FEDERAL COURT OF AUSTRALIA

Pharmacia Italia SpA v Mayne Pharma Pty Ltd [2006] FCA 305

PATENTS – infringement of pharmaceutical patent – existing injunction restrains respondents until conclusion of initial term of patent – extension of term of pharmaceutical patent granted prior to infringement proceedings – whether injunction restraining respondents should also apply to period of extension – basis upon which patent capable of extension – whether claim in respect of pharmaceutical substance per se – whether references in patent specifications to elements of “process” or “method” prevent claim from being a claim in respect of a pharmaceutical substance per se – rectification of Register – whether s 192 of Patents Act 1990 (Cth) allows only for the correction of clerical and like errors

ADMINISTRATIVE LAW – application for judicial review – decision by Commissioner of Patents to accept an application, and to fail to refuse to accept an application, for extension of term of patent – decision by Commissioner of Patents to grant an extension of term of patent – whether compound consisting of both therapeutic substance and inert substances is a “pharmaceutical substance” – whether patent for a pharmaceutical substance per se – effect of delay in bringing application for review

WORDS AND PHRASES – “pharmaceutical substance per se”, “pharmaceutical substance”

Administrative Decisions (Judicial Review) Act 1977 (Cth) ss 5 and 11

Judiciary Act 1903 (Cth) s 39B

Patents Act 1990 (Cth) ss 70, 78, 192

Patents Regulations 1991 (Cth) r 5

Boehringer Ingelheim International GmbH v Commissioner of Patents (2001) 112 FCR 595 applied

Boehringer Ingelheim International v Commissioner of Patents (2001) AIPC ¶91-670 followed

Lockwood Security Products Pty Ltd v Doric Products Pty Limited (2004) 217 CLR 274 cited

Pharmacia Italia SpA v Mayne Pharma Pty Ltd (2005) 222 ALR 552 discussed

Prejay Holdings Ltd v Commissioner of Patents (2003) 57 IPR 424 referred to

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

PHARMACIA ITALIA SpA and PFIZER (PERTH) PTY LIMITED (FORMERLY PHARMACIA (PERTH) PTY LIMITED) v MAYNE PHARMA PTY LTD, F H FAULDING & CO LTD and FAULDING HEALTHCARE PTY LTD

VID 439 OF 2003

INTERPHARMA PTY LTD v THE COMMISSIONER OF PATENTS and PHARMACIA ITALIA SpA

VID 1274 OF 2005

WEINBERG J

29 MARCH 2006

MELBOURNE

THE COURT ORDERS THAT:

1.         The parties file proposed minutes of orders in accordance with these reasons for judgment, and any other orders or directions appropriate for the future disposition of the matter, on or before 19 April 2006.

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

THE COURT ORDERS THAT:

1.         The application be dismissed.

2.         The applicant pay the second respondent’s costs

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

REASONS FOR JUDGMENT

Introduction

1                     There are two proceedings before the Court which, though separate, raise related issues.  With the consent of the parties, these two proceedings have been heard together.  By agreement, evidence in one is taken to be evidence in the other.

2                     VID 439 of 2003 (“the Pharmacia Proceeding”) concerns the scope of the final injunction to be granted and, in particular, its duration, in a matter that was heard by Crennan J: Pharmacia Italia SpA v Mayne Pharma Pty Ltd (2005) 222 ALR 552 (“the Pharmacia Infringement Proceeding”).  Her Honour found that Mayne Pharma Pty Ltd and the Faulding Co respondents (“Mayne”) had infringed Pharmacia Italia SpA’s (“Pharmacia”) patent, Australian patent no. 598197 (“the Patent”).  The injunction that she granted on 8 September 2005 restrains Mayne from infringing certain claims of the Patent until 19 June 2006, the end of the original term of the Patent, or until “such later date as the Court may hereafter order”.  Mayne objects to any further order being made that would extend the term of that injunction, namely to cover the period of the Patent’s extension from 19 June 2006 to 19 June 2011.

3                     In the second proceeding before the Court, VID 1274 of 2005 (“the Interpharma Review Proceeding”), Interpharma Pty Ltd (“Interpharma”) challenges the decisions of the Commissioner of Patents (“the Commissioner”) to:

(a)                accept an application for an extension of the term of the Patent;

(b)               fail to refuse to accept an application for an extension of the term of the Patent; and

(c)                to grant an extension of the term of the Patent.

4                     It does so pursuant to s 5 of the Administrative Decisions (Judicial Review) Act 1977 (Cth) (“the ADJR Act”) and s 39B(1) of the Judiciary Act 1903 (Cth) (“the Judiciary Act”).  Interpharma has also applied to the Court for rectification of the Register of Patents pursuant to s 192 of the Patents Act 1990 (Cth) (“the Patents Act”).  The basis of that claim is that the Register erroneously records the Patent as having been extended to 19 June 2011. 

5                     In addition to the substantive matters raised by the application for judicial review, there is an issue regarding Interpharma’s delay in having commenced that proceeding.

6                     The Pharmacia Infringement Proceeding raises the issue of what rights a patentee has during the term of an extension, pursuant to s 78(1)(b)(i) of the Patents Act, and therefore what timeframe the final injunction in that proceeding should have.  The Interpharma Review Proceeding raises the issue of whether the decisions leading up to, and including, the decision to grant an extension, were lawfully made under s 70(2)(a) of the Patents Act. 

7                     Both these issues are to be resolved by answering the same question:  is claim 1 of the claims of the Patent correctly characterised as a “pharmaceutical substance per se”?  Or does claim 1 involve elements of process or method that take it outside the scope of that expression?

8                     The answer to this question will determine whether Mayne’s plans regarding its own product, a competitor to that of Pharmacia, can go forward.  It will also affect Interpharma’s planning in relation to the products that it intends to market.

FACTUAL background

9                     Pharmacia, a company incorporated in Italy, is the registered proprietor of the Patent.  The Patent is titled “Injectable ready-to-use solutions containing an antitumor anthracycline glycoside”.  In simple terms, the ready-to-use solution of the invention can be described as a mixture of:

·               a solute (the anthracycline glycoside);

·               a solvent; and

·               an acid. 

10                  The second applicant in the Pharmacia Proceeding, Pfizer (Perth) Pty Limited (formerly Pharmacia (Perth) Pty Limited) (“Pfizer”), is a company incorporated in Australia.  Since 1 June 2003, it has had an exclusive licence in this country in respect of the invention described in the Patent in relation to a product known as “epirubicin hydrochloride”.  The first respondent in the Pharmacia Proceeding, Mayne Pharma Pty Ltd is a manufacturer, distributor and exporter of pharmaceutical products.  The second and third respondents, F H Faulding & Co Ltd and Faulding Healthcare Pty Ltd are related entities and form part of the Mayne Pharma group of companies.

11                  The Patent commenced on 19 June 1986, with a priority date of 2 August 1985.  The original term of the Patent was 20 years, ending on 19 June 2006.  On 14 March 2001, Pharmacia applied to the Commissioner to extend the Patent, and on 24 October 2001, the Commissioner accepted the extension application.  The effect of that acceptance was to trigger the operation of various procedures under the Patents Act enabling the application to be considered.

12                  On 6 April 2002, the Commissioner granted Pharmacia a five year extension of the term of the Patent to 19 June 2011.  There was no opposition at that stage to the grant of the extension.

13                  As previously indicated, Pharmacia and Pfizer subsequently brought the Pharmacia Infringement Proceeding against Mayne, under ss 117 and 120 of the Patents Act, alleging that Mayne had infringed certain claims of the Patent by “manufacturing, selling, using and keeping a ready-to-use antitumor anthracycline glycoside solution as claimed in the Patent”.  The only question resolved in that proceeding was whether Mayne had infringed certain claims of the Patent by making and selling epirubicin hydrochloride in injectable ready-to-use solutions.  Liability was dealt with separately from any question of damages, or account of profits, which issues remain unresolved.

14                  According to Crennan J, at [4] of her reasons for judgment, the primary issue in relation to infringement was whether Mayne’s product had “not been reconstituted from a lyophilizate”, as that phrase appeared in claim 1 of the Patent.  A secondary issue identified by her Honour was whether Mayne avoided infringement on the specific occasions on which they used sodium hydroxide, in addition to hydrochloric acid, to adjust the pH of the solution, given that claim 1 of the Patent refers to the pH being adjusted “solely with a physiologically acceptable acid”.

15                  On 5 August 2005, Crennan J delivered judgment.  Aspects of the dispute between the parties that were dealt with by Crennan J provide relevant background to the proceedings currently before me.  Her Honour found that the Patent had been infringed.  However, she did not make final orders on that day.  Rather, she ordered:

“The parties to prepare short minutes of final orders on liability in accordance with these reasons and include any other orders or directions as appropriate for the further disposition of the matter.”

16                  Pursuant to her Honour’s orders, each party prepared proposed minutes of final orders.  On 8 September 2005, Crennan J made orders by consent, including the following order:

“Until 19 June 2006 or such later date as the Court may hereafter order, the respondents and each of them, whether by themselves, their directors, officers, servants or agents or otherwise, be restrained in Australia from exploiting any anthracycline glycoside ready-to use solution as claimed in any of claims 1 to 30 (inclusive), 5 to 10 (inclusive), 13 to 15 (inclusive), 18, 19, 22, 25 and 26 of Australian patent no. 598197, save that the respondents may until further order exploit:

i.                    doxorubicin hydrochloride injection; and

ii.                  daunorubicin hydrochloride injection.” (emphasis added)

17                  The orders reflect the reasons given in her Honour’s judgment.  However, they gave rise to the further issue that is now the subject of the two proceedings presently before this Court.  In the Pharmacia Proceeding, Mayne contends that the term of the injunction granted by Crennan J should not be extended to 19 June 2011 to cover the extension of patent granted by the Commissioner, but rather should end on 19 June 2006.  In the Interpharma Review Proceeding, Interpharma challenges the validity of the extension itself.

18                  Of relevance to both proceedings currently before the Court, Crennan J, at [5], summarised the three aspects of the invention to which the Patent relates:

“(a)     a pharmaceutical product, being a stable intravenously injectable ready-to-use solution of an antitumor anthracycline glycoside, for example, doxorubicin;

(b)       a process for preparing such a solution, [providing] the same in a sealed container; and

(c)        a method for treating tumours by the use of the ready-to-use solution.”

19                  These three aspects of the invention are reflected in the 26 claims of the Patent which define the invention.  Using the language adopted by Crennan J in her judgment at [19], Pharmacia submits that there are 20 product (“solution”) claims, four “process” claims and two “method” claims.  Of course, whether that is in fact a wholly accurate characterisation of the claims is the very point in issue in the proceedings before me.

20                  The parties do not contend that all the claims are in issue.  Relevantly, claims 3 to 19, and claim 22 (described by Crennan J as the “solution” claims), are dependent on claim 1.  If claim 1 is not properly to be characterised as a “solution” claim, but does, in fact, incorporate significant elements of “process”, Pharmacia acknowledges that none of the remaining “solution” claims can lawfully be the subject of an extension.  The parties are agreed that resolution of the construction of claim 1 will resolve the controversy between them.  It is convenient therefore, to deal with each of the alleged “process” features in the context of claim 1.

21                  Claim 1, in its current form, is in the following terms:

“1.       A sterile, pyrogen-free, anthracycline glycoside solution which comprises a physiologically acceptable salt of an anthracycline glycoside dissolved in a physiologically acceptable aqueous solvent therefor at an anthracycline glycoside concentration of from 0.1 to 50 mg/ml, which has not been reconstituted from a lyophilizate and the pH of which has been adjusted [to] from 2.5 to 5.0 solely with a physiologically acceptable acid.”

22                  As will be seen, in broad terms Mayne focuses upon the terms “dissolved”, “not being reconstituted from a lyophilizate” and “adjusted” as the basis for its submission that claim 1 contains elements of process that prevent it from being the subject of a lawful extension.  I should interpolate that it was common ground between the parties that the word “to”, which appears in square brackets in claim 1, as set out above, but does not appear in the claim as it actually stands, should be read into it.  It does not matter, for present purposes, whether that is because the word was excluded inadvertently, or whether it is necessary to insert it in order to give sensible meaning to the claim.

23                  In the Interpharma Review Proceeding exactly the same issue arises.  The applicant, Interpharma, is a company incorporated in Australia.  On 22 May 2003 it signed an exclusive Supply and Distribution Agreement with EBEWE Pharma for two products known as “doxorubicin EBEWE” and “epirubicin EBEWE”.  In that proceeding, it is accepted that at least from 22 May 2003, Interpharma was a “person aggrieved” within the meaning of s 5(1) of the ADJR Act.  It should be noted that, in accordance with the usual practice, the Commissioner did not seek to be heard in relation to the challenge to the extension decision.  However, the Commissioner’s decision was supported by Pharmacia, the second respondent in the Interpharma Review Proceeding.

the relevant legislative provisions

24                  Part 3 of Ch 6 of the Patents Act provides a statutory framework for the extension of the term of standard patents relating to pharmaceutical substances.  Section 70 relevantly provides:

“(1)     The patentee of a standard patent may apply to the Commissioner for an extension of the term of the patent if the requirements set out in subsections (2), (3) and (4) are satisfied.

(2)       Either or both of the following conditions must be satisfied:

(a)       one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;

(b)       one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.”

25                  The patent under consideration in these proceedings falls into the first category,
s 70(2)(a).  Section 70(2)(b) is of no relevance.

26                  The expression “pharmaceutical substance” is defined in Schedule 1 of the Act to mean:

“a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:

(a)       a chemical interaction, or physico‑chemical interaction, with a human physiological system; or

(b)       action on an infectious agent, or on a toxin or other poison, in a human body;

but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing.”

27                  The term “therapeutic use” is also defined in Schedule 1.  It means:

“use for the purpose of:

(a)       preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or

(b)       influencing, inhibiting or modifying a physiological process in persons; or

(c)        testing the susceptibility of persons to a disease or ailment.”

28                  Section 70(3) provides that the following conditions must be satisfied in relation to at least one of the pharmaceutical substances referred to in s 70(2):

“(a)     goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods;

(b)       the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years.”

29                  Section 70(4) requires that the patent must not have been previously extended under Pt 3.

30                  It is accepted by the parties that the Patent satisfies the requirements set out in ss 70(3) and (4).  The only issue that must be resolved is whether it also satisfies the requirements set out in s 70(2)(a).

31                  Section 74(1) provides that if the Commissioner is satisfied that the requirements of ss 70 and 71 (form and timing of an application) are satisfied, then the Commissioner must accept the application for an extension.  Section 74(2)(a) provides that if the Commissioner accepts the application, the applicant must be notified in writing of the acceptance, and s 74(2)(b) requires the Commissioner, in that event, to publish a notice of the acceptance in the Official Journal, as that publication is defined in s 222.

32                  Section 76(1)(a) provides that the Commissioner must grant an extension of the term of a standard patent if there is no opposition to that grant.  Of course, that presupposes that the requirements for an extension set out in ss 70 and 71 are satisfied.

33                  Section 78 sets out the exclusive rights of the patentee during the term of the extension.  The effect of this section is to limit the scope of the patentee’s monopoly on the patent so that the exclusive right to exploit the invention is limited to a pharmaceutical substance which has satisfied the extension criteria in s 70(2)(a).

34                  Section 78(1)(b)(i) provides that the exclusive rights of the patentee during the term of the extension are not infringed:

“by a person exploiting any form of the invention other than:

(i)        a pharmaceutical substance per se that is in substance disclosed in the complete specification of the patent and in substance falls within the scope of the claim or claims of that specification…” (emphasis added)

35                  This section has the potential to provide Mayne with a defence if it proceeds to exploit its own anthracycline glycoside product after 19 June 2006.  It is that potential that is of central importance to the resolution of the issues raised in the Pharmacia Proceeding.  Self evidently, an injunction should not go to prevent a person from engaging in conduct during the term of any extension that is entirely lawful, as Mayne’s proposed exploitation of its product would be if the Patent does not involve a pharmaceutical substance per se.

the pharmacia proceedings

Mayne’s submissions

36                  Mr Macaw QC, on behalf of Mayne, submitted that the various claims of the Patent that Crennan J found had been infringed (namely, claims 1 to 3, 5 to 10, 13 to 15, 18, 19, 22, 25 and 26) were not claims to a “pharmaceutical substance per se” within the meaning of s 78(1)(b)(i), and therefore do not warrant any protection by injunctive relief beyond the expiry date of the original term of the Patent, 19 June 2006.

37                  Mr Macaw submitted that claim 1 (and therefore the dependent claims as well) was a “product by process” claim, because of the various process elements that were included in the claim, as formulated.  He contended that the introduction of “process elements” as part of the description of the product prevented claim 1 from being a claim to a “pharmaceutical substance per se”.

38                  According to Mr Macaw, it followed that any infringing activity on Mayne’s part was, and is, by way of exploitation of a form of the invention other than a “pharmaceutical substance per se”.  As a result, by reason of section 78(1)(b)(i), the final injunction to be granted should not continue for the extended period of the Patent but, rather, should end at the expiry of the original patent period, on 19 June 2006.

39                  Mr Macaw referred to the judgment of a Full Court of this Court in Boehringer Ingelheim International GmbH v Commissioner of Patents (2001) 112 FCR 595 (“Boehringer”).  He submitted that Boehringer was authority for the proposition that the requirement that a patent involve a claim to a “pharmaceutical substance per se” requires more than that a pharmaceutical substance simply forms some element of the claim or claims.  Mr Macaw also relied upon Boehringer as authority for the proposition that, in order to satisfy the requirements of s 70(2)(a), the pharmaceutical substance must fall within the scope of the claim, that is, it must be included among the things claimed.

40                  In addition, Mr Macaw referred to the later judgment of a Full Court of this Court in Prejay Holdings Ltd v Commissioner of Patents (2003) 57 IPR 424 (“Prejay”), where the decision in Boehringer was expressly approved.  The Court in Prejay held that s 70(2)(a) requires a pharmaceutical substance itself to be an integer of a claim in the relevant patent.  It is not enough that the substance appears in a claim in combination with other integers, or as part of the description of a method (or process) that is the subject of a claim.  The Court noted at [24] that “[t]he policy adopted in s 70 was to confine extensions to patents that claim invention of the substance itself”. 

41                  Mr Macaw submitted that claim 1 had the following process components, and therefore was not a claim to a pharmaceutical product per se:

“(a)     the product of claim 1 must be made by a process other than by reconstitution from a lyophilizate (in a vial immediately prior to administration);

(b)       the salt of the active ingredient must have been dissolved in an aqueous solvent;

(c)       the product must be made by a process of adjustment of the pH into a range of between 2.5 and 5.0;

(d)       that adjustment must solely have been done with a physiologically acceptable acid.”

42                  According to Mr Macaw, it was not any anthracycline glycoside solution that would infringe claim 1, but only a solution obtained in accordance with the process integers of that claim.  He referred to a series of amendments that Pharmacia had made to the form in which claim 1 was drafted at various stages. He contended that by adding “pH adjustment integers”, for example, Pharmacia appeared to have made a conscious decision to include a process element in the claim, thereby widening the scope of the protection sought for its product.  It was in part for this reason that Mr Macaw contended that the product of claim 1 was defined by the process by which it was obtained.

43                  In addition, Mr Macaw submitted that even if his primary contention was not accepted by the Court, the injunction should be worded so as to reflect the limitation upon the rights of a patentee under an extension of the term of a standard patent contained in
ss 78(2)(c) and (d).  Those provisions make it clear that if the Commissioner grants an extension, the exclusive rights of the patentee are not infringed by a person exploiting a pharmaceutical substance:

“…solely for purposes in connection with:

(c)       having goods included in the Australian Register of Therapeutic Goods, where the goods are intended for therapeutic use; or

(d)       obtaining similar regulatory approval under a law of a foreign country or of a part of a foreign country.”

44                  Mr Macaw noted that in addition to manufacturing epirubicin hydrochloride solution, Mayne manufactured anthracycline glycoside solutions such as doxorubicin hydrochloride and daunorubicin hydrochloride, neither of which was alleged, nor found by Crennan J, to infringe the Patent in the Pharmacia Infringement Proceeding.  Mr Macaw contended that the scope of the injunction should therefore be limited, on a permanent basis, to include only the epirubicin hydrochloride solution that was found to infringe, and not the other anthracycline glycoside solutions, such as doxorubicin hydrochloride and daunorubicin hydrochloride, that Mayne produces.

45                  It seems that the position regarding these other anthracycline glycoside solutions remains somewhat uncertain.  Order 1 of the orders made by Crennan J on 8 September 2005 reflected an agreement between the parties, on an interim basis, that doxorubicin hydrochloride and daunorubicin hydrochloride should be excluded from the scope of the injunction.  There was also an agreement that they be excluded from any order for damages, or an account of profits, again on an interim basis only, pending Pharmacia having further time to consider its position in relation to them.  Mr Macaw submitted that given that Pharmacia had now had that opportunity, but was unprepared to commit itself to a stance, the interim position should be made permanent. 

46                  In the course of oral submissions Mr Macaw referred to Mayne’s licence to produce doxorubicin hydrochloride and daunorubicin hydrochloride and the question of “the appropriate formulation of the injunction”.  He stated:

“[T]he parties have attempted a commercial resolution of that matter and my instructions are that it’s close and we would seek merely have that aspect of the matter adjourned to a date to be fixed”.

47                  Mr Caine SC, on behalf of Pharmacia, did not have anything to say regarding this matter.  It may be, therefore, that the form of the injunction granted by Crennan J will have to be varied irrespective of the outcome of this proceeding, in order to make it clear that Mayne’s entitlement to manufacture its non-infringing products is not in any way impaired by that injunction.

48                  Finally, Mr Macaw referred to order 2 of Crennan J’s orders of 8 September 2005.  That order is in the following terms:

“Save for the samples referred to at paragraph 27 to 29 of the affidavit of Joanna Elizabeth Johnson sworn on 7 September 2005, the respondents, within 21 days of the date of this Order, destroy all epirubicin hydrochloride ready-to-use solutions in their possession, custody, power or control, the sale, supply or use of which by the respondents, their servants or agents or by any person to whom such epirubicin hydrochloride solution were to be supplied would be in breach of the foregoing injunction.”

49                  Mr Macaw contended that it was implicit that the injunction should not prevent use of the retained samples, referred to in order 2, for the particular purposes identified in the affidavit of Joanna Elizabeth Johnson sworn on 7 September 2005.  In relation to this matter, Mr Macaw stated:

“…I don’t think I need to trouble your Honour with [the samples point], because I understand that it’s not contentious.  We’ll hand your Honour a form of the order which incorporates those – which accommodates those matters… in due course, but we apprehend to say that that’s not an issue.

HIS HONOUR:  So, on any view the injunction would be limited if the injunction extends beyond June of this year in the weigh [sic] group.

MR MACAW:  Would in any event be limited, yes.

HIS HONOUR:  Yes, I follow.”

50                  Mr Caine did not have anything to say about this matter.  Accordingly, it may be necessary, once again, to vary the terms of the injunction to reflect any agreement that is reached between the parties regarding this issue.

Pharmacia’s submissions

51                  Mr Caine did not contend that the “process” or “method” claims defining the invention (by which he meant claims 2, 20, 21 and 23-26) could provide a basis for the extension of the term of the Patent.  He agreed that the claims in issue were limited to claim 1, and claims 3 to 19.  Claim 22, though not regarded as a “process” or “method” claim, was expressly abandoned by Mr Caine during the course of the hearing.

52                  Mr Caine submitted that the solution that was the subject of the Patent was plainly a “pharmaceutical substance” within the meaning of Schedule 1 of the Patents Act.  He further submitted that claim 1 involved a claim in relation to a pharmaceutical substance per se.  In simple terms, he argued that the injectable ready-to-use solution was a mixture of substances which had particular characteristics.  Those characteristics were what I referred to in argument as “descriptors”, enabling the substance to be readily defined, and differentiated from other pharmaceutical substances that were not within the protection of the Patent.

53                  Mr Caine submitted that the characteristics identified in claim 1 were, in broad terms, as follows.  The substance was a solution which was administered to a patient for the purpose of curing or alleviating a disease, and which had a chemical or physico-chemical effect on the physiological system of the patient.

54                  In his submissions, Mr Caine distinguished claim 1 from the claims considered in Boehringer, and in Prejay.  He noted that in Boehringer the claim had not been limited to a pharmaceutical substance alone, but included a container with a nozzle designed to deliver that substance.  He also noted that in Prejay the claim had been expressed in terms of a method for treating menopausal women using a transdermal patch to provide continuous dosages of progesterone and estrogen.  He submitted that in each case, whilst the invention claimed was patentable, the claim related to a known substance coupled with a novel delivery system.  He contended that this was in marked contrast to the invention the subject of the Patent, which claimed a new and inventive pharmaceutical substance, on its own.

55                  Mr Caine next referred to the requirement under s 70(2)(a) that a patent disclose and include within the scope of the claims a pharmaceutical substance per se.  He rejected Mayne’s submission that the Patent did not disclose or claim a pharmaceutical substance per se, but rather a pharmaceutical substance produced by a defined process or method.  He submitted that the question whether claim 1, as currently formulated, identified a pharmaceutical substance per se, or extended into the realms of process or method, had to be approached as a matter of substance, and not form.  That is, it was a question to be resolved by considering the scope of the claim “broadly, that is to say in a general sense”: Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 at 95 per Gummow J, cited with approval by the High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Limited (2004) 217 CLR 274 at [69].

56                  In reply to Mr Macaw’s contention that claim 1 included process components, Mr Caine submitted that:

(a)        by excluding anthracycline glycoside solutions which were prepared by reconstitution from a lyophilizate (solid), Pharmacia, in claim 1, had expressly disclaimed the prior art “the better to mark out the monopoly and to define the invention”.  Accordingly, the exclusionary integer did no more than identify the scope of the monopoly claimed.  It did not itself define any feature of the solution that was claimed, nor describe a claimed process;

(b)       the use of the word “dissolved” in claim 1 merely described the physical status of the salt of the anthracycline glycoside claimed.  It described the fact that the physiologically acceptable salt of anthracycline glycoside was in solution, the solvent being a physiologically acceptable aqueous liquid.  It did not convey the process to be followed in order to put the relevant salt into solution, nor assert any novelty associated with that process;

(c)        the words “the pH of which has been adjusted [to] from 2.5 to 5.0…” imported a requirement that the pH of the claimed solution be in the required range.  The reference to pH was a reference to the acidity/alkalinity of the solution.  This integer described a characteristic of the sterile, pyrogen-free anthracycline glycoside solution identified in claim 1. The claim, as formulated, did not limit the time at which, or the manner in which, the acid was to be added.  All that the claim required was that the mixture, at some point during the course of its production, have an acid included in an amount suitable to achieve a pH in the claimed range; and

(d)       the words “solely with a physiologically acceptable acid” simply imposed a requirement that the claimed pH range was achieved by the inclusion of acid alone, and did not describe the process by which that required range was to be achieved.

57                  Mr Caine also rejected Mr Macaw’s submission that Pharmacia deliberately amended the Patent in order to encompass a process requirement, so that it could achieve wider protection.  Mr Caine submitted that the reason for that amendment had nothing to do with seeking wider protection, but rather was simply to remove earlier references to buffers, and to make clear that only a physiologically acceptable acid should be used to ensure the correct pH.

58                  Mr Caine submitted that, when read as a whole, claim 1 disclosed and identified a pharmaceutical substance per se.  The elements of that claim described attributes of the solution which was a mixture of substances that could be administered to the body so as to cause a therapeutic effect.  It was the solution in its final ready-to-use form that was administered to patients which had the required physico-chemical interaction with the patient’s physiological system.  It was the properties of that solution which provided advantages over the prior art formulations of anthracycline glycosides.

59                  Finally, Mr Caine referred to the judgment of Crennan J in the Pharmacia Infringement Proceeding.  He noted that her Honour had found Mayne liable for infringing Pharmacia’s patent rights, and submitted that it was at least implicit in her Honour’s reasoning that Mayne had been seeking to exploit a form of the invention that was a pharmaceutical substance per se.  It was equally implicit in that reasoning that the product was in substance disclosed in the complete specification of the Patent and that its product fell within the scope of the relevant claims of that specification, as Boehringer required.  Accordingly, he submitted, Mayne would not be able to avoid infringement by reason of s 78(1)(b)(i).  It followed that the term of the injunction granted by Crennan J should extend to 19 June 2011.

the interpharma review proceeding

INTERPHARMA’s submissions

60                  Interpharma seeks an order of review under s 5 of the ADJR Act of the following decisions of the Commissioner:

(a)        the decision of 24 October 2001 to accept Pharmacia’s application for an extension of the term of the Patent filed on 14 March 2001;

(b)       the failure on or about the 24 October 2001 to refuse Pharmacia’s application for an extension of the term of the Patent;

(c)        the decision to grant an extension of the term of the Patent by certificate dated 6 April 2002 for five years to 19 June 2011.

61                  Ms Strong SC, who appeared on behalf of Interpharma, submitted that each of these decisions was of an administrative character, and that Interpharma was, and is, a “person aggrieved” within the meaning of s 5 of the ADJR Act.  Pharmacia did not take issue with these contentions.

62                  Ms Strong submitted, as did Mr Macaw, that the Patent does not disclose or claim a pharmaceutical substance per se.  Her arguments on this issue largely mirror those made by Mr Macaw in the Pharmacia Proceeding.  However, in one respect they go further.

63                  Interpharma called as an expert witness in this proceeding Dr Geraldine Anne Elliott.  Dr Elliott is currently employed by Imaginot Pty Ltd in Brisbane as its Director of Research and Development.  That company engages in the development of orally administered drug delivery systems.  Dr Elliott has a PhD from the University of London, an MBA from the University of Melbourne and has for many years been a registered pharmacist in the United Kingdom, and elsewhere.  From 1997 to 2004 she was employed by Mayne, and was responsible for its injectable product development program which included a number of projects on anthracycline glycosides.  Those projects involved the development of stable formulations of lyophilizates.

64                  Dr Elliott was asked by Interpharma to prepare an expert report dealing with the major issue in these proceedings.  In particular, she was asked to consider whether one or more “pharmaceutical substances” as defined in Schedule 1 of the Patents Act “in substance” fell within the scope of claim 1 of the Patent.

65                  Dr Elliott was provided with a copy of Schedule 1, with its definition of “pharmaceutical substance”, set out above at [26].  She focussed upon the following words of that definition: “a substance (including a mixture or compound of substances) for therapeutic use…”.  She said that she understood this definition, when considered in its proper context, to mean a specific chemical compound which, when administered, will exert a pharmacological effect in the body as a direct result of the interaction between that compound, and the physiological system.  She accepted that anthracycline glycosides are therapeutic agents used in the treatment of cancers, and are administered by injection as they are not absorbed when administered orally.

66                  Dr Elliott then turned to claim 1 as currently formulated.  Her opinion was that the “physiologically acceptable salt of an anthracycline glycoside” described in claim 1 was a pharmaceutical substance as this was “the compound that exerts a therapeutic effect in the body, in this case a cytotoxic effect against cancer cells”.  However, neither the “physiologically acceptable aqueous solvent” nor the “physiologically acceptable acid” for pH adjustment described in claim 1 had any cytotoxic pharmacological action.  They were pharmacologically inert ingredients in the solution, necessary to stabilise the product, and prevent degradation of the anthracycline glycoside, but were not themselves “pharmaceutical substances”.

67                  Dr Elliott was cross-examined at some length by Mr Caine.  It is unnecessary for present purposes to set out in any great detail the nature of the cross-examination.  Put simply, Mr Caine suggested to Dr Elliott that her opinion was idiosyncratic, and failed to reflect the authoritative interpretation that had been accorded to the definition of “pharmaceutical substance” by both Heerey J at first instance (Boehringer Ingelheim International v Commissioner of Patents (2001) AIPC ¶91-670), and by the Full Court in Boehringer.

68                  The transcript of Mr Caine’s cross-examination sheds considerable light on this issue:

“MR CAINE:…Dr Elliott, just to identify it for the transcript, that is a copy of the Boehringer decision at first instance before Heerey J which is document 5 in the briefing documents that you were given for the purpose of preparing your report.  Would you be good enough to go to paragraph 18 of that decision where his Honour sets out an extract from the Patent Office Manual of Practice and Procedure?‑‑‑Yes, I have it.

Would you go to the part of paragraph 18 where his Honour extracts from the Manual paragraph 25.2.3 which is headed, “Mixture or Compound of Substances”.  Do you see in the first paragraph under that sub-heading his Honour - I am sorry, the Patent Office Manual says:

The definition of a pharmaceutical substance includes a mixture or compound of substances.

Just pausing there, you would accept that that is part of the statutory definition in schedule 1 of the Act, would you not?‑‑‑It is.

Yes, and the Manual goes on to say:

In the case of such mixtures or compounds the test of whether or not a substance is a pharmaceutical substance applies to the mixture or compound as a whole, not to an individual component of the mixture or compound.

And then in the next paragraph the Manual says:

Thus a typical ARTG registration might refer to an active ingredient in a particular carrier or excipient.  In this situation the pharmaceutical substance is the active ingredient in the carrier or excipient, not the active ingredient alone.

Now pausing there, do you recall reading those two paragraphs and taking them on board when you were reading Heerey Js decision for the purpose of your report?‑‑‑Yes, I did.

Did you - the view that you have expressed in your report as I understand it is that the pharmaceutical substance as defined in the Act should be narrowly considered as the active ingredient on its own?‑‑‑I do.

Yes.  That is at odds, is it not, with what is set out in those two paragraphs in the Patent Office Manual?‑‑‑I don’t believe so and as far as the active ingredient is the pharmaceutical substance that is going to interact with the body and regardless of what the other components are, that is the product that is going to be exerting its pharmacological effect.

I understand that is your view but the view expressed here in the Manual and extracted by his Honour is that it is the active ingredient, my words, together with the carrier or excipient, not the active ingredient alone.  Do you see that?‑‑‑For clarification I would read that saying it is the pharmaceutical substance is the active ingredient in the carrier or excipient so that they go together and that is those components are being put in the body but in fact it will be only the pharmaceutical substance that is having an effect so you can have multiple products with the same active ingredient.

Yes.  Why then do the words appear at the end of that sentence:

            Not the active ingredient alone.

MS STRONG:   I don’t think Dr Elliott can really answer that question, your Honour.

HIS HONOUR:   Sorry, I didn’t quite catch what you were saying, Ms Strong.

MS STRONG:   Well, my learned friend has asked her why there is a particular sentence put into the Patent Office Manual.  I doubt that she would know why.

HIS HONOUR:   It seems to me this is cross-examination as to credit and quite permissible, Ms Strong.

MS STRONG:   If your Honour pleases.

HIS HONOUR:   Yes, you can ask the question again.

MR CAINE:   As a result of that, I will put it again if I can.  What I am simply putting to you, Dr Elliott, is I understand that the view you have expressed in the report is that the pharmaceutical substance defined in the Act is to be confined to the active ingredient alone and all I am putting to you is that the Manual, the Australian Patent Office Manual, does not share your view.  It says that:

For the purposes of the Act the pharmaceutical substance is the combination of the active ingredient together with the carrier or excipient, not the active ingredient alone.

Do you accept that your view is at odds with the Manual?‑‑‑In relation to that specific paragraph?

Yes?‑‑‑The interpretation could be that it is.

Yes, and if the Manual expresses the correct test according to law and that will be a matter for his Honour later on, you would accept that your view is at odds with that test?‑‑‑If that is that particular sentence as opposed to the other guidances that are provided in that extract from the Manual which again clearly are at odds there would appear to be an internal inconsistency within that.

Yes.”

69                  When Dr Elliott’s attention was drawn to what the Patent Office Manual of Practice and Procedure (“the Manual”) said about the meaning of “pharmaceutical substance”, and what both Heerey J and the Full Court had said about that matter, she remained doggedly of the view that her position was correct, and what was said elsewhere was of little consequence.  She regarded the Manual as leading to “confusion in terms of understanding what is the active component”, and rejected its essential tenor.

70                  In closing submissions, Mr Caine invited me to disregard the opinion expressed by Dr Elliott.  He submitted that if her interpretation of “pharmaceutical substance” were correct, it would be impossible to obtain an extension of a patent involving any invented solution, of which only one component was of direct therapeutic use.  That would be so even if the product as a whole, including inert compounds designed to achieve stability for the actual substance that exerts a therapeutic effect, had a therapeutic effect in the body (in this case a cytotoxic effect against cancer cells).

71                  It is important to note that Mr Macaw expressly declined to adopt Ms Strong’s submission that Pharmacia’s product was not, relevantly, a “pharmaceutical substance”.  He confined his submission to contending that the product was not a “pharmaceutical substance per se”, essentially because it encompassed elements of process.

72                  Ms Strong also made a number of submissions regarding the timing of Interpharma’s application for review.  She noted that s 11(4) of the ADJR Act provides this Court with the discretion to refuse to entertain an application for an order of review if “the court is of the opinion that the application was not made within a reasonable time after the decision was made” (emphasis added).  She also noted that when forming its opinion, s 11(5) of that Act provides that the Court “shall have regard to the time when the applicant became aware of the making of the decision; and…may have regard to such other matters as it considers relevant.”  Ms Strong then sought to explain, and to justify, Interpharma’s delay. 

73                  On this point, Ms Strong submitted that there was nothing in the evidence led on behalf of Pharmacia to suggest that it would, in any way, be prejudiced if time were extended to allow the application for review to proceed.  She described that evidence as “broadbrush” and speculative.  She further submitted that Interpharma had acted reasonably in assuming that the processes by which EBEWE Pharma proposed to manufacture doxorubicin EBEWE and epirubicin EBEWE for the Australian market did not come within the claims specified in the Patent.

74                  Ms Strong argued that it was not until Interpharma was in a position to market doxorubicin EBEWE, in about August 2005, after the judgment of Crennan J in the Pharmacia Infringement Proceeding had been delivered, that it was reasonable to expect Interpharma to challenge the extension of the Patent.  Interpharma had filed its application for review of the Commissioner’s decisions on 11 October 2005, not long after her Honour’s judgment had become available.  According to Ms Strong, “[f]rom August 2005, Interpharma moved with great expedition”.

75                  It should be remembered that Interpharma also relied upon s 39B of the Judiciary Act in challenging the validity of the Commissioner’s decision to grant the extension of the Patent.  Ms Strong noted that there was no specific time limit, under the Federal Court Rules, for the grant of certiorari, which was the principal remedy sought.  It was only necessary, as a matter of discretion, to persuade the Court that relief should not be withheld by reason of excessive delay.  She submitted that in context, the delay was adequately explained. 

76                  Finally, Ms Strong sought to invoke s 192 of the Patents Act, as a separate basis upon which relief should be granted.  That section allows for rectification of the Register.  She submitted that the need to ensure that the Register was properly maintained justified the relief sought, no matter how long, or how unjustified, the delay might be.

Pharmacia’s submissions

77                  Mr Caine accepted that at least from 22 May 2003 (the date on which Interpharma signed an exclusive Supply and Distribution Agreement with EBEWE Pharma), Interpharma was a “person aggrieved” within the meaning of section 5(1) of the ADJR Act.

78                  For the reasons outlined in his submissions in the Pharmacia Proceeding, Mr Caine contended that the Commissioner had been justified in extending the term of the Patent.  He therefore submitted that the substantive merits of Interpharma’s application were conspicuously weak, a matter that was relevant when considering whether to grant an extension of time for the application for review.

79                  However, in the event that Interpharma’s application for review was thought to have some arguable basis, Mr Caine submitted that the Court should nonetheless refuse to entertain it because of the delay that had ensued, and the prejudice that would be occasioned to Pharmacia if the decision to extend the Patent were now to be set aside.  He submitted that Interpharma had been aware, at least from 30 July 2003, that the Patent had been extended.  According to Mr Caine, Interpharma had simply made a calculated business decision to delay commencing the Interpharma Review Proceeding until 17 October 2005, more than two years later, because:

(a)        Interpharma (incorrectly) believed that the EBEWE Pharma products it proposed to market in Australia would not infringe the Patent; and

(b)       it was prepared to wait for the final outcome of the Pharmacia Infringement Proceeding.

80                  Mr Caine submitted that neither of these two factors adequately explained, or justified, the inordinate delay that had taken place.  As regards the ADJR Act, the application was not made within a reasonable time.  With regard to the Judiciary Act application, he submitted that the Court should decline to grant the prerogative relief sought.

81                  In relation to Interpharma’s claim for relief under s 192 of the Patents Act, Mr Caine noted that the section formed part of Ch 19 which was directed to “the Register and official documents”.  He submitted that s 192 was intended merely to allow for the correction of clerical errors, or other mistakes of that type, in the Register.  He submitted that if the section were given the broad interpretation for which Ms Strong contended, and applied generally to challenges of various types to the validity of patents, the suitability of applications for grant, and the extension of patents, the effect would be to undermine the proper working of the Patents Act.

82                  Mr Caine submitted that s 192 was a general provision, and did not limit the time in which an application could be made for an order rectifying the Register, whereas s 75 of the Patents Act specifically prescribes the circumstances within which a person may oppose the grant of an extension.  Mr Caine noted that reg 5 of the Patents Regulations 1991 (Cth), which applies if a notice of opposition has been filed for the purposes of s 75 of the Act, strictly prescribes a three month time limitation within which a person may oppose the grant of an extension.  He contended that the broad construction of s 192 contended for by Ms Strong would also conflict with the specific requirements of s 75 (and reg 5).  Accordingly, he submitted, s 192 should be construed more narrowly, and not as permitting a wholesale review of the exercise of statutory powers by the Commissioner.

CONCLUSION

83                  The only issue to be determined in the Pharmacia Proceeding is whether claim 1, in its current form, is a claim that involves a “pharmaceutical substance per se”.

84                  Unlike Interpharma, in the Interpharma Review Proceeding, Mayne does not contend that Pharmacia’s product is not relevantly a “pharmaceutical substance”.  It focuses upon the Latin words “per se”, and their effect upon the requirements of s 70(2)(a).

85                  The meaning of the expression “pharmaceutical substance per se” in s 70(2)(a) has been authoritatively considered by a Full Court of this Court in Boehringer.  The facts of that case were set out succinctly by Heerey J, at first instance.

86                  As previously indicated, the patent in that case related to compositions for the treatment of nasal hypersecretion (runny nose), containers adapted for nasal administration and containing compositions for such treatments, and methods of treating the condition.  Claim 1 of the patent in that case was as follows:

“A container comprising an aerosol or spray composition for nasal administration which composition comprises as active ingredient a quaternary tropane alkaloid derivative with atropine-like activity [hereafter “the Substance”], the container being provided with a nozzle adapted for nasal administration of the composition.”

87                  His Honour described at [4] the remaining claims in the following terms:

“Claims 2 and 3 are for a container where the composition comprises or contains specified substances, being more particular forms of the Substance.  Claim 4 is for a container claimed in any one of the preceding claims having a metering device.  Claim 5 is for the container of claim 4 wherein the metering device is adapted to deliver specified quantities of the Substance.  Claims 6 to 9 are directed to methods of treatment of nasal hypersecretion comprising the nasal administration of an effective amount of a pharmaceutical composition comprising as active ingredient the Substance or particular forms or quantities of the Substance.  Claims 10 to 12 are omnibus claims.  Claim 13 is for a method of treatment as claimed in claim 6 with reference to any one of the Examples. Claims 14 to 16 are directed to an aerosol or spray composition as claimed in claim 1 when used in the container of claim 1.”

88                  Heerey J found it useful to consider the history of s 70 in order to understand why the expression “pharmaceutical substance per se” had been introduced.  His Honour observed at [8]-[13]:

“Under Part IX of the Patents Act 1952 (Cth) (“the 1952 Act”) a patentee could seek an extension of up to ten years if it could be shown that the patentee had been “inadequately remunerated”.  Section 93 directed the court to have regard to the nature and merits of the invention, the profits made by the patentee and all the circumstances of the case.  In practice patentees produced substantial accounting evidence endeavouring to show great expenditure on research and development and only modest sales.

Part IX applied to all patents, irrespective of subject matter.  However extension applications were frequently brought in the case of pharmaceutical patents because regulatory approval requirements often meant that the product could not enter the marketplace until a substantial part of the patent protection period had already passed.

The first particularised legislative treatment of pharmaceutical patents came in 1989.  By the Patents Amendment Act 1989 (Cth) a new s 90 was inserted in the 1952 Act.  The new s 90(1) provided:

“90(1)Where:

(a)       a pharmaceutical substance is in substance disclosed in the complete specification of a standard patent and in substance falls within the scope of the claim or claims of that complete specification; and

(b)       the patentee has requested the issue of a marketing approval certificate in respect of that substance,

the patentee may, by notice in writing in accordance with the prescribed form given to the Commissioner not later than 12 months before the end of the term of the patent, apply for an extension of the term of the patent in respect of that substance and any other pharmaceutical substance which is in substance disclosed in the specification and in substance falls within the scope of the claim or claims of the specification.”

When the 1990 Act was introduced, Part IX of the 1952 Act, as amended in 1989, was in substance re-enacted.

By the Patents (World Trade Organization Amendments) Act 1994 (Cth) Div 2 of Pt 3 of Ch 6 of the 1990 Act, containing the extension provisions in ss 70 to 79, was repealed.  Section 70 and related sections in their present form were introduced by the Intellectual Property Laws Amendment Act 1998 (Cth).  For the first time, provision was made for the extension of not just of a “pharmaceutical patent”, but a “pharmaceutical patent per se”.

The 1990 Act in its present form manifests a policy which draws a distinction between, on the one hand, a pharmaceutical substance that is the subject of a patent claim and, on the other hand, a pharmaceutical substance that forms part of a method or process claim.  The specific exception to the latter (an exception which proves the rule) is the provision for recombinant DNA technology in s 70(2)(b).”

89                  Heerey J went on to say at [14]-[16]:

“Broadly speaking, a claim in relation to a pharmaceutical substance can be made in three ways

(i)      a new and inventive product alone;

(ii)     an old or known product prepared by a new and inventive process;

(iii)    an old or known product used in a new and inventive mode of treatment.

What is clear in s 70 is that only the first type of claim to a pharmaceutical product is to be subject to extension rights.  So far as a new process is concerned, it is only when the new process answers the particular description in s 70(2)(b) (recombinant DNA process) that it can be the subject of an extension.  As counsel for the Commissioner submitted, the policy to be deduced in the light of the legislative history is that Parliament has decided that what is intended to be fostered is primary research and development in inventive substances, not the way they are made or the way they are used, with the sole (and important) exception of recombinant DNA techniques, this being an area particularly worthy of assistance for research and development. 

In the light of this history, the relevance of the expression “per se” becomes clear.  Section 70(2)(a) is only to make extension rights available when the claim is for a pharmaceutical substance as such, as opposed to a substance forming part of a method or process.”

90                  His Honour next referred to the Manual, a work used as an internal guide to the administration of the Patents Act, and available to the patent attorney and legal professions.  He drew attention, in particular, to the following passages from the Manual:

 “25.2.2  Pharmaceutical Substance per se

Except for substances produced by a process involving the use of recombinant DNA technology, an extension of term is only available in respect of a pharmaceutical substance per se being within the scope of a claim of the patent.

The explanatory memorandum to the Intellectual Property Laws Bill of 1997 noted that, except for substances produced by a process involving the use of recombinant DNA technology, claims to pharmaceutical substances per se would usually be restricted to new and inventive substances.  The memorandum also mentioned a number of specific instances where an extension would not be available:

‘Patents that claim pharmaceutical substances when produced by a particular process (product by process claims) will not be eligible unless that process involves the use of recombinant DNA technology.  Claims which limit the use of a known substance to a particular environment, for example claims to pharmaceutical substances when used in a new and inventive method of treatment, are not considered to be claims to pharmaceutical substances per se.’

This distinction is specifically evident as between the reference in the Act to ‘pharmaceutical substances per se’, and to ‘pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology’.  The use of the word ‘per se’ requires the claim to the substance to be unqualified by process, temporal, or environmental, components.

Thus, in order that the term of a patent be extended, the patent must contain one or more claims in the form:

            a)         A substance of formula ****

            b)         Substance X mixed with substance Y

Examples of claims that are not directed to substances per se are:

            a)         Substance X when used …

            b)         Substance X for use …

            c)         Substance X when produced by method Y

d)         An antiseptic comprising substance X [unless the label ‘antiseptic’ was clearly non-limiting on the scope of the claim.]

e)         A method of preparing substance X

f)          A substance of formula …, where component Y is produced by …

g)         [A specified quantum] of substance X

h)         ‘Swiss’ – style claims referring to substance X

i)          Use of substance X in the treatment of Y

In limited circumstances, a substance could be new and inventive but can only be defined by reference to the process in which it was made (for example, compound X obtainable by process Y) because the chemical structure or composition is undetermined.  In such circumstances, a claim which defines the substance by reference to such method steps would be a claim to the substance per se.

25.2.3.  Mixture or Compound of Substances

The definition of a pharmaceutical substance includes a mixture or compound of substances.  In the case of such mixtures or compounds, the test of whether or not a substance is a pharmaceutical substance applies to the mixture or compound as a whole, not to an individual component of the mixture or compound.

Thus, a typical ARTG [Australian Register of Therapeutic Goods] registration might refer to an active ingredient in a particular carrier or excipient.  In this situation, the pharmaceutical substance is the active ingredient in the carrier or excipient – not the active ingredient alone.

Of course, under patent law a patent is not granted for a substance capable of being used as a medicine if it is a mere mixture of known ingredients.  Similarly, a collocation of known integers with no working interrelationship is not patentable.  Consequently, while the ARTG may contain many entries involving an active substance with different carriers or excipients, separate patents corresponding to the differing ARTG entries are unlikely to have been granted.

25.2.4 ‘within the scope of the claim’

The mere fact that a substance is mentioned in a claim does not mean that the substance is within the scope of the claim.  The phrase ‘in substance fall within the scope’ has been the subject of judicial interpretation in the context of amendments.  In The Distillers Co. Ld.’s Application, (1953) 70 RPC 221 at page 223 the test for ‘in substance fall within the scope’ was stated to be:

‘would the amendment make anything an infringement which would not have been an infringement before the amendment?’

This was considered by the Commissioner in Astra Lakemedal AG 29 IPR 183, (1994) AIPC ¶91-087, in deciding that a substance was not in substance within the scope of certain claims.  On appeal to the Federal Court in Astra Lakemedal AG 31 IPR 1, the Commissioner’s decision was overturned, having regard to the words ‘to which the application relates’ as present in the then s. 70 (and which are not present in the present legislation).”

91                  His Honour said that he found this material to be of assistance, though he recognised that it was not extrinsic material of the normal type.  Importantly, he implicitly approved of the examples set out at [25.2.2] as aiding in the interpretation of the expression “pharmaceutical substance per se” considered in the light of the history of the relevant section, and its evident purpose.

92                  Not surprisingly, having regard to the nature of the claims relied upon in that case, Heerey J concluded that all of them were for “modes of treatment involving the Substance, not for the Substance in itself”.  Accordingly, the application to review the Commissioner’s refusal to grant the extension was dismissed.

93                  On appeal, the Full Court in Boehringer (Wilcox, Whitlam and Gyles JJ) held that the decision at first instance was correct.  The Court noted that it had been conceded by counsel for the appellant that a container was fundamental to each of the claims, in the sense that, absent a container as described claim 1, there would be no infringement of the patent.  However, it had been submitted that the requirements of s 70(2)(a) were met, and that Heerey J had erroneously interpreted paragraph (a) “as requiring the claim or claims of the patent to exclusively define a pharmaceutical substance per se or to be limited or confined to a pharmaceutical substance per se”.  It had been further submitted that the paragraph required “no more than that a pharmaceutical substance… be included in one or more of those claims as an essential feature”, and that all the relevant claims in that case had specifically included as an essential feature a pharmaceutical substance per se.  The appellant submitted that it did not matter that each claim also included one or more other elements.

94                  The Full Court regarded these submissions as being tantamount to an argument that the words “per se” made no substantial contribution to, and provided no limitation upon, the statutory provisions of s 70(2)(a).  The Court rejected that argument.  It referred with approval, at [34] and [37], to the submission of the respondent that the introduction of the words “per se” by the 1998 amendments indicated a clear intention, on the part of the legislature, to limit the operation of s 70 to patents disclosing and claiming a pharmaceutical substance “by or in itself, intrinsically, essentially” (New Shorter Oxford English Dictionary), or “taken alone; essentially; without reference to anything else” (Butterworth’s Australian Legal Dictionary).

95                  The Full Court noted that the appellant’s argument, if accepted, would have the effect of reading out of s 70(2)(a) the words “per se”.  In addition, the Court regarded the second reading speech and the explanatory memorandum as providing no support to the appellant’s argument; quite the contrary.  The emphasis in those materials was upon the development of new drugs, not drugs in combination with other elements.  The explanatory memorandum, in particular, excluded the application of the new provisions to “new processes of making pharmaceutical substances or new methods of using pharmaceutical substances, where the substances themselves are known”.

96                  Boehringer is of some assistance to Mayne in limiting the scope of extensions that can be granted to pharmaceutical substances.  If a claim, properly understood, is, in effect intended to protect some novel process or method, no extension can be granted.  The claim, when read sensibly, and as a whole, must be to a “pharmaceutical substance per se”.  At least in circumstances where the substance itself is known, the claim must not be, in essence, to a new process of making that substance, or a new method of using it.

97                  The issue to be resolved is how the principles laid down in Boehringer are to be applied to the facts of the present case.  Is claim 1, when read sensibly, and as a whole, properly to be understood as a claim to a new and inventive substance, or are the various references to process elements in that claim, upon which Mayne relied, sufficient to take it outside the ambit of a “pharmaceutical substance per se”?

98                  The matter must largely be one of impression, and degree.  Reasonable minds may differ as to whether the legitimate boundaries of a “pharmaceutical substance per se” have been crossed. 

99                  In my view, when claim 1 is read fairly, and not perversely, and when it is read as a whole, it states a claim to a new and inventive substance, and not to a novel process or method.  In identifying that substance, claim 1 refers to a “sterile, pyrogen-free, anthracycline glycoside solution”.  That is nothing more than a description of the broad characteristics of the solution in question.  The claim next stipulates that the solution “comprises a physiologically acceptable salt of an anthracycline glycoside dissolved in a physiologically acceptable aqueous solvent”.  The use of the verb “dissolved” does not, in context, describe a process that is said to be new and inventive, but merely links the therapeutically significant substance (or active ingredient) with the solvent which, when taken together, go to make up the overall product.

100               The further references in claim 1 to the concentration to be achieved, the fact that the substance has not been reconstituted from a lyophilizate, and the fact that the pH has been adjusted [to] from 2.5 to 5.0 solely with a physiologically acceptable acid, though certainly having elements of process about them, are not, when understood in context, to be regarded as seeking to protect “process”.  They simply mark out the basis upon which the new and inventive substance can be distinguished from other prior art, and enable the scope of the protection to be more accurately understood.

101               Patent rights, and in particular the right to an extension, are very much dependent upon the language of the claim which defines the invention.  When construing a claim, in order to determine whether the requirements set out in s 70(2)(a) are satisfied, it is appropriate to have regard to the reason why any reference to process has been included in the claim as formulated.  There is a difference between seeking to protect a process (which can be the subject of a patent, but cannot be the subject of an extension), and merely referring incidentally to some elements of process, that are not themselves novel, in order to better describe the new and inventive substance.  Section 70(2)(a) provides that a new and inventive substance that is a “pharmaceutical substance per se” can be the subject of an extension.  The approach for which both Mayne and Interpharma contended would deprive the section of much of its force.  It would deny a patentee of a pharmaceutical substance the right to have the protection afforded by its patent extended, in the face of sound economic and policy reasons embodied in the legislation as to why, in the limited cases therein set out, such extension ought to be possible.

102               It follows that, in my view, the injunction granted by Crennan J, with some minor modifications, should continue over the life of the extension of the Patent, until 19 June 2011.  I will order that the parties file proposed minutes of orders giving effect to these reasons for decision.  The proposed minutes of orders should also deal with any other matters the parties consider appropriate, such as the resolution of the issues discussed above at [43]-[50].

103               That takes me to the Interpharma Review Proceeding.  The first issue to be determined in that proceeding is whether claim 1 relevantly describes a “pharmaceutical substance”, putting to one side any additional requirements imposed by the words “per se”.

104               In that regard, I reject the evidence given by Dr Elliott.  I accept that she is a highly qualified expert, and that she genuinely holds the opinions that she expressed in her report.  However, she was cross-examined to very good effect by Mr Caine who demonstrated, to my satisfaction, that Dr Elliott’s view of s 70(2)(a), and the meaning of the expression “pharmaceutical substance” in the context of that section, did not accord with the law as authoritatively determined in Boehringer.

105               As extracted at [88] and [89] of these reasons for judgment, in Boehringer, Heerey J at first instance distinguished a pharmaceutical substance that is the subject of a patent claim from a pharmaceutical substance that forms part of a method or process claim.  His Honour said that, broadly speaking, a claim could be made in relation to a pharmaceutical substance in three ways:

(a)        a new and inventive product alone;

(b)        an old or known product prepared by a new and inventive process; or

(c)        an old or known product used in a new and inventive mode of treatment.

106               It is important to note that Heerey J did not distinguish between the “active ingredients” in a compound, and other components of that compound, in the way that Dr Elliott did.  Nor did the Full Court.

107               His Honour’s approval of the Manual, and its analysis of the concept of a pharmaceutical substance which was generally accepted as correct by the Full Court, cannot be reconciled with Dr Elliott’s view that the introduction of any non-active ingredient into a product prevents it from being a pharmaceutical substance.  For one thing, her approach would effectively mean that s 70 had almost no function to perform.  Almost every pharmaceutical product will consist of a combination of individual substances, some of which may be intrinsically therapeutic (active ingredients), while others serve different, albeit essential, roles.  To restrict the capacity to extend a patent to those unlikely cases where every component of the compound is itself therapeutically useful would be to deprive the section of any real utility, and largely defeat the purpose of its enactment.

108               For the reasons already given in the Pharmacia Proceeding, I reject Interpharma’s alternative contention that claim 1 does not, by reason of any reference that it makes to process elements, disclose a “pharmaceutical substance per se”.

109               This makes it unnecessary for me to consider whether to grant Interpharma an extension of time within which to bring its application for review under the ADJR Act.  It also makes it unnecessary to consider whether, as a matter of discretion, I would refuse relief to Interpharma, under the Judiciary Act, because of the lengthy delay that took place between the time the Commissioner granted the extension, and the institution of the Interpharma Review Proceeding.  The simple fact is that, as in the case of Mayne, Interpharma cannot make good its contention that claim 1 does not involve a “pharmaceutical substance per se”.  For that reason, Interpharma’s application must be dismissed, with costs.

Associate:

Dated:              29 March 2006