What's Ahead for Biosimilar Litigation?

In the 10 years since the passing of the Biologics Price Competition and Innovation Act (BPCIA), the field of biosimilar legislation and litigation has rapidly expanded, creating a new, complex legal environment. To help navigate the expanding biosimilar legal space, Goodwin law released the Guide to Biosimilars Litigation and Regulation in the U.S. which provides a guide to each section of the BPA. Goodwin partners Robert Cerwinski, JD, and Alexandra Valenti, JD, discussed the guide on a recent podcast on The Center for Biosimilars.

“The guide covers all legal and regulatory issues that we've either already seen litigated or expect to see litigated in the coming years that relate to biosimilar products,” Valenti said. The publication is meant as both a guide for those who work closely with biosimilars and biosimilar litigation as well as for those who are new to the space.

Valenti noted that since the passage of the BPCIA, the Supreme Court, in Sandoz v Amgen, resolved the issue as to whether a private party had the ability to enforce the act's provisions that pertain to the prelitigation information exchange, or patent dance. "That decision also held that notice of commercial marketing under the statute could be given at any time by the biosimilar, that the biosimilar didn't need to wait for product approval to provide notice of commercial marketing," she said.

One possible issue that is being watched is to see if product liability claims arise in biosimilars. “The interesting thing that we’ll be watching in that space is whether federal preemption principles that have been held to shield generic small molecule drug manufacturers from certain types of product liability claims will also apply in the biosimilar context,” Valenti said.

Anotjher issue to watch is the streamlining of patent issues by district judges, said Cerwinski. A judge may attempt to manage the process in such a way that might be considered more timely and efficient, but this is raising concerns by branded manufacturers.

“Brands have really been concerned about this as a streamlining by district court judges on the ground that not permitting a brand or a patentee to assert whatever patents the [Patent Trade Office] PTO has issued it is unconstitutional,” Cerwinski said. “And is somehow taking a property right or preventing them from exercising them property right? And we expect to see that actually appealed all the way up to the Supreme Court at some point.”

To learn more about the Guide to Biosimilars Litigation and Regulation in the US, visit the purchase page here and listen to the full interview here.