Today the Federal Circuit issued another important decision regarding the meaning of certain provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Apotex Inc., Fed. Cir. Case No. 2016-1308. [Read full opinion here.]

In many respects, the decision can be viewed as an extension of the Court’s decision from a year ago in Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015). [See Amgen v. Sandoz] Both cases involved the 180-day “Notice of Commercial Marketing” provision that the BPCIA introduced into 42 U.S.C. § 262(l)(8)(A)[1], and both asked the question when that notice could effectively be given:  at some point before FDA licensure of the biosimilar product, or only after? 

In the Sandoz case, a divided panel ruled that a biosimilar applicant “may only give effective notice of commercial marketing after the FDA has licensed its product.”  794 F.3d at 1357 (emphasis added). Sandoz, however, involved a situation in which the biosimilar applicant had deliberately defaulted on the “information exchange” process envisioned by § 262(l) by not supplying to the reference product sponsor a copy of the biosimilar application pursuant to § 262(l)(2)(A).  A question remained after Sandoz whether the consequences – at least for purposes of the 180-day notice – might be different for a biosimilar applicant that did comply with paragraph (l)(2)(A). Apotex presented that follow-on scenario.

The Federal Circuit held that as goes Sandoz, so goes Apotex.  The Court rejected the notion that the different facts of Apotex should dictate a different statutory interpretation of 42 U.S.C. § 262(l)(8)(A):

[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.

Slip. Op. at 15. Thus, the Court affirmed its prior ruling that paragraph (l)8(A) of the BPCIA is a “standalone” provision – that is, one “not dependent on the information-exchange processes that begin with (2)(A).” Id. at 16.

Although it does not break new ground, several aspects of the Court’s decision in Apotex are notable.  First, the panel decision was unanimous.  This is in stark contrast to the fractured decision in Sandoz.  Second, the Court rejected the policy-based argument that its ruling would effectively give reference product sponsors 12.5 years (rather than 12 years) of market exclusivity.  The Court viewed the 12.5-year issue as a necessary consequence of the “early years” of the BPCIA. Id. at 17.  Even while this seeming anomaly might remain an issue for biosimilars directed toward “older” reference products, the Court noted that “it should occur less and less as time goes by.” Id.  Important to the Court’s thinking was the notion that for “newer” reference products – i.e., those that are not already pressing up against the 12-year window on account of an early BLA – there is nothing in the BPCIA to prevent the FDA from issuing a license to a biosimilar applicant at the 11.5-year mark, with the license to be “made effective” at year 12. Id.  Finally, the Court highlighted the two-phase nature of patent litigation that is envisioned by the BPCIA, and noted that the post-approval 180-day exclusivity period would permit “second-phase” litigation to occur in orderly fashion. Id. at 17-18.  “At the least,” the Court stated, “the reference product sponsor needs time to make a decision about seeking relief based 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.” Id.

Readers take note: there is a pending cert petition in the Amgen v. Sandoz case.  If the Supreme Court decides to hear the case, the BPCIA 180-day notice issue will be back on the table.  But until that time, and absent en banc rehearing, at least one of the “riddles” of the BPCIA, see Sandoz, 794 F.3d at 1351 n.1, appears to have been resolved by the Federal Circuit.

^{[1] The full text of 42 U.S.C. § 262(l)(8) provides as follows:}

• ^{(8) Notice of commercial marketing and preliminary injunction}
  • ^{(A) Notice of commercial marketing}
    • ^{The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).}
  • ^{(B) Preliminary injunction}
    • ^{After receiving the notice under subparagraph (A) and before such date of the first commercial marketing of such biological product, the reference product sponsor may seek a preliminary injunction prohibiting the subsection (k) applicant from engaging in the commercial manufacture or sale of such biological product until the court decides the issue of patent validity, enforcement, and infringement with respect to any patent that is—}
      • ^{(i) included in the list provided by the reference product sponsor under paragraph (3)(A) or in the list provided by the subsection (k) applicant under paragraph (3)(B); and}
      • ^{(ii) not included, as applicable, on—}
      • ^{(I) the list of patents described in paragraph (4); or}
    • ^{(II) the lists of patents described in paragraph (5)(B).}
  • ^{(C) Reasonable cooperation}
    • ^{If the reference product sponsor has sought a preliminary injunction under subparagraph (B), the reference product sponsor and the subsection (k) applicant shall reasonably cooperate to expedite such further discovery as is needed in connection with the preliminary injunction motion.}