News & Analysis as of

Life Sciences Hatch-Waxman Safe Harbors

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

Fish & Richardson

The Final Word on an Alleged Infringer’s Intent in a Hatch-Waxman Safe Harbor Analysis

Fish & Richardson on

We have been monitoring the dispute between Edwards Lifesciences Corp. (“Edwards”) and Meril Life Sciences Pvt., Ltd. (“Meril”) before and after the initial Federal Circuit decision. The dispute focused on whether Meril’s...more

McDonnell Boehnen Hulbert & Berghoff LLP

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. (Fed. Cir. 2024)

A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor...more

McDermott Will & Emery

What Use Does § 271(e)(1) Safe Harbor “Solely” Protect?

The US Court of Appeals for the Federal Circuit affirmed that the 35 U.S.C. § 271(e)(1) safe harbor protecting certain infringing acts undertaken for regulatory approval applied to an alleged infringer’s importation of...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Fish & Richardson

Federal Circuit to Consider the Relevance of an Alleged Infringer’s “Intent” in a Hatch-Waxman Safe Harbor Analysis

Fish & Richardson on

The Federal Circuit will consider the relevance of an alleged infringer’s intent in a safe harbor analysis in the appeal of Edwards Lifesciences Corp. v. Meril Life Scis. Pvt.1 The District Court granted summary judgment that...more

Proskauer - Life Sciences

A Guiding Light for the Research Safe Harbor and “Research Tools”?

Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more

8 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide