As we reported in a previous post, Amgen is the plaintiff in another suit litigating the patent information provisions of the BPCIA, this time against Hospira. Amgen’s complaint alleged that Hospira violated the BPCIA by (1) not providing manufacturing information within 20 days of FDA’s acceptance of Hospira’s biosimilar application for review as provided for in 42 U.S.C. § 262(l)(2)(A); and (2) “declar[ing] that it will not comply with 42 U.S.C. § 262(l)(8)(A), which requires Hospira to provide Amgen with 180 days’ notice of its first commercial marketing, on or after FDA licensure of the Hospira Epoetin Biosimilar Product.” Amgen’s complaint also asserts patent infringement claims for two patents (see our previous post for more detail).
In support of its motion, Hospira argues that “the fatal flaw in claiming that Hospira violated paragraphs (2)(A) and (8)(A) of the BPCIA is that Amgen seeks to privately enforce statutory provisions despite the fact that Congress did not create a structure for private enforcement of paragraph (2)(A) or paragraph (8)(A).” Hospira argues that the Federal Circuit’s “seminal ruling” in Amgen v. Sandoz “bears directly on certain issues presently before the Court”–i.e., the BPCIA issues.
Hospira denies that it failed to comply with the disclosure provisions of (l)(2)(A) because it provided its biosimilar application, which “contained hundreds of thousands of pages providing comprehensive and detailed information concerning Hospira’s product and the processes employed to make Epoetin Hospira” within the 20-day BPCIA timeframe. And even if Amgen could demonstrate that Hospira had failed to comply with the (2)(A) disclosure provision, Hospira argues, the Federal Circuit in Amgen v. Sandoz made it clear that “the alleged violation would be precisely an act of infringement under Section 271(e)(2)(C)(ii), for which Section 271(e)(4) provides the only remedies. As such, Amgen’s only remedy is to sue for patent infringement under Section 271, something it has already done in the Complaint.” (internal quotation marks and citations omitted).
On the notice issue, Hospira argues that Amgen v. Sandoz “established that a notice of commercial marketing pursuant to paragraph (8)(A) is not mandatory unless the applicant ‘completely fails’ to participate in the BPCIA patent-exchange process,” and “even assuming that a notice of commercial marketing is mandatory, there is no evidence of congressional intent that would allow a private enforcement of paragraph (8)(A) to stand.” Hospira asserts that it did not “completely fail” to participate in the BPCIA patent-exchange process–it timely provided its biosimilar application to Amgen, provided a “detailed factual and legal basis” for its opinion that the three patents identified by Amgen as patents for which a claim of infringement could reasonably be asserted pursuant to (l)(3)(B) were invalid and/or would not be infringed, and agreed to proceed to trial on the three listed patents, thereby “end[ing] the negotiations contemplated under paragraph (4)(A).” Therefore, Hospira argues, the (8)(A) notice provision is not mandatory.
According to Hospira, the “fatal flaw” in both of Amgen’s BPCIA claims, however, is that “[t]here is no evidence that Congress intended to create a private right of action to enforce paragraph (2)(A) or paragraph (8)(A). Indeed, the BPCIA sets forth the explicit consequences for failing to abide by these provisions. See 35 U.S.C. § 271(e)(4); 42 U.S.C § 262(l)(9)(B)-(C). Congress could have created a private right of action if that is what it intended. …Congress did not do so, even though it did expressly provide a remedy for statutory violations elsewhere in the BPCIA.” Hospira takes the Federal Circuit’s observation that “the BPCIA contains ‘certain similarities in its goals and procedures’ to 1984’s Hatch-Waxman Act” as a jumping-off point to support its claims regarding the lack of a private right of action, noting: “In the Hatch-Waxman context, the Federal Circuit declined to create a private right of action where the statute did not explicitly provide one. Similarly, there is no evidence here that Congress intended to create a private right of action to enforce compliance with paragraph (2)(A) or paragraph (8)(A).”
Hospira also notes that “other parties have begun to assert claims based on a private right of action under these provisions of the BPCIA in other recently filed district court cases. See, e.g., Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd., et al., No. 15-cv-10698 (D. Mass. 2015). However, this question remains a matter of first impression for the Court, as the Federal Circuit did not directly address this issue in Sandoz.”
We will continue to monitor developments in this case–check back here on the Big Molecule Watch for updates.