Strategies for Coping with the Evolving Landscape of Biosimilars Patent Resolution in the United States

Transcription

1 Strategies for Coping with the Evolving Landscape of Biosimilars Patent Resolution in the United States Andrew W. Williams, Ph.D. March 5, 2018

2 Biologics Price Competition And Innovation Act Two Distinct Sections of the BPCIA Regulatory (42 U.S.C. 262(k)) Patent Dispute Resolution (42 U.S.C. 262(k)) 2

3 Patent Exchange Process Under 42 U.S.C. 262(l) the Patent Dance Biosimilar files Application Biosimilar Application accepted by FDA 20 days Biosimilar 60 days RPS provides 60 days provides patent list to confidential Biosimilar info to RPS Biosimilar provides RPS with patent list and detailed statement RPS & Biosimilar negotiate final list of patents to litigate RPS provides Biosimilar with detailed statement 60 days 15 days 30 days yes Agreement reached no Biosimilar identifies number of patents that can be asserted 5 days RPS files complaint Simultaneous exchange of patent lists 30 days RPS files complaint 180 days before Biosimilar commercialization must notify RPS 3

4 BPCIA Litigation Overview 1. Biosimilar applicant provides application to reference produce sponsor (RPS) 2. Parties identify potentially relevant patents 3. First Litigation Phase a. Negotiation of list of patents to litigate b. Biosimilar applicant controls number of patents 4. Second Litigation Phase a. 180 day Notice of Commercial Marketing b. RPS may seek a injunction and bring DJ action 4

5 Patent Dispute Resolution and FDA Approval Regulatory process tied to licensure of reference product ( RP ), not to patent portfolio Cannot file until four years after RP is first licensed Cannot be approved until twelve years after first licensure Patent dispute resolution process does not stay FDA approval of biosimilar application Only way to stop biosimilar product from coming onto the market is injunction from the court FDA approval not tied to status of patent dispute resolution process Nor to participation in process by either party 5

6 BPCIA Statutory Remedies If Biosimilar applicant fails to act: If access is not provided to biosimilar application and related information, RPS may bring a DJ action on any patent the claims the biological product or its use If applicant fails to participate in any other step of the dance, RPS may bring DJ action on any patent it identified 6

7 BPCIA Statutory Remedies If RPS applicant fails to act: Biosimilar applicant cannot bring a DJ action But, For any patent that was not (but could have been) identified by the RPS, an action for infringement may not be brought under this section. 35 U.S.C. 271(e)(6)(c). If the first phase infringement action is not brought in the 30-day window, the exclusive remedy shall be a reasonable royalty. 35 U.S.C. 271(e)(6)(c). 7

8 The Supreme Court Weighs In Sandoz v. Amgen 8

9 Sandoz Zarxio TM Application abla filed under BPCIA on a biosimilar version of filgrastrim A 175 amino acid recombinant methionyl human granulocyte colony stimulating factor (r-methug-csf) Used to stimulate neutrophil production in patients undergoing chemotherapy Reference product: Amgen s NEUPOGEN Filed in May, 2014 Accepted July 7, 2014 Approved by FDA on March 6,

10 Sandoz v. Amgen: What about the patent issues? Sandoz refused to provide Amgen with its abla or description of its manufacturing methods Sandoz provided 180-day notice of commercial marketing with notice of acceptance and shortly after FDA approval 10

11 Sandoz v. Amgen: Litigation Background Amgen filed suit in federal court in California on October 24, 2014 To compel Sandoz to participate in the Patent Dance And to force Sandoz to provide proper notice of commercial marketing, i.e., after approval The district court sided with Sandoz The Court of Appeals for the Federal Circuit: The remedies contained within the BPCIA are the exclusive remedies Effective notice of commercial marketing cannot only occur after approval 11

12 Sandoz v. Amgen: The Supreme Court Weighs in RPS can not seek a federal injunction to enforce disclosure requirements The remedy provided by 262(l)(9)(c) excludes all other federal remedies, including injunctive relief. Declined to resolve whether state law injunction was available to RPS On remand, the Federal Circuit should determine whether... the BPCIA pre-empts any additional remedy available under state law.... On remand, the Federal Circuit held that state law claims were pre-empted 12

13 Sandoz v. Amgen: The Supreme Court Weighs in Notice of Commercial Marketing can be provided at any time The statutory context confirms that the [Biosimilar] applicant may provide notice either before or after receiving FDA approval Even if we were persuaded that Amgen had the better of the policy arguments, those arguments could not overcome the statute s plain language, which is our primary guide to Congress preferred policy. 13

14 Biologic Price Competition And Innovation Act What s a Biosimilar applicant to do? 14

15 What s a Biosimilar Applicant to Do? Should a Biosimilar applicant provide abla and related manufacturing information? Reasons to not provide: It would provide proprietary information to future competitor RPS may not know which patents to assert RPS may never obtain all the information Reasons to provide: Avoid immediate DJ action on all patents Obtain RPS s patent list and contentions Ability to control litigation timing and sequence Potentially prevent RPS from asserting unidentified patent Potentially limit damages to a reasonable royalty 15

16 What s a Biosimilar Applicant to Do? When should Notice of Commercial Marketing Be Provided? On abla filing or FDA acceptance? It would allow Biosimilar applicant to launch immediately upon approval But it would invite immediate DJ action on all patent On FDA approval? It would defer a preliminary injunction motion and DJ action But it would otherwise prevent launch until at least six months after approval Some intermediary time? Assess status of FDA review and provide Notice at such time to be able to launch on or near approval 16

17 AIA Post-Issuance Proceedings and the BPCIA What should a Biosimilar applicant do about reference product s patent thicket? 17

18 AIA Post-Issuance Proceedings and the BPCIA Consider utilizing the U.S. Patent Office s postissuance proceedings like inter partes review Advantages over district court litigation IPR petition can be filed by anyone as essentially any time No presumption of validity Friendlier claim construction for petitioner PTAB judges will likely have more familiarity with the technology and patent law than judges and juries. Speedier resolution Lower cost Potential disadvantages May not be able to appeal adverse decision Other biosimilar applicants can take advantage of your work 18

19 AIA Post-Issuance Proceedings and the BPCIA Different categories of patents covering biologics Core patents Composition of matter Methods of Use Secondary patents Formulations Indications Dosages Methods of manufacture 19

20 AIA Post-Issuance Proceedings and the BPCIA How have biosimilar applicants fared with IPRs? Generally unsuccessful Composition of matter Formulations Generally successful Methods of Use Dosages Mixed results Methods of manufacture 20

21 Thank You! Andrew W. Williams, Ph. D. is a partner with McDonnell Boehnen Hulbert & Berghoff LLP in Chicago. His practice includes patent litigation, PTAB proceedings, and prosecution in the areas of biotechnology and pharmaceuticals. He is also an author of the Patent Docs weblog /williams@mbhb.com 21

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