News & Analysis as of

Biotechnology Hatch-Waxman

Akin Gump Strauss Hauer & Feld LLP

District Court: Factual Disputes Preclude Application of Safe Harbor to Gene Editing Technology at the Pleading Stage

The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more

Fish & Richardson

The Not-So-Safe Harbor for Research Tools: Lessons From the District of Delaware

Fish & Richardson on

In BlueAllele Corp. v. Intellia Therapeutics, Inc., 2024 U.S. Dist. Lexis 222094 (D. Del. Dec. 9, 2024)1, the District of Delaware addressed several issues relevant to the safe harbor defense in Hatch-Waxman litigation. ...more

Polsinelli

Federal Circuit Clarifies Rules for Skinny Labeling for Generics and Biosimilar Companies

Polsinelli on

Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

Patterson Belknap Webb & Tyler LLP

Opposition to Rehearing Filed in Major Federal Circuit Case Narrowing Hatch-Waxman Venue

Last week, Mylan filed a brief in opposition to Valeant’s petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402. In November, a Federal Circuit panel held that venue in Hatch-Waxman...more

Troutman Pepper Locke

Why Biotech and Pharma Patents Survive IPR

Troutman Pepper Locke on

When the America Invents Act of 2011 ushered in a number of new administrative procedures for challenging issued patents, the biotechnology and pharmaceutical industries at first seemed largely unconcerned. Originally...more

McDonnell Boehnen Hulbert & Berghoff LLP

BIO CEO: IPR System Threatens Medical Innovation

In an article published earlier this fall on Medium, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood urges Congress to modify the inter partes review (IPR) system, which he argues has "turn[ed] the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Hatch-Waxman Watch: Safe Harbor Edition

Last week, two district courts dispensed with lawsuits based on the protections afforded by the safe harbor provision of the Hatch-Waxman statute. Both of the cases relied heavily on the Federal Circuit case Momenta Pharm....more

McDonnell Boehnen Hulbert & Berghoff LLP

MBHB Snippets: Review of Developments in Intellectual Property Law - Winter 2013 - Volume 11, Issue 1

In This Issue: Federal Courts Debate Safe Harbor Exemption for Patent Infringement Under 35 U.S.C. § 271(e) Following Merck v. Integra; If I Prioritize Examination of My Application, Should the Patent Office?;...more

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