Life Science Update | December 2025
Purdue Pharma’s $7.4 Billion Chapter 11 Plan Formally Approved Eric Furman, Ph.D. & Rhett D. Ramsey A federal bankruptcy court on November 18 formally approved Purdue’s $7.4 billion Chapter 11...
Purdue Pharma’s $7.4 Billion Chapter 11 Plan Formally Approved
A federal bankruptcy court on November 18 formally approved Purdue’s $7.4 billion Chapter 11 plan to settle thousands of opioid-related lawsuits. The plan requires (1) a $6.5 billion contribution from...
Knobbe Martens Celebrated as “Excellent IP Firm,” Dozens of Partners Recognized for Top-Tier Patent Work in IAM Patent 1000 Guide
IRVINE, Calif., June 3, 2025 – Knobbe Martens is pleased to share that the firm and two dozen of its partners from offices throughout the country have been featured in...
Executive Order 14297 and the Global Drug Market: Policy, Pricing, and Uncertainty
On May 12, 2025, President Trump issued Executive Order 14297[1] targeting prescription drug prices in America. The stated purpose of this order is to combat high drug prices in the...
FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers
Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and...
CDRH Announces Pilot Program to Improve Recall Communication
On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot communications program for improving the timeliness for communicating high-risk recalls.[1] The CDRH intends for...
Senate Seeks to Reduce Biosimilar Prices by “Pruning” “Patent Thickets”
On July 10, the Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S.150), which seeks to increase competition and lower drug prices by imposing limits on patent litigation related to biological products. The bill attempts to target “patent thickets” or the large patent portfolios companies create with significantly overlapping patent rights seen by lawmakers as obstacles to competitors entering the market.
Knobbe Martens’ Across-the-Board Strength in Patent Work Recognized in IAM 2024 Patent 1000 Guide
IRVINE, Calif., June 21, 2024 – Knobbe Martens is proud to announce that multiple practices across the firm and two dozen partners were recognized nationally and regionally for outstanding work...
FDA Issues Final Rule on Laboratory-Developed Tests
On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs).[1] The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for clinical use as medical devices, which are within the purview of the FDA.[2] The final rule will publish on May 6, 2024.[3] Until then, the unpublished version is available. [4]
Knobbe Martens Named a Top Performing Firm, Ten Individuals Ranked Highly for Patent Prosecution in Patexia Report
IRVINE, Calif., March 28, 2024 – Knobbe Martens is proud to announce that the firm and several of its professionals have achieved outstanding rankings in the 2024 Patexia Patent Prosecution...
USPTO Says Wands Still Controls Enablement Analysis Post-Amgen
On January 9, 2024, the USPTO published guidelines for its patent examiners when evaluating compliance with the enablement requirement in light of the U.S. Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023). In Amgen, the Supreme Court unanimously held that claims drawn to a genus of monoclonal antibodies, which were functionally claimed, were invalid due to a lack of enablement. Notably, the Supreme Court did not expressly cite the Wands factors in analyzing whether the specification at issue in Amgen enabled the claims, but the recently published USPTO guidelines underscore that “USPTO personnel will continue to use the In re Wands factors to ascertain whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable.”
IAM 2023 Patent 1000 Guide Recognizes More Than Two Dozen Knobbe Martens Partners and Practices
IRVINE, CALIF., June 26, 2023 – Knobbe Martens is pleased to announce that 23 of the firm’s partners were recognized as leading patent professionals and ranked nationally or regionally in the...
Merck Sues Federal Government Over Medicare Drug Price Negotiation Program
On June 6, 2023, Merck & Co. filed a lawsuit against the U.S. government in federal court over the Inflation Reduction Act (IRA)’s Medicare drug price negotiation program, which allows Medicare to directly negotiate prices with drugmakers. The suit is the first attempt by a pharmaceutical company to challenge the IRA’s Medicare drug price negotiation program.
Two Dozen Knobbe Martens Partners and Practices Recognized in IAM Patent 1000 Guide
Knobbe Martens is pleased to announce that 21 of the firm’s partners in offices on both the East and West Coasts were ranked nationally and regionally in the recently released...
Surfing the Waves of US IP Trends: Tips for Smoothly Riding the Waves in Written Description and Enablement
Partner Jason Gersting, Ph.D. moderated a panel of his peers in a discussion about learning how to identify the waves in current written description and enablement law and tips for...
What You Should Know About Non-Disclosure Agreements – Knobbe Martens Webinar Series for Start-ups: Part I and II
Part I – Introductory Session Partners Eric Furman, Ph.D. and Paul Stellman kicked off a two-part, comprehensive discussion of strategic considerations regarding non-disclosure agreements and confidentiality policies. The presentation as an...
Knobbe Martens Partner Eric Furman Secures Crucial Patent, Contributing to Multi-Million-Dollar Licensing Deal
Knobbe Martens partner Eric Furman, Ph.D., J.D. successfully obtained a U.S. patent that played an important role in securing a multi-million-dollar collaboration and licensing agreement for the firm’s client CombiGene...
Knobbe Martens and 21 Partners Recognized as IP Leaders in 2021 IAM Patent 1000 Guide
Knobbe Martens is pleased to announce that the firm and 21 partners have been recognized as industry leaders in the recently released 2021 edition of IAM’s Patent 1000 guide. Additionally,...
