Drug Patent Disputes Impede U.S. Access To Cheaper Biosimilars

Sterne Kessler Director Jacqueline Wright Bonilla, Ph.D. spoke to MLex about U.S. patent and litigation hurdles that are affecting the biosimilars industry.

A recent report from the Association for Accessible Medicines estimated that many biologic medicines approaching patent expiration lack biosimilar competitors in development in the U.S. and face a much a higher number of patent assertions than other countries. Bonilla noted, “That does tell you something about the U.S. litigation stratosphere, if you will, as it relates to the pharma space,” she continued, “The numbers are quite stark.”

She also explained that biologic medicines can involve legitimate patents on improvements, especially on the methods used to make and formulate them. “With biosimilars, it’s not just the composition; It’s the method of making it that’s a big deal,” she said. “People can have a difference of opinion about whether specific patents are good or not, and I think it would be helpful if there were a cheaper way to adjudicate those.”

Bonilla further explained how smaller generic and biosimilar companies do not have the same resources as a brand company, and that a complex biotechnology inter partes review at the Patent Trial and Appeal Board (PTAB) can be expensive, while litigation can cost many times more.

The cost of the science and manufacturing combined with the cost of litigation can deter possible entrants. “There should be a faster, cheaper alternative” to challenge potentially weak patents. She added, “And so, my view is that turning off the spigot of post-grant reviews (PGR) and IPRs does have an impact.”

Acknowledging that PGRs and IPRs can provide a route to challenge patents at the USPTO rather than in district court, Bonilla noted that making those proceedings harder to obtain can push disputes into more expensive litigation. “It is not a viable position to say that there aren’t ever patent thickets, and patents generally don’t impact drug pricing. That absolutely is true, but I think it’s also incorrect to say that patent thickets are the only thing that matters.”