Ewa Davison

Ewa Davison

Fenwick & West LLP

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Will the Supreme Court Review Whether FDA-Mandated Bioequivalence Testing to Maintain Approval Falls Within the § 271(e)(1) Safe...

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...more

8/18/2016 - 35 U.S.C. § 271(e)(1) Biosimilars FDA FDA Approval Generic Drugs Life Sciences Patent Infringement Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents Prescription Drugs Safe Harbors SCOTUS

Federal Circuit: A Biosimilar Applicant Must Provide Notice of Intent to Market a Biosimilar Product, No Exceptions

On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product....more

7/21/2016 - Amgen Apotex Biosimilars BPCIA FDA Generic Drugs Life Sciences Patent Dance Patent Litigation Pharmaceutical Patents Popular Sandoz v Amgen

No Exception to Statutory Requirement that a Biosimilar Applicant Provide Notice of Intent to Market its Product

Last week in Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), a unanimous Federal Circuit panel ruled that under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a biosimilar applicant...more

7/13/2016 - aBLA Amgen Apotex Biosimilars BPCIA Commercial Marketing Declaratory Judgments FDA Generic Drugs Notice of Intent Patent Dance Patent Infringement Patent Litigation Pharmaceutical Patents Sandoz v Amgen

Biosimilars: Supreme Court Calls for Solicitor General’s Views in Amgen v. Sandoz

On Monday, June 20, 2016, the Supreme Court deferred a decision on the certiorari petitions filed by both parties from the Federal Circuit’s decision in Amgen v. Sandoz, 794 F.3d 1347 (2015), and instead called for the views...more

6/24/2016 - Amgen Biologics Biosimilars BPCIA Certiorari FDA Life Sciences Patent Infringement Patent Litigation Patents Pharmaceutical Industry Pharmaceutical Patents Sandoz Sandoz v Amgen SCOTUS

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

8/13/2015 - aBLA Amgen Biosimilars BPCIA Commercial Marketing FDA Generic Drugs Hatch-Waxman License Agreements Patent Dance Patent Infringement Patents Pharmaceutical Industry Pharmaceutical Patents Preliminary Injunctions Sandoz Sandoz v Amgen

Intellectual Property Bulletin Winter 2013: Murky Waters: Post-Approval Regulatory Activities and the § 271(e)(1) Safe Harbor

On January 14, 2013, the U.S. Supreme Court refused to consider the U.S. Court of Appeals for the Federal Circuit's exclusion in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), of post-approval...more

4/5/2013 - Biogen Idec Classen Immunotherapies FDA GlaxoSmithKline Infringement Patents Safe Harbors SCOTUS

Intellectual Property Bulletin - Winter 2013

In This Bulletin: - Just Moot It: Supreme Court in Already v. Nike Clarifies When a Covenant Not to Sue Can Kill a Declaratory Judgment Case - Murky Waters: Post-Approval Regulatory Activities and the §...more

4/4/2013 - Covenant Not to Sue FDA Generic Drugs Mootness Nike Pharmaceutical Industry Public Performance Rights Safe Harbors SCOTUS Standing Trade Secrets Trademarks Transfer of Venue

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