FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases
Key Takeaway: The FDA is developing a “plausible mechanism framework” to facilitate approval of individualized therapies for the treatment of rare genetic diseases that currently face approval challenges. As discussed previously...
New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the U.S.
Key Takeaway: New FDA guidance released on February 23, 2026, and March 9, 2026, signals a continued shift toward regulatory flexibility aimed at accelerating approval of biosimilar treatments for rare...
Life Science Considerations on the USPTO’s New Guidelines for AI-Assisted Inventorship
On November 26, 2025, the United States Patent and Trademark Office (USPTO) issued revised guidelines for determining inventorship of AI-assisted inventions,[1] which is a significant development in life science innovations,...
USPTO’s Automated Search Pilot: Through a Biotech Lens
In October 2025, the U.S. Patent and Trademark Office (USPTO) launched the “Artificial Intelligence Search Automated Pilot Program,” or ASAP!, an initiative to identify potential prior art using artificial intelligence...
Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth
The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent...
Settlements Don’t Close the Door: Antitrust Claims Follow IPR Challenges in Life Sciences
In the ongoing case of Carefirst of Maryland Inc. v. Johnson & Johnson[1], the plaintiffs successfully overcame a motion to dismiss. At the heart of the case is J&J’s legal...
District Court Finds Mylan (Viatris) Infringes Regeneron’s Eylea Patent
On December 27, 2023, Judge Thomas S. Kleeh of the United States District Court for the Northern District of West Virginia issued an order finding that Mylan (Viatris) infringed claims 4, 7, 9, 11, and 14-17 of Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”) after a nine-day bench trial held in June 2023.
In IP & Tech Law Journal, Andrea Cheek and Ari Feinstein Discuss Patent Venues
Knobbe Martens partner Andrea Cheek and associate Ari Feinstein authored “Patent Venue, and How It Works in Abbreviated New Drug Application Litigation,” published in Intellectual Property & Technology Law Journal....
LMG Recognizes Knobbe Martens as Leading Life Sciences Firm
IRVINE, CALIF., September 21, 2023 – Knobbe Martens is pleased to announce that Legal Media Group (LMG) has again recognized the firm as having one of the top life sciences intellectual...
Knobbe Martens Shortlisted for “Firm of the Year,” Seven Other Categories, for Euromoney LMG Life Sciences Awards
IRVINE, CALIF., July 26, 2023 – Knobbe Martens is pleased to share that the firm and five of its partners are shortlisted in eight categories for the 2023 Euromoney Legal Media Group “LMG...
Knobbe Martens Attorneys Recognized by Washington D.C. Super Lawyers
Congratulations to partner William R. Zimmerman and associate Justin Culbertson for being included in Super Lawyers’ 2023 Washington D.C. “Super Lawyers” and “Rising Stars” lists. Mr. Zimmerman serves as managing...
Knobbe Martens Shortlisted in Six Categories for Euromoney LMG Life Sciences Awards
IRVINE, CALIF., July 22, 2022 – Knobbe Martens is pleased to share that the firm and its partners were shortlisted in six categories for the 2022 Euromoney Legal Media Group (LMG) “LMG Life Sciences...
Knobbe Martens Recognized as National Leader in Patent Challenges and PTAB Proceedings by Docket Navigator
Docket Navigator, a leading patent intelligence research platform, has recognized Knobbe Martens – along with its attorneys – as among the nation’s top patent challengers, as well as one of...
