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Amgen Inc. v. Hospira, Inc.

BPCIA Sponsor May List, and Sue On, Patents It Believes Infringed Even if Biosimilar Applicant Fails to Disclose Necessary Information

Amgen Inc. v. Hospira, Inc., (Fed. Cir. Aug. 10, 2017) (DYK, Bryson, Chen) (D. Del.: Andrews) (3 of 5 stars)

Fed Cir dismisses appeal relating to denial of discovery motion, and denies writ of mandamus concerning same, in case under the BPCIA. The district court had denied Amgen’s motion to compel discovery into certain cell culture mediums for lack of relevance (Amgen claimed the cell culture medium data should have been in Hospira’s paragraph (l)(2)(A) disclosures, and was trying to use discovery to learn about them so as to evaluate possible infringement of other patents). The Federal Circuit lacked jurisdiction over the appeal. Though the discovery order conclusively determined a disputed question (whether the cell mediums were discoverable), and was completely separate from the merits of the action, it was still an act that was reviewable on appeal from a final judgment, per Livesay, 437 U.S. 463 (1978). That the denial of discovery meant that Amgen was forced to wait until final judgment for review of whether the cell medium data should have been disclosed and/or discoverable under BPCIA was not contrary. “[T]he lack of immediate appeal over orders denying discovery of paragraph (l)(2)(A) information does not render such orders ‘effectively unreviewable’ or distinguish them from run-of-the-mill discovery disputes.” Op. at 8.

Amgen’s petition for mandamus is denied because Amgen did not establish that it had a clear and indisputable right to relief. Amgen was responsible for electing to neither list nor sue on its cell-culture patents, which the opinion reasons it could have done notwithstanding Hospira’s non-disclosure of its cell mediums in its paragraph (l)(2)(A) disclosures. “Paragraph (l)(3)(A) merely requires the sponsor to list patents that it ‘believes . . . could reasonably be asserted.’” Op. at 12. It does not impose sanctions for mistakenly (but in good faith) asserting patents that ultimately turn out to be noninfringed. Nor would Rule 11 have precluded Amgen from listing the cell-culture patents, as one of the reasons for Amgen’s uncertainty about the infringement question was Hospira’s own failure to make its disclosure. Because Amgen could have listed the patents in question (in which case it could have taken discovery relating to them), the opinion concludes that the denial of discovery did not undermine the purpose of the BPCIA.

KEYWORDS: BPCIA; MANDAMUS; JURISDICTION