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Amgen Argues “Entire Balance of BPCIA” in Jeopardy unless Federal Circuit Overturns Discovery Ruling

September 20, 2016

Amgen Argues “Entire Balance of BPCIA” in Jeopardy unless Federal Circuit Overturns Discovery Ruling

September 20, 2016

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In its brief filed September 12, 2016, Amgen asks the Federal Circuit to reverse Judge Andrews’ (Civil Action No. 15-cv-00839, D. Del.) decision denying its motion to compel discovery of information related to cell culture manufacturing methods used by Hospira in creating a biosimilar of Amgen’s Epogen®.  Amgen argues that the lower court’s refusal to grant its discovery request “threatens to undermine the entire balance of the BPCIA.” (Brief for Plaintiffs-Appellants Amgen Inc. and Amgen Manufacturing, Limited at 17.)

Amgen asserts that it has tried repeatedly to obtain this information and has been frustrated at every turn.  First, Amgen claims that it sought this specific cell culture information during the patent dance multiple times, yet Hospira did not produce the required manufacturing information under the BPCIA. (See § 262(l)(2)(A), stating that a biosimilar applicant must provide a copy of its aBLA and “such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.”) Amgen then sued for patent infringement on other patents identified during the patent dance, and requested the cell culture information during discovery. Hospira again refused to divulge the information, and Amgen moved to compel, citing Amgen v. Sandoz, in which the Federal Circuit held that when a biosimilar applicant does not engage in the BPCIA’s patent dance, a reference product sponsor (“RPS”) can bring a patent infringement suit to “access required information through discovery.” Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1356 (Fed. Cir. 2015). Hospira again refused and claimed that it had satisfied its burden by providing Amgen with its 700,000+ page aBLA, which included manufacturing processes, and that Amgen’s request for the ingredients of four commercially-available cell culture materials was outside of the scope of the BPCIA’s requirements. (D. Del. Dkt. 29, Hospira Reply Letter.)  Hospira also argued that the cell culture information was not relevant to any of the patents currently at issue in the litigation, and therefore Amgen’s discovery request exceeded the bounds of Federal Rule of Civil Procedure 26. Finally, Hospira pointed out that Amgen never identified even a single cell culture patent that could potentially be infringed, claiming that Amgen was simply going on a “fishing expedition” to identify other potentially infringed patents. The district court denied Amgen’s motion to compel, and Amgen filed a timely appeal to the Federal Circuit.  In denying Hospira’s motion to dismiss the appeal, the Federal Circuit gave Amgen the opportunity to brief both the merits of its appeal as well as jurisdictional issues. (See Fish Litigation Blog: Federal Circuit Denies Motion to Dismiss Appeal of BPCIA-Related Discovery Order.)

In its recent opening brief on the merits, Amgen claims that the denial of its motion to compel upsets the balance of the BPCIA because it denies a RPS the opportunity to obtain information necessary to determine whether the applicant’s manufacturing processes infringe the RPS’s patents. Amgen argues that both available paths, the disclosure requirements of the BPCIA during the patent dance (see § 262(l)(2)(A)) and discovery in a patent infringement case (see 35 U.S.C. § 271(e)(2)(c)(ii)) have been closed off. Without obtaining this cell culture information during the patent dance, Amgen alleges it could not identify its cell culture patents as potentially infringed, given that the BPCIA limits the RPS’s patent list to only those patents “for which the reference product sponsor believes a claim of patent infringement could be reasonably asserted.” 42 U.S.C. § 262(l)(3)(A) (emphasis added).  In light of the district court’s denial of its motion to compel, Amgen was also unable to gain access to the information during the patent infringement litigation. The court determined that Hospira’s cell culture information would have been relevant to one term in one asserted patent claim. However, because Hospira conceded infringement of that limitation, the information remained undiscoverable by Amgen. Amgen contends that Hospira decided to concede infringement to “continue to shield its cell-culture information from disclosure.” (Brief for Plaintiffs-Appellants at 37.)  Amgen explains that its only other option would be to risk Rule 11 sanctions by suing on patents that may or may not be infringed by an applicant. (Brief for Plaintiffs-Appellants at 21.)  According to Amgen’s interpretation of the statute, the prohibition of § 271(e)(6)(C) is “draconian” as the RPS is “forever barred from suing” over the biosimilar product on patents not listed on its § 262(l)(3)(A) list. (Brief for Plaintiffs-Appellants at 34.) Amgen thus argues that unless the Federal Circuit grants relief, Hospira and other biosimilar applicants “could avoid suit on process patents forever.” (Brief for Plaintiffs-Appellants at 17 citing Amgen v. Sandoz.)

Hospira has 40 days to file its response to Amgen’s opening brief.  We will continue to follow this litigation and provide updates.

Authors: Tasha Francis, Ph.D., Holly Chamberlain Rigby, Jenny Shmuel, Ph.D.

The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.

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Jenny Shmuel, Ph.D. | Principal

Jenny Shmuel, Ph.D., represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and has examined and cross-examined witnesses at trial. Over the last several...