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Following all of the latest IP developments in life sciences.

 

Lessons on Inherency Challenges After Hospira v. Fresenius Kabi USA

The Federal Circuit’s recent decision in Hospira v. Fresenius Kabi USA is the latest to show how the court handles allegations of inherency in life sciences patent litigation. Jonathan Roses dissects the case, addresses whether the court created a new burden-shifting framework for such challenges and summarizes lessons that parties on both sides on an inherency argument can take away from the decision. To read the full article, which was published in Westlaw Journal, click here.

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Galderma Prevails At The Federal Circuit, Forcing Case Back To The District Court To Consider Teva’s Additional Invalidity Theories

Overview

On January 29, 2020, the Federal Circuit reversed and remanded an August 21, 2019 decision (Galderma v. Teva, 390 F.Supp.3d 582 (2019)) handed down by the United States District Court for the District of Delaware in the patent infringement dispute between Galderma Laboratories and generic manufacturer, Teva Pharmaceuticals, relating to Teva’s Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of Galderma’s Soolantra® (1% ivermectin cream for topical use) for treating inflammatory lesions of rosacea. Galderma Laboratories, L.P. et al. v. Teva Pharmaceuticals USA, Inc., Nos. 2019-2396, 2020-1213 (Jan 29, 2020). Each of the asserted claims recite administering a 1% ivermectin formulation together with the appearance of one or more functional efficacy metrics. In siding with Galderma, the Federal Circuit reversed the district court’s finding that Galderma’s asserted claims were anticipated based on two references (McDaniel-U.S. Patent No. 5,952,372 and Manetta-US Patent No. 7,550,440), contrary to the axiom that “a patent claim can only be invalid for anticipation if a single reference discloses each and every limitation of the claimed invention.” According to the Federal Circuit, the district court erred in two ways.

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Genentech, Inc. v. Hospira, Inc. – Overlapping Temperature Ranges Can Leave a Patentee Out in the Cold

When can a prior art reference that discloses a protein purification step at room temperature render invalid a patent claim with a temperature range from about 10°C to about 18°C? Answer: When that prior art reference defines room temperature to include 18°C (which is about 64.4°F). The Federal Circuit reiterated, in Genentech, Inc. v. Hospira, Inc., that even a small overlap at the extremes of a range can invalidate claims that incorporate that range, absent a showing that the particular range is critical or that the parameter is not a result-effective variable.

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