Life Science Update | August 2025
Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul Jane Dai, Ph.D. & Susan M. Janicki, Ph.D. The Trump administration is considering changing the U.S....
Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul
The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay...
National Institutes of Health (NIH) Announces Plan to Centralize Peer Review Process
On March 6, 2025, the National Institutes of Health (NIH) announced plans to centralize peer review of all applications for grants, cooperative agreements and research and development contracts within its...
New Tool From EPA, FDA, and USDA Guides Developers of Genetically Modified Microorganisms Through Regulatory Landscape
On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) released a new web-based interactive tool on the Unified Website for Biotechnology Regulation for companies that develop microbial biotechnology products. The purpose of the tool is to help developers fulfill the regulatory requirements necessary to work with genetically modified microorganisms. The tool defines "genetic modification" as any technique that uses recombinant, synthesized, or amplified nucleic acids to modify or create a genome. “Microorganisms” include prokaryotes (e.g., bacteria and archaea), protists (e.g., amoebas), fungi (e.g., yeast, mold, mushrooms), green and red algae, and viruses or virus-like particles. Through a series of prompts, the tool provides users with information on regulatory requirements and the approval process across agencies. A built-in feedback function allows stakeholders to submit feedback directly to the agencies, which have expressed a commitment to continuing to improve the tool and expand its utility, scope and user base.
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.
WIPO Member States Adopt New Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge
On May 24, 2024, member states of the World Intellectual Property Organization (WIPO) adopted a new treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge that was over 20 years in the making. Genetic resources, which can include medicinal plants, agriculture crops and animal breeds, cannot themselves be claimed as intellectual property. However, inventions developed using genetic resources can be protected, usually through patents. The stated goals of the treaty include enhancing the efficacy, transparency, and quality of the patent system and preventing patents from being granted erroneously for inventions that are not novel or inventive with regard to genetic resources and traditional knowledge.
The Federal Trade Commission Put Brand Drug Manufacturers on Notice About Improperly Listing Patents in the Orange Book and Then Followed Through With More Than 100 Patent Challenges
The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations, known as the ‘Orange Book.’” The FTC’s stated goal was to notify market participants of the FTC’s intent to scrutinize improper Orange Book listings to determine whether they constitute unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act. On November 7, 2023, the FTC followed through on its warning by sending notice letters to more than 10 companies challenging the Orange Book listing of more than 100 patents covering products including specific asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors.
