Life Science Compliance Update

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August 24, 2016

Federal Circuit Interprets BPCIA Provision on Notice of Commercial Marketing

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In early July 2016, a three-judge panel of the Federal Circuit Court of Appeals issued a unanimous decision in Amgen v. Apotex interpreting a provision of the Biologics Price Competition and Innovation Act (BPCIA) that requires biosimilar applicants to give reference product sponsors Notice of Commercial Marketing at least 180 days before market launch of the biosimilar.

The question the Court faced was whether compliance with the “Patent Dance” provisions of the BPCIA eliminates the need for a biosimilar applicant to provide the aforementioned 180-day notice. The Court determined, in no uncertain terms, that the answer is “No,” and that notice of commercial marketing is always required after FDA’s date of licensure for the biosimilar.

History

This case follows Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015), which also involved the 180-day “Notice of Commercial Marketing” provision and also asked the question of when the notice could effectively be given. In Sandoz, the Court ruled (via a divided panel) that a biosimilar applicant “may only give effective notice of commercial marketing after the FDA has licensed its product.”

Sandoz, however, answered questions surrounding a situation where the biosimilar applicant had deliberately defaulted on the information exchange by not supplying to the reference product sponsor a copy of the biosimilar application pursuant to § 262(I)(2)(A). The question still remained as to whether the consequences for the purposes of the 180-day notice might be different for a biosimilar applicant that did comply with the requirement in § 262(I)(2)(A).

Are the Cases that Different?

The Court rejected the idea that the facts in Apotex should lead to a different result from Sandoz, instead affirming that paragraph (I)(8)(A) is a standalone provision and is not dependent on information-exchange processes, stating,

[T]hat Apotex gave a (2)(A) notice provides only a factual distinction, not a legally material distinction, between its situation and that of Sandoz in Amgen v. Sandoz.  The (8)(A) requirement of 180 days’ post-licensure notice before commercial marketing, we conclude, is a mandatory one enforceable by injunction whether or not a (2)(A) notice was given.

Why Is This Case Important?

One notable aspect of this case is that the decision was unanimous, a very different result from the fractured decision reached in Sandoz. Another important thing to note is that the Court rejected the policy-based argument that its ruling would give reference product sponsors twelve-and-a-half-years (instead of twelve years) of market exclusivity. The Court felt that the twelve-and-a-half-year issue was a necessary consequence of the “early years” of the BPCIA.

While it is possible that this will continue to be an issue for biosimilars directed at “older” reference products, the Court noted that it “should occur less and less as time goes by.” The Court felt that for “newer” reference products, there is nothing in the BPCIA to prevent the FDA from issuing a license to a biosimilar applicant at the eleven-and-a-half-year mark, with the license to be “made effective” at year twelve.

The Court also highlighted the two-phase nature of patent litigation emphasized under the BPCIA and that the post-approval 180-day exclusivity period would permit “second phase” litigation to occur in proper and orderly fashion. The Court felt that “the reference product sponsor needs time to make a decision about seeking relief on yet-to-be litigated patents, and a district court needs time for litigants to prepare their cases, in a complicated area, to provide a reliable basis for judgment.”

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