FEDERAL COURT OF AUSTRALIA

H Lundbeck A/S v Commissioner of Patents [2005] FCA 1718

PRACTICE AND PROCEDURE – joinder of parties – three proceedings in which patentee (L) a party – in first, another company (A) seeks revocation of patent, and an order rectifying Register of Patents accordingly, in the alternative an order removing an extension of term from the Register – in second, L seeks against the Commissioner of Patents a declaration that reg 10.7(7) of the Patents Regulations 1991 (Cth) is invalid – in third, L seeks order that Secretary, Department of Health and Ageing not use certain information provided to Secretary by L in connection with application by A for registration of competing pharmaceutical substance – on A’s motion to be joined as second respondent to the second proceeding, general principle that A should not be joined, subject to no issue of construction which A wished to advance in first (revocation) proceeding being raised and pre-empted in second (reg 10.7(7)) proceeding – on A’s motion to be joined in third (Secretary) proceeding, order for joinder made because of common issues and evidence as between this proceeding and first (revocation) proceeding.

Federal Court Rules O 6 rr 2, 8

Patents Act 1990 (Cth)  ss 71, 138, 192

Patents Regulations 1991 (Cth) reg 10.7(7)

H LUNDBECK A/S v COMMISSIONER OF PATENTS

NSD 1704 OF 2005

LUNDBECK AUSTRALIA PTY LTD v SECRETARY OF THE DEPARTMENT OF HEALTH & AGEING OF THE COMMONWEALTH OF AUSTRALIA

NSD 1870 OF 2005

LINDGREN J

28 NOVEMBER 2005

SYDNEY

THE COURT ORDERS THAT:

1. The application by Alphapharm Pty Ltd (‘Alphapharm’) to be joined as second respondent, brought by notice of motion filed on 2 November 2005, be adjourned part heard to the final hearing of this proceeding.

2.      The costs of the motion to date be reserved.

3.      The applicant filed and serve its submissions, and provide a copy to Alphapharm, by Monday, 12 December 2005.

4.      The respondent file and serve her submissions, and provide a copy to Alphapharm, by Friday, 23 December 2005.

5.      The applicant file and serve any submissions in reply, and provide a copy to Alphapharm, by Wednesday, 26 January 2006.

6.      Alphapharm notify the parties and the Court, by Monday, 30 January 2006, of the stance it proposes to take, in relation to its motion, at the final hearing.

7.      The proceeding be fixed for hearing on Wednesday, 8 February 2006 at 10.15 am.

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

THE COURT ORDERS THAT:

1. Alphapharm Pty Ltd (‘Alphapharm’) be added as second respondent.
2. If Alphapharm notifies the applicant and the Court by Monday, 5 December 2005 that it wishes to resist the proposed order for concurrent hearings:

(a)    the applicant file and serve a notice of motion seeking such an order, and supporting affidavits, by Wednesday, 14 December 2005;

(b)   Alphapharm file and serve affidavits on that motion by Monday, 19 December 2005;

(c)    the motion be returnable on Thursday, 22 December 2005 at 10.15 am for hearing.

3. The costs to date of Alphapharm’s motion, brought by notice of motion filed 2 November 2005, be reserved.

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

REASONS FOR JUDGMENT

INTRODUCTION

1                     There are three related ‘Lundbeck’ proceedings before the Court. 

2                     The first proceeding to be commenced was NSD 1120 of 2005, between Alphapharm Pty Ltd (‘Alphapharm’) as applicant and H Lundbeck A/S (‘Lundbeck’) as respondent.  In that proceeding, Alphapharm seeks a declaration that claims 1 – 6 of Lundbeck’s Australian Patent No 623144 (‘the Patent’) are invalid and an order that they be revoked, or, in the alternative, an order that the Register of Patents (‘the Register’) be rectified pursuant to s 192 of the Patents Act 1990 (Cth) (‘the Act’) to remove an extension of the term of the Patent from the Register.  Alphapharm seeks another supportive declaration related to the extension of the term of the Patent, which I set out (at [32]) below.  The ‘particulars of invalidity’ filed refer to many commonly encountered grounds, then set out grounds why Alphapharm contends that the Patent ‘as extended’ is invalid.  I will call proceeding NSD 1120 of 2005 ‘the revocation proceeding’.

3                     In the revocation proceeding, Lundbeck and its Australian subsidiary, Lundbeck Australia Pty Ltd (‘Lundbeck Australia’), cross-claim against Alphapharm for infringement of the Patent.  Lundbeck Australia is the exclusive licensee of the Patent in Australia.

4                     The second proceeding to be commenced is NSD 1704 of 2005, between Lundbeck and the Commissioner of Patents (‘the Commissioner’).  In this proceeding, Lundbeck seeks relief designed to prevent the Commissioner from amending the entry in the Register in relation to the extension of the term of the Patent.  The Commissioner wishes to consider and decide whether she is required to do so by reg 10.7(7) of the Patents Regulations 1991 (Cth), but Lundbeck contends that reg 10.7(7) is invalid.  (Regulation 10.7(7) is set out at [18] below.)

5                     Alphapharm’s contention is that Lundbeck obtained the extension by making a misrepresentation to the Commissioner as to what was the ‘first regulatory approval date’ for the purposes of s 70 of the Act and of reg 10.7(7).  It was Alphapharm which drew to the attention of the Commissioner the alleged mistake, which the Commissioner accepts would support her taking a decision under reg 10.7(7) to amend the relevant entry in the Register.  Alphapharm contends, however, that the entire extension was invalidly granted and all reference to it should be removed from the Register, whereas the Commissioner contends only that the extension was granted for a longer period than it should have been and that the Register should be amended only to refer to the shorter extension.

6                     Alphapharm has moved to be joined as second respondent to this proceeding, which I will call ‘the regulation 10.7(7) proceeding’.

7                     The third proceeding is NSD 1870 of 2005 between Lundbeck Australia as applicant and the Secretary of the Department of Health & Ageing of the Commonwealth of Australia as respondent (‘the TGA proceeding’).  In the TGA proceeding, Lundbeck Australia has applied for orders restraining the respondent (‘the Secretary’) from using what it contends is ‘protected information’ within the meaning of s 25A of the Therapeutic Goods Act 1989 (Cth) (‘the TGA’) in considering any application made by any third party for registration of therapeutic goods containing (+)-citalopram.  On 15 June 2005, Alphapharm applied to the Secretary for the registration of such therapeutic goods under the TGA.  In the TGA proceeding also Alphapharm has moved to be joined as second respondent.

8                     The Commissioner consents to joinder of Alphapharm as second respondent in the regulation 10.7(7) proceeding, but Lundbeck resists that joinder. 

9                     The Secretary not only consents to the joinder of Alphapharm as second respondent to the TGA proceeding, but positively supports it.  Lundbeck Australia, however, would acquiesce in Alphapharm’s joinder only if the TGA proceeding and the revocation proceeding are heard together, the evidence in each being evidence in the other.

facts

10                  The date of the Patent is 13 June 1989 (so its twenty-year term expires on 13 June 2009) and its title is ‘(+)-Enantiomer of Citalopram and Process for the Preparation Thereof’.  An Agreed Statement of Facts in the regulation 10.7(7) proceeding states, relevantly, as follows:

‘The Patent and listing on the ARTG

1.         ...

2.         Citalopram (International Nonproprietary Name (INN)) is a compound belonging to the therapeutic category of selective serotonin re-uptake inhibitors.  Citalopram is a racemate which was invented and developed by Lundbeck which (along with its subsidiaries) manufactures and markets citalopram hydrobromide (tablets) under the brand name Cipramil.  Cipramil was first registered on the Australian Register of Therapeutic Goods (ARTG) on 9 December 1997.  ...

3.         The invention the subject of the ... Patent relates to the (+) enantiomer of citalopram (escitalopram (International Nonproprietary Name)) and processes for preparation thereof.

4.         The ... Patent discloses processes for synthesising escitalopram, and data showing that escitalopram is over 100 fold more potent than
(-) citalopram.

5.         Lundbeck instructed its subsidiary Lundbeck Australia Pty Ltd (Lundbeck Australia) to make an application with the Therapeutic Goods Administration (TGA) for registration of escitalopram oxalate on the ARTG.

6.         Pursuant to that application, on 16 September 2003, escitalopram oxalate was registered on the ARTG for its various dose strengths under the brand name Lexapro ...

Extension of term

7.         In the absence of any extension of term the ... Patent was due to expire at the end of 13 June 2009.

8.         On 22 December 2003, Lundbeck applied to the Commissioner of Patents for an extension of term of the Patent. ...

9.         An extension of term of the Patent until 13 June 2014 was granted by the Commissioner of Patents on 27 May 2004. ...

10.       No opposition was entered to the grant of this extension within the time provided by the Patents Regulations.

11.       On 13 July 2005, D Herald, acting as Deputy Commissioner of Patents, wrote to Lundbeck setting out certain correspondence from Alphapharm Pty Ltd to the Commissioner. The letter states inter alia:

(a)       the ... Patent claims a specific isomer of a compound;

(b)       the ARTG registration relied upon to support the extension of term of the ... Patent was in respect of a good containing that specific isomer;

(c)        there is an earlier ARTG registration for Cipramil, which the Commissioner understands is the racemic mixture of the isomers having the chemical formula of the substance of the ... Patent;

(d)       that “the relevant date for the purpose of extending the term of this patent is the date of inclusion in the ARTG of the substance Cipramil”;

(e)        the Commissioner considers that she is obliged to amend the register in relation to the term of the ... Patent from 13 June 2014 to 9 December 2012 under Regulation 10.7(7) of the Patents Regulations 1991; and

(f)        the letter also states that the Commissioner considers herself “functus officio with respect to any of the considerations required prior to the grant of the extension of term of this patent”.

The letter requested Lundbeck either to provide reasons why the Commissioner should not make the amendment or to accede to the amendments proposed. ...

12.       By letter dated 3 August 2005, Corrs Chambers Westgarth (Corrs), solicitors for Lundbeck wrote to the Commissioner of Patents advising her than Lundbeck does not accede to the proposed amendment to the Register of Patents in respect of the term of the ... Patent. ...

13.       Accordingly, the Patents Office set a hearing date of 19 October 2005 for Lundbeck to be heard in relation to the Commissioner of Patents’ proposed amendment of the register under Regulation 10.7(7).  Subsequent to the institution by Lundbeck of these proceedings, that hearing date has been rescheduled to 22 March 2006.’ (emphasis in original)

11                  The ‘correspondence from Alphapharm Pty Ltd’ referred to in para 11 consisted of a letter dated 7 July 2005 from Mallesons Stephen Jaques (‘Mallesons’), the solicitors for Alphapharm, asserting that Lundbeck had obtained the extension of the term of the Patent ‘in circumstances where its application for an extension of time was out of time’.  Lundbeck’s request for the extension was filed on 22 December 2003.  The pharmaceutical substance the subject of the Patent is the S-enantiomer of the compound Citalopram.  In its application for the extension, Lundbeck represented that the first product included on the Australian Register of Therapeutic Goods (‘ARTG’) containing or consisting of this pharmaceutical substance was Lundbeck’s product LEXAPRO.  LEXAPRO had been included on the ARTG only since 16 September 2003.  According to Mallesons’ letter, however, the first product included on the ARTG containing the S-enantiomer of Citalopram was Lundbeck’s earlier product CIPRAMIL.  Mallesons’ letter claimed that CIPRAMIL had been included earlier in the ARTG since 20 November 1997.  In fact the correct date is 9 December 1997, but nothing turns on this discrepancy.  Alphapharm’s contention is that 9 December 1997 was the date of the first inclusion in the ARTG of goods that contained or consisted of the pharmaceutical substance, the S-enantiomer of Citalopram, because, according to the letter, CIPRAMIL comprises both the S-enantiomer of Citalopram and the R-enantiomer of Citalopram.

12                  Section 70 of the Act provides for applications for an extension of the term of standard patents relating to pharmaceutical substances.  One condition which must be satisfied in relation to at least one of the pharmaceutical substances disclosed in the complete specification falling within the scope of the claim or claims, is that the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least five years: s 70(3)(b).  For this purpose, the expression ‘first regulatory approval date’ in relation to a pharmaceutical substance is defined in s 70(5).  Paragraph (a) of that subsection has the effect that if, as here, no pre-TGA marketing approval was given in relation to the substance, the first regulatory approval date is the date of commencement of the first inclusion in the ARTG of goods that ‘contain, or consist of’ the substance.  At the heart of the present dispute is whether Lundbeck’s product CIPRAMIL satisfies that description.  If so, the first regulatory approval date is 9 December 1997, rather than 16 September 2003, the date of the inclusion of LEXAPRO in the ARTG. 

13                  The period from the date of the Patent (13 June 1989) to 9 December 1997 is eight years, five months and four days.  The period from the date of the Patent (13 June 1989) to 16 December 2003 is fourteen years, three months and three days.  Accordingly, whichever is the correct ‘first regulatory approval date’, Lundbeck’s application for the extension of time satisfied s 70(3)(b), because each of these periods was at least five years.

14                  Subsection 71(2) of the Act provides that an application for an extension of term must be made during the term of the patent and within six months of the latest of the following dates:

(a)        the date the patent was granted;

(b)        the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, any of the pharmaceutical substances referred to in subs 70(3);

(c)        the date of commencement of s 71.

In this case, the latest of those three dates is that referred to in para (b).  If the date referred to in para (b) was, as Lundbeck contends, 16 September 2003, Lundbeck had until 16 March 2004 in which to apply for the extension, and therefore its application made on 22 December 2003 was within time.  If, on the other hand, the date referred to in para (b) was 9 December 1997, Lundbeck had only until 9 June 1998 in which to apply for an extension, and, therefore, the application which it made on 22 December 2003 was out of time.

15                  The term of an extended patent is defined by s 77(1) of the Act as being equal to:

‘(a)      the period beginning on the date of the patent and ending on the earliest first regulatory approval date (as defined by s 70) in relation to any of the pharmaceutical substances referred to in subs 70(2);

reduced (but not below zero) by:

(b)       five years.’

16                  If the correct first regulatory approval date is 9 December 1997, this formula yields a calculation of eight years, five months and four days minus five years, which is three years five months four days.  This period, added on to the twenty-year term of the Patent expiring on 13 June 2009, would extend the term to 9 December 2012.

17                  If, on the other hand, the correct first regulatory approval date is 16 September 2003, the s 77 formula would give a period of fourteen years, three months and three days minus five years, which is nine years, three months and three days.  But s 77(2) provides that the term of an extension cannot be longer than five years.  This extension of five years, added on to the twenty-year term of the patent expiring on 13 June 2009, would extend that term to 13 June 2014.  This was the extension which the Commissioner in fact allowed and which is reflected in the entry in the ARTG. 

18                  Regulation 10.7(7) provides:

‘(7)      If:

            (a)        an extension of the term of a standard patent for a pharmaceutical substance has been granted under section 76 of the Act; and

            (b)        the Commissioner becomes aware that the first regulatory approval date in relation to the pharmaceutical substance is earlier than:

                        (i)         the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods that was supplied, under subregulation 6.9(2), with the application for the extension of the term; or

                        (ii)        the date of the first approval that was supplied, under subregulation 6.10(2), with the application for the extension of the term;

The Commissioner must amend the relevant entry in the Register to insert the correct extension of the term of the patent.’ (my emphasis)

19                  The Commissioner’s position is that reg 10.7(7) obliges her to amend the Register in relation to the term of the Patent, but only to record the extended term as running to 9 December 2012, rather than to 13 June 2014.  In her letter dated 13 July 2005 to Watermark, Lundbeck’s Patent Attorneys, the Commissioner stated:

‘The term of this patent (as factually determined under s 77 on the basis of the registration of Cipramil) expires on 9 December 2012, and not 13 June 2014 (the date currently included in the Register).  Accordingly the Register does not reflect the correct term of this patent.’

20                  The Commissioner pointed out that in these circumstances under reg 10.7(7), she must amend the relevant entry in the Register to insert the correct term of the patent, but not without first giving the patentee an opportunity to be heard: see reg 10.7(8).

21                  While Lundbeck opposes any amendment of the Register, Alphapharm contends that the whole of the extension to the term of the Patent was not authorised by the Act, because Lundbeck’s application for it was made outside the six month period laid down in s 71(2) of the Act (see [14] above).

Alphapharm’S MOTION FOR JOINDER AS SECOND RESPONDENT IN THE REGULATION 10.7(7) PROCEEDING

22                  The relevant Rules of Court are O 6 rr 2 and 8 which are, relevantly:

‘2         Two or more persons may be joined as applicants or respondents in any proceeding –

            (a)        where –

                        (i)         if a separate proceeding were brought by or against them, as the case may be, some common question of law or fact would arise in all the proceedings; and

                        (ii)        all rights to relief claimed in the proceeding (whether they are joint, several or alternative) are in respect of or arise out of the same transaction or series of transactions; or

            (b)        where the Court gives leave so to do.’

‘8         (1)        Where a person who is not a party –

                        (a)        ought to have been joined as a party; or

                        (b)        is a person whose joinder as a party is necessary to ensure that all matters in dispute in the proceeding may be effectually and completely determined and adjudicated upon,

                        the Court may order that the person be added as a party and to make orders for the further conduct of the proceeding.

            (2)        A person shall not be added as an applicant without the person’s consent.’

In my opinion, rules 2(a) and 8 have no application and it is only rule 2(b) that needs to be considered.

23                  Alphapharm points out that it was Alphapharm which drew the Commissioner’s attention to the supposed earlier ‘first regulatory approval date’, and that it has an interest in the outcome, but these considerations do not dictate joinder.

24                  As I see it, the only issue which might suggest joinder of Alphapharm is whether the Commissioner will be an adequate contradictor of Lundbeck.  In so far as the proceeding concerns the question whether reg 10.7(7) is not authorised by s 228 of the Act and is therefore invalid and of no force or effect, it was not suggested that the Commissioner was an inadequate contradictor: the Commissioner’s position would be quite different from that of the Australian Broadcasting Tribunal in The Queen v Australian Broadcasting Tribunal; Ex parte Hardiman (1980) 144 CLR 13, see especially 35-36.

25                  In her letter dated 13 July 2005 to Watermark, the Commissioner advised that she was proceeding on the basis that she was ‘functus officio with respect to any of the considerations required prior to the grant of the extension of term of this Patent’.  In saying this, the Commissioner was responding to Alphapharm’s submission to her that she should reconsider the grant of the extension.  Perhaps taking up this idea, Lundbeck, in its application, in the regulation 10.7(7) proceeding, also seeks a declaration that the Commissioner is ‘functus officio in relation to her decision made on or about 3 June 2004 to extend the term of the ... Patent’. 

26                  It therefore appears that the Commissioner will consent to the making of this declaration sought by Lundbeck (of course, it is a matter for the Court whether it is appropriate to make a declaration). 

27                  Paragraph 9 of Lundbeck’s Statement of Claim states:

‘The challenged regulations are not authorised or permitted by section 228 of the Act.

Particulars

(a)       ...

(b)       ...

(c)        There is no power vested in the Commissioner by the Act to reconsider a grant by the Commissioner of an extension of the term of a patent under Chapter 6 Part 3 of the Act.

(d)       ... .’

Paragraph 6.3 of the Commissioner’s defence states:

‘Paragraph 9(c) is admitted but the Respondent denies that a determination under Reg 10.7(7) is a reconsideration of a grant of an extension of the term of the patent under Chapter 6 Part 3 of the Patents Act 1990.’

28                  The ‘functus officio’question raises difficulties.  Subparagraph (c) in para 9 of the Statement of Claim is a particular of the ‘material fact’ pleaded in the opening words of para 9, namely, that, relevantly, reg 10.7(7) is not authorised by s 228 of the Act.  The significance of particular (c) as a true particular of invalidity can only be that reg 10.7(7) does, upon its proper construction, purport to empower the Commissioner to reconsider the grant of an extension.  If this were not the significance of particular (c), that ‘particular’ would not be a particular of the allegation that reg 10.7(7) was ‘not authorised or permitted by s 228 of the Act’.

29                  Paragraph 6.3 of the Commissioner’s defence pleads to particular (c) in para 9.  It admits that there is no power vested in the Commissioner by the Act to reconsider the grant of an extension of a patent term.  In effect, it then asserts that para (c) is not a proper particular of the allegation that reg 10.7(7) is ‘not authorised or permitted by s 228 of the Act’, because, on its proper construction, reg 10.7(7) does not purport to empower the Commissioner to reconsider the grant of an extension.

30                  It may be that the various references to the Commissioner’s being ‘functus officio’ are in substance intended to indicate that upon its proper construction reg 10.7(7) does not empower the Commissioner to amend an entry in the Register so as to remove any reference to any extension of term having been granted.  As indicated above, however, that construction would be inconsistent with particular (c) of para 9 of Lundbeck’s statement of claim, regarded as a particular of invalidity of reg 10.7(7).

31                  So long as Lundbeck seeks a ‘functus officio’declaration, the regulation 10.7(7) proceeding will involve more than a simple question as to the validity of reg 10.7(7).  Moreover, the question of the validity of reg 10.7(7) will require that regulation to be construed.  Neither Lundbeck nor the Commissioner has suggested that the argument that the Commissioner was not authorised to grant any extension and that the Register should be rectified pursuant to s 192 of the Act to remove all reference to it would not be available to Alphapharm in the revocation proceeding.  However, I am troubled by the possibility that I will be invited to give to s 71(2) of the Act and reg 10.7(7) a construction inconsistent with Alphapharm’s argument to be made in the revocation proceeding that:

·        by reason of s 71(2) of the Act the Commissioner was not able to grant any extension; and

·        the extension was granted without authority and all reference to it should be removed from the Register pursuant to s 192.

32                  By its application in the revocation proceeding, Alphapharm seeks, no doubt in support of the order which it also seeks, that the entry of the extension of term be removed from the Register, the following declaration:

‘4.        A declaration that:

            (a)        CIPRAMIL was the first good included on the Australian Register of Therapeutic Goods that contained (+)1-(3-dimenthylaminopropyl)-1- (4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile; and

            (b)        the Respondent’s application for an extension of the term of the Patent post dated by more than 6 months the latest permissible date for the purpose of s 71(2) of the Act.’

33                  If I am to be required in the regulation 10.7(7) proceeding to decide between the construction supported by Lundbeck and the Commissioner on the one hand and that supported by Alphapharm on the other, it would be appropriate for Alphapharm to be joined to present argument relating to that issue.  After all, it would be at least embarrassing and wasteful if the Court were to be led to construe legislation in conformity with the position adopted by Lundbeck and the Commissioner in the regulation 10.7(7) proceeding, only to be asked by Alphapharm to construe it differently in the revocation proceeding.

34                  What is to be done in these circumstances?  A final decision should not be taken on Alphapharm’s motion until it becomes clear whether or not I will be invited to adopt the construction mentioned in the revocation proceeding.  In the meanwhile, Alphapharm’s motion should be stood over part heard.

alphapharm’s motion for joinder as second respondent in the tga proceeding

35                  In the TGA proceeding, Lundbeck Australia seeks the following substantive relief:

‘1.        A declaration that the information provided by Lundbeck Australia to the Secretary of the Department of Health and Ageing of the Commonwealth of Australia (the Secretary) in respect of applications for registration of therapeutic goods containing the active substance escitalopram oxalate described in paragraph 4 of the Statement of Claim herein (the information), is Protected Information within the meaning of s 25A(2) of the Therapeutic Goods Act 1989 (the Act).

2.         Prohibition, alternatively an injunction prohibiting the Secretary from using or permitting to be used the information when evaluating any application by a person other than Lundbeck Australia for the registration of therapeutic goods pursuant to s 25(1) of the Act for so long as that information remains Protected Information within the meaning of s 25A(2) of the Act.’ (emphasis in original)

36                  On 15 June 2005, Alphapharm filed an application with the TGA seeking approval for the marketing in Australia of goods containing (+)-Citalopram, and if marketing approval is granted, Alphapharm will wish to manufacture and sell those goods in Australia.

37                  In connection with the Secretary’s consideration of Alphapharm’s application, the Secretary will apparently deal with or use information provided to the Secretary by Lundbeck Australia in relation to Lundbeck Australia’s application to register LEXAPRO.  But Alphapharm contends that that information was provided by Lundbeck Australia to the Secretary many years earlier when Lundbeck Australia applied to register CIPRAMIL.

38                  The TGA provides for the registration and listing of therapeutic goods.  Section 25A of that Act provides:

‘(1)      When evaluating therapeutic goods for registration, the Secretary must not use information about other therapeutic goods that is protected information.

(2)       Information is protected information if:

            (a)        the information was given to the Secretary in relation to an application to register therapeutic goods (the new goods):

                        (i)         not being therapeutic devices; and

                        (ii)        consisting of, or containing, an active component; and

            (b)        the information is about the active component and is not available to the public; and

            (c)        when the application to register the new goods was lodged:

                        (i)         no other therapeutic goods consisting of, or containing, that active component were included in the Register; and

                        (ii)        no such therapeutic goods had been included in the Register at any time before then; and

            (d)        the new goods became registered on or after the commencement of this subsection; and

            (e)        5 years have not passed since the day the new goods became registered; and

            (f)        the person in relation to whom the new goods are registered has not given the Secretary permission in writing for the Secretary to use the information.

(3)       For the purposes of subsection (2), an active component, in relation to therapeutic goods, is a substance that is, or one of the substances that together are, primarily responsible for the biological or other effect identifying the goods as therapeutic goods.

(4)       The use of protected information contrary to subsection (1) does not render the Commonwealth, the Secretary or a delegate of the Secretary liable to a person in respect of loss, damage or injury of any kind suffered by the person as a result of, or arising out of, the use of that information.’

39                  Lundbeck Australia complains that the information which it provided to the Secretary in respect of its application to register LEXAPRO was ‘protected information’ within s 25A, and, in particular, that at that time ‘no other therapeutic goods consisting of or containing, [its] active component were included in the Register’ (see s 25A(2)(c)(i)).  Alphapharm’s contention, on the other hand, is that there was already a therapeutic good consisting of, or containing, that active component, escitalopram oxalate, namely, CIPRAMIL, which had been registered on 9 December 1997.

40                  It is clear that the TGA proceeding will, in this respect, raise the same issue as will form part of the revocation proceeding.  The declarations that are sought in the revocation proceeding relating to the extension of the term of the Patent were noted at [2] and [32].  The revocation proceeding, in so far as it relates to the extension, will raise the question posed by s 70(5)(a) of the Act: what was the date of commencement of the first inclusion in the ARTG of ‘goods that contain, or consist of, the [pharmaceutical] substance disclosed in the complete specification of the Patent’. 

41                  Although the language of s 25A(2)(c)(i) of the TGA (‘consisting of, or containing the active component’) is not identical with the language of s 70(5)(a) of the Act (‘goods that contain, or consist of, the [pharmaceutical] substance’), they are sufficiently similar for me to be satisfied that the same evidentiary ground will, to the extent of the present issue, be traversed in both cases.  In so far as the present issue is concerned, common questions of fact or law or both arise in the revocation proceeding and the TGA proceeding, and if Alphapharm were to commence a proceeding against the Secretary with a view to compelling the Secretary to register therapeutic goods containing(+)-Citalopram, that proceeding would raise the same question of fact or law or both: cf Federal Court Rules, O 6 r 2(a)(i); (b)

42                  Alphapharm should be joined as second respondent in the TGA proceeding.

43                  Lundbeck Australia submits that, as a matter of case management, the revocation and TGA proceedings should be heard together, the evidence in each being, so far as relevant, evidence in the other.  Alphapharm is concerned that its reliance on the numerous other grounds of revocation in the revocation proceeding may lead to the preparation and trial of the proceeding occupying much more time than the similar preparation and trial in the case of the TGA proceeding.  In short, Alphapharm would not wish the hearing and determination of the TGA proceeding, and as it hopes, the consequential marketing of its product, to be delayed until the revocation proceeding is heard and determined.

44                  As noted earlier, the Secretary not only consents to the joinder of Alphapharm as second respondent, but makes submissions in support of it.  On the other hand, the Secretary is concerned not to incur legal costs by reason of its involvement in a proceeding which involves many issues of no interest to the Secretary.  Appropriate case management will overcome that particular difficulty, at least to a substantial extent.

45                  It seems clear on what I have been told from the Bar table that on the issues common to both proceedings to which I have referred, the same expert witnesses will be called to give, in substance, the same testimony.  Obviously, it is undesirable for various reasons that the two proceedings be heard separately.  At present, I am minded to order that they be heard together, the evidence in each being evidence in the other, but Alphapharm and Lundbeck Australia should have an opportunity to put on evidence relating to this question, if Alphapharm wishes to resist the making of such an order.

conclusion

46                  Alphapharm’s motion in the regulation 10.7(7) proceeding, brought by notice of motion filed on 2 November 2005, should be adjourned part heard to the final hearing of that proceeding.

47                  On Alphapharm’s motion in the TGA proceeding, brought by notice of motion also filed on 2 November 2005, there should be an order that Alphapharm be joined as second respondent.  There should also be directions that if Alphapharm notifies Lundbeck Australia and the Court by Monday, 5 December 2005, that it wishes to resist the proposed order for concurrent hearings, Lundbeck Australia file a notice of motion seeking an order for concurrent hearings, and serve affidavits in support by Wednesday, 14 December 2005, Alphapharm file and serve affidavits on that motion by Monday, 19 December 2005, and Lundbeck Australia’s motions be returnable on Thursday, 22 December 2005 at 10.15 am for hearing.

Associate:

Dated:              29 November 2005

NSD 1704 of 2005

NSD 1870 of 2005