Biosimilars Council Urges Supreme Court to Reject Additional Six Months Exclusivity for Biologics

Regulatory NewsRegulatory News | 20 February 2017 |  By 

In an amicus brief filed on Friday, the Biosimilars Council, a division of the newly rebranded Association for Accessible Medicines (previously the Generic Pharmaceutical Association), argues that the US Supreme Court should not give biologic manufacturers an additional six months of market exclusivity beyond the “already-generous twelve years” granted.

The 49-page brief comes as the Supreme Court will hear oral arguments on 26 April over a dispute between Novartis’ Sandoz and Amgen that could set the stage for whether a Federal Circuit court ruled erroneously or properly in granting an additional six months of exclusivity to biologic sponsors because of a provision in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

“The Federal Circuit turned this mere notice provision into a grant of 180 days of additional exclusivity for all biological products beyond the exclusivity period Congress expressly provided—delaying the launch of all future biosimilars by six months,” Sandoz has argued.

Costly 180 Days

The Biosimilars Council, an industry group representing biosimilars sponsors, takes Sandoz’s side in its brief, noting that: “Congress gave sponsors a period of exclusivity that is 12 years and 12 years only, extendable only based on pediatric research. Proponents and critics alike recognized that the period is 12 years in all cases; no one referred to the period as 12½ years, as respondents would have it.”

But the Council also says the Federal Circuit “was right to hold that when a biosimilar applicant decides not to provide its confidential information to a biologic sponsor, the sponsor’s sole remedy is the one set out in the statute: a patent infringement action.”

Under the BPCIA, biosimilar applicants are required to “provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product.”

But the purpose of that notice, the Council argues, is to allow patent litigation to precede a biosimilar’s launch, not to “make the parties wait for a ‘fully-crystallized controversy’ before litigation begins.”

And after a long fight over how long the BPCIA should set the exclusivity period (President Barack Obama wanted seven years, others wanted five), the Council notes that it “ultimately set the period at ‘12 years,’ not 12½.”

At 12 years, companies enjoy a longer period of exclusivity for their biologics in the US than any other country in the world.

“Europe has the second-longest exclusivity period, generally providing for ten years of market exclusivity; Canada’s biologic exclusivity period is eight years,” the brief reads. “Other countries (including Australia, New Zealand, Japan, and South Korea) permit just five or six years of market exclusivity.”

The Council also claims that developing each new biosimilar is a costly and timely endeavor (estimates are between $100 million and $200 million and between eight and 10 years) and developers need to recoup their costs. These six additional months of exclusivity might seem insignificant, the Council adds, but “for a company that has spent or is considering spending half a billion dollars to build an appropriate manufacturing facility and successfully develop a biosimilar, the need to recoup that investment is very real.”



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