According to the Federal Circuit website, the appeal from the Amgen Inc. v. Apotex Inc. case will be argued on April 4, 2016 in Courtroom 402. This case is an appeal from a decision by Judge Cohn of the Southern District of Florida ordering a preliminary injunction requiring Apotex to "provide Amgen with at least 180 days notice before the date of the first commercial marketing of the biological product approved by the FDA." Moreover, Apotex was "enjoined from any commercial marketing of it biosimilar pegfilgrastim product, including selling that product or offering it for sale for use in the United States, until Apotex gives Amgen proper notice . . . and the 180-day notice period is exhausted." At first glance, this case appears to fit squarely within the Federal Circuit's Amgen v. Sandoz case -- indeed Judge Cohn felt bound by that prior decision. However, there is one crucial difference -- Apotex provided Amgen with its aBLA and participated in the so-called "Patent Dance." Therefore, the Federal Circuit will have the opportunity to address the apparent loophole that it created in its prior decision.
The issue in this case stems from the patent-dispute-resolution section of the BPCIA, found at 42 U.S.C. § 262(l). This section is related to, but distinct from, the regulatory licensure provisions found at subsection (k) of the same statute. The so-called patent dance is supposed to begin within 20 days of acceptance of a subsection (k) "biosimilar" application with the applicant providing to the reference product sponsor (or RPS) the aBLA "and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application." This begins a cascade of information exchange regarding patents that might possibly be asserted against the biosimilar applicant if they were to launch before expiration. The culmination of this process is a (potential) two-phase litigation, where (potentially) only a subset of patents are asserted initially, and the balance of patents are held in reserve until the subsection (k) applicant provides notice that it intends to market sometime after 180 days from the date of notice. At that time, the RPS can seek a preliminary injunction with regard to the second-phase patents. Importantly, the statute provide in section (l)(9)(B) that "[i]f a subsection (k) applicant fails to complete an action required" by this patent resolution mechanism -- including the Notice of Commercial Marketing provision of paragraph 8(A) -- the RPS "may bring an action . . . for a declaration of infringement, validity, or enforceability of any patent included in the list described in paragraph 3(A), including as provided under paragraph (7)." In other words, the RPS can immediately bring suit with respect to any identified patent.
The Federal Circuit, in the Amgen v. Sandoz case, appeared to turn this process on its head. Even though the word "shall" is used in the provision beginning this process -- the providing of the aBLA and other information -- the Court held that because the statute contemplates such an action and provides a remedy, the subsection (k) applicant can voluntarily choose not to participate. In the cases where the applicant fails to participate in the patent dance by not turning over the aBLA, the statute provides in (l)(9)(C) that the RPS can bring a declaratory judgment suit for "any patent that claims the biological product or a use of the biological product." It is presumed that this remedy was provided because in such situations there would be no list of identified patents. The Court also provided that the notice of commercial marketing could only be effective after the FDA has licensed the product, in other words after approval. However, the "majority," (in this instance Judges Lourie and Newman), held that the Notice provision was a standalone provision, and therefore was independent of the patent dance. Judge Chen disagreed in his dissent in part. He believed that the Notice provision was "part and parcel to, and contingent upon" the patent dance. This is where the Amgen v. Apotex case picks up.
This dichotomy stems from section B(II)(b) of the majority decision and Judge Chen's dissent-in-part. The majority noted that the BPCIA does not specify the consequence for noncompliance with paragraph (l)(8)(A) (the Notice of Commercial Marketing provision), even while acknowledging that paragraph (l)(9)(B) specifically references a remedy for violating this provision. However, according to the Court, this remedy is only available "after the applicant has complied with paragraph (l)(2)(A) . . . ." (emphasis in original). Therefore, "because Sandoz did not provide the required information to Amgen under paragraph (l)(2)(A), Amgen was unable to compile a patent list as described in paragraph (l)(3)(A) or paragraph (7)." And, after stating that "Paragraph (l)(8)(A) is a standalone notice provision in subsection (l)," the Court concluded that:
[W]here, as here, a subsection (k) applicant completely fails to provide its aBLA and the required manufacturing information to the RPS by the statutory deadline, the requirement of pargraph (l)(8)(A) is mandatory. Sandoz therefore may not market Zarxio before 180 days from March 6, 2015, i.e., September 2, 2015.
This of course leaves open the question of what happens if the subsection (k) applicant provides its aBLA.
Judge Chen, on the other hand, found that "[t]he interwoven structure of subsection (l) indicates that Congress viewed the procedures of (l)(8) as inseverable from the preceding steps in (l)." To reach this conclusion, he looked to the purpose behind the Notice provision: "the entirety of (l)(8), including (l)(8)(A)'s notice provision, serves to ensure that an RPS will be able to assert all relevant patent before the (k) applicant launches it biosimilar product." As such, "the most logical conclusion when reading (l)(8) in context is that (l)(8)'s vitality is predicated on the performance of the proceeding steps in subsection (l)'s litigation management process [the patent dance]." Indeed, according to Judge Chen, "[w]ithout first engaging in these procedures, (l)(8) lacks meaning." Therefore, according to him:
The most persuasive reading of subsection (l) as a whole is that Congress provided two paths to resolve patent disputes: (1) the intricate route expressed in (l)(2)-(l)(8); and (2) the immediate, more flexible route provided in (l)(9), should the (k) applicant falter on any of its obligations recited in (l)(2)-(l)(8).
With such a reading, the Notice provision should be as optional as the patent dance, with (l)(9) providing the requisite remedy should the subsection (k) applicant choose not to comply.
We will continue to preview this case in upcoming posts, including detailing the positions advocated by both parties and the various amici that filed briefs in this case. And, of course, we will assuredly have plenty of analysis once the Federal Circuit issues its decision sometime later this year.
