Bill on USPTO-FDA Collaboration Reintroduced

March 27, 2025

This is a subtitle for your new post

A bill titled “The Interagency Patent Coordination and Improvement Act,” or S. 1097, was reintroduced in the U.S. Senate which would create a task force between the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) “to improve communication and coordination in implementing each agency’s activities related to pharmaceutical patents,” according to a press release


The legislation is a response to criticisms that the patent system is being gamed in a way that allows for delays in the introduction of generic and biosimilar drugs. 


The U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) published a blog post in 2024 urging the USPTO to resist such “misguided ‘coordination’ efforts”. Moreover, critics charge that further coordination requirements between the USPTO and FDA would create additional red tape that would ultimately slow down the innovation process, and most importantly, seemingly invites the FDA to participate in substantive legal decisions on patent law where they have no jurisdiction nor expertise. 

RECENT ARTICLES

April 24, 2025
Prenuptial Patenting: Responsible Engagement with Engineering Firms
April 24, 2025
PharmOptima, a Poratge, Michigan-based preclinical contract research organization (CRO) is advancing drug discovery through its comprehensive suite of services. Specializing in in-vivo ADME/PK, ocular research, as well as regulated large and small molecule bioanalytical and ligand binding services, PharmOptima supports clients in optimizing drug development programs efficiently and effectively. With a staff averaging 11 years of industry experience and multiple individuals with advanced degrees, PharmOptima also boasts one of the most capable and engaging teams in the industry. The company collaborates with board-certified veterinary ophthalmologist Dr. Ryan Boyd, further enhancing its ocular research capabilities. PharmOptima's team of experts is dedicated to providing high-quality services to the pharmaceutical biotechnology industries. Looking ahead, PharmOptima scientists will be presenting posters at the 2025 The Association for Research in Vision and Ophthalmology (ARVO) conference, showcasing their latest research and innovations in ocular drug development. For more information visit www.pharmoptima.com .
April 24, 2025
Two bills, HB 4332 and HB 4333 were recently re-introduced that would prohibit pathogen gain-of-function (GoF) research. Given that the House is now Republican-led raises concerns for MichBio and others that the legislation might gain traction due to misinformation over biosafety and pandemic origins. MichBio opposes such broad legislative bans as they risk undermining critical scientific progress, public health preparedness, and economic innovation. GoF research has been instrumental in developing life-saving therapies and vaccines. For instance, viral vector-based gene therapies, such as Sarepta's Elevidys for Duchenne muscular dystrophy, and oncolytic virotherapies like Amgen's Imlygic for melanoma, rely on genetically modified viruses to deliver therapeutic genes or selectively destroy cancer cells. These advancements stem from GoF methodologies that enhance viral capabilities for therapeutic purposes. Moreover, GoF research has played a pivotal role in vaccine development. Examples like the AstraZeneca and Janssen COVID-19 vaccines and Merck's ERVEBO vaccine against Ebola employs a genetically modified virus to confer protection, underscore the public health benefits derived from GoF studies. ​ Contrary to concerns that GoF research operates without sufficient oversight, multiple layers of regulation are in place. Since 2017, the U.S. Department of Health and Human Services has implemented a framework to evaluate and guide funding decisions for GoF research, particularly those involving potential pandemic pathogens. This framework includes stringent safety protocols, risk assessments, and ethical reviews. ​ MichBio is most concerned that any legislative bans that broadly define and prohibit GoF research risk stifling innovation across various scientific fields. Such bans could inadvertently encompass research in virology, microbiology, molecular biology, and synthetic biology—disciplines vital for developing new therapies, sustainable agricultural practices, and environmental remediation technologies. ​ In turn, state-level bans on GoF research could have detrimental effects on local economies and academic institutions. Such a ban could impede research critical to understanding and combating diseases, leading to a loss of federal and philanthropic funding. This could hamper the growth of the Michigan's biotech and biomedical sectors. ​  MichBio advocates for a balanced approach that reinforces existing oversight mechanisms and fosters transparent, responsible research practices essential to safeguard both public health and scientific progress.