On February 16, 2016, Sandoz Inc. filed a petition for a writ of certiorari with the U.S. Supreme Court, asking the Court to review the Federal Circuit's interpretation of the Biologics Price Competition and Innovation Act (BPCIA). The petition presents the following questions to the Court:
Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating Section 262(l)(8)(A) as a standalone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper.
Petition for Writ of Certiorari at ii, Sandoz, Inc. v. Amgen, Inc., No. 15A672 (Feb. 16, 2016). If granted, this case will be one of first impression for the Court, and will likely have significant ramifications for both brand-name biologics companies and companies developing biosimilars.
On July 21, 2015, a divided panel of the Federal Circuit issued its decision ruling that: 1) the information exchange and "patent dance" procedures of the BPCIA are optional and that a biosimilar applicant could choose not to engage in them; and 2) for biosimilar applicants that opt out of the patent dance, the 180-day notice of commercial marketing requirement is mandatory, and effective notice can be provided only after the FDA has approved the abbreviated biologics application. Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347 (Fed. Cir. 2015).1 On October 16, 2015, the Federal Circuit opted not to rehear its split decision. Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347 (2015), reh'g denied, No. 2015-1499, slip. op. at 2 (Fed. Cir. Oct. 16, 2015).2
In its petition, Sandoz asserts that the Federal Circuit erred by requiring FDA approval of the biosimilar before the biosimilar applicant can provide effective notice of commercial marketing to the reference product sponsor, which, according to Sandoz, provides an additional 180-day exclusivity period to the reference product sponsor. Petition for Writ of Certiorari at 6. Further, Sandoz asserts that the Federal Circuit erred by divorcing the Notice of Commercial Marketing provision, set forth in Section 262(l)(8)(A), from the BPCIA's patent resolution regime, thereby "creating a new remedy . . . an injunction against commercial marketing until 180 days after post-approval notice is given." Id. at 6-7. According to Sandoz, "the Federal Circuit has disrupted the careful balance struck by Congress between competition and innovation" (id. at 5), and "[a]bsent intervention from this Court, the Federal Circuit's ruling in this case will apply nationwide to delay the availability of every FDA-approved biosimilar for six months longer than Congress intended" (id. at 8; emphasis in original).
Amgen has 30 days (extendable with permission from the Court) to file a brief in opposition. Additionally, although the normal deadline has passed for Amgen to seek review of the Federal Circuit's ruling that the "patent dance" procedures are optional, Sandoz's filing of its petition will now allow Amgen to seek review of that issue as well, should it so choose.
Footnotes
1 See http://bakerlaw.com/alerts/federal-circuit-confirms-both-new-biosimilar-bring-to-market-procedural-option-and-additional-six-month-exclusivity-period-for-brand-name-biologics for more details on the initial ruling.
2 See http://www.ipintelligencereport.com/2015/10/20/a-split-decision-remains-split-no-en-banc-review-of-amgen-v-sandoz/ for more details on the denial of en banc review.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
