The STRONGER Patents Act Could Create Roadblocks for Biosimilars

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:

  • Aligning IPRs and PGRs with District Court Standards. To date, IPRs and PGRs have operated under different claim construction standards than has the district court; while IPR and PGR proceedings interpret claims within the “broadest reasonable interpretation,” the act would require these proceedings to adopt the much narrower interpretation used by the district court. That move could limit the scope of claims that petitioners could bring under IPR and PGR proceedings. Furthermore, the act would require that IPR and PGR proceedings fall in line with district court standards with regard to proving unpatentability; the proposed law would require unpatentability to proven by clear and convincing evidence, not by the lower burden represented by the “preponderance of the evidence” standard.

  • Limits on Petitioners and Petitions. The act would exclude a party from filing a petition for review of a patent unless that party has been sued for infringement of that patent. Additionally, the act would allow for only one IPR or PGR on any given claim; litigants seeking to challenge a patent on a repeated claim would be relegated to the district courts. Those who previously petitioned for a review of a patent in an IPR would be prohibited for petitioning for a subsequent IPR for the same patent on any ground that could have been raised in the initial proceeding.

  • Limits on Appeals and Parallel Litigation. The act would make any decision not to institute an IPR or PGR final, and petitioners would be unable to appeal such decisions. However, patent owners would be given the ability to appeal the PTAB’s decision to institute an IPR or PGR on some grounds. The act would also preclude petitioners from litigating claims in district courts that are parallel to claims litigated in IPRs or PGRs.

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.