Amgen And Sandoz Do The Biosimilar Patent Dance Over Neulasta

17 May 2016 PharmaPatents Blog

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.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services

Insights

PATH Summit 2019
18-20 December 2019
Arlington, VA
MedTech Impact Expo & Conference
13-15 December 2019
Las Vegas, NV
Review of 2020 Medicare Changes for Telehealth
11 December 2019
Member Call
BRG Healthcare Leadership Conference
06 December 2019
Washington, D.C.