Life Sciences Webinar Series Impact of PTE on Litigation Under the Hatch-Waxman Act: A Look at the Federal Circuit’s Decision in Biogen v. Banner Life Scis.
August 13, 2020 Date
Kelly Allenspach Robert Oakes Del Dotto Agenda
• Background Regarding Patent Term Extension and the Hatch-Waxman Act • Pre-Biogen Case Law Regarding Patent Term Extension • The Biogen Int’l GMBH v. Banner Life Sciences Decision • Policy Implications of the Biogen Decision
fr.com | 2 Patent Term Extension and the Hatch-Waxman Act Hatch-Waxman Act Overview
• Compromise between “pioneering development of pharmaceutical formulations and methods and facilitating efficient transition to a market with low- cost, generic copies of those pioneering inventions at the close of a patent term.” – Novo Nordisk A/S, et al. v. Caraco Pharmaceutical Laboratories, Ltd., et al., No. 2010- 1001 (Fed. Cir., April 14, 2010), at 2. • Brand Industry (§ 505(j)(5)(F)): • 5 year “filing” exclusivity (“data exclusivity”) for new chemical entities (NCE) • 3 year “marketing” exclusivity based on new clinical trials • Patent Term Extension for time patented product is under review by FDA • Generic Industry: • Use of Abbreviated New Drug Applications (ANDAs) • 180-Day Generic Drug Exclusivity for first Paragraph IV filer(s) • Ability to develop product free of worry of infringement suit (Safe Harbor) • Both • Opportunity for Court to decide patent issues pre-launch
9 Patent Term Extension | 35 U.S.C. § 156
• Accounts for delays associated with regulatory review by extending patent term
• PTE = (½ x IND Phase) + NDA Phase – Applicant Delay • Cannot exceed 5 years from patent’s expiration • Not to exceed 14 years from NDA approval – Measured from date of regulatory approval to date of expiration with PTE and any PTA • Important for pharmaceutical patents, because patents covering pharmaceutical products cannot be exploited until regulatory approval
fr.com | 5 Patent Term Extension | 35 U.S.C. § 156
• Applies to patents that claim a product, a method of using a product, or a method of manufacturing a product.
• Product must have undergone a period of regulatory review; must be first permitted commercial marketing/use of product.
• Patent must not have been previously extended.
fr.com | 6 Patent Term Extension | 35 U.S.C. § 156 • 35 U.S.C. § 156(a) (excerpted):
fr.com | 7 Patent Term Extension | 35 U.S.C. § 156 • 35 U.S.C. § 156(b) (excerpted):
. . .
fr.com | 8 Patent Term Extension | 35 U.S.C. § 156 • 35 U.S.C. § 156(f):
fr.com | 9 Pre-Biogen Case Law Regarding Patent Term Extension Pfizer Inc. v. Dr. Reddy's Labs., Ltd.
• Facts: – Pfizer’s patent covered dihydropyridine compounds, including amlodipine and its salts. – Pfizer obtained clinical data on two salts covered by the patent: amlodipine besylate and amlodipine maleate. – Pfizer chose to proceed with amlodipine besylate and got FDA approval. Pfizer also obtained PTE for the FDA’s delay in approving the product. • Argument: – Dr. Reddy’s filed a paper NDA on amlodipine maleate, arguing that while Pfizer’s patent covered the maleate salt the PTE did not apply because only the besylate salt was the “product” under § 156.
Pfizer Inc. v. Dr. Reddy’s Labs.. Ltd., 359 F.3d 1361 (2004) fr.com | 11 Pfizer Inc. v. Dr. Reddy's Labs., Ltd.
Pfizer Inc. v. Dr. Reddy’s Labs.. Ltd., 359 F.3d 1361 (2004) fr.com | 12 Glaxo Ops. UK Ltd. v. Quigg
Glaxo Ops. UK Ltd. v. Quigg, 894 F.2d 392, 395 (Fed. Cir. 1990)
fr.com | 13 PhotoCure ASA v. Kappos
PhotoCure ASA v. Kappos, 603 F.3d 1372 (Fed. Cir. 2004)
fr.com | 14 The Biogen Int’l GMBH v. Banner Life Sciences Decision Biogen Int’l GMBH v. Banner Life Sciences
• Dimethyl Fumarate (“DMF”) active ingredient in Biogen’s Tecfidera® product, used to treat multiple sclerosis • Banner submitted a § 505(b)(2) application (“paper NDA”) to market a generic equivalent to Tecfidera® • Banner’s product contained monomethyl fumarate (“MMF”) as the active ingredient • Upon administration to a patient, one of DMF’s methyl ester groups is metabolized to a carboxylic acid group, becoming MMF before the compound reaches its pharmacological site of action
fr.com | 16 U.S. Patent No. 7,619,001
fr.com | 17 U.S. Patent No. 7,619,001
• The ’001 patent originally set to expire on April 1, 2018 • Term of the ’001 patent extended 811 days per 35 U.S.C. § 156, to June 20, 2020 • Question presented: whether methyl hydrogen fumarate (i.e., MMF), which is covered by the claim, is covered by the patent term extension
fr.com | 18 35 U.S.C. § 156
• 35 U.S.C. § 156(b)(2): “the rights derived from any patent the term of which is extended under this section shall during the period during which the term of the patent is extended…. in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent and approved for the product…As used in this subsection, the term “product” includes an approved product.”
• U.S.C. § 156(f): For purposes of this section: (1) The term “product” means: (A) A drug product. (B) Any medical device, food additive, or color additive subject to regulation under the Federal Food, Drug, and Cosmetic Act. (2) The term “drug product” means the active ingredient of— (A) a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act) …… including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient
fr.com | 19 Biogen Int’l GMBH v. Banner Life Sciences: District Court
• Banner Argument: § 156(b)(2) limits the scope of the ’001 patent’s extension to methods of using the approved product as defined in § 156(f)—i.e., DMF, its salts, or its esters—MMF is not covered • Biogen Arguments: 1) § 156(b)(2) does not limit extension to uses of the approved product; applies to use of any product within the scope of the claims 2) “Product” in § 156 has a broader meaning, encompassing any compound that shares with the approved product an “active moiety.”
Biogen Int’l GmbH v. Banner Life Sciences LLC, 424 F.Supp.3d 303, 309-10 (D. Del. 2020) fr.com | 20 Biogen Int’l GMBH v. Banner Life Sciences: District Court
Biogen Int’l GmbH v. Banner Life Sciences LLC, 424 F.Supp.3d 303, 310, 314 (D. Del. 2020)
fr.com | 21 Biogen Int’l GMBH v. Banner Life Sciences: Federal Circuit
Biogen Int’l GmbH v. Banner Life Sciences LLC, 956 F.3d 1351, 1357 (Fed. Cir. 2020) fr.com | 22 Biogen Int’l GMBH v. Banner Life Sciences: Federal Circuit
Biogen Int’l GmbH v. Banner Life Sciences LLC, 956 F.3d 1351, 1357-58 (Fed. Cir. 2020) fr.com | 23 Implications of Biogen Decision Policy Implications of Biogen Decision
• Generic applicant may avoid innovator’s patent term extension by using active moiety of compounds in innovator’s drug product • Shift in Hatch-Waxman balance between innovator and generic drug companies? • Potential impact on innovation of certain classes of drugs (e.g., prodrugs) • Is decision consistent with Hatch-Waxman Act’s language and intent?
fr.com | 25 Policy Implications of Biogen Decision
fr.com | 26 Policy Implications of Biogen Decision
fr.com | 27 Policy Implications of Biogen Decision
fr.com | 28 Thank You!
Kelly Allenspach Del Dotto Robert Oakes 302-778-8403 302-778-8477 [email protected] [email protected]
fr.com | 29 © Copyright 2020 Fish & Richardson P.C. The opinions expressed are those of the authors and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This presentation is for general information purposes and is not intended to be and should not be taken as legal advice and does not establish an attorney-client relationship.
These materials may be considered advertising for legal services under the laws and rules of professional conduct of the jurisdictions in which we practice.. Legal advice of any nature should be sought from legal counsel. Unsolicited e-mails and information sent to Fish & Richardson P.C. will not be considered confidential and do not create an attorney-client relationship with Fish & Richardson P.C. or any of our attorneys. Furthermore, these communications and materials may be disclosed to others and may not receive a response. If you are not already a client of Fish & Richardson P.C., do not include any confidential information in this message. For more information about Fish & Richardson P.C. and our practices, please visit www.fr.com.