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Federal Circuit Denies Motion to Dismiss Appeal of BPCIA-Related Discovery Order

August 15, 2016

Federal Circuit Denies Motion to Dismiss Appeal of BPCIA-Related Discovery Order

August 15, 2016

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The Federal Circuit has denied Hospira’s motion to dismiss Amgen’s appeal of a discovery order in an underlying BPCIA district court litigation (Civil Action No. 15-cv-00839, D. Del.) and has instructed the parties to address in their appeal briefs both the “the merits [of the appeal] and also whether this [Appeals] court has jurisdiction under the collateral order doctrine or under the All Writs Act, 28 U.S.C. § 1651(a).”

The discovery issue at the heart of the appeal is whether Hospira should be compelled to provide Amgen with detailed cell culture manufacturing information.  The dispute originated in the parties’ positions during the “patent dance” that occurred after Hospira filed an aBLA for a biosimilar of Amgen’s Epogen®.  According to Amgen, Hospira refused to produce all manufacturing information as required under the BPCIA. (See § 262(l)(2)(A), which states an applicant should provide a copy of the 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 on certain patents and sought discovery into additional areas of manufacturing to potentially identify other infringed patents.  When Hospira refused to provide the requested discovery, Amgen moved to compel.  (D. Del. Dkt. 48.) In its letter brief, Amgen argued that the Federal Circuit’s opinion in Amgen v. Sandoz supported Amgen’s discovery request because that case held that when a biosimlar applicant does not provide information under Section (l)(2)(A), the reference product sponsor can commence a patent infringement suit to “access the required information through discovery.” Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1356 (Fed. Cir. 2015).

Hospira countered that the discovery sought was not related to any patent actually at issue in the litigation and that Hospira had already provided the “voluminous” manufacturing information included in its aBLA.  According to Hospira, Amgen refused to identify even a single relevant cell culture patent during the “patent dance,” despite access to all of the manufacturing information in the aBLA, and thus Amgen could not now go on a fishing expedition to remedy that error.  Hospira also argued that Amgen’s reliance on Sandoz was “misplaced” because the biosimilar applicant in that case did not provide its aBLA to Amgen, and, as a result, Amgen had no access to any manufacturing information without filing suit. Hospira argued that here, by contrast, it had provided its manufacturing processes as part of its aBLA.  Hospira also noted that the information Amgen sought concerned “the exact composition of four raw materials” that were commercially available.  According to Hospira, this information was “well beyond the information contemplated in Paragraph 2(A).” (D. Del. Dkt. 29, Hospira Reply Letter.)

After Judge Andrews of the District of Delaware denied Amgen’s motion to compel discovery, Amgen filed an immediate appeal to the Federal Circuit. Hospira moved to dismiss the appeal for lack of jurisdiction, arguing that the discovery order was neither a final judgment nor a collateral order.  Amgen responded that the discovery dispute fell under the collateral order doctrine and that if Amgen’s appeal was to be dismissed, Amgen would have no other way to access the information in a timely manner and would be forced to wait for a final judgment.  Amgen argued that the discovery issue could not be “effectively” reviewed after final judgment because Hospira would have likely already launched its product by that time.  That is, dismissing the appeal would effectively “deny Sponsors the opportunity to seek pre-marketing injunctions on process patents.” (Amgen Opp. to Motion to Dismiss Appeal, at 10.)  The Federal Circuit, in denying Hospira’s motion to dismiss, has allowed Amgen an opportunity to brief the merits of its appeal while leaving open the question of the Court’s jurisdiction to decide the appeal.

We will continue to monitor the events of this case and provide updates as they become available.

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...