The Evolving World of Biosimilars

Amgen, Inc. v. Sandoz, Inc.

Addressing two new issues in the Biologics Price Competition and Innovation Act (BPCIA), the Northern District of California issued an order, on summary judgment, dismissing claims by Amgen that would have delayed Sandoz’s bid to market a biosimilar version of Amgen’s Neupogen. The first issue involved what remedies are available if the biosimilar applicant refuses to comply with various sections of the BPCIA (42 U.S.C. §262: paragraphs (l)(2)-(l)(6)). The second issue involved the question of when the 180-day notice can begin under the BPCIA (42 U.S.C. §262: paragraph (l)(8)). As outlined below, the court decided both of these issues in Sandoz’s favor.

In regard to the first issue, the BPCIA provides for a series of disclosures between a biosimilar applicant and the Reference Product Sponsor (RPS) for the reference product (see 42 U.S.C. §262(l), the “Patent Dance”). In the present case, Sandoz had elected not to share proprietary information regarding its Biologics License Application (BLA) with Amgen (or initially, even the BLA itself). Amgen brought suit asserting patent infringement, along with state law unfair competition claims for Sandoz’s alleged non-compliance with the disclosure requirements of the BPCIA.

The Case

While the exchange of information is clearly outlined in the BPCIA, the Northern District held that the language of the relevant sections of the statute was in keeping with a process in which various advantages to both parties could be obtained by compliance with the statute, while non-compliance would only result in the consequences specified in the statute. In other words, if one is willing to accept the consequences outlined in the statute for failure to comply with the statutory scheme, then one need not comply with the noted sections of the statute.

The court reasoned that the statutory scheme was established so that a biosimilar applicant can either opt for the safe harbor from litigation by providing the disclosures, or alternatively can seek expedient litigation by foregoing the disclosures. Interestingly, the court took the position that “[t]he statute contains no stick to force compliance in all instances,” suggesting that its holding might be generally applied to other sections of the statute as well. To the extent that such a holding stands, such a broad “optional” interpretation of the statute may encourage many biosimilars to consider moving forward more rapidly, especially where risks of litigation are lower. Similarly, such an interpretation will also alter the calculus for providing any confidential information to the RPS, if the downside is limited to what is provided in the statute.

In regard to the second issue, the BPCIA also requires that the biosimilar applicant provide the RPS with a 180-day notice before the first commercial marketing of the product. Amgen had asserted that the required 180-day notice could not be given until after the FDA had granted approval of biosimilarity. The court found that such a reading would provide a reference product sponsor with an extra half-year of market exclusivity tacked onto the 12 years of exclusivity already provided under the BPCIA. The court reasoned that if Congress had intended for 12.5 years of exclusivity, it would have provided a less convoluted method for doing so.

Next Steps

While Amgen’s state law claims and motion for a preliminary injunction were dismissed, Amgen’s patent infringement claims are still outstanding, as are Sandoz’s noninfringement and invalidity counterclaims (and the court found that such claims are not barred by Sandoz’s failure to comply with the BPCIA). The parties had previously agreed to seek expedited review of any appeal and Amgen has indicated that it will seek appellate review of the decision.