As reported on February 17, 2016 in IP Law360, Sandoz has petitioned the U.S. Supreme Court for certiorari to review the Federal Circuit's decision that reversed the District Court in Amgen v. Sandoz. In its decision, two members of the Federal Circuit panel (Judges Lourie and Newman) held that the BPCIA required notice of commercial marketing of a biosimilar product be given by the biosimilar applicant to the reference product sponsor only after the FDA had given regulatory approval for the biosimilar. Judge Chen dissented, on the grounds that this constituted an extra 180 days of regulatory exclusivity beyond the 12 years expressly set forth in the statute.
Sandoz argues that this decision was outside the scope of the plain meaning of the statutory language, was inconsistent with the policy objectives of the BPCIA and in conflict with Supreme Court decisions on statutory interpretation. Specifically, Sandoz argues that Amgen's remedy to prevent commercial marketing immediately upon approval was to ask a district court for an injunction based on patent infringement, which Amgen has not done (and Sandoz pointed out to the Court). Indeed, Sandoz inferred that Amgen could not do so, based on SEC filings related to whether Amgen owned an unexpired patent related to filgrastim.
Sandoz's petition also argues that the decision "disrupts the careful balance struck by Congress by delaying the launch of every biosimilar product by six months" (emphasis added). Again in this argument Sandoz maintains that the only remedy in the statute providing for an injunction was based on patent litigation, either pursuant to the "patent dance" or, according to its successful arguments below, as provided by the "remedies" in the statute when a biosimilar applicant refuses to provide the reference product sponsor with its application or relevant manufacturing methods. According to Sandoz, the statute is clear that "once the expressly granted [12 year] exclusivity period has run, the FDA's approval is 'made effective,' and the biosimilar applicant should be able to market immediately, absent the successful assertion by the sponsor of any valid patent claims."
The last portion of Sandoz statutory arguments contend that the Federal Circuit's interpretation "erroneously divorced the notice of commercial marketing provision from the patent resolution scheme and created an extra-textual injunctive remedy to enforce it." Sandoz characterizes the Federal Circuit's action as an extra-statutory judicial intervention into the process, by granting an injunction against commercial marketing (that was lifted 180 days after FDA approval, on September 4, 2015). Sandoz's point is that an "already approved biosimilar" was (and will be, for other biosimilars) kept off the market for an additional 180 days "without regard to whether the sponsor could show any valid patent rights or any irreparable harm." The argument with regard to the statutory scheme is as follows:
With the exception of the confidentiality provision -- which is not applicable here -- Congress did not make the provisions in Section 262(l) specifically enforceable. In other words, it created no cause of action for either the applicant or the sponsor to obtain an injunction to compel the other party to comply with any of the provisions in that subsection. In contrast, Congress expressly made the confidentiality provision enforceable by an injunction -- and that provision proves that Congress knew how to provide an injunctive remedy when it wished to do so.
Further:
As particularly relevant here, and consistent with the BPCIA's overall patent-based remedial approach, the remedy Congress provided for the failure to provide the notice of commercial marketing under subsection (l)(8)(A) is the ability to bring an artificial infringement suit. Specifically, when an applicant engages in the patent exchange process, yet does not provide notice of commercial marketing: "the reference product sponsor, but not the subsection (k) applicant, may bring" an action for a "declaration of infringement, validity, or enforceability" with respect to certain patents identified earlier in the patent exchange process.
Sandoz also noted that the Federal Circuit did not consider the "traditional equitable factors" involved in a decision to grant an injunction, which decision is in conflict with the Court's eBay decision.
The petition also makes the public policy argument that, left intact, the Federal Circuit's decision will impact not only Sandoz but every biosimilar applicant, supporting this argument with citations to the FTC's Report on biosimilars and other references regarding the importance of biosimilar drugs to patient accessibility to biologic drugs. This outcome will "disrupt[] the careful balance struck by Congress between competition and innovation" Sandoz asserts, in language certain to get the attention of at least some members of the Court.
The Court will take up the petition in due course (and in view of the public policy implications may solicit the Solicitor General's views), and of course Amgen will have the opportunity to oppose. There were a few amici who filed briefs supporting Sandoz's position on these issues in its petition for rehearing en banc, and those briefs will be due in the coming weeks.
