evidence, it became apparent to Novartis that Bausch & Lomb was proposing to rely upon the ion permeability values stated in the patent as an additional ground in support of its claim of invalidity.

41                  Novartis was reluctant to amend the patent. But its counsel advised in September 2002 that unless the ionoton values in claim 1 were amended, it was likely the Court would find the patent invalid “not just for lack of fair basis but for ambiguity of definition”, including because “the ionoton value [in claim 1] might well be regarded by the Court as unduly avaricious because it exceeds the experimental data not by a small amount but by a factor of thousands.” Counsel also advised that the ionoflux value in claim 1 should be amended so as to make that value and the ionoton value “impervious to attack on fair basis grounds”. On 6 December 2002 Novartis filed a notice of motion seeking amendment of the patent. With the agreement of the parties the motion was adjourned for hearing together with all of the other issues arising in the proceeding.

Proposed amendment to correct minor errors

42                  At the final hearing Bausch & Lomb did not oppose amendments that corrected minor typographical or clerical errors. Those errors, and the amendments seeking to correct them, are as follows:

(i)                  On page 4, at lines 11-12, the patent reads: “…wherein said lens allows oxyperm polymerizable material forms a phase or phases substantially separate from …”. The words “lens allows” appear to have been included accidentally. It is proposed that they be deleted.

(ii)                Also on page 4, at line 22, an ionoton ion permeability coefficient is given in units of mm²/sec. Everywhere else in the patent ionoton ion permeability coefficients are given in units of cm²/sec. This is clearly a typographical error. It is proposed to amend in order to make the units cm²/sec.

(iii)               On page 22, at the 7^th last line, the patent reads: “A preferred ophthalmic lens material will have an oxygen transmissibility, Dk/t, of at least…”. Novartis seeks amendment to remove the word “material” so that the sentence refers to the transmissibility of a lens, rather than of a material. This would reflect the fact that oxygen transmissibility is measured in relation to a particular lens, not a material, because it takes into account the lens thickness.

(iv)              On page 22, at lines 25-26, the patent reads: “The oxygen permeability of a lens and oxygen transmissibility of a lens material may be determined by the following technique.” Here the terms “permeability”, which should refer to a material, and “transmissibility”, which should refer to a lens, have been confused. Amendment is sought to correct this error.

(v)                On page 23, at the 11^th last line, the patent reads: “The oxygen transmissibility (D_k/t) of the material may be calculated…” Again, permeability and transmissibility have been confused in this sentence. Novartis seeks to replace the word “material” with “lens”.

(vi)              On page 99, at line 1, the patent reads: “Considering only Examples F-1 through F-13 of Table F…” However Table F contains only 12 examples (F-1 to F-12). The applicants seek amendment to replace “F-13” in that sentence with “F-12”.

43                  Novartis advertised the amendments in sub-paras (i)-(vi) above in the Official Journal of Patents and no notices of opposition were received. These amendments do not affect the validity of the claims in the patent and seek only to clarify the specification by removing inadvertent errors. The amendments were not opposed by Bausch & Lomb at any stage and there is no reason why the amendments should not be allowed. In the circumstances it is appropriate to make orders directing that the proposed amendments be made.

Proposed deletion and consolidation amendments

44                  Novartis also seeks the deletion of all claims other than claims 8, 11, 12 and 13 (which also incorporate the content of claim 1). The claims now sought to be deleted were abandoned  by Novartis at the trial and that abandonment was not opposed by Bausch & Lomb. The deletion of a claim would not ordinarily be refused by the Court unless there were exceptional circumstances: see Eli Lilly and Co v Pfizer Research and Development Co NV/SA (2003) 59 IPR 234 (“Eli Lilly”) at 237 [20]. Further, the deletion of the claims, even if they were invalid, does not affect the validity of the patent in relation to the remaining claims: see s 22 of the Act.  Although the deletion of the claims has not been advertised it is appropriate to dispense with the advertising required by O 58, r 10 of the Federal Court Rules.  The reason for that is that it is difficult to see what purpose would be served by advertising as there appears to be no special circumstances that could warrant disallowing the deletions sought.  I would add that none of the parties before the Court submitted that the deletions should be refused. Although, as I later explain, there are special circumstances in the present case, they are not such that the Court should refuse Novartis’ application to delete all claims other than claims 8, 11, 12 and 13. In the circumstances it is appropriate to make orders allowing the deletion of all claims other than claims 8, 11, 12 and 13 as presently formulated. 

45                  Plainly, the deletion amendments will require claim 1 to remain to the extent necessary to allow the incorporation of that claim as part of claims 8, 11, 12 and 13.  In an endeavour to deal with that issue Novartis has applied to consolidate the remaining claims together with the substance of claim 1.  Putting to one side for the moment the ion permeability amendments that were opposed at trial by Bausch & Lomb, the proposed consolidated claims are as follows:

“1.       An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:

(a)       at least one oxyperm polymerizable material and

(b)       at least one ionoperm polymerizable material,

wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material,

wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and

wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions,

wherein said polymeric material comprises a plurality of co-continuous phases, including at least one oxyperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens and at least one ionoperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens.

2. An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:

(a)       at least one oxyperm polymerizable material and

(b)       at least one ionoperm polymerizable material,

wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material,

wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and

wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions,

wherein said polymeric material comprises a plurality of co-continuous pathways, at least one being an ion or water pathway and at least one other being an oxygen pathway, which pathways extend continuously from the inner surface of the lens to the outer surface of the lens.

3.         An ophthalmic lens of claim 2, wherein said co-continuous pathways include a continuous phase of ionoperm polymeric material and a continuous phase of siloxane-containing polymeric material.

4.         An ophthalmic lens of claim 2, wherein said pathways have a domain size which is less than a size which undesirably distorts visible light in an amount which is visible to the eye of the wearer.”

46                  The consolidation gives effect to Novartis’ abandonment of claim 1, other  than as a basis for claims 8, 11, 12 and 13 as presently formulated in the patent. The substantial issue remaining is whether the proposed amendments concerning the ion permeability values in the original claim 1 (and now in the consolidated claims 1 and 2) and the related amendments in the specification, should be allowed.  Accordingly, I propose to allow the consolidation and turn separately to consider the question of the proposed amendments concerning the ion permeability values.  In considering those amendments it is appropriate to treat the patent as having been amended as directed above.

Proposed ion permeability amendments

47                   As explained above, one of the significant breakthroughs Novartis claimed to have made as part of the patented invention was the discovery of a correlation between ion permeability and on-eye movement, which led to the conclusion that high ion permeability is necessary to achieve the on-eye movement required for an extended wear lens. Further, the minimum ion permeability values for on-eye movement are values that will indicate whether the required separate and continuous ionoperm phase has been established. Thus, those values relate to significant features of the invention.

48                  Also, as explained above (at [35]), two sets of values for preferred ion permeability levels are given in the patent – one calculated by the ionoton measurement, and the other calculated by the ionoflux measurement. Novartis seeks to amend both sets of values, which provide alternative integers in claim 1 (and now in consolidated claims 1 and 2).

(a)                             The ionoton ion permeability values

49                  Data relating to ionoton ion permeability is contained in Table E in the patent. That table sets out the ionoton ion permeability coefficients of various materials that were tested and states whether those materials moved on the eye. Table E, which sets out the test results for examples E-1 to E-13, discloses that the lowest ionoton ion permeability coefficient for a lens which did move on the eye was 2.5 x 10^‑3 cm²/sec and that the highest coefficient for a lens which did not move on the eye was 0.008 x 10^‑3 cm²/sec. A value of “-0.063 [x 10^‑3 cm²/sec]” also appears in the table and, on the assumption that the negative sign is a typographical error, would be the highest value that did not show on-eye movement. However, presumably because of the negative sign, that measurement was ignored in the text under the table which states that the highest co-efficient of a lens that did not move on the eye was 0.008 x 10^-3 cm²/sec. That text states:

“Considering Examples E-1 through E-13 of Table E, the lowest value of Ionoton Ion Permeability Coefficient for which a lens moves on the eye is 0.25 x 10^-3 cm²/sec. The highest value of Ionoton Ion Permeability Coefficient for a lens which bound on the eye is 0.008 x 10^-3 cm²/sec. Thus a contact lens preferably has an Ionoton Ion Permeability Coefficient greater than about 0.008 x 10^‑3 cm²/sec., more preferably greater than about 0.25 x 10^‑3 cm²/sec.”

50                  Elsewhere in the specification a range of values is provided for ionoton ion permeability, which are ranked as the “preferred”, “more preferred”, and “most preferred” values. The values are “greater than about 0.2 x 10^-6 cm²/sec” (“preferred”), “greater than about 0.3 x 10^‑6 cm²/sec” (“more preferred”), and “greater than about 0.4 x 10^-6 cm²/sec” (“most preferred”). The “preferred” value is given in claim 1 of the patent, which includes the integer “an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec.” None of those preferred, more preferred or most preferred values correlates with any of the values in Table E.

51                  Novartis seeks to amend the ionoton ion permeability values in the patent in two inter-related respects:

(i)                  First, it wishes to change the exponent used in all ionoton values given outside Table E from -6 to -3. Novartis claims that the exponent of -6 is a typographical error which has been duplicated throughout the patent as a result of the “cutting and pasting” of erroneous sections of text. It contends that after amendment the text will reflect Table E in which all of the ionoton values have an exponent of -3.

(ii)                Secondly, it wishes to modify the lowest “preferred” ionoton value from “greater than about 0.2…” to “no less than about 0.25…”. The value of “no less than about 0.25 x 10^-3 cm²/sec” would reflect the data in Table E, which discloses that value as the lowest ionoton ion permeability coefficient that correlates with on-eye movement.

(b)               The ionoflux ion permeability values

52                  Data relating to ionoflux ion permeability is contained in Table F in the patent. That table sets out the ionoflux ion permeability coefficients of twelve different lens materials, cited as Examples E1 to E12, that were tested and states whether those materials moved on the eye. Table F discloses that the lowest ionoflux ion permeability coefficient for a lens that did move on the eye was 2.6 x 10^-6 mm²/min and that the highest coefficient for a lens that did not move on the eye was 1.5 x 10^-6 mm²/min. The text under Tables F (after the amendments set out at [42] above are made) states:

“Considering only Examples F-1 through F-12 of Table F, the lowest value of Ionoflux Ion Permeability Coefficient for which a lens moves on the eye is 2.6 x 10^-6 mm²/min. The highest value of Ionoflux Ion Permeability Coefficient for a lens which binds on the eye is 1.5 x 10^-6 mm²/min. Thus, a contact lens preferably has an Ionoflux Ion Permeability Coefficient greater than about 1.5 x 10^-6 mm²/min., more preferably greater than about 2.6 x 10^-6 mm²/min.”

53                  The order of figures used in the body of specification (on page 16) is “greater than about 6.4 x 10^-6 mm²/min” for the “preferred” ionoflux permeability coefficient, “greater than about 2.6 x 10^-6 mm²/min” for the more preferable co-efficient and “greater than about 1.5 x 10^‑6 mm²/min” for the most preferable coefficient. Claim 1 of the patent includes as an integer “an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10 ^-6 mm²/min”.

54                  Novartis seeks to amend the ionoflux values in the patent in two inter-related respects:

(i)                  First, it wishes to reverse the order of the figures on page 16 of the specification. At trial Bausch & Lomb did not dispute that the order of the figures given for the preferable, more preferable and most preferable values should be stated in an increasing, rather than a decreasing, order; and that the decreasing order stated in the specification was the result of error and, in the usual course, should be corrected. Thus, it was common ground that the values intended to be given should reflect the fact that the preferable value was intended to be the lower ionoflux ion permeability coefficient and the “more” and “most” preferable values were intended to be the higher coefficients. If this amendment was permitted the specification would state that the preferable ionoflux permeability coefficient is “greater than about 1.5 x 10^-6 mm²/min” or “more preferably… greater than about 2.6 x 10^-6 mm²/min” or “most preferably… greater than about 6.4 x 10^-6 mm²/min”.

(ii)                Second, it wishes to change the lowest preferred value for the ionoflux ion permeability coefficient from “greater than about 1.5 x 10^-6 mm²/min” to “no less than about 2.6 x 10^-6 mm²/min”. The alteration is sought to be made in the specification and in claim 1. This alteration will also result in the deletion of “1.5 x 10^-6 mm²/min” as a preferred value in (i) above.

55                  At the final hearing Bausch & Lomb opposed the substantive amendments. It argued that they do not comply with s 102 of the Act and are therefore impermissible under s 105(4). It also argued that, in any event, in the particular circumstances of the present case the Court should decline to exercise its discretion to direct that the proposed amendments be made.

Amendments under the Act

56                  Section 105 of the Act provides:

“(1)       In any relevant proceedings in relation to a patent, the court may, on the application of the patentee, by order direct the amendment of the patent, the patent request or the complete specification in the manner specified in the order.

(2)         An order may be made subject to such terms (if any) as to costs, advertisements or otherwise, as the court thinks fit.

(3)         The patentee must give notice of an application for an order to the Commissioner, who is entitled to appear and be heard, and must appear if the court directs.

(4)         A court is not to direct an amendment that is not allowable under section 102.

(5)         The patentee must file a copy of an order within the prescribed period.

(6)         On the filing of a copy of an order, the patent, patent request or complete specification is to be taken to have been amended in the manner specified in the order.”

Section 102 provides:

“(1)     An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.

 (2)      An amendment of a complete specification is not allowable after the relevant time if, as a result of the amendment:

(a)          a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment; or

(b)          the specification would not comply with subsection 40(2) or (3)

(2A)     For the purposes of subsection (2), relevant time means:

(a)          in relation to an amendment proposed to a complete specification relating to a standard patent—after the specification has been accepted; or

(b)          in relation to an amendment proposed to a complete specification relating to an innovation patent—after the Commissioner has made decisions under paragraphs 101E(a) and (aa) in respect of the patent.

(2B)     An amendment to a patent request relating to an innovation patent applicationis not allowable if:

(a)          the patent application was provided for in section 79C; and

(b)          the effect of the proposed amendment would be to convert the application from an application for an innovation patent to an application for a standard patent.

(2C)    An amendment of a complete specification relating to a patent is not allowable if:

(a)          the patentee or the patentee’s predecessor in title failed to ensure the provision to the Commissioner of the information required by subsection 45(3) or section 101D in relation to the patent; and

(b)          the effect of the proposed amendment would be to remove a lawful ground of objection under paragraph 18(1)(b) or 18(1A)(b) to the specification arising from the existence of some or all of the information not provided.

(3)       This section does not apply to an amendment for the purpose of correcting a clerical error or an obvious mistake made in, or in relation to, a complete specification.”

57                  Section 105 confers on the Court a wide discretionary power to direct the amendment of a patent (cf s 104: New England Biolabs Inc v Commissioner of Patents (2001) 110 FCR 357). The power, however, may not be exercised to direct an amendment that is not allowable under s 102: see s 105(4). Accordingly, before directing an amendment, the Court is required to consider whether the amendment is prohibited by s 102 and, if it is not, whether the discretion to direct the amendment should be exercised in favour of the patentee: see Wimmera Industrial Minerals Pty Ltd v RGC Mineral Sands Ltd (No 3) (1997) AIPC ¶91-366 (39,772) (“Wimmera”).

Section 102

58                  Section 102 sets out circumstances in which an amendment is not allowed. Bausch & Lomb relied in its submissions on subs 102(1). Under that subsection an amendment is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed. As was contended by Bausch & Lomb, the subsection does not only have the effect of prohibiting claim broadening: that function is performed by s 102(2). In Wimmera Sundberg J considered the scope of s 102(1) and observed (at 39,783) that:

“A two stage process is involved. The first stage involves a comparison between the specification as it stands and how it would stand after amendment. Once the matter resulting from the amendment has been identified, that matter is compared with the specification as filed in order to determine whether the specification as amended would claim matter not in substance disclosed in the specification as filed.”

On appeal (RGC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd (1998) 89 FCR 458) Carr and Goldberg JJ stated at 466:

“[Subsection 102(1)] requires one first to identify precisely what is the amendment. In this case that is done by identifying the difference between the specification as accepted (and as it stood at the hearing of the motion at first instance) on the one hand and, on the other hand, as the specification would read if amended in the manner sought. Then one reads the specification as a whole (as so amended in the manner sought) to see whether as a result of the amendments sought (which must mean by reason of the amendment sought) the specification would claim matter not in substance disclosed in the specification as filed. The subsection focuses on the amendment proposed and it must be that amendment which has the result of pushing the claimed matter over the line defined by the expression ‘matter not in substance disclosed in the specification as filed’. The key point to keep in mind is, as counsel for the respondent contended (in our view correctly), that the words ‘as a result of the amendment’ are not to be confused with the expression ‘after the amendment’.”

See also Fina Research SA v Halliburton Energy Services Inc (2003) 127 FCR 561 at 574 [37]; ICI Chemicals & Polymers v Lubrizol Corp (1999) AIPC ¶91-521 (40,012) (“ICI”)at 40,016 [15]; and on appeal in ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc (2000) 106 FCR 214 at 252 [117].

59                  The task required by s 102 is to consider whether, if the amendments now proposed were allowed the patent would, as a result of those amendments, claim matter not in substance disclosed by the specification as filed. Although changes were made to the specification (in particular to the consistory clause and claim 1) after it was filed but before it was granted, they were not such as to materially alter the disclosure contained in the specification in relation to ion permeability values.  Accordingly, the disclosure relevantly made in the specification as filed is not materially different to that contained in the patent as it now stands.

60                  The proposed amendments concern the changes to the ion permeability values set out above at [49] to [54]. The amendments would have the effect of amending the ion permeability values throughout the patent so that they are consistent with the results recorded in Tables E and F in the specification. After the amendments sought, the patent would both disclose and claim lenses with ionoton ion permeability of no less than 0.25 x 10^‑3 cm²/sec or an ionoflux ion permeability of no less than 2.6 x 10^‑6 mm²/min. Table E as filed shows that the lowest tested ionoton value which correlated with on-eye movement was 0.25 x 10^‑3 cm²/sec and  Table F as filed shows that the lowest tested ionoflux value which correlated with on-eye movement was 2.6 x 10^-6 mm²/min. Tables E and F purport to record the results of clinical tests in relation to ion permeability. Although, as I later explain, inconsistent ion permeability values disclosed elsewhere in the patent would cause a person skilled in the art some confusion, I consider that, notwithstanding that fact, the disclosure of the ion permeability values contained in Tables E and F is such that the proposed amendments do not claim matter not in substance disclosed in the specification as filed. 

61                  Accordingly s 102(1) does not prohibit the proposed amendments.

Section 105

62                  The remaining issue is whether the discretion conferred under s 105 should be exercised.  In relation to the discretion a distinction has been made between amendments that merely delete invalid claims (“deletion amendments”) and amendments that cure otherwise invalid claims (“validating amendments”): see Terrell on the Law of Patents (15th Ed, 2000) at pages 264–266. In the case of a validating amendment a court will consider the conduct of the patentee in order to determine whether it is in the public interest that the amendment be allowed. Terrell (at [9.38]) explains the approach in the United Kingdom:

“Where the amendment was sought to validate claims, the court refused amendment if it considered that the patentee’s conduct had been such that as a matter of discretion it should refuse to allow amendment. In earlier cases, the court was comparatively strict and would refuse leave to amend if the patentee had shown any lack of diligence or had originally made unduly wide claims. From about the 1970s onwards, however, the courts became more liberal in the exercise of the discretion and, as a general rule, the discretion would not be adversely applied unless the patentee had deliberately elected to maintain invalid claims which he knew or should have known required amendment: ‘covetous claiming’. Attempts to assert or enforce such claims in the unamended form were regarded with particular distaste.”

63                  In C. Van der Lely NV v Bamfords Limited [1964] RPC 54 (“Van der Lely”) at 76 Willmer LJ observed:

“It cannot, I think, be too strongly emphasised that at the present stage of this litigation the question with which we are concerned is the plaintiffs’ right to relief in respect of claims which have been found to be valid. The plaintiffs do not seek, by the amendment for which they ask, to validate claims which have been found to be invalid, but merely, by deleting the invalid claims, to put themselves in a position the better to enforce such rights as they have in respect of their valid claims.

It has been strenuously argued on behalf of the defendants that what the plaintiffs seek is none the less an amendment of the specification, and it has been said that there is no distinction in principle between an amendment of the specification designed to validate invalid claims and an amendment such as that for which the plaintiffs now ask.

I find myself unable to accept that contention, which appears to me to be wrong in principle, contrary to the authority of decided cases and, furthermore, inconsistent with the plain terms of the statute. So far as the matter is one of principle, it seems to me that there is all the difference in the world between an amendment designed to assist in the enforcement of a valid claim and one designed to validate an invalid one. Where a claim has been found to be valid, the patentee has made good his claim to monopoly rights to that extent. But where a claim has been found to be invalid, the patentee has failed; and it may well be said that no good reason exists why he should be accorded a second chance.”

See also Chiron Corporation v Organon Teknika Limited (No. 5) [1994] FSR 258 at 263-265 and 266; and Kirin-Amgen Inc’s Patent [2002] RPC 43.

64                  Although the Australian legislative regime makes no specific provision for a distinction between validating and other amendments, and in that respect differs from the United Kingdom legislation, the distinction has been recognised in this Court.  In that regard in ICI Emmett J observed at 40,021 [39]:

“A question of principle arises as to whether the conduct of a patentee in relation to invalid claims should in any way impinge upon its entitlement in relation to valid claims or claims that, with amendment, would be valid claims. It may be that persisting in a claim found to be invalid is enough to warrant refusal of relief, including leave to amend, in relation to such a claim. Such persistence by a patentee in invalid claims may be a good ground for refusing leave to amend such invalid claims – see Raleigh Cycle Co. Ltd v H. Miller & Co. Ltd (1948) 65 RPC 141. However, the position will be different where some claims are found to be valid. There is no reason why the fact that a patentee has failed on some claims should be held to deprive it of his prima facie right to put a specification in order so as to be able to enjoy the fruits of victory in relation to other claims. The position in such a case will be different from the position that would prevail where a patentee seeks to amend an invalid claim – Van der Lely NV v Bamfords Ltd [1964] RPC 54 at 78 per Willmer LJ.”

65                  In Eli Lilly at 237 [20], (see also above at [44]) Heerey J considered that an amendment involving the deletion of a claim on the ground that it is invalid should be treated differently from other amendments:

“One obvious reason for this approach is that there is a public interest in the validity of a patent, extending beyond the patentee and those currently seeking revocation. The existence of patent claims which are in truth invalid, and which the patentee does not seek to propound, may inhibit persons from engaging in lawful and productive economic activity, with resultant disadvantage to the public by loss of competition and innovation.”

That situation is plainly to be distinguished from the situation where an amendment, rather than removing one of the claims that is invalid, cures the invalidity. 

66                  Of course, the present case is not one in which a patentee’s claims have been found to be invalid and a second chance is being sought. Rather, it is one in which the opponent at trial contended that the patent is invalid, inter alia, for lack of fair basis and that the amendments sought are designed to cure any alleged invalidity. As explained above, the issue of whether the amendments are validating amendments can be relevant to the amendment application. The issue is not relevant because any higher standard of proof or higher standard of conduct is required to be established in respect of such amendments. Rather, the relevance relates to whether the more lenient approach that might be applied to deleting amendments, or amendments that merely seek to correct errors or mistakes or remove ambiguities might be applicable. The reason for the leniency was explained by Pearson  LJ in Van der Lely at 74–75 where his Lordship observed that a court is prima facie disposed to the deletion of invalid claims because if such claims were to remain in the patent they would constitute a potential “nuisance to industry”. A similar observation can be made in respect of the mere correction of errors or mistakes which are not sought to cure any actual or potential invalidity.

67                  Putting to one side cases where the more lenient approach may be taken, well established principles have been applied by the courts in the United Kingdom and Australia in relation to the wide discretion to direct or to refuse to direct an amendment: see Smith Kline & French Laboratories Limited v Evans Medical Limited [1989] 1 FSR 561 (“Smith Kline & French”) at 569; Rescare Limited v Anaesthetic Supplies Pty Ltd (unreported, Federal Court of Australia, Gummow J, 4 March 1993) (“Rescare”) at 11; Wimmera at 39,789; Gambro Pty Ltd v Fresenius Medical Care South East Asia Pty Ltd (1999) 48 IPR 625 (“Gambro”) at 638-639 [69] and ICI at 40,020–40,021  [37]. The principles which guide the exercise of the discretion were helpfully summarised by Aldous J in Smith Kline & French, at 569:

“The discretion as to whether or not to allow amendment is a wide one and the cases illustrate some principles which are applicable to the present case. First, the onus to establish that amendment should be allowed is upon the patentee and full disclosure must be made of all relevant matters. If there is a failure to disclose all the relevant matters, amendment will be refused. Secondly, amendment will be allowed provided the amendments are permitted under the Act and no circumstances arise which would lead the court to refuse the amendment. Thirdly, it is in the public interest that amendment is sought promptly. Thus, in cases where a patentee delays for an unreasonable period before seeking amendment, it will not be allowed unless the patentee shows reasonable grounds for his delay. Such includes cases where a patentee believed that amendment was not necessary and had reasonable grounds for that belief. Fourthly, a patentee who seeks to obtain an unfair advantage from a patent, which he knows or should have known should be amended, will not be allowed to amend. Such a case is where a patentee threatens an infringer with his unamended patent after he knows or should have known of the need to amend. Fifthly, the court is concerned with the conduct of the patentee and not with the merit of the invention.”

68                  The above passage was cited with approval by the Court of Appeal in the United Kingdom in Hsiung’s Patent [1992] RPC 497 at 522-523; and in this Court by Gummow J in Rescare at 11; by Sundberg J in Wimmera at 39,789; and by Tamberlin J in Gambro at638-639 [69]. One or more of the principles stated by Aldous J have also been applied in ICI at 40,021 [38], Neurizon Pty Ltd v Lth Consulting and Marketing Services (No 2) (2003) AIPC ¶91-882 (35,633) eg at 35,638 [17] and 35,639 [25] and Eli Lilly eg at 237 [21].

69                  In Wimmera Sundberg J considered the manner in which the discretion should be exercised. He stated (at 39,790) that the discretion in s 105, like any other, is to be exercised in the light of all the circumstances of the case, and that the principles set out in the cases should be treated as guidelines and not as fixed or inflexible rules. As his Honour pointed out, there may be circumstances which mitigate, explain or excuse a matter that would otherwise call for the exercise of the discretion to be refused. His Honour also stated (at 39,790) that the Court should not approach the discretion in “a manner hostile or antipathetic to amendment.”  See also Tamberlin J in Gambro at 641 [86].

70                  Before turning to the application of the above principles it is appropriate to first consider whether the amendments in question in the present case are properly to be characterised as validating amendments or, rather, are amendments that merely seek to correct errors or mistakes or remove ambiguities. In particular, if the amendments fall into the latter category Novartis may be entitled to rely on that fact as a circumstance that might call for the application of a more lenient approach to be applied to its conduct. As explained above the determination of that question can be relevant to how the Court might consider the conduct of the patentee in relation to the amendments it is seeking.

Are the ion permeability amendments validating amendments?

71                  At trial Novartis claimed that the amendments, that were at that time opposed by Bausch & Lomb, would “put the matter [of validity] beyond doubt” and “make it perfectly plain what the appropriate values are”. However, it contended that the amendments were not essential for validity. If that is correct the amendments would not be validating amendments.

72                  The relevant ground of invalidity relied upon by Bausch & Lomb at trial was a lack of fair basis. It claimed that the claims in question, being claims 8, 11, 12 and 13, (now the consolidated claims 1-4) do not comply with s 40(3) of the Act, which requires that “[t]he claim or claims must be clear and succinct and fairly based on the matter described in the specification”. The failure of a patent to comply with s 40(3) is a ground for revocation of the patent under s 138(3)(f) of the Act. If Bausch & Lomb’s contentions at trial were correct the amendments then sought by Novartis to claim 1 and thereby also to claims 8, 11, 12 and 13 (and now to the consolidated claims 1–4), and the related amendments in the specification, can be fairly described as validating amendments.

73                  Determining whether there is a lack of fair basis involves a comparison between the disclosure provided in the body of the specification on the one hand, and the scope of the invention defined in the claims on the other: Kimberly-Clark Australia Pty Limited v Arico Trading International Pty Limited  (2001) 207 CLR 1 (“Kimberly-Clark”) at 12. The body of the specification must provide a “real and reasonably clear disclosure” of the matters that are claimed: in Société des Usines Chimiques Rhône-Poulenc v Commissioner of Patents (1958) 100 CLR 5 per Fullager J at 11, followed in F. Hoffman-La Roche & Co. Aktien-Gesellschaft v Commissioner of Patents (1971) 123 CLR 529 at 359, Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 at 93, Leonardis v Sartas No 1 Pty Ltd (1996) 67 FCR 126 at 142, CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 at 281-282 and Lockwood Security Products Pty Ltd  v Doric Products Pty Ltd (2003) 56 IPR 479 (“Lockwood”) at 499 [92].  Correlatively, the claims must not travel beyond the matter described in the body of the specification: per Barwick CJ in Olin Corporation v Super Cartridge Co. Pty. Ltd. (1977) 180 CLR 236 (“Olin”) at 240 followed in Kimberly-Clark at 12, and Lockwood at 499 [91]. See also Atlantis Corporation Pty Ltd v Schindler (1997) 39 IPR 29 (“Atlantis”) at 50.

74                  When s 40(3) requires that a patent’s claims must be fairly based on “the matter described in the specification”, it refers to the description required by s 40(2)(a): see eg Atlantis at 49-50. That subsection provides that a complete specification must “describe the invention fully, including the best method known to the applicant of performing the invention…”.

75                  On the present application it is necessary to consider whether the ion permeability values in the original claim 1 (and now in consolidated claims 1 and 2) travel beyond the ion permeability values for the invention disclosed in the specification.

76                  On Novartis’ submissions, a crucial aspect of the invention described in the specification is the role of ion permeability in achieving on-eye movement and, more specifically, the discovery described in the specification that “above a certain threshhold [sic] of ion permeability through a lens… the lens will move on the eye, and below the threshhold [sic] the lens will adhere to the eye.”  It is common ground that in order to be “ophthalmically compatible” an extended wear contact lens must move on the eye. Although Bausch & Lomb disputed the extent to which the threshold theory is valid, it is clear from the specification that a key aspect of the invention there disclosed is the discovery of minimum ion permeability values that are claimed to correlate with on-eye movement. Although the evidence establishes that the values may in fact be more accurately described as necessary but not sufficient requirements for on-eye movement rather than threshold values, the body of the specification discloses that the “threshold” values are significant features of the invention. The quantified level of ion permeability at which that threshold is disclosed to exist is therefore also an important part of the invention. Further, as explained elsewhere in these reasons, the body of the specification also reveals, albeit implicitly, that the minimum ion permeability values are also significant in determining whether the requirement of a separate and continuous ionoperm phase has been met.

77                  It is necessary first to consider the disclosure that is made in the specification regarding ion permeability values.

(a)        Ionoton values

78                  In two places in the body of the specification the preferred, more preferred and most preferred ionoton values given are given as “greater than about” or “at least” 0.2, 0.3, and 0.4 x 10^-6 cm²/sec. The consistory clause states that the minimum ionoton value required is greater than about 0.2 x 10^-6 cm²/sec. However, Table E discloses that the lowest tested ionoton value which correlated with on-eye movement was 0.25 x 10^-3 cm²/sec. The text under Table E gives the preferred ionoton value as greater than about 0.008 x 10^-3 cm²/sec and the more preferred value as greater than about 0.25 x 10^-3 cm²/sec.

(b)        Ionoflux values

79                  In the body of the specification the preferred, more preferred and most preferred ionoflux values are first given as greater than about 6.4, 2.6 and 1.5 x 10^-6 mm²/min respectively. The consistory clause gives the minimum ionoflux value as greater than about 1.5 x 10^-6 mm²/min. Table F shows that the lowest tested ionoflux value which correlated with on-eye movement was 2.6 x 10^-6 mm²/min. The text under Table F gives the preferred value as 1.5 x 10^-6 mm²/min and the more preferred value as 2.6 x 10^-6 mm²/min.

80                  The critical disclosure (at page 14) in the specification is that “above a certain threshhold [sic] of ion permeability” the lens “will move on the eye” and “below the threshhold [sic] the lens will adhere to the eye”. I am satisfied that the ion permeability disclosures which a person skilled in the art would look to in order to determine the threshold for on-eye movement are the clinical test results in Tables E and F. Indeed, those results contain the only real and reasonably clear disclosures of the ion permeability values that might reasonably be described as a threshold that will result in or enable on-eye movement. That disclosure is that the ionoton and ionoflux values at which on-eye movement has been shown to occur are 0.25 x 10^-3 cm²/sec and 2.6 x 10^-6 mm²/min respectively, being the values set out in Tables E and F. There is no disclosure that on-eye movement occurs in the case of lenses with ionoton or ionoflux values of less than 0.25 x 10^-3 cm²/sec or 2.6 x 10^-6 mm²/min respectively. Although the values given in the text below the tables are lower than the values for on-eye movement set out in the tables, that text is expressly stated to be based on the data and examples summarised in the tables and does not purport to provide any disclosure beyond that which is set out in the tables. In particular, the text does not state that on-eye movement will occur at values lower than those disclosed in the tables as correlating with on-eye movement.

81                  There are also references elsewhere in the specification (see for example pages 16 and 18) that provide ionoton and ionoflux values that are “preferred” or are “preferred for achieving sufficient on-eye movement”. The lowest ionoflux ion permeability value cited in that context is greater than about 1.5 x 10^-6 mm²/min and the lowest ionoton ion permeability value cited is greater than 0.2 x 10^-6 cm²/sec. I am satisfied that a person skilled in the art would not regard those values, which are referred to in the sections of the specification describing the “Ionoflux Measurement Technique” and the “Ionoton Measurement Technique”, as disclosing the thresholds referred to at page 14 of the patent. Rather, a person skilled in the art would look to the test data disclosed in Tables E and F in order to establish those thresholds. That test data is the only data of that kind disclosed in the specification and, as it so happens, was also the only test data in existence at that time. I would add that the preferred values would require some clarification in any event as the ionoton value of “0.2 x 10^-6 cm²/sec” is not explained in the specification and finds no support in Table E, and the ionoflux value of “1.5 x 10^-6 mm²/min” only appears in Table F as a value (albeit the highest value) for which there was no on-eye movement.

82                  Further, resort by a person skilled in the art to Tables E and F in order to determine the relevant threshold for on-eye movement is also consistent with Dietz’s evidence that he believed:

“a fair reading of the specification as a whole by a skilled person would indicate to that person the need for amendments because the experimental values (in eg. Tables E and F) are obviously intended to be the bases for the ion permeability levels claimed.”

83                  While I accept Dietz’s view that a person skilled in the art would ultimately rely upon the data in Tables E and F to determine the real and reasonably clear disclosure made concerning the ion permeability thresholds that enable on-eye movement, I do not accept Dietz’s further view that a person skilled in the art would conclude that the ion permeability values now sought to be corrected are “mistakes” or that they were “obviously intended” to be based on Tables E and F. In my view the correct position is that a person skilled in the art would have some difficulty in reconciling those figures with the results shown in Tables E and F and would resort to the tables, rather than to the commentary on them and elsewhere, in order to determine the threshold for on-eye movement. Accordingly, while a person skilled in the art may find the text concerning the lower “preferred” ion permeability values, found below the tables and elsewhere in the specification, confusing and difficult to reconcile with Tables E and F, I am satisfied that that person would rely on Tables E and F for their specific disclosures in relation to on-eye movement.

84                  The ionoton and ionoflux values contained in claim 1, and therefore in the subsequent claims that are reliant on it (including those sought to be defended by Novartis: claims 8, 11, 12 and 13), are “greater than about 0.2 x 10^-6 cm²/sec” and “greater than about 1.5 x 10^‑6 mm²/min” respectively. Plainly, the claimed values “travel beyond” the relevant disclosure made in the specification. The specification does not teach that extended wear contact lenses with ion permeability at those levels will achieve the requisite on-eye movement. Rather, the specification discloses that extended wear contact lenses with ion permeability of at least 0.25 x 10^-3 cm²/sec (ionoton) and at least 2.6 x 10^-6 mm²/min (ionoflux) will achieve on-eye movement.

85                  In considering this question I have focused on the disclosure of values that will enable on-eye movement because claim 1 is concerned with that outcome. In any event, thresholds are also disclosed in Tables E and F for a lens that will adhere to the eye, being 0.008 x 10^‑3 cm²/sec (or if the negative value is treated as an obvious mistake, 0.063 x 10^‑3 cm²/sec) (ionoton) and 1.5 x 10^-6mm²/min (ionoflux). What is not disclosed is any figure that might reasonably be regarded as providing a real and reasonably clear disclosure of the “threshold” between the highest value that did not move on the eye and the lowest value that did move on the eye.

86                  As the Full Court said in ICI Chemicals & Polymers Ltd v The Lubrizol Corporation Inc (2000) 106 FCR 214 at 247, “what will deprive a claim of fair basis in a complete specification is that the claim is broader than the invention as described in the specification.”

87                  By claiming ophthalmically compatible lenses with ionoflux and ionoton values lower than those disclosed in the specification as correlating with on-eye movement, the patent claims results which are not disclosed in the specification. The minimum ionoflux value claimed (1.5 x 10^-6) is a little over half that which is disclosed in the specification as ophthalmically compatible (2.6 x 10^-6). The minimum ionoton value claimed (0.2 x 10^-6) is 1250 times smaller than that which is disclosed in the specification as ophthalmically compatible (0.25 x 10^-3). Even if the exponent error were corrected the claimed ionoton value (which would then be 0.2 x 10^-3) would still be 20% below the value disclosed in the specification for on-eye movement. Thus, the claims travel beyond the invention disclosed in the specification. For this reason the claims are not fairly based on the matter described in the specification.

88                  As claim 1 (now embodied in consolidated claims 1 and 2), and the subsequent claims that rely on it (now consolidated claims 3 and 4) in the patent, are not fairly based, the patent has failed to comply with s 40(3) of the Act. The amendments sought by Novartis will cure the lack of fair basis and therefore are properly to be characterised as validating amendments and not amendments that merely seek to correct errors and mistakes or remove ambiguities. Accordingly, the principles to be applied are those set out at [67] to [69] above.

Novartis’ case for amendment

89                  Some consideration is required of the explanation given by Novartis for the presence in the patent of the ion permeability values now sought to be amended. Novartis’ case was opened on the basis that the preferred ionoton and ionoflux values contained in the patent were “the product of the judgment of the inventors most closely involved in the exercise.” It is necessary to set out separately the evidence that relates to the ionoton and ionoflux ion permeability values.

(a)        ionoton values

90                  It was Novartis’ case that the preferred ionoton values of 0.2, 0.3 and 0.4 were chosen as a matter of scientific judgment in the light of the results shown in Table E, but that a typographical error was made in relation to the exponent (making it ‑6 instead of the correct ‑3), which was repeated throughout the patent because of “cutting and pasting” by its authors. The text under Table E states that the highest ionoton value measured which did not correlate with on-eye movement was 0.008 x 10^-3 cm²/sec (although Table E also contains the figure “‑0.063”). The lowest value measured which did correlate to on-eye movement was 0.25 x 10^-3 cm²/sec. The exercise of  “scientific judgment” was said to be choosing 0.2 as the number between 0.008 (or 0.063) and 0.25 which represented the value at which a lens would move on the eye. Novartis claims that the proposed amendments will correct the exponent error, and will raise the 0.2 value to 0.25 in order to reflect the empirically measured values contained in Table E.

91                  Evidence as to how the relevant figures found their way into the patent was given by Meece, who stated that during the drafting process he contacted inventors and received input from them as to the appropriate ionoton values. He stated that the inventors concluded that a reasonable value would be one between the highest value at which on-eye movement did not occur and the lowest value at which it did. Meece stated:

“More specifically, the inventors were asked to specify an Ionoton Ion Diffusion Coefficient value between the values that showed movement and non-movement that was likely to be the turning point at which movement occurs and movement ceases. After some discussion, correspondence and thought, in the joint and mutual opinions of the relevant inventors, a value of 0.2, which is between 0.25 (movement empirically shown) and 0.063 (movement empirically did not occur), was chosen for the patent application disclosure and as a limitation of some of the claims. The process of settling upon the particular value was the result of my efforts in extracting from the relevant inventors (those within whose area of responsibility ion permeabilities and on-eye movement fell) a consensus as to a realistic value. I gathered the test data from the team members, analysed it, and started circulating memos to those members proposing conclusions. This process resulted in feed-back from team members and I was able to conclude a value which reflected the joint inventors’ view.”

92                  Meece’s reference to 0.063 (which is stated in the table as “-0.063”) is inconsistent with the text under Table E (written by him) which states that 0.008 was the highest value which did not correlate with on-eye movement.

93                  Novartis also claimed that the ionoflux values in the specification were the deliberate result of scientific judgment (see below [94] – [95]). However, Novartis’ witnesses did not explain why the exercise of “scientific judgment” resulted in a specific in-between value (0.2, which fell between 0.008 and 0.25) for the minimum ionoton value, but not for the minimum ionoflux value, which was chosen so as to claim any value greater than the highest value that did not correlate with on-eye movement. Novartis’ proposed amendments would change the ionoton values so that they reflect the experimental data in Table E, by claiming the lowest value which correlated with on-eye movement, namely “no less than 0.25 x 10^-3”, as the preferred minimum value. If the amendment to “no less than 0.25” is permitted there appears to be no reason why the exponent amendment (to x 10^‑3 instead of x 10^‑6) would not also be permitted.

(b)        ionoflux values

94                  In respect of the ionoflux values senior counsel for Novartis stated in opening:

“The way in which the values were derived for inclusion in the specification involved reference to the testing of materials which had occurred over a significant period of time and by reference to which it was adjudged by the persons most closely involved that a value of above 1.5 x 10^-6 would work. 1.5 x 10^-6 was shown not to, but it was adjudged that a value above 1.5 would.”

95                  Novartis again relied on the evidence of Meece, who stated that during the patent drafting process he contacted inventors and received input from them as to the appropriate ionoflux values. He stated that the inventors concluded that a reasonable value would be one between the highest value at which on-eye movement did not occur (1.5 x 10^-6 mm²/min) and the lowest value at which it did (2.6 x 10^-6 mm²/min). Meece stated:

“More specifically, the inventors were asked to specify an Ionoflux Ion Diffusion Coefficient value between the values that showed movement and non-movement that was likely to be the turning point at which movement occurs and movement ceases. After some discussion, correspondence and thought, in the joint and mutual opinions of the relevant inventors, a value of greater than 1.5, which is between 2.6 (movement empirically shown) and 1.5 (movement empirically did not occur), was selected for the patent application disclosure and some of the claims. The process of settling upon the particular value was the same as that for the ionoton value, namely the result of my efforts in extracting from the relevant inventors (those within whose area of responsibility ion permeabilities and on-eye movement fell) a consensus as to a realistic value. I gathered the test data from the team members, analysed it, and started circulating memos to those members proposing conclusions. This process resulted in feed-back from team members and I was able to conclude a value which reflected the joint inventors’ view.”

Bausch & Lomb’s case at trial against amendment

96                  At the final hearing Bausch & Lomb contested Novartis’ version of how the ionoton and ionoflux figures in the patent were arrived at, and presented its own theory. Bausch & Lomb disputed that the figures contained in the patent were the result of the scientific judgment of the inventors in choosing between the two known values which did and did not correlate with on-eye movement. Rather, it contended that Novartis intentionally selected values that would increase the breadth of the claims in the patent, notwithstanding that Novartis was aware that there was no empirical evidence that the selected values correlated with on-eye movement. It contended that, for this reason, the highest values at which on-eye movement did not occur were included in the patent as the base figure for the preferred values, instead of the lowest values at which on-eye movement did occur. This was said to explain why any value “greater than about 1.5 x 10^-6 mm²/min^” was selected as the minimum preferred ionoflux value, since it was the highest value in Table F which did not correlate with on on-eye movement. It was also said to explain why the text under Table E specifies “greater than about 0.008 x 10^‑3 cm²/sec^” as the preferred ionoton value, since 0.008 x 10^-3 is shown in Table E as the highest value which did not correlate with on-eye movement.

97                  Bausch & Lomb pointed to the lack of any documentary corroboration for the “scientific judgment” explanation proffered by Meece. It also relied upon a facsimile sent by Meece to Dietz in November 1995 which states, inter alia, “Please confirm the conclusions I have drawn after Tables E and F.” Bausch & Lomb contends that the facsimile supports the contention that no scientific judgment was involved in the selection of ion permeability figures. Rather, Bausch & Lomb contended that the only exercise of “judgment” involved was a decision by Novartis’ patent attorneys to choose values below those known to result in on-eye movement in order to claim as broadly as possible, notwithstanding that the empirical data did not support those values. In substance, Bausch & Lomb argued that Novartis should not be permitted to intentionally claim protection broader than that justified by its data, and then only seek amendment when the breadth of those claims is raised as the basis of a challenge to the patent’s validity.

98                  In further support of its submissions that the “scientific judgment” theory should be rejected, Bausch & Lomb proposed an alternative version of how the particular ionoton and ionoflux values came to be included in the patent.

(a)        ionoton values

99                  Bausch & Lomb alleged that the ionoton value of 0.2, as claimed in the patent, was not chosen as a matter of judgment but, rather, was included as a result of an error whereby it was confused with the hydrodell figures contained in claims 18, 19 and 20. Those hydrodell figures are 0.2 x 10^-6 cm²/sec, 0.3 x 10^-6 cm²/sec and 0.4 x 10^-6 cm²/sec respectively. Bausch & Lomb claims that there is no other satisfactory explanation for the inclusion of “ionoton” values of 0.2 x 10^-6 cm²/sec, 0.3 x 10^-6 cm²/sec and 0.4 x 10^-6 cm²/sec, which do not appear at all in Table E. This is particularly so, it is said, given that the text under Table E also refers to other figures, namely 0.008 x 10^-3 cm²/sec (the highest value recorded in Table E which did not correlate with on-eye movement) and 0.25 x 10^-3 cm²/sec (the lowest value recorded in Table E which did correlate with on-eye movement). It was noted that all ionoton references in the patent other than those found in and directly below Table E were the same as those given in claims 18, 19 and 20 for hydrodell permeability, suggesting that the two sets of values may have been mixed up as a result of the “cutting and pasting” used during the preparation of the document. However, it should be noted that the hydrodell values of 0.2, 0.3 and 0.4 which appear in claims 18, 19 and 20 (and on page 22 of specification) do not appear in Table G, which summarises test data relating to hydrodell permeability values and on-eye movement, nor in the text under that table. No satisfactory explanation of that discrepancy was provided. Thus the origin of the values used in claims 18, 19 and 20 remains uncertain.

100               Bausch & Lomb’s theory would, however, explain why the 0.2, 0.3 and 0.4 values have an exponent of -6 (the same as the hydrodell numbers) rather than the exponent of -3 which was used for the ionoton figures in Table E. Bausch & Lomb’s version is also consistent with evidence showing that at a late stage the decision was made to claim ion, as well as water (hydrodell), permeability. This evidence would explain how the alleged mixing-up of hydrodell and ionoflux figures could have arisen, since some hydrodell figures used in the original drafts may not have been replaced when the change to ion permeability was made.

101               Bausch & Lomb’s version is consistent with some of the documentary evidence discovered by Novartis. For example, on 24 August 1996 Dietz sent an email requesting comments which might assist in the creation of a “JUMP II” patent, including in relation to possible errors in the original “JUMP” patent. In that context he wrote:

“P Ionoton: These values are questioned in general – could they have been mixed up with D Water values?”

102               On 9 September 1996 John Court (“Court”), a Ciba Vision employee named as an inventor, emailed Nicolson, Dietz and others involved in the SEE3 project, stating in respect of the JUMP patent:

“The preferred values for Ionoton Diffusion Coefficient given on Page 18, line 9 onwards, do not match the actual measured values quoted in Lynn’s report. It appears that the values for Water [Hydrodell] Diffusion Coefficient have been used instead. Note that this error has been carried into the Claims section of the document.”

103               An even earlier fax, sent from CRCERT on 10 November 1995 (before the patent’s United States filing), also raised the theory that water and ionoton permeability figures had been confused. The author (who is not identified) referred to a summary of proposed JUMP claims which included the following:

a.   Ion perm. by Winterton technique.

0.2 x 10^-6 cm²/sec

0.3 x 10^-6 cm²/sec

0.4 x 10^-6 cm²/sec

and

b.   Water permeability:            equal to 0.3 x 10^-6 cm²/sec

                                               greater than 0.3 x 10^-6 cm²/sec

In response to these figures the author of the fax comments:

“We measured water permeability. I’m not sure Lynn’s technique gives values of cm²/sec. Have they just substituted water permeability results, and said they were measured by Lynn’s technique?”

104               The version advanced by Bausch & Lomb is also supported by documents demonstrating that the earlier versions of the patent, which referred to water permeability, were edited so as to refer instead to ion permeability, specifically ionoton ion permeability. For example:

(i)                  a SEE3 draft discussion paper produced in August 1993 includes the following paragraph:

“Based on the tensile mechanical and water permeability results, it can be predicted that a lens (of appropriate fit) with the following parameters will be a non-binder:

a.      tensile modulus, E < 1.5 MPa

b.      short relaxation time constant, t1 > 4 s

c.       water permeability, P_w > 0.3 x 10^-6 cm² s^-1”

[My emphasis]

(ii)                a draft version of the patent specification dated 27 October 1995 includes a section as follows:

“In order to assure appropriate movement of the lens on the eye, one may select materials which have a combination of the above-discussed properties. Therefore, a particularly preferred group of extended-wear contact lens materials have (a) a modulus of elasticity (E) of about 1.5 MPa or less, (b) a short time relaxation constant (t₁) of about 2.5 to 8  seconds, and (c) a water permeability rate of greater than about 0.3 x 10^-6 cm²/sec.” [My emphasis]

That draft appears to be an early version of the paragraph now included on page 25 of the patent:

“In order to assure appropriate movement of the lens on the eye, one may select materials which have a combination of the above-discussed properties. Therefore, a preferred group of extended-wear contact lens materials have (a) a modulus of elasticity (E) of about 1.5 MPa or less, (b) a short time relaxation constant (t₁) of greater than about 4 seconds, and (c) an Ionoton Ion Permeability Coefficient of greater than about 0.3 x 10^-6 cm²/sec and/or an Ionoflux Diffusion Coefficient greater than about 6.4 x 10^-6 mm ²/min.” [My emphasis]

105               Nicolson conceded in cross-examination that it appeared that the discussion paper had been used as the basis for this section of the patent and that, although the values given had not changed, “water permeability” had been replaced by “an Ionoton Ion Permeability Coefficient”.

106               The above instances support an inference that numerical values used in the patent remained unchanged despite the replacement of some references to water permeability with references to ionoton permeability. Other examples were provided of instances in which general references to water permeability (without numerical values) were replaced by references to ion permeability, and in which the term “hydroperm” was replaced by “ionoperm”.

107               At trial the parties proffered different explanations as to why the alleged change in emphasis from water permeability to ion permeability may have occurred. Bausch & Lomb claimed the change was an attempt to artificially distinguish the invention from the prior art. Novartis argued that during the drafting of the patent scientific debate continued among the inventors as to whether ion or water permeability was the appropriate parameter for inclusion in the patent. One document which may support that view is a draft of the patent from November 1995 in which water permeability was re-introduced. However, it is unnecessary to make a finding on this question. Rather, it is sufficient to note that water and ion permeability were interchanged during the patent’s drafting. In those circumstances the preferred hydrodell (water) permeability values could easily have been mistakenly confused with the preferred ionoton values. The significance of the documentary evidence is that it is not only inconsistent with Novartis’ “scientific judgment” explanation, but it also establishes that Novartis was made aware of serious problems with its ionoton figures long ago.

(b) ionoflux values

108               In relation to the ionoflux figures, Bausch & Lomb claimed that all the values contained in the patent are erroneous, and that the amendments sought by the applicants would result in the perpetuation of these errors, which the Court should not permit. Bausch & Lomb’s version of the likely events that led to the alleged errors is as follows. The ionoflux figures in the patent were calculated by reference to the ionoflux value of a material called Alsacon, specifically a particular batch of Alsacon material (078-91) with an ionoflux ion permeability coefficient of 3.14 x 10^-4 mm²/min. Tests had shown that the lowest point at which on-eye movement was achieved was 0.2 of the Alsacon ionoflux value. By rounding the Alsacon value (3.14 x 10^-4) up to 3.2 x 10^-4 and then multiplying that figure by 0.2, being the value relative to Alsacon at which on-eye movement was achieved, a cut-off for on-eye movement was calculated. This gives a value of 6.4 x 10^-5 mm²/min which is the minimum value for ionoflux permeability that correlates with on-eye movement according to Novartis’ tests. That value can also be expressed as 64 x 10^-6 mm²/min. However, the preferred ionoflux values claimed in the patent (1.5 x 10^-6 mm²/min, 2.6 x 10^-6 mm²/min and 6.4 x 10^‑6 mm²/min)are all substantially less than 64 x 10^-6 mm²/min. Bausch & Lomb claimed that because those figures are lower than the cut-off for on-eye movement, they would all produce binding results. According to the Bausch & Lomb theory the claimed ionoflux values are erroneous because an incorrect Alsacon value (3.14 x 10^-5 rather than 3.14 x 10^-4) was used in the calculation of the values.

109               Bausch & Lomb’s version finds some support in the emails exchanged between Ciba Vision employees in 1996 and 1997. The first, from Court on 9 September 1996 states:

“…the values are an order of magnitude too low. Karen Sentell has now confirmed the source of this error; the diffusion coefficient of Alsacon NC was quoted as 3.14 x 10^-5 mm²/min instead of 3.14 x 10^-4 mm²/min.

In the following comments, I will correct the order of magnitude error by increasing all quoted values by 10.

On Page 16, line 35 onwards, the preferred value for Ionoflux Diffusion Coefficient is given as greater than 6.4 x 10^-5 mm²/min, more preferred as greater than 2.6 x 10^-5 mm²/min, and most preferred as greater than 1.5 x 10^-5 mm²/min. The first preferred value seems reasonable since it corresponds to the so-called ‘binding cut-off’ value of 0.2 relative to Alsacon. However, it is of concern that the subsequent more preferred values are decreasing in magnitude, especially since these values refer to binding materials.”

Consequently, all the values for Ionoflux Diffusion Coefficient quoted in the Claims are in error.

Similarly, several of the values quoted for non-binding materials in the Examples section (pages 92-96) actually correspond to binding materials.” [Emphasis in original]

In May 1997 another email from Court states:

“The biggest error is in the quoted values for Ionofux, [sic] i.e. Ion Diffusion Coefficient. The values are an order of magnitude too low! Basically, this means that virtually all SEE3 materials meet the requirement for preferred Ion Diffusion, and should (according to the JUMP document) all be non-binding materials.” [Emphasis in original]

In an email sent by Arthur Ho a few days later he states:

“We believe the quoted values for ionoflux (i.e. Ion Diffusion Coefficient) are an order of magnitude too low. The consequence of this is that virtually all SEE3 materials meet the requirements specified in the patent for preferred ion diffusion, and should therefore, all be non-binding materials.”

110               The references to the ionoflux values being an order of magnitude too low are references to “x 10^-6” being used in those values instead of “x 10^-5”. As a result of the lower exponent being used examples that resulted in binding outcomes would fall within the ionoflux values claimed to result in non-binding outcomes.

111               Bausch & Lomb also relied on evidence showing that ionoflux values were measured relative to Alsacon. When cross-examined on this question Nicolson said that “[t]he number reported was a number relative to that value recorded for Alsacon.” Jurgon Vogt, another person named as an inventor in the patent, and Dietz both also acknowledged in cross-examination that ionoflux values had been measured relative to an Alsacon value. Meece stated that he wasn’t sure he “recall[ed] that specifically”, but that he “recall[ed] something like that”. In addition reference was made to numerous SEE3 documents indicating that ion diffusion coefficients were measured relative to Alsacon NC (078-91). Accordingly, despite evidence from Brien Holden (director of CRCERT and the CCLRU) to the contrary, there was significant evidence to support Bausch & Lomb’s contention that ionoflux values were measured relative to Alsacon.

112               Evidence was also adduced to show that the ionoflux value of the Alsacon material in question was 3.14 x 10^-4 mm²/min. An article published by a Ciba Vision employee which discusses ionoflux diffusion coefficients set out those values as relative to “3.14 EXP‑4 mm²/min”. The value is also contained in a Ciba Vision document which tabulates measured ion diffusion coefficients and states that they are expressed relative to the Alsacon 078-91 value, as measured in Basel, of “3.14 E-04 mm/min”.

113               In addition there was evidence that the ionoflux threshold at which on-eye movement was found to commence was 0.2 relative to Alsacon. In that regard a SEE3 report in 1996, which stated that ion permeability was being measured relative to Alsacon 078-91, recorded that “[t]he lowest relative ion permeability measured at Basel for a non-binder was 0.2”, and later that “[m]aterials with low relative ion diffusion coefficients (<0.2) are binders.” An internal Ciba Vision email of July 1995 states:

“The most important and critical parameter in the table is the ion permeability data. We have found empirically during the past year or so that all lenses with a relative ion diffusion constant of 0.2 or higher (relative to one specific lot of Alsacon lenses set equal to 1.0) all moved on the cornea…”

114               Finally, Bausch & Lomb relied on a draft of the patent dated 20 November 1995, in which the following paragraph appears:

“An Ionoflux Diffusion Coefficient of greater than about 6.4 x 10^-6 mm²/minis preferred for achieving sufficient on-eye movement. More preferably, the Ionoflux Diffusion Coefficient is greater than about ___________ mm²/min, while most preferably, the Ionoflux Diffusion Coefficient is greater than about ___________ mm²/min. It must be emphasized that the Ionoflux Diffusion Coefficient correlates with ion permeability through the lens, and thereby is a predictor of on-eye movement.

In the document relied on by Bausch & Lomb, the blank spaces in this paragraph have been filled in by the handwritten numbers “2.6” and “1.5” respectively. This paragraph is clearly a precursor to that which currently appears on pages 16 to 17 of the patent, in which ionoflux values were given in descending rather than ascending order. In cross-examination Meece acknowledged that he was most likely the source of the handwritten numbers, but not the “6.4 x 10^-6 mm²/min” which had been typed in. Bausch & Lomb relies on this evidence as showing that the value of 6.4 was arrived at earlier than, and separately from, the numbers 1.5 and 2.6; and that at an early stage 6.4 had been determined to be the cut-off or minimum ionoflux value for achieving on-eye movement. This evidence may also explain how the ionoflux numbers came to appear in descending order: Meece, having taken the 1.5 and 2.6 from the data in Table F, may have sought to arrange them in a sequence with the 6.4 that was already contained in the existing draft.

115               The documentary evidence in relation to the ionoflux values is significant as it also does not support Novartis’ scientific judgment case. Further, that evidence raises serious questions about the correctness of the values which Novartis now seeks to include in the patent by its proposed amendments.

116               If Bausch & Lomb’s, rather than Novartis’, version of the evolution of the ionoton and ionoflux permeability values in the patent is correct, that would leave Novartis’ delay in seeking amendment unexplained. It is also so inconsistent with Novartis’ explanation of the relevant events that it would suggest a lack of candour by Novartis in relation to the disclosures it has made in support of its amendment application.

117               The main evidence in support Novartis’ explanation of how the ionoton and ionoflux values were arrived at was given by Meece, Winterton and Dietz. As explained above, Meece stated that the ion permeability figures were arrived at as a matter of scientific judgment. However, under cross-examination Meece stated that he had “no idea” whether the ionoflux figure of 6.4 x 10^-6 min²/min in the specification was derived from an Alsacon figure. He also acknowledged that there was no data available at the time the specification was drafted relating to ionoflux values between 1.5 and 2.6 which could have been used in reaching a judgment as to the appropriate the ionoflux figures. When Bausch & Lomb’s suggestion that the ionoton values of 0.2 x 10^-6, 0.3 x 10^-6 and 0.4 x 10^-6 were the result of a mix-up with the hydrodell values was put to Meece he stated:

“That is possible, but I think it’s also possible that the 0.2 x 10^-6 corresponds basically with the 0.25 x 10^-3, both in cm²/sec and merely an exponent error. There were certainly a lot of numbers floating round in this application, and unfortunately I’m not perfect at getting all those correct. But I really can’t tell you which it was.” [My emphasis]

When pressed Meece acknowledged: “I really have no idea how the 0.2 got onto that page times 10^-6…” and stated that his “rationalisation” was based on “applying logic to the numbers on the document”.

118               In his affidavit Meece claimed that the inventors considered Table E and, in particular, Example E-2 in that table which is recorded as having an ionoton permeability of “-0.063 x 10^-3 cm²/sec”. Meece stated the negative sign is an obvious error since a negative ion permeability value is not possible. He then stated that the negative sign was ignored and 0.063 x 10^-3 cm²/sec was treated as the highest value at which on-eye movement did not occur. However, in the text under Table E in the patent 0.008 x 10^-3 cm²/sec, rather than 0.063 x 10^-3 cm²/sec, is described as the highest value for a lens which bound on the eye. The text appears to have been written by Meece because in a fax sent to Dietz on 30 November 1995 he (Meece) asked for confirmation of “the conclusions that I have drawn after Tables E and F.” Plainly, there is an inconsistency between Meece’s alleged reliance on the “0.063” figure and his adoption of “0.008” in the text under Table E.

119               Further, Meece’s claim that the ion permeability values were the result of “discussion, correspondence and thought” by and amongst the inventors is not corroborated by any documentary record of “discussion, correspondence and thought” on that subject. That is surprising as the documents in evidence, which include communications in respect of which privilege has been waived, appear to represent a fairly comprehensive and extensive record of significant communications between the inventors and Novartis’ attorneys concerning ion permeability values in the patent. Ultimately, Meece’s claim of “scientific judgment” appears to be little more than assertion on his part; it was not supported by any detail of the process by which the values were arrived at or of the principles applied in arriving at the values.

120               Novartis also relied on Winterton’s evidence to the effect that test data gathered since the drafting of the specification showed that materials with an ionoton value of 0.2 x 10^-3 do move on the eye. This was said to support the contention that 0.2 was the correct value chosen as a matter of scientific judgment and that the exponent of -6 was a simple typographical error. Winterton did not give evidence as to when the tests were carried out and whether the material tested was the same as the material described in the specification. In any event, Winterton also acknowledged that at the time the specification was drafted Novartis’ only relevant test data was that set out in the specification. Evidence to the same effect was given by Nicolson and Meece. Consequently, his evidence that later tests showed 0.2 x 10^-3 to be a workable ionoton value does not assist in explaining the process by which those figures were arrived at. When Winterton was questioned as to the source of the ionoton figures in the patent he admitted that he could not recall their derivation or whether their inclusion was an error.

121               In his affidavit evidence Dietz claimed that in preparing the PCT patent he largely relied upon the United States patent (drafted by Meece) and only became aware of the ion permeability discrepancies in October 2001. However, under cross-examination he conceded that he had “very likely” received emails discussing the problems at an earlier time, and said that prior to the filing of the patent in the United States he had been involved in an “intense discussion” with the inventors about the correctness of the ion permeability values. But Dietz did not explain how that discussion resulted in the decision to include the criticised values in the patent. Nicolson, who headed the SEE3 project, appeared to assume that the relevant values were based on scientific judgment, but he was unable to state the basis for his assumption.

122               No evidence was led by Novartis which adequately explained how the exercise of scientific judgment could have led to the conclusion that between the two values which are shown in Table E to produce on eye movement and binding respectively, 0.2 x 10^-3 was the appropriate threshold value. The absence of such evidence, together with Winterton’s acknowledgement that no data relevant to this question existed other than that contained in Table E, has left me unable to accept that the choice of an ionoton figure for on eye movement below that demonstrated by the data to produce that movement was the result of an exercise in “scientific” judgment.

123               Similarly, no data appears to have existed that supported a “scientific judgment” that lenses with an ionoflux value of “greater than about 1.5 x 10^-6 mm²/min” would move on the eye. The only ionoflux data in the possession of the patentees at the time the patent was drafted gave no indication as to the point between the ionoflux values of 1.5 x 10^-6 mm²/min and 2.6 x 10^-6 mm²/min at which a lens would be expected to move on the eye.

124               Further, if the claim that the ionoton and ionoflux figures were arrived at by a process of “scientific judgment” is correct it would have assisted Novartis’ case for some evidence to have been given by those who were said to have made that judgment as to how they arrived at the values and whether they now regard them as incorrect. Apart from Winterton’s evidence of an ionoton value of “0.2” moving on the eye in subsequent tests no such evidence was proffered.

125               Finally, no reasonable or satisfactory explanation has been given as to why the errors pointed out by Court and Karen Sentell were disregarded. Court observed that “[t]he preferred values for Ionoton Diffusion Coefficient given on Page 18, line 9 onwards, do not match the actual measured values quoted in Lynn’s report” but the report referred to was not produced, nor the discrepancy explained. Also, no evidence was led by the applicants as to why Karen Sentell, the person credited by Court with discovering the source of the ionoflux exponent error, was wrong.

126               The above matters have led me to conclude that the “scientific judgment” explanation offered by Novartis for the inclusion of the relevant ionoton and inonoflux ion permeability values in the patent should not be accepted. In my view the most likely explanation for the selection of ion permeability values below those recorded as correlating with on eye movement is that the values were selected in pursuance of a policy on the part of Novartis’ attorneys to express the claims in the patent as broadly as possible, irrespective of whether the scientific evidence then available to the patentees supported those claims. Indeed, the inference that this is what occurred is compelling once the “scientific judgment” explanation has not been accepted. The reason for that is that there is no other satisfactory explanation for Novartis’ inclusion of values in claim 1, and in the specification, that were significantly less than those found to correlate with on-eye movement. In arriving at that conclusion I acknowledge that errors of the kind suggested by Bausch & Lomb might well have been made. However, even those errors would not explain why claim 1 includes an integer of any value “greater than” the highest binding value shown in Table F, nor why values of “greater than .008” and “greater than 1.5” respectively were cited as the preferred values in the text under Tables E and F. Thus, while there is considerable substance in the explanations proffered by Bausch & Lomb in respect of the alleged Alsacon and hydrodell errors, those explanations do not explain why the ion permeability values that correlated with non-binding outcomes were ignored in claim 1 nor do they take into account the policy applied by Novartis’ attorneys in formulating its claims in the patent. Rather, the evidence suggests that the pursuit of that policy led Novartis’ attorneys to disregard any suggestions that appeared to them to alter the broad claims they wished to make in relation to the invention. In disregarding, or not acting upon, those suggestions the attorneys appear to have acted somewhat peremptorily. The inference I am prepared to draw helps to explain why they acted in that manner.

127               Further, the inference is supported by evidence indicating that a policy prevailing within the SEE3 project when the patent was drafted was to create claims of sufficient breadth to cover the field of extended wear contact lenses. In an email sent to Dietz, Meece wrote:

“As you know, we all (esp. Adrian) consider this a possibility for excluding all others from a commercially viable EW lens, with the proviso that we can select claim limitations that exclude the prior art, while including any commercially viable EW lens.”

A memo from both Meece and Dietz in August 1995 states:

“The claims should be as broad as possible, in order to exclude others from as much territory as possible. One must consider as many variations and permutations as possible, because competitors will attempt to design around the claims and avoid infringement”.

This approach is also evident in choice of the name (“Joint Umbrella Patent” or “JUMP”) given to the patent by the SEE3 inventors, which Nicolson stated was intended to indicate that it was to cover the field of extended wear lenses. It is also to be noted that at trial Novartis did not seek to support claim 1, which does not claim separate and co-continuous phases and appears to have been drawn with the intention of covering the field of ophthalmically compatible extended wear contact lenses.

128               There is no difficulty with broad protection being claimed in a patent. However, a patent’s claims may not travel beyond the matters disclosed in the specification and should not include embodiments of the invention that are known not to work or which cannot reasonably be expected to work. In that regard Dietz, when challenged on making claims in the patent for outcomes that “wouldn’t work” responded as follows:

“MR CATTERNS: …the risk was, wasn’t it, doctor, that there is a whole range of materials …which came within the claim, which your results did not support? ---Which wouldn’t work.

Which wouldn't work?---Right. And that's exactly why I said we were claiming on the safe side. Again, coming from a European perspective it is not a problem if a few embodiments of the claim do not work, because what do you take away from the public if you claim something which doesn't work?  That is why, from the European perspective, I didn't see a reason to amend the claims or the ‑ ‑ ‑

HIS HONOUR:   Sorry. Maybe I don't understand it, but aren't you claiming a monopoly that is greater than that to which you were entitled to, based upon your invention?---No. We are, based on a patent, not having a monopoly but we have a right to exclude others. And if we exclude others from doing something that doesn't work I don't think that's a problem. The patent claims shouldn't comprise too much which doesn't work, that is clear. But if it's a bit, no problem.”

129               Although Dietz was directing his comments toward the question of amendment, they evidence a general approach by Novartis in the present matter that sees the breadth of the claims as more important than their accuracy or justification. Such an approach, and the patent drafters’ stated intention of achieving claims of sufficient breadth to exclude all other extended wear contact lenses, is the likely explanation of why values below those known to work were claimed by Novartis.

130               It follows from my rejection of Novartis’ explanation that I am not satisfied that Novartis has made a full and accurate disclosure of all relevant matters, as it has not candidly disclosed the “whole story of how it was that amendment had come to be sought”: Terrell on the Law of Patents (15^th ed) at 261; Chevron Research Company’s Patent [1970] RPC 580 at 586. Novartis’ witnesses purported to give evidence of all of the relevant events leading to the amendment application but I am not satisfied that that evidence has given “the full picture”.

131               In not accepting the evidence of Novartis’ witnesses concerning the events leading up to the incorporation of the disputed ion permeability values in the patent, I do not go so far as to find that Meece, Dietz and the other Novartis witnesses who gave evidence concerning those matters intended to give false evidence. Rather, I am satisfied that they had, by the time of the hearing, only a slight recollection of the events that led to the adoption of the ion permeability values that were in issue on the amendment application and that they sought to reconstruct, somewhat inaccurately, the circumstances that led to those values being incorporated into the patent. Indeed, the “scientific judgment” explanation given by Meece in his affidavit was plainly inconsistent with the evidence he gave while under cross-examination that he had little or no recollection of the relevant events. The contemporaneous documentary record, which does not support Novartis’ explanation, is a more reliable guide than the evidence of Meece, Dietz and the other Novartis witnesses who sought to explain how the disputed values found their way into the patent.

132               The onus lies on Novartis to satisfy the Court that its discretion to direct the amendments sought should be exercised. In so far as that onus requires a satisfactory and reasonable explanation of how the errors or other matters now sought to be corrected came about Novartis has not discharged that onus in the present case. However, although Novartis’ inadequate disclosure is to be taken into account, it is not decisive in itself, as there are other matters that should also be taken into account.

133               I turn to consider one of those matters, being the issue of delay. Delay, without more, may not be a sufficient reason to refuse an amendment application: see for example C. Van der Lely N.V. v Bamfords Limited [1964] RPC 54 at 80 and 81; Bristol Myers Company v Manon Freres Limited [1973] RPC 836 (“Bristol Myers”)at 857; Matbro Limited v Michigan (Great Britain) Limited [1973] RPC 823 (“Matbro”) at 833; Bentley Engineering Co. Ltd.’s Patent [1981] RPC 361 (“Bentley”) at 376–377 and Wimmera at 39,791. However, amendment has been refused in cases of “culpable delay”. This can arise where “the delay was a deliberate ploy designed to gain some illicit advantage”: Wimmera at 39,792. See also Bentley at 377. Also, if the patentee knew of the need for an amendment but failed to apply for it for a long period, amendment may be denied because “in the meantime the patentee has represented to the public that he has a valid claim when he knows it cannot be supported in its present form”: Rescare at 10–11. See also Smith Kline & French at 567 and Bristol Myers at 857. The policy underlying the above observations is that “it is in the public interest that patentees should not delay in seeking to amend and that amendment will not be permitted in cases where a patentee knows or ought to know that amendment should be sought and fails to do so for any substantial period of time”: Smith Kline & French at 567.

134               Amendment may also be denied if a patentee’s delay has caused detriment to any particular party or to the general public: see Wimmera at 39,792 and Matbro at 833-834. Detriment, however, may be inferred. In Raleigh Cycle Co. Ld. v H. Miller & Co. Ld. [1951] AC 278 (“Raleigh”) at 291 Lord Morton, responding to the patentee’s objection that there was no evidence detriment had been suffered, stated:

“…it is impossible to say how many inventors and workers in this art may have been deterred from research and experiment by reason of the fact that the plaintiffs had marked out so wide a territory as their own.”

That passage was later cited by Gummow J in Rescare (at 12). The issue of detriment has particular significance where a patentee has unjustifiably drawn claims as broadly as possible in an endeavour to “cover the field”.

135               Where a lengthy delay has occurred before an application for amendment is made, the patentee is expected to give a reasonable explanation for the delay even if no public detriment is apparent. In Smith Kline & French at 577 Aldous J, who refused to allow the amendments sought in that matter, stated that:

“The fact that nobody has suffered detriment due to the control of cimetidine by the generic and master patents is not, in my view, a ground for failing to amend for eight years. That fact was not the reason why the plaintiffs did not seek to amend; it was the consequence of the ambit of the generic and master patents. If there be delay in amending by a patentee who knows or ought to know of the need to amend, as is the position in this case, then he must establish a reason for his decision not to amend or to do nothing and also that the reason was reasonable. It is not sufficient to show that nobody has been hurt by the delay, as that is not a reason for the delay. Even if it be assumed that it be a reason, it is not a reasonable reason in that it disregards the public interest in ensuring that patents are amended promptly when the need arises, so that the public can rely on patents as representing that to which the patentee believes that he is entitled. Further, if the plaintiffs had decided not to amend earlier because they had concluded that nobody would suffer damage by the delay, that would not have been a reasonable ground for the delay as it disregarded the public interest.” [My emphasis]

It has also been observed that stating that it was considered unnecessary to amend is insufficient without “a statement of convincing reasons” for that decision: see Bentley at 377.

136               In the present matter the application for the patent was made in Australia on 22 March 1996, the proceeding for infringement was commenced on 29 February 2000, and the motion seeking the amendment of the patent was filed on 6 December 2002. Bausch & Lomb contended that Novartis was aware of the substantive errors now sought to be corrected by September 1996. If that is correct the period of delay is in excess of six years.

137               On 9 September 1996 Court sent an email to a number of senior members of the SEE3 project, including Nicolson, Winterton, Meece and Dietz, in which he drew attention to a number of errors in the patent, including:

·               the error in the ionoflux figures whereby the numbers given are an order of magnitude too low;

·               the error whereby ionoflux figures are given in descending instead of ascending order; and

·               the error whereby hydrodell figures were accidently given as preferred ionoton values.

138               It is also likely that Court had raised the issue of the accuracy of the ionoton and ionoflux values earlier than September 1996. An email from Dietz sent on 24 August 1996 stated:

“In addition to finding a consolidated version or values/ranges/parameters it seems very important to me that some inconsistencies pointed out by John Court are clarified:

In this context I ask you to refer to John’s Lotus Notes memo dated July 22, 1996 (if you do not have it: please contact Scott Meece who may provide it to you).

D Ionoflux: Please note that there is an uncertainty about one order of magnitude. Secondly, the lower limitation of the JUMP values is becoming LOWER, the more preferred they are, while John proposed that the values should be higher in absolute terms, and becoming HIGHER the more preferred they are.

P Ionoton: These values are questioned in general – could they have been mixed up with D Water values? …”

The email suggests that Court had raised the issue of the errors by email on 22 July 1996, and that by 24 August 1996 others in the SEE3 project, including at least Dietz and Meece, had turned their minds to the issue.

139               On 19 May 1997 a further email from Court to members of the SEE3 project once again addressed the question of errors in the patent:

“At Debbie [Sweeney]’s request, here is a brief summary of things wrong with JUMP. Perhaps Brien will recall the phone conference we had with Atlanta (a year ago) in which the errors were ‘explained away’. A subsequent Note’s [sic] message from Joerg Dietz stated; ‘…the deficiencies in JUMP with respect to units or numerical values, if they exist at all,are small and, in our view, not very significant.’

At that point I gave up banging my head against the brick wall. So what has changed?”

140               Court’s reference, in May 1997, to a phone conference held “a year ago” indicates that the errors in the patent may have been known to the patentees as early as May 1996.

141               An email sent on 22 May 1997 by Arthur Ho and addressed to Nicolson and Dietz  states:

“One of the Steering Committee Meeting action items involved revisiting JUMP in order to ensure the See3 Team all agree on a coherent set of the hypotheses/models/parameters expressed in that patent. Below, you will find the points which we believe need to be reviewed in order to arrive at this state.”

Ho then sets out some errors in the patent, including the error in the ionoflux exponent.

142               Initially, when cross-examined, Dietz claimed he did not know of “inconsistencies” in the patent until 2001 when that issue was raised by “B & L documents which [he] read in the course of these court proceedings”. However, when shown Court’s September 1996 email addressed to him, Dietz conceded that it was very likely that he (Dietz) had seen that email. Meece also conceded that “at some point I was aware of some problems in the numbers in the application and in the patent,” and when shown Court’s email of 9 September 1996 Meece said “it looks like I must have been aware of [the problem with the ionoflux values].”

143               Further, copies of correspondence with the United States Patent and Trademark Office show that on 25 February 1999 a request was made to amend the United States patent, inter alia, to change the “preferred” ionoflux value from 1.5 to 2.6, and the “more preferred” value from 2.6 to 6.4. This is one of the changes now sought to be made to the Australian patent. Presumably, Novartis had good reason to seek amendment of those ionoflux values in the United States by early 1999. No satisfactory explanation was given by Novartis as to why that amendment was sought in the United States in 1999 but was not sought in Australia until nearly four years later.

144               Finally, there is evidence suggesting that Novartis had reason to know of the errors in the ionoton values even before the patent was filed in the United States. A fax (referred to in [103] above) sent from the CRCERT on 10 November 1995 by an unidentified author referred to the proposed claim parameters for the patent and commented:

“We measured water permeability. I’m not sure Lynn’s [ionoton] technique gives values of cm²/sec. Have they just substituted water permeability results, and said they were measured by Lynn’s technique?”

The evidence does not explain why this theory and the other suggestions of error were not accepted; nor does Novartis put forward any reasonable explanation for why the suggestions were either disregarded or not acted upon.

145               I am satisfied that the patentees were made aware of substantive errors in the patent, including the ion permeability errors now sought to be corrected, at least by September 1996 and probably earlier. The errors pointed out at that time were significant, clearly articulated and warranted a reasoned response, which did not occur. Plainly, by addressing some of those errors in its current amendment application Novartis is now accepting much of the criticism of Court and others, but it has not explained why it has taken so long to do so. Novartis claimed in its Statement of Grounds in Support of Amendment that “[k]nowledge of the errors giving rise to the amendments was first acquired in October 2001…” but in light of the documentary evidence before me I consider that contention to be unsupportable. Rather, I am satisfied that the patentees were made aware, by September 1996 at the latest, of the substantive ion permeability errors they now seek to correct by amendment, and that they have delayed for over six years in bringing their application for amendment. Even if I were in error about the patentees’ actual awareness, I am in no doubt that by September 1996 they ought to have been aware of the errors and other matters they now seek to address by their application to amend the patent.

146               Having concluded that at least six years elapsed between the time at which the patentees became aware, or ought to have become aware, of problems with the ion permeability values stated in the patent and the time at which application for amendment was made, I turn to consider whether reasonable grounds for that delay have been demonstrated. In Smith Kline & French Aldous J stated at569:

“…in cases where a patentee delays for an unreasonable period before seeking amendment, it will not be allowed unless the patentee shows reasonable grounds for his delay.Such includes cases where a patentee believed that amendment was not necessary and had reasonable grounds for that belief.”  [My emphasis]

An apparent example of a patentee demonstrating reasonable grounds for delay can be seen in Wimmera. There Sundberg J (at 39,791) considered that the delay in question was “a consequence of an initially sensible decision to await further particulars.”

147               Novartis sought to rely on Dietz’s evidence to demonstrate the reasonableness of any delay. Dietz stated that discussion was ongoing after the filing of the patent as to the correctness of some of the values in it:

“and that in all situations we came to the conclusion that what was proposed [to be amended] was not correct or not necessary to be done, so that’s why we didn’t do anything.”

148               Novartis pointed to the email sent by Dietz on 19 September 1996 to SEE3 project members in which he stated that he and Meece had concluded that:

“…the deficiencies in JUMP with respect to units or numerical values, if they exist at all, are small and, in our view, not very significant. There is an enormous amount of disclosure in JUMP the correctness of which has not been questioned by any of the inventors, and we believe that we can successfully rely on said disclosure in order to delineate the claims from the prior art known to us.” [My emphasis]

149               However, Dietz’s email proffers no explanation as to why the deficiencies might not exist and, if they do, why they are “small” and “not very significant”. It does not explain the considerations that he and Meece took into account in reaching that view. In any event, the email was sent in the context of considering whether a new and additional patent (“JUMP II”) should be created, rather than whether the JUMP patent should be amended in any of the jurisdictions in which it was filed. That is, Dietz was explaining that he and Meece had decided that a JUMP II patent was not required, in part because “the deficiencies in JUMP… if they exist at all, are small and, in our view, not very significant”. There is no evidence of consideration having been given to whether there was a need for amendment of the existing patent.

150               Further, there is no reasonable basis for concluding that the errors alleged were “small and … not very significant”. In the case of the ionoflux figures, if the theory advanced by Court, and adopted by Bausch & Lomb, is correct, and the lowest ionoflux value which will not bind to the eye is in fact 6.4 x 10^-5 mm²/min, then the “preferred” value claimed in the patent (1.5 x 10^-6 mm²/min) would be more than 40 times too low. In respect of the ionoton values Novartis conceded that the ‘preferred’ value in the patent (0.2 x 10^‑6 cm²/sec) is more than a 1000 times too low (when compared to the value which resulted in on-eye movement, namely 0.25 x 10^-3 cm²/sec). Plainly, such errors are not capable of being reasonably characterised as small or insignificant. This is particularly so when it is considered that the errors pointed out were in both the body of the specification and in the claims.

151               Another explanation given by Dietz for the delay in seeking amendment was his unfamiliarity with Australian patent law. In that regard, he stated:

·        that he was not aware that a patentee wishing to amend should apply as early as possible, and that this is not the case in Europe; and

·        that he does not view it as a problem if some embodiments of an invention claimed by a patent do not work (“because what do you take away from the public if you claim something which doesn’t work?”).

152               As late as 21 August 2002, in an email to Novartis’ solicitors, Dietz continued to maintain that amendments to move the preferred values from “greater than” the highest value that did not work to “no less than” the lowest value which did work should not be made. In relation to the ionoflux values, he stated:

“…example F8 does not work, while example F4 does. F8 has the 1.5 ionoflux value, F4 has the 2.6 ionoflux value. Thus we disclose: 2.6 is okay, 1.5 is too low. What the claim says (and corresponding portions of the specification) is: The value for ionoflux must be GREATER than (about) 1.5 – and I believe this is exactly what one is allowed to deduce from the F4/F8 comparison. In view thereof, I am strongly in favour not to replace the 1.5 ionoflux value by 2.6 as a lower limitation.”

While it may be literally correct to state that the data in the patent shows that the ionoflux value must be greater than 1.5 to achieve on-eye movement, that data does not indicate that values above 1.5 but below 2.6 will achieve movement on the eye. Dietz’s evidence is consistent with the view that Novartis’ policy in respect of the patent was to maintain wide claims irrespective of whether the data justified such claims.

153               In his email of 21 August 2002 Dietz applied the same logic to the ionoton figures. His view was that substantial amendment was to be avoided “if ever possible”. At that time Elisabeth Opie, a lawyer for the CSIRO agreed with Dietz’s recommendation that in principle “amendments [should] be kept to a minimum”, although acknowledging that she did not feel qualified to comment on the particular amendments proposed.

154               Novartis’ conduct in relation to the question of amendment demonstrates little regard for the requirements of Australian patent law. Indeed, it appears that the first occasion on which those requirements were considered was in late 2001 and early 2002 when, in the context of Bausch & Lomb’s claim of invalidity, advice was sought on the issue of amendment from senior and junior counsel representing Novartis in the present proceeding. Although the patentees had employed an Australian patent attorney during the drafting of the patent there was no evidence that that attorney was consulted on the question of amending the patent.

155               For the foregoing reasons I am satisfied that no reasonable or satisfactory explanation has been provided for the long period of delay in making the application for amendment in respect of the ion permeability values. It was open to Novartis, at any time prior to the commencement of the current proceeding, to apply to the Commissioner for an amendment under s 104. After the proceeding had been commenced Novartis was able to apply to the Court under s 105 for amendment. It did not do so until December 2002. Further, the general lack of candour displayed by Novartis in relation to its amendment application, which I discussed above (at [130]), also taints the explanations proffered for its delay in seeking amendment. The result is that the patentees, without having reasonable grounds to do so, have maintained, for over six years, claims that are significantly broader than those to which they were entitled on the basis of the disclosures they made and the examples they provided in the patent.

156               I have also found earlier in these reasons (at [126] – [129]) that the ion permeability values claimed in the patent were chosen as part of a policy of claiming as broadly as possible. Where a claim is “covetous”, in that it is unjustifiably wide, the Court may refuse amendment of that claim: see Bristol Myers at 856 and Rescare at 13. This approach may also extend to the refusal of an amendment in cases where a claim is, perhaps for innocent reasons, drawn too broadly, and is unjustifiably persisted in. As was observed by Lord MacDermott in Raleigh at 295:

“There are times when it may be to the commercial advantage of a patentee to leave a claim, wide or vague enough to be bad, unamended, and I see no reason why the court should not be free to prevent this in cases which do not call for the deletion of all but the valid claims.”

157               In the present case it is clear that Novartis remained reluctant to amend the patent until advised by counsel that at least one of the amendments now sought was essential to the patent’s validity. It is likely that Novartis, for commercial reasons, sought to maintain, as far as practical, a common form of the patent in the respective jurisdictions in which it was granted. Novartis’ persistence in maintaining the patent in its current wide form does not assist its case for amendment.

158               I turn next to Bausch & Lomb’s contention at trial that, if permitted, the amendments would result in an erroneous ionoflux value continuing to appear in the patent. Novartis claims that that contention is mere conjecture and has not been proved. I have referred earlier in these reasons (see [109] – [114]) to the evidence relied upon by Bausch & Lomb which raises serious questions about the accuracy of the ionoflux values in the patent, and which Novartis’ proposed amendments do not address. No evidence has been adduced by Novartis to demonstrate that the relevant ionoflux values are accurate. In the result I am left in some doubt as to whether the ionoflux values proposed by Novartis are in fact correct.

159               In Minerals Separation Ltd v Potter’s Sulphide Ore Treatment Ltd (1909) 8 CLR 779 at 800 O’Connor J stated:

“In the exercise of the discretion it is clear that an amendment ought not to be allowed which would make a patent obviously bad – bad either by reason of insufficient description of the process or invention, or by reason of any failure in the duty of fully informing the public as to the manner in which the invention is to be carried out.”

O’Connor J’s approach was later embodied in s 102 and its predecessor. It may well be that other matters that would render a patent “bad” may be considered as part of the Court’s discretion in amendment cases. Such a case may arise where a patentee seeks to amend a claim so as to include a value or values shown by empirical evidence external to the patent not to work, thereby raising a case of inutility. In the United Kingdom the Court may refuse amendments that fail to cure a claim that is invalid due to obviousness or lack of novelty: see Mullard Radio Valve Co. Ltd. v British Belmont Radio Ltd. [1939] RPC 1 eg at 18; Great Lakes Carbon Corporation’s Patent [1971] RPC 117 at 123 and 126; and more generally Texas Instruments Ltd v Hyundai Electronics UK Ltd (unreported, UK Patents Court, Pumfrey J, 30 July 1999) at [35]. On the other hand, there are grounds for contending that in such cases it may be appropriate to permit the amendment on the basis that the validity of the amended patent should be determined in revocation, rather than amendment, proceedings: see for example Richardson-Vicks Inc.’s Patent [1995] RPC 568 (where Jacob J allowed an amendment before revoking the amended patent for obviousness) and Minister of Agriculture’s Patent  [1990] RPC 61 at 65.

160               In view of the other conclusions at which I have arrived I have not found it necessary to determine Bausch & Lomb’s contention that, if permitted, the proposed amendments would result in erroneous ionoflux values continuing to appear in the patent.

161               The factors that militate against the granting of Novartis’ application to amend can be summarised as follows:

(i)                  the history of the patent’s drafting indicates that the ion permeability values contained in it were chosen not as a matter of scientific judgment but, rather, as part of a policy of claiming as broadly as possible, even if this meant overstating the patent’s claims without having reasonable grounds to do so;

(ii)                when problems with the ion permeability values were revealed, no steps were taken to correct those values by the amendment of the patent until more than six years after the patentees were aware or ought to have been aware of the problems, and no reasonable or satisfactory explanation for that delay has been provided;

(iii)               notwithstanding the problems concerning the ion permeability values, including the overstating of those values, there is no evidence that Novartis considered, or consulted its Australian legal advisers about, whether the patent should be amended until after the commencement of this proceeding and until after Bausch & Lomb had raised the issue of invalidity by reason of those ion permeability values;

(iv)              the patentees have not made a full and candid disclosure to the Court of all the circumstances relevant to the amendment application.

162               In summary, the present case is one in which the patentees knew or ought to have known that the substantive amendments they now seek to make should have been sought long ago, but have failed to provide a reasonable or satisfactory explanation for their delay, which can fairly be characterised as culpable delay. Further, the errors and other matters now sought to be corrected came about as part of a policy of overstating claims without having reasonable grounds for doing so.

163               Several factors, however, support the amendment application:

(i)                 Some of the problems evident in the patent and its history might be referable to carelessness or a lack of diligence on the part of the patentees (whether in relation to proof reading the patent for errors, investigating alleged errors in the patent, familiarising themselves adequately with the legal requirements of various jurisdictions, or carelessness in other respects);

(ii)                the amendments now sought aim to give effect to the ionoton and ionoflux values disclosed in Tables E and F in the specification with respect to on-eye movement;

(iii)               no specific detriment has been shown to have been suffered by any particular person by reason of the claims in the patent being broader than was justifiable by reference to the disclosures made in the specification; however, this factor needs to be balanced against the public interest in a patentee not representing that it has valid claims when it knew, or ought to have known, that those claims cannot be supported in their present form;

(iv)              Bausch & Lomb now consent to the amendments with the consequence that they are no longer opposed amendments;

(v)                The Commissioner has not objected to the amendments; however, that needs to be balanced against the fact that the Commissioner is not in a position to consider the merits of the application as she has not examined the evidence of the parties in relation to that question.

After taking into account all of the matters to which I have referred, I have concluded that the proposed substantive amendments should be refused because Novartis has failed to discharge the onus on it to satisfy the Court that those amendments should be granted. I have borne in mind the comment of Sundberg J in Wimmera (at 39,790) that “the Court does not approach the exercise of its discretion in a manner hostile or antipathetic to amendment.” However, the factors militating against amendment are powerful. In that regard I consider the extent of the delay, which I regard as “culpable delay”; the failure of Novartis to provide a satisfactory or reasonable explanation for its omission to act earlier to correct the ion permeability values and the other matters which it now seeks to address; and Novartis’ lack of candour in respect of those matters as weighing heavily against its application to amend. Further, the persistence by Novartis with claims drawn as broadly as possible, without having reasonable grounds for doing so, called for it to satisfy the Court that there were circumstances that mitigated, explained or excused the delay that has taken place. In my view that has not occurred.  Finally, I would add that the fact that the amendments are no longer opposed must be balanced against the opposition to the amendments at trial, the evidence adduced at trial in support of that opposition, and the Commissioner’s submission that if the Court is concerned about the validity of the patent it may be appropriate to direct the Commissioner to re-examine the patent.

164               I have considered whether the Court should permit Novartis to amend the ionoton exponent (from -6 to -3) and the descending order of the preferred ionoflux values on page 16 of the patent (to an ascending order) on the ground that (at least in Novartis’ submission) they are obvious errors that ought to be corrected. However, Court had pointed out both of those errors in 1996 and no step was taken to correct them.  In any event these errors do not stand alone. The ionoton exponent and the order of the ionoflux figures are both integral to the source of the values to which they relate. Further, those values were maintained pursuant to a policy of Novartis which I have found to have been persisted in by it in a manner antithetical to the public interest. Accordingly, I am not satisfied that it is appropriate to consider the ionoton exponent of -6 separately from the 0.2 to which it is applied and which I have not permitted Novartis to amend, or to consider the erroneous ascending order separately from the values contained in the order, particularly the 1.5 ionoflux value, in respect of which I have also refused amendment.

165               For the above reasons I have concluded that the validating and related amendments sought by Novartis, and which were opposed at trial by Bausch & Lomb, should be refused. Accordingly, it is appropriate to dismiss the application for those amendments. It is also appropriate that liberty to apply be reserved to enable any further application that may be appropriate, including any application the Commissioner may wish to make in the light of these reasons for judgment.

Orders

166               The orders that are appropriate are:

1.         The application and the cross claim be dismissed by consent with no order as to costs.

2.         Compliance with the requirements of Order 58 rule 10 of the Federal Court Rules be dispensed with in respect of the amendments set out in paragraph  3(g) hereunder.

3.         Australian Letters Patent No 704749 (“the patent”) be amended as follows:

(a)        On page 4 at lines 11–12, delete the words “lens allows”.

(b)        On page 4 at line 22, replace “mm²/sec” with “cm²/sec”.

(c)        On page 22 at the 7^th last line, delete the word “material”.

(d)        On page 22 at line 25, replace “permeability” with “transmissibility”, and replace “transmissibility” with “permeability”.

(e)        On page 23 at the 11^th last line, replace “material” with “ lens”.

(f)                 On page 99 at line 1, replace “F-13” with “F-12”.

(g)                On pages 102–113 delete claims 1–66 and replace with:

1. An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:

(a)        at least one oxyperm polymerizable material and

(b)        at least one ionoperm polymerizable material,

wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material,

wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and

wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions,

wherein said polymeric material comprises a plurality of co-continuous phases, including at least one oxyperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens and at least one ionoperm phase which extends continuously from the inner surface of the ophthalmic lens to the outer surface of the ophthalmic lens.

2. An ophthalmic lens having ophthalmically compatible inner and outer surfaces, said lens being suited to extended periods of wear in continuous, intimate contact with ocular tissue and ocular fluids, said lens comprising a polymeric material which has a high oxygen permeability and a high ion permeability, said polymeric material being formed from polymerizable materials comprising:

(a)        at least one oxyperm polymerizable material and

(b)        at least one ionoperm polymerizable material,

wherein said lens allows oxygen permeation in an amount sufficient to maintain corneal health and wearer comfort during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said oxyperm polymerizable material forms a phase or phases substantially separate from the phase or phases formed by said ionoperm polymerizable material,

wherein said lens allows ion or water permeation via ion or water pathways in an amount sufficient to enable the lens to move on the eye such that corneal health is not substantially harmed and wearer comfort is acceptable during a period of extended, continuous contact with ocular tissue and ocular fluids,

wherein said ionoperm polymerizable material, if polymerized alone would form a hydrophilic polymer having a water content of at least 10 weight percent upon full hydration, and

wherein said ophthalmic lens has an oxygen transmissibility of at least about 70 barrers/mm and an ion permeability characterized either by (1) an Ionoton Ion Permeability Coefficient of greater than about 0.2 x 10^-6 cm²/sec, or (2) an Ionoflux Diffusion Coefficient of greater than about 1.5 x 10^-6 mm²/min, wherein said ion permeability is measured with respect to sodium ions,

wherein said polymeric material comprises a plurality of co-continuous pathways, at least one being an ion or water pathway and at least one other being an oxygen pathway, which pathways extend continuously from the inner surface of the lens to the outer surface of the lens.

3. An ophthalmic lens of claim 2, wherein said co-continuous pathways include a continuous phase of ionoperm polymeric material and a continuous phase of siloxane-containing polymeric material.

4. An ophthalmic lens of claim 2, wherein said pathways have a domain size which is less than a size which undesirably distorts visible light in an amount which is visible to the eye of the wearer.”

4.         Save for the orders set out in paragraph 2 above, the applicants’ motion dated 6 December 2002 for amendment of the patent be dismissed.

5.         The applicants pay any costs of the Commissioner of Patents that were incurred after 2 July 2004 in respect of the applicants’ motion for amendment of the patent.

6.         The motion of Johnson & Johnson Pacific Pty Limited dated 16 July 2004 be dismissed.

7.         Johnson & Johnson Pacific Pty Limited is to pay the costs of the applicants of and incidental to the motion.

8.         Reserve liberty to apply.

Associate:

Dated:              24 August 2004