Overview
Our extensive Hatch-Waxman litigation practice and successful practice in post-grant PTO proceedings, combined with our deep technical expertise in biotechnology, uniquely positions us to develop and implement effective IP strategies for biosimilars. This industry-specific expertise is backed by one of the largest and most experienced biotechnology groups in IP law, with more than 75 attorneys and scientists representing clients in all stages of their business and technology development, as well a talented litigation group adept in all aspects of biotechnology IP law.
Biosimilars Pathway Bench Strength:
- Up-to-date knowledge of biosimilars legislation
- IP litigators with numerous trial and appellate successes
- Extensive Hatch-Waxman litigation experience
- Successful Post-Grant PTO practice on behalf of patent owners and petitioners
- More than 20 attorneys with PhD’s in the life sciences
- Extensive experience in biologics patent prosecution
- Licensing and other transactional experience related to biologics
Latest Updates and News
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....