FEDERAL COURT OF AUSTRALIA

Apotex Pty Ltd v ICOS Corporation (No 4) [2018] FCA 1316

ORDERS

THE COURT DECLARES THAT:

1.     The applicant/cross-respondent has threatened to infringe each of claims 1-6, 8-17, 19-29 and 31-35 of Australian Patent No. 769946 (‘946 Patent).

2.     The applicant/cross-respondent has threatened to infringe each of claims 1-3, 5-8, 10-12, 14-18 and 24-38 of Australian Patent No. 773666 (‘666 Patent).

THE COURT CERTIFIES THAT:

3.     Pursuant to section 19(1) of the Patents Act 1990 (Cth), the validity of each of claims 1-6, 8-17, 19-29 and 31-35 of the ‘946 Patent was questioned unsuccessfully in this proceeding.

4.     Pursuant to section 19(1) of the Patents Act 1990 (Cth), the validity of each of claims 1-3, 5-8, 10-12, 14-18 and 24-38 of the ‘666 Patent was questioned unsuccessfully in this proceeding.

THE COURT ORDERS THAT:

5.     The applicant/cross-respondent, whether by itself, its directors, officers, servants, agents or otherwise, be restrained from infringing or threatening to infringe any of claims 1-6, 8-17, 19-29 and 31-35 of the ‘946 Patent, including, in particular, from engaging in any of the following acts within Australia without the licence or authority of the patentee during the term of the ‘946 Patent:

(a)    selling, supplying or otherwise disposing of any Tadalafil ‘946 Product (as defined in Annexure A);

(b)    offering to sell, supply or otherwise dispose of any Tadalafil ‘946 Product;

(c)    using, importing or otherwise exploiting any Tadalafil ‘946 Product;

(d)    keeping any Tadalafil ‘946 Product for the purpose of doing any of the acts referred to in sub-paragraphs (a) to (c) above;

(e)    authorising any other person to do any act referred to in sub-paragraphs (a)-(d) above; and

(f)    procuring or inducing or joining in a common design with any other person to do any act referred to in sub-paragraphs (a)-(d) above.

6.     The applicant/cross-respondent, whether by itself, its directors, officers, servants, agents or otherwise, be restrained from infringing or threatening to infringe claims 1-3, 5-8, 10-12, 14-18 and 24-38 of the ‘666 Patent, including, in particular, from engaging in any of the following acts within Australia without the licence or authority of the patentee during the term of the ‘666 Patent:

(a)    selling, supplying or otherwise disposing of any Tadalafil ‘666 Product (as defined in Annexure A);

(b)    offering to sell, supply or otherwise dispose of any Tadalafil ‘666 Product;

(c)    using, importing or otherwise exploiting any Tadalafil ‘666 Product;

(d)    keeping any Tadalafil ‘666 Product for the purpose of doing any of the acts referred to in sub-paragraphs (a) to (c) above;

(e)    authorising any other person to do any act referred to in sub-paragraphs (a)-(d) above; and

(f)    procuring or inducing or joining in a common design with any other person to do any act referred to in sub-paragraphs (a)-(d) above.

7.     The respondent/cross-claimant’s Notice of Cross-claim dated 11 July 2016, as amended on 16 December 2016 and 17 May 2017, be otherwise dismissed.

8.     The applicant’s Originating Application dated 1 April 2016 be dismissed.

9.     Subject to:

(a)    Order 5 of the orders made by the court in this proceeding on 15 December 2016;

(b)    Order 3 of the orders made by the court in this proceeding on 9 May 2017; and

(c)    Order 13 of the orders made by the court in this proceeding on 17 May 2017;

the applicant/cross-respondent pay the respondent/cross-claimant’s costs of the proceeding, including any reserved costs, as agreed or taxed on a party-party basis.

10.     The bank guarantee referred to in paragraph 4 of the orders made by the Court in this proceeding on 23 October 2017 be discharged.

11.     Pursuant to section 37AF of the Federal Court of Australia Act 1976 (Cth), Annexure E of Besanko J’s judgment dated 14 August 2018:

(a)    will be disclosed to the following persons only:

   (i)   any judge, employee or other personnel of this Court;

   (ii)  the respondent, including its employees and external legal representatives;

   (iii)  Eli Lilly and Company and its related entities, including their employees and external legal representatives;

   (iv)  external legal representatives of the applicant for the purposes of the proceeding and any appeal therefrom; and

   (v)  such other persons authorised by the respondent or Eli Lilly and Company, or as the Court may order; and

(b)    will not be published, made open to public inspection or disclosed in open Court or disclosed in the open part of any Court transcript.

12.     Order 11 is made on the ground of being necessary to prevent prejudice to the proper administration of justice within the meaning of section 37AG(1)(a) of the Federal Court of Australia Act 1976 (Cth).

13.     Order 11 will continue until further order.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

Annexure A

Tadalafil ‘946 Products

Tadalafil ‘666 Products

REASONS FOR JUDGMENT

BESANKO J:

1    I delivered reasons for judgment in this proceeding on 14 August 2018 (Apotex Pty Ltd v ICOS Corporation (No 3) [2018] FCA 1204). Subject to four matters, the parties are agreed as to the final orders which should be made in light of the reasons for judgment. Three of the four matters relate to the terms of the injunctions sought. The relevant paragraphs are as follows:

5.    The applicant/cross-respondent, whether by itself, its directors, officers, servants, agents or otherwise, be restrained from infringing or threatening to infringe any of claims 1-6, 8-17, 19-29 and 31-35 of the ‘946 Patent, including, in particular, from engaging in any of the following acts within Australia without the licence or authority of the patentee during the term of the ‘946 Patent:

(a)    making, selling, supplying or otherwise disposing of any Tadalafil ‘946 Product (as defined in Annexure A);

(b)    offering to making, sell, supply or otherwise dispose of any Tadalafil ‘946 Product;

(c)    using, importing or otherwise exploiting any Tadalafil ‘946 Product;

(d)    …

(e)    making or maintaining any commitment or guarantee in connection with any application to list any Tadalafil ‘946 Product on either of the Schedule of Pharmaceutical Benefits or the Repatriation Schedule of Pharmaceutical Benefits (Schedules) wherein the commitment or guarantee is to supply any Tadalafil ‘946 Product during the term of the ‘946 Patent

6.    The applicant/cross-respondent, whether by itself, its directors, officers, servants, agents or otherwise, be restrained from infringing or threatening to infringe claims 1-3, 5-8, 10-12, 14-18 and 24-38 of the ‘666 Patent, including, in particular, from engaging in any of the following acts within Australia without the licence or authority of the patentee during the term of the ‘666 Patent:

(a)    making, selling, supplying or otherwise disposing of any Tadalafil ‘666 Product (as defined in Annexure A);

(b)    offering to make, sell, supply or otherwise dispose of any Tadalafil ‘666 Product;

(c)    using, importing or otherwise exploiting any Tadalafil ‘666 Product;

(d)    …

(e)    making or maintaining any commitment or guarantee to supply in connection with any application to list any Tadalafil ‘666 Product on either of the Schedules wherein the commitment or guarantee is to supply any Tadalafil ‘666 Product during the term of the ‘666 Patent

Annexure A refers to the Tadalafil ‘946 Products and the Tadalafil ‘666 Products and then, in paragraphs (a) to (c), any other product which infringes claims in the patents.

2    As to the first matter, the final orders contain a penal notice which, on the face of it, is appropriate, having regard to the fact that the orders include an injunction. Apotex submits that it is not appropriate to include the penal notice as part of the orders of the Court; the penal notice follows from the provisions of the Federal Court Rules 2011 (Cth) (see r 41.06). I do not accept this submission. There is no difficulty with the orders being made with the penal notice included as required by the Rules. Apotex made a further submission to the effect that the penal notice should not refer to imprisonment because a corporation cannot be imprisoned. I reject this submission. The penal notice is in the standard form and, as counsel for ICOS pointed out, an officer of a corporation may be committed where the notice carries the relevant endorsement (see r 41.08).

3    As to the second and third matters, the starting point is that the proposed orders contain the usual form of injunctive order, that is, an order restraining Apotex from infringing the claims in suit (Coflexip SA v Stolt Comex Seaway MS Ltd [2001] RPC 9 at [12]-[14], [19] per Aldous LJ with whom Chadwick and Buxton LJJ agreed). There is then a second layer, if I may put it that way, of prohibitions. It is not inappropriate to have a second layer of prohibitions when those prohibitions specifically relate to the facts of the case which is the subject of the proceeding. The reference to “making” or “make” in paragraphs 5(a) and (b), and 6(a) and (b) and the matters in (a), (b) and (c) with respect to each patent in Annexure A, do not relate to the facts of the case in that sense, and should be removed. I see no difficulty with the word “using” in paragraphs 5(c) and 6(c) and that word can remain in the orders.

4    The fourth matter relates to subparagraph (e) of paragraphs 5 and 6. Apotex submits that this prohibition should not be made because making or maintaining a commitment or guarantee in connection with an application to list a product is not an infringement of a patent. In Warner-Lambert Company LLC v Apotex Pty Ltd [2017] FCAFC 58; (2017) 249 FCR 17, the Full Court of this Court said at [18]-[19]:

Characterising these circumstances as involving an offer to the Minister to supply the products to third parties, being wholesalers and pharmacists, during the guaranteed period overlooks the nature of the assurance required to be provided and the fact that the statutory guaranteed supply provisions operate from the coming into force of the determination which will be after the term of the patent. An assurance to the Minister that sufficient stock of the product to meet demand will be available to allow for delivery to PBS dispensers (eg pharmacies, hospitals or other dispensers) in time for the PBS listing day is not an offer to the Minister to supply those third parties during the guaranteed period. It is an assurance that the responsible person will be able to supply those third parties during the guaranteed period if requested to do so. The guaranteed supply provisions do not operate on the making of an application. As is apparent from the definition of “guaranteed period” in s 99AEA, which cross-refers to ss 99AEC(3) and 99AED(3), it is the coming into force of a determination which starts the guaranteed period. It is during that period that the responsible person guarantees supply under s 99AEB. Until that time, however, there is merely the application accompanied by the required assurance.

Characterising the application as involving a statutory bargain, as the appellants urge, does not advance the matter. If there be a bargain, it is an assurance by the applicant for listing that the applicant will have sufficient stock to meet demand on the listing day (the coming into force of the determination) in exchange for a listing which will enable the product to be part of the PBS. An assurance of this kind is not an offer to the Minister to sell or otherwise dispose of the products to wholesalers and pharmacists. It is nothing more than what it purports to be, an assurance that stock will be available to meet demand. To adopt the appellants’ approach of arguing by way of analogy, party A does not offer to supply to party B merely by assuring party C that, when the relevant time comes, party A will be able to supply party B.

5    ICOS seeks to distinguish this case by relying on the qualification in the proposed order, that is to say, “wherein the commitment or guarantee is to supply any Tadalafil ‘946 Product during the term of the ‘946 Patent”. ICOS submits that supply during the term of the patent was not in issue in Warner-Lambert; rather, it was supply after the term had expired. ICOS submits that a listing of Apotex’s products would cause an irreversible statutory price reduction for ICOS’ products. ICOS submits that conduct falling within subparagraph (e) would be a threatened infringement or, in the alternative, the order is properly ancillary to the other orders. As to the latter submission, ICOS referred to Janssen Securities Ireland UC v Alphapharm Pty Ltd [2017] FCA 1399 (Janssen) at [179]-[185] per Yates J.

6    I think that conduct falling within subparagraph (e) of paragraphs 5 and 6 could be a threatened infringement or the order itself a proper ancillary order. However, I am not satisfied that it is an appropriate order in the circumstances of this case.

7    Counsel for Apotex told me that his instructions were that Apotex had not applied for “PBS listing”. Quite why it would consider doing so now, in view of the restraint, is not clear to me. I agree with counsel for Apotex that the matter has not been litigated as he put it and nor is it the subject of evidence. As far as Janssen is concerned, that is quite a different case involving an interlocutory injunction and the withdrawal of an assurance already given. I will not make the orders in paragraphs 5(e) and 6(e).

Associate:    

Dated:    31 August 2018