United States: Amgen And Sandoz Do The Biosimilar Patent Dance Over Neulasta

Amgen Inc. has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Sandoz Inc. seeking approval of a biosimilar version of Neulasta® infringes two of its patents. According to the complaint, the parties followed the steps of the biosimilar patent dance and agreed which patents should be litigated. Amgen has asserted one of the patents against Sandoz in a BPCIA suit stemming from Sandoz's Neupogen® biosimilar application, and has asserted the other patent against Apotex, Inc. in a BPCIA suit stemming from Apotex's Neulasta® biosimilar application.

The Biosimilar Patent Dance

According to Amgen's complaint filed in the U.S. District Court for the Northern District of California, Sandoz filed its Neulasta® biosimilar application prior to October 2015, and it was accepted by FDA on October 26, 2015. The parties exchanged information under the patent dance provisions of the BPCIA, and agreed by April 12, 2016 that U.S. Patent No. 8,940,878 and U.S. Patent No. 5,824,784 should be "included in any immediate infringement action" brought under 42 USC §262(l)(6)(A).

(These articles discuss the biosimilar patent dance in more detail.)

A complaint filed by Amgen in the U.S. District Court for the District of New Jersey in March tells a different story. In that proceeding, Amgen seeks relief from Sandoz's alleged violations of the biosimilar patent dance provisions of the BPCIA. Specifically, Amgen asserts that Sandoz's attempts to cut the dance short by agreeing with Amgen's list of patents, "waiving" its right to receive Amgen's responsive statement under 42 U.S.C. § 262(l)(3)(C), and declaration that "negotiations pursuant to 42 U.S.C. § 262(l)(4) and (5) were unnecessary" violated the BPCIA. (Similar issues have been raised in the biosimilar litigation between Janssen Biotech, Inc. and Celltrion Healthcare Co., Ltd. over Remicade®.) The New Jersey case is still pending, but it appears that the parties may have engaged in further negotiations between March and April that led to the filing of the biosimilar patent litigation in California.

The Patents At Issue

The '878 patent is directed to methods of purifying a protein, and according to Amgen has an expiration date of October 8, 2031. This patent was asserted against Sandoz in the Neupogen® biosimilar litigation. That litigation led to the Federal Circuit's first decision construing the BPCIA, which Sandoz has petitioned the Supreme Court to review, but the patent claims still are being litigated at the district court.

The '784 patent is directed to a "substantially homogenous preparation of N-terminally PEGylated G-CSF or analog thereof," and expired October 20, 2015. This patent was asserted against Apotex in the Apotex Neulasta® biosimilar litigation. That litigation led to a Federal Circuit appeal regarding the meaning of 180-day notice provision of the BPCIA, which is awaiting decision after the April 4, 2016 oral hearing, but the patent claims still are being litigated at the district court.

Fending Off Multiple Biosimilar Products

When multiple generic companies file Abbreviated New Drug Applications (ANDAs) seeking FDA approval of generic versions of the same drug, the cases often can be consolidated because they raise substantially the same issues with the same Orange Book-listed patents being asserted against the same (or essentially the same) products. With biosimilars, however, because each biosimilar product may differ from the approved product in unique ways, patent litigation against different biosimilar products may raise substantially different issues, particularly with regard to which patents may be infringed and how the biosimilar products compare to the claimed subject matter. That means that the reference product sponsor (like Amgen here) may need to fend off multiple biosimilar products in separate infringement actions, rather than being able to address them together in a consolidated proceeding.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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