Biosimilars Council Petitions Courts to Reject Adding Exclusivity Period

The Association for Accessible Medicines’ Biosimilars Council has filed an amicus brief contesting a Federal Circuit decision that allowed biologic manufacturers market exclusivity beyond 12 years. 

The argument precedes the Supreme Court hearing on a dispute between Sandoz and Amgen concerning the interpretation of 2009’s Biologics Price Competition and Innovation Act (BPCIA). Although the act establishes a 12-month period of market exclusivity for new biologics—a period longer than those implemented in any other country—the Federal Circuit court’s decision granted Amgen—and as a result any subsequent biologic manufacturers—an additional 180 days of exclusivity.

This additional exclusivity period is in direct contrast to Congress’ intent, the Biosimilars Council wrote, and should be rejected.

“The Federal Circuit was wrong to give biologic manufacturers an additional 6 months’ market exclusivity beyond the already-generous 12 years the BPCIA expressly provides,” the council wrote in the brief. “When Congress provided a 12-year exclusivity period in that statute, it meant 12 years, not 12½; when Congress omitted an injunctive remedy, its omission was no accident.”

The 180-day period would serve as a window for biosimilar applicants to submit the required advanced notice of commercial marketing after FDA approval.  The Biosimilars Council argued that notice could be given prior, as was intended by Congress, and that the additional 6 months places biosimilar manufacturers under considerable financial strain. 

“If Congress wanted to delay litigation until after final FDA licensure, it would not have created an early patent-resolution process  that begins just ‘20 days’ after a biosimilar application is accepted for filing … which can occur eight years before licensure,” they wrote.

Amgen also argued that an applicant’s failure to engage in the “patent dance” could leave them subject to an automatic injunction order, which would require the applicant to supply confidential business information. The council supported the Federal Circuit’s decision to deny this action, as “the sponsor’s sole remedy is the one set out in the statute: a patent infringement action.” —Dave Muoio