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Inherent Claim Limitation Necessarily Present in the Prior Art Invalidates Patent

Addressing the issue of obviousness, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that a patent was invalid based on inherency because the claim limitation was necessarily present in the prior art. Hospira, Inc. v. Fresenius Kabi USA, LLC, Case Nos. 19-1329, -1367 (Fed. Cir. Jan. 9, 2020) (Lourie, J). The patent at-issue is directed to premixed pharmaceutical compositions of dexmedetomidine that do not require reconstitution or dilution prior to administration and remains stable and active after prolonged storage. Hospira makes and sells dexmedetomidine products, including a ready-to-use product called Precedex Premix covered by the patent at-issue. Fresenius filed an Abbreviated New Drug Application (ANDA) seeking approval by the Food and Drug Administration (FDA) to market a generic ready-to-use dexmedetomidine product. Hospira brought suit alleging infringement under the Hatch-Waxman Act. After a five-day bench...

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Making the Most of Markush

The US Court of Appeals for the Federal Circuit expanded the Markush doctrine, determining that the claim language “comprising . . . [at least] . . . a group consisting of . . .” absent some basis or extrinsic evidence for limiting the group, such a group could capture an alleged infringement  having an additional component  present, as long as the additional component is “functionally similar” to the component identified in the Markush group limitation. ,Amgen Inc. v. Amneal Pharm. LLC, Case No. 18-2414 (Fed. Cir. Jan. 7, 2020) (Lourie, J). This case involves an abbreviated new drug application (ANDA) litigation over Amgen’s Sensipar®, a rapid dissolution formulation of cinacalcet hydrochloride. To overcome a US Patent and Trademark Office rejection in an office action citing prior art, Amgen filed an amendment narrowing the cinacalcet formulation limitation and later accepted the examiner’s claim amendment that modified the binder claim elements of the...

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Slipping Through the Cracks of the § 271(e)(1) Safe Harbor

The US Court of Appeals for the Federal Circuit affirmed that the majority of the batches of an accused biosimilar manufactured by Hospira were not protected by the Safe Harbor exemption of § 271(e)(1), and that patent infringement damages were not unreasonable, notwithstanding that none of the accused product had been sold. Amgen Inc. v. Hospira, Inc., Case Nos. 19-1067; -1102 (Fed. Cir., Dec. 16, 2019)(Moore, J.). EPO is a glycoprotein that regulates red blood cell development. Recombinant versions of EPO are used to treat anemia. One example is Amgen’s product Epogen. In 2014, Hospira submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) requesting approval for its EPO biosimilar. Amgen then sued Hospira for infringement of its patent directed to methods of producing EPO isoforms and its patent directed to recombinant cells producing EPO at certain rates. Specifically, Amgen asserted that 21 pre-approval batches of EPO...

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