News & Analysis as of

Safe Harbors Food and Drug Administration (FDA) Intellectual Property Protection

American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...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

McDermott Will & Schulte

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

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...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

Herbert Smith Freehills Kramer

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

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