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Synopsis: In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera,...more
The U.S. Supreme Court has decided a closely watched case regarding patent law’s enablement requirement, Amgen Inc. v. Sanofi. The Supreme Court affirmed the Federal Circuit’s decision that Amgen’s patent claims were invalid,...more
The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...more
Amgen Inc. et al. v. Sanofi et al, No. 21-757 (S. Ct. May 18, 2023) The Supreme Court issued a long-awaited decision today concerning the enablement requirement found in Section 112 of the Patent Act. Specifically, the...more
The questions from the high court during oral argument at the end of March 2023 were fairly telling of the 9-0 ruling that came down yesterday in Amgen, Inc. v. Sanofi (No. 21-757). In fact, it did not come as much of a...more
In Laboratoire Francais du Fractionnement et des Biotechnologies S.A. v. Novo Nordisk Healthcare AG, the Patent Trial and Appeal Board (PTAB) denied the Petitioner’s motion to terminate the inter partes review (IPR) and to...more
[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more
15 Years of Pharma & Biotech Patent Litigation in Europe - C5’s Pharma & Biotech Patent Litigation in Europe will take place 23–24 February, 2022 in Amsterdam, the Netherlands. This is the only industry-shaping event that...more
On Aug. 26, 2021, the Federal Circuit held the asserted claims of Sloan Kettering’s CAR-T patent invalid for lack of written description, reversing the final judgment of a California district court awarding Sloan Kettering...more
Anticipation by inherent disclosure requires that a single prior art reference necessarily includes the unstated limitation. The unpredictable nature of biological processes means that winning summary judgment of invalidity...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Horizon Therapeutics, Inc. v. Lupin Ltd. et al. 1:16-cv-04438; filed July 21, 2016 in the District Court of New Jersey -...more
Judge Gaughan of the U.S. District Court for the Northern District of Ohio granted the defendant’s motion to dismiss after finding three Cleveland Clinic Foundation diagnostic patents invalid under 35 USC § 101. While the...more
Last week, Appellee Natera, Inc. filed its response to the petition for rehearing en banc filed by Appellants Sequenom, Inc. and Sequenom Center for Molecular Medicine, LLC in August (see "Sequenom Requests Rehearing En...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Mylan Pharma Acquisition Ltd. et al. v Fresenius Kabi USA, LLC 1:15-cv-06700; filed July 30, 2015 in the Northern District...more