Federal Circuit Confirms That the BPCIA Always Requires Post-Licensure Notice

The Federal Circuit answered one of the questions left open by its July 27, 2015, decision in Amgen Inc. v. Sandoz Inc. (Appeal No. 2015-1499): whether the 180-day commercial marketing notice under the Biologics Price Competition and Innovation Act (BPCIA) is mandatory even for a biosimilar applicant that has participated in the so-called patent dance. Yesterday, in a decision that may delay lower-cost competition for biologics, the Federal Circuit ruled in Amgen, Inc. v. Apotex, Inc. (Appeal No. 2016-1308) that all biosimilar applicants must provide their reference-product rivals at least 180 days’ notice before launching a biosimilar.

As was discussed in a July 27, 2015, BakerHostetler Alert, the Federal Circuit had found in the earlier Sandoz case that the 180-day notice was mandatory at least for a biosimilar applicant that had elected not to participate in the BPCIA’s patent dance – an exchange of patent information intended to streamline disputes that starts with the applicant’s providing its application and related information to the reference-product sponsor. That decision did not address the situation of an applicant that did participate in the patent dance. Yesterday’s decision holds that the requirement applies to applicants in both situations, and reiterated that the notice may be effectively given only after the FDA approves the biosimilar application.

In yesterday’s case, Apotex had fulfilled the requirements of the patent dance for its biosimilar version of Amgen’s anti-infection biologic Neulasta. But the court rejected Apotex’s argument that applying the 180-day notice requirement to it would effectively extend, by six months, the lengthy exclusivity period that BPCIA already grants to a reference-product sponsor by prohibiting the FDA from licensing a biosimilar sooner than 12 years after the approval of the reference product itself. Like the associated ruling in the earlier Sandoz case, this decision has a big impact. If Apotex had been allowed to skip the notice, Amgen would have faced competition six months earlier for a product that earned $3.9 billion in U.S. sales last year.

Yesterday’s decision also shed light on another aspect of the 180-day provision: the question of what would happen should the FDA approve a biosimilar application before the 12-year exclusivity period of the reference product expired. Could the approved applicant give effective notice at that time, so that the 180 days runs and expires within that period and the applicant can launch as soon as the 12th year is up? Or even if notice is then given, does its legal effectiveness not ripen, and the running of the 180 days not begin, until after the 12 years? This question was not before the court in either the Sandoz case or the current Apotex appeal because in both, the 12 years had expired before the biosimilar applications had been filed. But at least yesterday’s Apotex panel stated that the 180 days could run concurrently with the 12-year period: “[W]e have been pointed to no reason that the FDA may not issue a license before the [12 years expires] and deem the license to take effect on the 12-year date . . . . And we read [BPCIA section] B(8)(A) as allowing the 180-day notice of commercial marketing to be sent as soon as the license issues, even if it is not yet effective.” This statement, strictly speaking, is dicta, and  although  it provides some  guidance, the issue will likely be addressed directly in future litigation.

In the meantime, the Supreme Court has been considering whether or not to review last year’s Amgen v. Sandoz ruling, and if that case is accepted, the question of whether 180-day notice is always mandatory will get another look.