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...
Patent Exclusivity and Price Controls: Teva v. Kennedy
On November 20, 2025, the D.C. District Court issued its opinion [1] in a lawsuit where Teva Pharmaceuticals USA, Inc. challenged the validity of the Medicare Drug Price Negotiation Program...
PTAB Update | August 2025
No Shenanigans: IPRs and Interference Estoppel Jacob R. Rosenbaum & Alistair J. McIntyre IGT v. ZYNGA INC. Before Prost, Reyna, and Taranto. Appeal from the Patent Trial and Appeal Board (PTAB). Summary: Interference...
No Shenanigans: IPRs and Interference Estoppel
IGT v. ZYNGA INC. Before Prost, Reyna, and Taranto. Appeal from the Patent Trial and Appeal Board (PTAB). Summary: Interference estoppel does not apply when the interference was terminated due...
FDA Accuses Third Party Testing Labs of Falsifying Data
The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...
Two Bills Introduced to Target “Patent Thickets” and “Product Hopping”
On March 17, 2025, a bipartisan group of senators introduced two bills intended to decrease the cost of prescription drugs. The sponsors include Chuck Grassley (R-Iowa), John Cornyn (R-Texas), Richard...
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...
Test Anxiety: FDA Issues Warning Letters to Test Laboratories
The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise concerns with the quality and integrity of data generated.” The press release can be found here.
Science Group Sues FDA Over New Laboratory-Developed Test Rule
On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). The rule, which became effective on July 5, 2024, explicitly categorizes in vitro LDTs intended for clinical use as medical devices, placing such LDTs within the purview of the FDA. The complaint was filed in the Southern District of Texas. AMP’s suit follows another suit filed by a trade association, the American Clinical Laboratory Association, targeting the same rule.
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]
New Ethylene Oxide Regulations May Raise Cost of Sterilization
Last week, the Environmental Protection Agency (EPA) announced new regulations to reduce ethylene oxide emissions. According to the EPA’s press release, the new regulations are “the strongest measures in U.S. history to reduce emissions of [ethylene oxide], one of the most potent cancer-causing chemicals.” The new regulations can be found here. The press release states that the regulations will affect “nearly 90 commercial sterilization facilities . . . owned and operated by approximately 50 companies.” The regulations require installation of air pollution controls to reduce emissions by more than 90%. The regulations are intended to reduce lifetime cancer risk for those living nearby sterilization facilities.
Defining Indefiniteness: When Are Claim Limitations Contradictory?
MAXELL, LTD., V. AMPEREX TECHNOLOGY LIMITED
Before Prost, Taranto, and Chen. Appeal from the United States District Court for the Western District of Texas.
Summary: Two claim limitations are not contradictory if they can be satisfied simultaneously.
Shutdown Will Impact FDA
The looming government shutdown will likely slow the pace of work at the FDA. The federal government will shut down on October 1, 2023 unless a deal is reached. In the event of a shutdown, 19% of FDA employees would be furloughed immediately.
FDA Approves Generic Fluorescein Injection
On September 26, 2023, Nexus Pharmaceuticals, LLC announced that it had received approval from the U.S. Food and Drug Administration (FDA) for Fluorescein Injection, USP. Nexus Pharmaceuticals is a maker of generic drugs.
Weighty Considerations: Objective Indicia of Non-obviousness
VOLVO PENTA OF THE AMERICAS, LLC, v. BRUNSWICK CORP.
Before Moore, Lourie, and Cunningham. Appeal from the Patent Trial and Appeal Board.
Summary: The Board must consider the combined weight of multiple objective indicia of non-obviousness and must provide an explanation for the weight attributed to each objective indicia proven by the patent owner.
Supreme Court Issues Stay in Mifepristone Case, Preserving Status Quo for Now
On April 21, 2023, the Supreme Court granted a stay in Alliance for Hippocratic Medicine v. FDA, a case concerning the Food and Drug Administration’s approval of and access to the widely used abortion pill mifepristone. The stay preserves access to mifepristone as the Biden administration and Danco Laboratories, the drug’s manufacturer, appeal a lower court ruling that would greatly limit the availability of the drug.
FDA Issues Final Guidance on Transitioning from COVID-19 EUAs
The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as their devices transition from Emergency Use Authorizations (EUAs). Just over three hundred EUAs were issued for diagnostic devices during the COVID-19 pandemic. In the announcement, the FDA characterized the issuance of EUAs as “proactive steps to help facilitate the availability of critical medical devices, including in vitro diagnostic tests.” Draft versions of the guidance documents were made available for public comment in December 2021.
Collateral Estoppel Is Applicable in IPRs When the Question of Patentability Is the Same
GOOGLE LLC v. HAMMOND DEVELOPMENT INTERNATIONAL, INC.
Before Moore, Chen, and Stoll. Appeal from the Patent Trial and Appeal Board.
Summary: Collateral estoppel applies to IPRs where differences in claims do not materially alter the question of patentability.
Knobbe Martens Team Authors “Recent Developments in Intellectual Property Law 2022” For ABA Business Law Today Section
Knobbe Martens attorneys Julia Hanson, Alistair McIntyre, Nyja Prior and Michelle Ziperstein co-authored the article “Recent Developments in Intellectual Property Law 2022” for the ABA’s Business Law Today section. Partner...
Boston Scientific Acquires Embolization Gel Developer Obsidio, Inc.
Boston Scientific announced on August 15, 2022, that it acquired Obsidio, Inc. for an undisclosed fee. Obsidio has technology called the Gel Embolic Material (GEM™), which is used in minimally invasive blood vessel embolization. According to its press release, Boston Scientific intends to expand its interventional oncology and embolization portfolios.
An ANDA Specification that Directly Addresses Issues of Infringement Controls the Infringement Inquiry
PAR PHARMACEUTICAL, INC. V. EAGLE PHARMACETICALS, INC.
Before Moore, Prost, and Hughes. Appeal from the United States District Court for the District of Delaware.
Summary: An ANDA was held not to infringe asserted claims because the ANDA specifies pH ranges that fall outside of those recited in the asserted claims.
