Congress Unlikely to Revisit Complex Biosimilars Statute Soon


The complexity of the Biologics Price Competition and Innovation Act (BPCIA), which created an abbreviated licensing pathway for biosimilars, has led to litigants playing games with the statutory language, a consequence Congress may not have foreseen.

Because biosimilars are biological products that are shown to be similar to a reference product that already has been licensed by the FDA, biosimilar applicants are at an information advantage over the reference product sponsor, the maker of the original biologic medicine, Kevin E. Noonan of McDonnell Boehnen Hulbert & Berghoff LLP in Chicago told me in a June 5 telephone interview. In some cases, the biosimilar applicants have been able to gamely use the language of the BPCIA’s patent infringement litigation resolution procedure to justify withholding manufacturing information from the maker of the original biologic.

In spite of the gamesmanship, Noonan told me he doesn’t think Congress will revisit the BPCIA anytime soon, especially until the U.S. Supreme Court rules in the pending biosimilar case involving Amgen and Sandoz.

“I don’t think anything will be done until the supreme court rules, and maybe not then,” Noonan told me. “We have to see how the next six months of politics shakes out.”

Upcoming High Court Ruling

The supreme court heard oral argument in April in the case involving Amgen Inc.’s biologic drug Neupogen and Sandoz Inc.’s Zarxio, a Neupogen biosimilar. At issue are the law’s provisions requiring 180 days’ advance notice of marketing of a biosimilar—and an exchange of patent and manufacturing information between the makers of the biosimilar and the original biologic.

The BPCIA’s complex patent infringement litigation resolution procedure, often called the “patent dance,” has led to considerable uncertainty and high stakes for litigants, including the implications of patent dance strategies on what patent infringement remedies will be available.

Those uncertainties played out recently when Janssen Biotech Inc., which makes the blockbuster arthritis biologic medicine Remicade (infliximab), sued Celltrion Healthcare and Hospira Inc. May 31 for infringement for the third time over Inflectra, their biosimilar copy of the drug (Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd., D. Mass., No. 1:17-cv-11008, complaint filed 5/31/17). Janssen said it’s suing Celltrion and Hospira again to prevent any limitations on what infringement damages, including the recovery of lost profits, could be available to it in the future.

Read my full story on the Janssen suit here.

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