Source: https://www.fenwick.com/publications/Pages/Riddle-Me-This-The-Federal-Circuit-Provides-a-Measure-of-Clarity-to-the-Enigmatic-Biosimilar-Approval-Pathway.aspx
Timestamp: 2019-04-23 14:20:04+00:00

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The BPCIA establishes an abbreviated pathway, analogous to that created by the Hatch-Waxman Act for generic pharmaceutical drugs, that allows a company to seek regulatory approval for a follow-on biological product without the rigor required of the original biologics license. Whereas a biologics license application (“BLA”) requires extensive clinical data establishing the safety and efficacy of the original product, an abbreviated biologics license application (“aBLA”) requires only that the follow-on applicant (also known as a “subsection (k) applicant”) establish that its product is either “biosimilar” to or “interchangeable” with the previously licensed biologic (known as the “reference product”). Compare 42 U.S.C. § 262(a) with id. § 262(k). However, Congress also provided a twelve-year period of exclusivity for the reference product from the date of its first licensure, such that no follow-on product may be sold during that interval, regardless of patent protection. Id. § 262(k)(7)(A). In fact, an application for a biosimilar cannot even be submitted until four years after first licensure of the reference product. Id. § 262(k)(7)(B). In this way, the BPCIA seeks to balance the interests of those engaging in original biologics discovery with the public’s desire for lower cost medical treatment.
The BPCIA also establishes a regime for the reference product sponsor and subsection (k) applicant to narrow and resolve patent infringement disputes. In addition to creating an artificial act of infringement, again not unlike that created by the Hatch-Waxman Act for generic pharmaceutical drugs, the BPCIA also establishes a complex process, often referred to as the “patent dance,” for the exchange of information between the subsection (k) applicant and reference product sponsor. See generally 42 U.S.C. § 262(l). First, within 20 days after an aBLA is accepted by the FDA for review, the BPCIA specifies that a subsection (k) applicant “shall provide to the reference product sponsor a copy of the application submitted . . . under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.” Id. § 262(l)(2)(A). Subsequent to that exchange, the BPCIA also establishes a schedule for the parties to provide each other with lists of patents they believe applicable, along with their respective positions on infringement and validity. Id. § 262(l)(3). The BPCIA then allows the reference product sponsor to bring an action for patent infringement. Id. § 262(l)(6). Finally, a subsection (k) applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of first commercial marketing of the biological product licensed under subsection (k),” thus allowing the reference product sponsor to seek a preliminary injunction prohibiting such activity pursuant to any patent listed by either party as part of the patent dance but excluded from the § 262(l)(6) infringement action. Id. § 262(l)(8)(A)–(B).
Amgen began marketing the biological product filgrastim, branded Neupogen®, in 1991. Sandoz filed an aBLA in May 2014 seeking approval for a biosimilar version of filgrastim and, upon receiving notification from the FDA that its aBLA had been accepted for review, notified Amgen on July 8, 2014 that it intended to launch its biosimilar immediately upon FDA approval of the follow-on product. When Sandoz shortly thereafter elected not to engage in the patent dance, Amgen brought suit in the Northern District of California asserting claims of unfair competition and conversion under California state law, premised on Amgen’s allegation that Sandoz violated the BPCIA by failing to disclose its aBLA and manufacturing information and by prematurely providing notice of commercial marketing prior to licensure by the FDA. Amgen also claimed infringement of its U.S. Patent No. 6,162,427, which claims a method of using filgrastim, under federal law. The FDA approved the aBLA filed by Sandoz on March 6, 2015, on which day Sandoz (again) provided notice of commercial marketing to Amgen.
The district court agreed with Sandoz’s interpretation of the BPCIA, holding that the subsection (k) provision regarding the exchange of information was permissive and not mandatory and further that Sandoz’s notice of its intent to commercially market a filgrastim follow-on product was effective despite being given prior to the FDA’s approval. After the district court dismissed Amgen’s unfair competition and conversion claims and entered final judgment as to that portion of the case, Amgen appealed.

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