In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195 (U.S. June 12, 2017). The Court’s decision grants more flexibility to biosimilar companies and filers of abbreviated Biologics License Applications (“aBLAs”), holding that (1) a reference product sponsor is not entitled to injunctive relief under federal law for an applicant’s refusal to provide a copy of its aBLA and manufacturing information during the information exchange period contemplated by the BPCIA, and (2) an applicant may provide statutory 180-day pre-launch notice of commercial marketing before its proposed biosimilar product is licensed by FDA. An overview of the parties’ oral arguments before the Court on these issues can be found here.
On May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S. Patent No. 8,273,707 (the “’707 patent”) by filing an abbreviated Biologic License Application (“aBLA”) for a biosimilar version of Amgen’s Neulasta (pegfilgrastim) product. Amgen asserted that the biosimilar manufacturing process disclosed in the Coherus aBLA will infringe the ’707 patent’s claimed protein purification process.
Yesterday, the U.S. Supreme Court heard oral argument in the much-anticipated Amgen v. Sandoz case, representing the first time the Court has had to grapple with the Biologics Price Competition and Innovation Act (“BPCIA”) since this key law went into effect in 2010. The BPCIA created a new, abbreviated pathway for highly similar biological products to enter the U.S. market by following in the footsteps of a reference biological product. The Court’s decision, which should issue in June, will be closely watched by participants in the pharmaceutical, biotech, and health care sectors.
To read our full alert on the oral argument, please click here.
On March 2, 2017, the United States District Court for the District of Massachusetts issued an order in Janssen v. Celltrion explaining that an accused patent infringer’s failure to fully engage in the Biologics Price Competition and Innovation Act (“BPCIA”) “patent dance” information exchange process may expose the biosimilar maker to eventual infringement damages in the form of lost profits, and preclude limiting damages to a reasonable royalty. Janssen Biotech, Inc. et al v. Celltrion Healthcare Co., Ltd. et al, 1:15-cv-10698 (D. Mass, 2017).
Janssen sued Celltrion for patent infringement under the BPCIA following the FDA’s acceptance of Celltrion’s abbreviated Biologics License Application (“aBLA”) for a biosimilar version of Janssen’s Remicade (infliximab). In the course of litigation, Celltrion moved to dismiss the complaint for lack of standing based on Janssen’s alleged failure to add a necessary party. To guide the parties’ settlement negotiations, the court sought to clarify whether, in the event the action was dismissed and Janssen was forced to refile the complaint with the proper plaintiffs, Janssen would be prevented from seeking lost profits damages under the BPCIA.
On September 9, 2016, Apotex Inc. filed a petition for writ of certiorari in the U.S. Supreme Court seeking review of the Federal Circuit’s decision in Amgen Inc. v. Apotex Inc., Case No. 2016-1308. This case involves Apotex’s proposed filgrastim product, which is a biosimilar version of Amgen’s Neulasta®. At issue is whether the 180-day “Notice of Commercial Marketing” period provided by 42 U.S.C. § 262(l)(8)(A) of the BPCIA is always mandatory, and whether the Federal Circuit’s decision improperly extended the 12-year exclusivity period for reference product sponsors from 12 to 12 ½ years by holding that a biosimilar applicant cannot give effective Notice of Commercial Marketing for its biosimilar product until after it receives FDA license approval.
As previously discussed on this blog, the Federal Circuit held in Amgen Inc. v. Apotex Inc. that even though Apotex participated in the “information exchange” (a.k.a. the “patent dance”) envisioned by § 262(l) of the BPCIA, the statute’s “requirement of 180 days’ post-licensure notice before commercial marketing … is a mandatory one enforceable by injunction.”
On July 5, 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 Mintz Levin post re: 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), 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? Continue Reading Fed Circuit’s “Amgen v. Apotex” Decision: Clarification of a BPCIA Riddle (Unless, of course, the Supreme Court Steps In)
In an order released on March 19, 2015, U.S. District Court Judge Richard Seeborg of the Northern District of California denied Amgen’s motion for judgment on the pleadings as well as its request for a preliminary injunction to prevent Sandoz from marketing its drug Zarxio®. Amgen v. Sandoz, No. 14-cv-04741-RS (N.D. Cal. Mar. 19, 2015). The ruling was consistent with the judge’s earlier statements regarding Amgen’s motions during a hearing held on March 13, 2015.
On March 6, 2015, the U.S. Food and Drug Administration (FDA) granted approval for Zarxio®, making the pharmaceutical company Sandoz the first company to win approval of a “biosimilar” product. Zarxio® is biosimilar to Amgen’s Neupogen® (filgrastim), which was originally approved for use in 1991 to stimulate the proliferation and differentiation of white blood cells. On July 24, 2014, Sandoz announced that the FDA had accepted its Biologics License Application (BLA) for filgrastim, an application which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).