Experts Discuss BPCIA Litigation Confusion, Differences Between IPRs and PGRs

In order to understand the case law that is emerging from the Biologics Price Competition and Innovation Act of 2009 (BPCIA), one first needs to understand what the patent dance is and the purpose behind it, explained Christopher Loh, partner at Venable, in a presentation during the SMi Biosimilars USA Conference held November 14-15, 2018, in Iselin, New Jersey.

The statute is meant to resolve patent disputes between biosimilar developers and reference product sponsors before FDA approval or the launch of the product. “However, that might be the intent of the statute, but reality doesn’t necessarily match that intent,” said Loh.

This is due to the patent dance being deemed as optional, with biosimilar developers or reference product manufacturers either able to “opt out” of taking part in the dance at all or leaving the dance before it’s completed. Loh and his co-presenter Peter Waibel, head of patent litigation at Novartis, went on to discuss examples that have caused confusion within the BPCIA statute that have already led to litigation or may do so in the future.

“Take labeling for example, if there’s an indication not currently on the label but work or studies completed for the biosimilar application that might be covered by the patent, when do you bring that into [the patent dance]?” Waibel said. “If you’re precluded from bringing it in at a later time than what is dictated, and if you don’t bring it up at that point then you never can… it makes it a difficult issue. On the other hand, if you’re litigating an issue that might go away or be settled, then why should you bring it in at all?”

In similar fashion, Ha Kung Wong, partner at Venable, and John Kirkland, director at Alkermes, presented about other litigation commonly seen in the biosimilar space, such as inter partes review (IPR) and post grant review (PGR).

While there are 14 biosimilars currently approved in the United States, only 6 are available on the market, largely due to patent litigation. IPR and PGR are trial proceedings that take place before the Patent Trial and Appeal Board reviews the patentability of one or more claims.

However, there are a number of differences between IPR and PGR litigation, such as the burden of proof. In district court, the burden is clear and convincing evidence where the patent is presumed valid. Conversely, in IPR or PGR litigation, the potential for invalidation of the process is much higher and there is no preponderance of validity of the patent.

Interestingly, Wong noted that most patent claims brought to litigation are method of treatment patents (tried 51% of the time), process or manufacturing patents, composition of matter, and formulation patents. Both composition of matter and formulation patents were tried at the next highest rate of 17% each.