Study: Generic Drug Industry Embraces Faster, Cheaper Pathway For Challenging Patents

A newly released study shows that generic drug companies win nearly half the time when challenging patents on United States government-approved pharmaceutical products through the Patent Trial and Appeal Board (PTAB) process.

The study, entitled, “The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents,” was published in “Applied Health Economics and Health Policy.” The authors are: Jonathan J. Darrow, S.J.D., J.D., M.B.A., Reed F. Beall, Ph.D., and Aaron S. Kesselheim M.D., J.D., M.P.H.

From the authors:

A new study by researchers at the Program On Regulation, Therapeutics, And Law (PORTAL) at Harvard Medical School and Brigham & Women’s Hospital reveals that generic drug companies have been successful about 50% of the time when challenging patents covering FDA-approved pharmaceutical products via a new, administrative review procedure of patent validity created by Congress called “inter partes review.”

Most new brand-name drugs are protected by patents from generic competition, but these patents are occasionally granted in error. Invalidating such patents has traditionally been accomplished via court litigation by generic manufacturers, which is expensive and time-consuming. In 2011, Congress created inter partes review—an administrative alternative to court litigation of patents that was intended to be much faster and less expensive.

PORTAL’s new study demonstrates that generic drug manufacturers have embraced the new process, challenging 198 patents covering 134 different drug products over the last 5 years. In 43% of the inter partes review cases since 2011, the challengers succeeded in overturning all challenged patent claims. In addition, inter partes review for drug patents has consistently been completed within 12 months, as required by statute—much faster than litigation. According to Dr. Darrow, “In the pharmaceutical market, the inter partes review process can meaningfully contribute to competition and lower drug prices by ensuring that invalid patents do not block timely availability of generic drugs and by resolving many patent disputes in a more efficient manner than was previously possible.”

For more information or for a copy of the study, contact Jonathan Darrow (PORTAL@partners.org, 617-278-0930).  Article link: https://link.springer.com/article/10.1007/s40258-018-0420-8