A bipartisan bill, introduced by US Senators Chris Coons (D-Delaware), Tom Cotton (R-Arkansas) Dick Durbin (D-Illinois), and Mazie Hirono (D-Hawaii), seeks to make a number of reforms that would make it easier for innovators—including the manufacturers of reference biologics—to defend against challenges to their patents.
A bipartisan bill, introduced by US Senators Chris Coons (D-Delaware), Tom Cotton (R-Arkansas) Dick Durbin (D-Illinois), and Mazie Hirono (D-Hawaii), seeks to make a number of reforms that would make it easier for innovators—including the manufacturers of reference biologics—to defend against challenges to their patents.
The bill, known as the Support Technology and Research for Our Nation’s Growth and Economic Resilience Patents Act of 2017, or the STRONGER Patents Act of 2017, proposes changes to inter partes review (IPR) proceedings and their counterparts, post-grant review (PGR) proceedings. (While IPR is a trial proceeding before the Patent Trial and Appeal Board, or PTAB, that provides for a review of patentability after a patent has been issued for 9 months, PGR provides for such a review during the 9 months following a patent’s issuance.) As reported by JD Supra, the act’s proposed changes to IPRs and PGRs would favor patent owners in several ways, including the following:
While Senator Coons says that the STRONGER Patents Act is designed to bolster investor confidence and foster the development of new technologies, the act does have the potential to create difficulty for biosimilar manufacturers in bringing their products to the US marketplace. IPR petitions—on the rise for the biopharmaceutical industry throughout early 2017—have presented biosimilar developers a litigation option that is both faster and potentially less expensive than litigation under the Biologics Price Competition and Innovation Act (BPCIA). If the STRONGER Patents Act is passed into law, the biologics industry could lose IPRs as a viable means by which to challenge innovators’ patents, further delaying patient access to biosimilar treatments.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development
July 17th 2024The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.