Merck Sharp & Dohme Corp v Wyeth LLC (No 4)

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FEDERAL COURT OF AUSTRALIA

Merck Sharp & Dohme Corp v Wyeth LLC (No 4) [2020] FCA 1719

File number: NSD 1381 of 2017
Judgment of: BURLEY J
Date of judgment: 30 November 2020
Catchwords:

PATENTS – whether appropriate to grant injunction in general form – where public health considerations not raised during trial – injunction granted

COSTS – where parties achieved mixed success – whether appropriate to make separate costs orders with respect to different patents in suit
Legislation: Patents Act 1990 (Cth) ss 19, 138, 140, 187 and Schedule 1
Cases cited:

Calidad Pty Ltd v Seiko Epson Corporation (No 2) [2019] FCAFC 168; 147 IPR 386

Davies v Lazer Safe Pty Ltd (No 2) [2019] FCAFC 118

Evalve Inc v Edwards Lifesciences Ltd [2020] EWHC 513

Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477

Seiko Epson Corp v Calidad Pty Ltd [2018] FCA 104

Division: General Division
Registry: New South Wales
National Practice Area: Intellectual Property
Sub-area: Patents and associated Statutes
Number of paragraphs: 24
Date of hearing: 19 November 2020
Counsel for the Applicants/Cross-Respondents: Ms K. Howard SC with Mr D. Larish
Solicitor for the Applicants/Cross-Respondents: Corrs Chambers Westgarth
Counsel for the Respondent/Cross-Claimant: Mr A. Bannon SC with Ms C. Cochrane and Mr R. Clark
Solicitor for the Respondent/Cross-Claimant: Allens

ORDERS

NSD 1381 of 2017
BETWEEN:

MERCK SHARP & DOHME CORP

First Applicant

MERCK SHARP & DOHME (AUSTRALIA) PTY LTD

Second Applicant
AND:

WYETH LLC

Respondent
AND BETWEEN:

WYETH LLC

Cross-Claimant
AND:

MERCK SHARP & DOHME CORP. (and another named in the Schedule)

First Cross-Respondent

ORDER MADE BY:

BURLEY J

DATE OF ORDER:

30 NOVEMBER 2020

IN THESE ORDERS:

15-valent vaccine means pneumococcal polysaccharide-protein conjugate vaccine together with a physiologically acceptable vehicle in which each of the following serotypes is conjugated to CRM197: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.

THE COURT DECLARES THAT:

1.The Applicants/Cross-respondents have, without the licence or authority of the Respondent/Cross-claimant, threatened to infringe claims 1 to 8 (inclusive), 10 to 13 (inclusive) and 16 to 17 (inclusive) of Australian Patent No. 2006235013 (013 Patent) by threatening to import into, and offer to sell and sell, and keep for the purposes of offering to sell and sell, in the patent area (as that term is defined in Schedule 1 to the Patents Act 1990 (Cth) (Patents Act)) the 15‑valent vaccine.

THE COURT CERTIFIES THAT:

2.Pursuant to s 19 of the Patents Act, the validity of each of claims 1 to 8 (inclusive), 10 to 13 (inclusive) and 16 to 17 (inclusive) of the 013 Patent was questioned in this proceeding.

THE COURT ORDERS THAT:

3.The Applicants/Cross-respondents, whether by themselves, their directors, officers, servants or agents, or otherwise, in the patent area (as that term is defined in Schedule 1 to the Patents Act), during the term of the 013 Patent, without the licence or authority of the Respondent/Cross-claimant, be permanently restrained from infringing claims…

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Details
Case
[2020] FCA 1719
Decision Date

CaseChat Overview and Summary

Merck Sharp & Dohme Corp v Wyeth LLC (No 4) involved a dispute over the validity and infringement of certain patents relating to pneumococcal conjugate vaccines. Merck Sharp & Dohme Corporation (MSD) sought to challenge the validity of Wyeth's patents, while Wyeth sought injunctive relief for alleged infringement of their patents. The court was required to determine whether an injunction should be granted to Wyeth and how to allocate costs between the parties, who had achieved mixed success in the litigation.

The court considered whether public health considerations should influence the granting of injunctive relief. MSD argued that a separate hearing was necessary to address public health implications before granting an injunction. However, the court found that public health considerations had not been raised during the trial and were not a basis for deferring the injunction. The court granted Wyeth an injunction restraining MSD from engaging in acts that may infringe the asserted patent claims, noting that MSD had not provided sufficient evidence to justify deferring the injunction.

Regarding costs, the court considered that both parties had achieved partial success. The court decided to make separate costs orders for different patents. MSD was ordered to pay 85% of Wyeth's costs relating to the 013 and 844 Patents, while Wyeth was ordered to pay 80% of MSD's costs relating to the Container Patent. The court noted that these orders reflected the mixed outcomes of the litigation and the respective successes of each party.

The final orders included a permanent injunction restraining MSD from infringing certain claims of the 013 Patent, revocation of specific claims of the 844 and Container Patents, a stay on the revocation orders pending any appeal, and specific cost orders between the parties.

Orders

Orders of the court

3. The Applicants/Cross-respondents, whether by themselves, their directors, officers, servants or agents, or otherwise, in the patent area (as that term is defined in Schedule 1 to the Patents Act), during the term of the 013 Patent, without the licence or authority of the Respondent/Cross-claimant, be permanently restrained from infringing claims 1 to 8 (inclusive), 10 to 13 (inclusive) and 16 to 17 (inclusive) of the 013 Patent, including by engaging in the following acts in the patent area, without the licence or authority of the Respondent/Cross-claimant:

(a) importing, making, selling, supplying or otherwise disposing of, or offering to import, make, sell, supply or otherwise dispose of, the 15-valent vaccine;

(b) using or keeping the 15-valent vaccine for the purpose of doing any of the acts described in sub-paragraph 3(a) above;

(c) authorising other people to engage in any of the acts described in sub-paragraphs 3(a) and (b) above.

4. Pursuant to s 138 of the Patents Act, claims 1 to 6 (inclusive) and 11 to 14 (inclusive) of Australian Patent No. 2013206844 (844 Patent) be revoked.

5. Pursuant to s 138 of the Patents Act, claims 1 to 9 (inclusive), 16 to 18 (inclusive) and 20 to 23 (inclusive) of Australian Patent No. 2012216628 (Container Patent) be revoked.

6. Upon the undertakings referred to in paragraph 11 below, orders 4 and 5 be stayed:

(a) initially, for a period of 28 days after the date on which these orders are pronounced; and

(b) if an appeal or cross-appeal is lodged within that period, until the determination of that appeal or cross-appeal, or further order.

7. The Applicants’ Further Amended Originating Application dated 22 November 2019 be otherwise dismissed.

8. The Cross-claimant’s Amended Notice of Cross-claim dated 12 November 2019 be otherwise dismissed.

9. The Applicants/Cross-respondents pay 85% of the Respondent’s/Cross-claimant’s costs of the proceeding insofar as they relate to the 013 and 844 Patents, including any reserved costs as agreed or taxed, but excluding any costs the subject of any other previous costs order.

10. The Respondent/Cross-claimant pay 80% of the Applicants’/Cross-respondents’ costs of the proceeding insofar as they relate to the Container Patent, including any reserved costs as agreed or taxed, but excluding any costs the subject of any other previous costs order.

THE COURT NOTES THAT:

11. The Respondent/Cross-claimant undertakes to the Court during the period of the stay referred to in order 6:

(a) to prosecute any appeal or cross-appeal expeditiously;

(b) forthwith to serve on the Commissioner of Patents copies of these orders pursuant to s 140 of the Patents Act with a request that particulars of orders 4 and 5 be registered in accordance with s 187 of the Patents Act;

(c) not to threaten any person with proceedings, or bring proceedings against any person, for infringement of:

(i) claims 1 to 6 (inclusive) and 11 to 14 (inclusive) of the 844 Patent;

(ii) claims 1 to 9 (inclusive), 16 to 18 (inclusive) and 20 to 23 (inclusive) of the Container Patent;

(d) not to seek to amend any claims of the 844 Patent or the Container Patent otherwise than in the course of, or in connection with, these proceedings.

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

Background

Background to the litigation

Full text does not contain this section.

Evidence

Evidence Before The Court

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Decision

Reasons for decision

On 14 October 2020, I delivered reasons in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477 (judgment) in which I found (adopting the definitions used in the judgment) that Wyeth had established that the asserted 013 patent claims are valid and infringed by MSD, and that MSD had established that the asserted 844 patent claims and the asserted container patent claims are invalid. I directed that the parties confer and provide to my chambers proposed short minutes giving effect to the reasons. The parties have done so and arrived at a measure of agreement as to the form of orders, with two areas of dispute. The first concerns whether or not orders for injunctive relief should be made restraining MSD from engaging in any acts that may infringe the asserted 013 patent claims. The second concerns the award of costs. INJUNCTIVE RELIEF Wyeth proposes the following form of order:3. The Applicants/Cross-respondents, whether by themselves, their directors, officers, servants or agents, or otherwise, in the patent area (as that term is defined in Schedule 1 to the Patents Act), during the term of the 013 Patent, without the licence or authority of the Respondent/Cross-claimant, be permanently restrained from infringing claims 1 to 8 (inclusive), 10 to 13 (inclusive) and 16 to 17 (inclusive) of the 013 Patent, including by engaging in the following acts in the patent area, without the licence or authority of the Respondent/Cross-claimant:(a)importing, making, selling, supplying or otherwise disposing of, or offering to import, make, sell, supply or otherwise dispose of, the 15-valent vaccine;(b)using or keeping the 15-valent vaccine for the purpose of doing any of the acts described in sub-paragraph 3(a) above;(c)authorising other people to engage in any of the acts described in sub-paragraphs 3(a) and (b) above. MSD does not challenge the form of this proposed order, but contends that there is a substantive question to be determined, which is whether, for public interest reasons, any injunction should be ordered at all. It submits that, in any event, no order should be made now, and that the question should be deferred until after the determination of any appeal from the judgment, and will only subsequently arise if MSD’s appeal fails. It offers undertakings to prosecute any appeal or cross-appeal expeditiously, and to give Wyeth notice of when it intends to import or sell its 15-valent vaccine (unless the appeal is determined in its favour or the injunctive relief issue is determined in its favour before that event occurs). MSD’s position can be briefly summarised. It submits that its 15-valent vaccine will provide health advantages over Wyeth’s Prevnar 13. It wishes to adduce evidence going to this point, and for the Court to conduct a separate hearing on whether it is against the public interest to grant an injunction restraining infringement. The proposed additional evidence would address:(1)the prevalence in the community of invasive pneumococcal disease caused by serotypes 22F and 33F;(2)the ability of the MSD 15-valent vaccine to provide additional protection against those serotypes;(3)recent changes in government policy concerning making pneumococcal conjugate vaccines more available in Australia; and(4)evidence that Wyeth’s Prevnar 13 vaccine does not provide effective protection against serotype 3.

Ratio Decidendi

Legal Principle Established

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