The Biosimilars Council, a division of the Association for Accessible Medicines (formerly the Generic Pharmaceutical Association) filed an amicus brief with the US Supreme Court to offer its position regarding a six-month market exclusivity issue regarding biosimilars. So what are the issues at play?
Earlier this year, the US Supreme Court agreed to hear a case regarding a 180-day notification requirement by a biosimilar developer to the innovator company that arose in patent litigation with Sandoz, a division of Novartis, and Amgen. At issue is the timing of such notification, which impacts the exclusivity period granted to an innovator product. DCAT Value Chain Insights examines the key issues at the center of the debate.
At the heart of the debate
In January 2017, the US Supreme Court agreed to review a case, a dispute involving Amgen and Novartis’ Sandoz, regarding the interpretation of notification requirements under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which set the US regulatory pathway for biosimilars. The case deals with Sandoz’s Zarxio (filgrastim-sndz), which was approved as the first biosimilar in the US in March 2015 and is a biosimilar to the reference product of Amgen’s Neupogen (fligrastim). A federal appeals court had ruled that a 180-day notification required under the BPCIA by a biosimilar developer to the innovator company follows US Food and Drug Administration approval. Sandoz is arguing that the notification should be able to occur earlier in the development process. The US Supreme Court will hear the case later this year, which will have implications for biosimilar launches in the US.
Making the case
In an amicus brief filed earlier on February 17, 2017, the Biosimilars Council, part of the Association for Accessible Medicines (AAM) (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 Biosimilars Council of the AAM is supporting Sandoz’s position in the case with a focus on two major points. First, the Council asserts that the lower court was “wrong to give biologic manufacturers an additional six months’ market exclusivity beyond the already-generous 12 years the BPCIA expressly provides,” pointing out that allowing the 180-day notification period to begin after a biosimilar approval effectively provides an additional six months of marketing exclusivity to the innovator product. “The BPCIA’s multi-year history makes clear that, in light of the needed cost-saving benefits of abbreviated approval for biosimilars, Congress gave sponsors a period of exclusivity that is 12 years and 12 years only, extendable only based on pediatric research,” said the Council in its brief. “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."
The second major point made by the Biosimilars Council in its brief was agreeing with the federal circuit court ruling regarding remedy through patent-infringement action. “… 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,” the Biosimilars Council said in its brief. It emphasized that the purpose of the 180-day notice rule is to allow patent litigation to precede launch, not to “make the parties wait for a ‘fully crystallized controversy’ before litigation begins,” asserting that Congress created a pre-licensure dispute-resolution process and built in substantial incentives for litigants to avail themselves of that process. It also dispelled a further argument against allowing for patent litigation prior to market approval “…The Federal Circuit’s concern with the waste of resources that could result from patent litigation over products that may never obtain FDA approval or that may be changed during the approval process, is simply unfounded.”
The Biosimilars Council in its brief also said that Amgen had argued that its interpretation of the BPCIA is necessary to protect against a surprise FDA filing and product launch by biosimilar applicants, something that the Council counters.”But the biosimilar pipeline is significantly transparent: there is no reason to suggest that a stealth filing or launch has ever been or could ever realistically be an actual concern, and it would be nonsensical to adopt a countertextual interpretation of the statute based on such imagined pragmatic worries,” said the brief. “Moreover, the notion that a biosimilar manufacturer would file secretly and launch at risk when patent issues remain to be adjudicated, solely for the sake of taking its brand-name competitor by surprise, is extremely unrealistic: the entire reason for creating the artificial act of infringement is that enormous potential damages are a powerful disincentive to a stealth launch.” Moreover, the Council asserted that the post-licensure notice Is not necessary to protect against a stealth launch.
In summing its argument that Biosimilars Council emphasized those two main points: “Congress did not extend biologic sponsors’ monopoly for an additional six months past the 12 years the statute unambiguously provides. Nor did Congress silently authorize an injunctive remedy to combat a stealth launch that it had no reason to believe would ever occur.”