News & Analysis as of

Precedential Opinion Pharmaceutical Industry

Lathrop GPM

Claim Construction Matters: Federal Circuit Decision Highlights the Significance of Lexicography in Patent Drafting

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A precedential ruling by the U.S. Court of Appeals for the Federal Circuit on June 4 affirmed that Moderna’s mRNA-based COVID-19 vaccine SPIKEVAX® does not infringe two patents owned by Alnylam Pharmaceuticals, upholding a...more

Goodwin

Federal Circuit Confirms Deductibility of Hatch-Waxman Litigation Expenses

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On March 21, the Court of Appeals for the Federal Circuit held in a precedential opinion that legal fees incurred by generic drug companies in defending against patent infringement suits brought under the Hatch-Waxman Act...more

WilmerHale

Federal Circuit Patent Watch: FDA Filing Can Create Personal Jurisdiction; “Compelling” Arguments that Reverse Doctrine of...

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Precedential and Key Federal Circuit Opinions - STEUBEN FOODS, INC. v. SHIBUYA HOPPMANN CORPORATION [OPINION] (2023-1790, 1/24/2025) (Moore, Hughes, Cunningham) - Moore, Chief J. The Court reversed the district...more

WilmerHale

Federal Circuit Patent Watch: Orange Book Patents Can Be Delisted If They Do Not Claim Active Ingredient

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Precedential and Key Federal Circuit Opinions - TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. AMNEAL PHARMACEUTICALS OF NEW YORK, LLC [OPINION] (2024-1936, 12/20/2024) (Prost, Taranto, Hughes) - Prost, J. The...more

Lathrop GPM

Federal Circuit Upholds Validity of Entresto Patent In Precedential Decision Concerning Written Description and Enablement

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In a Jan. 10 precedential ruling by the United States Court of Appeals for the Federal Circuit, the validity of the U.S. patent covering Novartis’s blockbuster drug Entresto was upheld, reversing an earlier decision by the...more

WilmerHale

Federal Circuit Patent Watch: The Party Presentation Rule: Parties Map the Course of Litigation, Not Judges

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Precedential and Key Federal Circuit Opinions - 1.  ASTELLAS PHARMA v. SANDOZ INC. [OPINION] (2023-2032, 2023-2063, 2023-2089, 9/18/24) (Lourie, Prost, Reyna) - Lourie, J. The Court vacated and remanded the district...more

Lathrop GPM

Federal Circuit Overrules ODP Rejection of Parent Patent Based on In re Cellect

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In a new precedential decision issued August 13, 2024, the Court of Appeals for the Federal Circuit in Allergan USA. v. MSN Labs, 24-1061, held that a first-filed, first-issued parent patent that receives a patent term...more

WilmerHale

Federal Circuit Patent Watch: A comparative statement in a patent specification can be “definitional” for purposes of claim...

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Precedential and Key Federal Circuit Opinions - 1.  PARKERVISION, INC. v. VIDAL [OPINION] (2022-1548, 12/15/2023) (Prost, Wallach, and Chen)* - Chen, J. The Court affirmed the PTAB’s determination that the patent...more

WilmerHale

Federal Circuit Patent Watch: PTAB may make implicit finding of reasonable expectation of success if arguments are intertwined...

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Precedential and Key Federal Circuit Opinions - BAXALTA INCOPORPORATED v. GENENTECH, INC. [OPINION] (2022-1461, 9/20/2023) (Moore, Clevenger, and Chen) - Moore, C.J. The Court affirmed a district court’s grant of...more

WilmerHale

Federal Circuit Patent Watch: IPR petitioner must be given opportunity to respond to new claim construction arguments by patent...

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Precedential and Key Federal Circuit Opinions - AXONICS, INC. v. MEDTRONIC, INC. [OPINION] (2022-1532, 2022-1533, 8/7/2023) (Lourie, Dyk, and Taranto) - Dyk, J. The Court vacated and remanded IPR decisions by the PTAB...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 2022 #2

Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., Appeal No. 2021-1070 (Fed. Cir. Jan. 3, 2022) - In this week’s Case of the Week, the Federal Circuit affirmed a district court’s bench trial finding that...more

Snell & Wilmer

Federal Circuit Upholds a Silent Written Description

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In a precedential opinion this week, the Federal Circuit affirmed a district court judgment in favor of Novartis Pharmaceuticals, in an appeal brought by HEC Pharm challenging the written description in Novartis’s 9,187,405...more

WilmerHale

CAFC Patent Cases - May 2021 #2

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Precedential Federal Circuit Opinions - CAP EXPORT, LLC v. ZINUS, INC. [OPINION]  (2020-2087, 5/5/21) (Dyk, Bryson, Hughes) - Dyk, J. Affirming decision to set aside judgment and injunction pursuant to Federal Rule of...more

Morrison & Foerster LLP - Federal Circuitry

Last Week in the Federal Circuit (November 2-6): Limits on Venue in Hatch-Waxman Cases

Last week was argument week at the Federal Circuit, which as usual meant the Court issued several Rule 36 affirmances and short non-precedential decisions. But tucked in between those was at least one case—a Hatch-Waxman...more

WilmerHale

CAFC Patent Cases, 10/26/20 – 11/09/20

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Precedential Federal Circuit Opinions: In Re NITRO FLUIDS L.L.C. [ORDER] (2020-0142, 10/28/28) (REYNA, WALLACH, and CHEN)  - Reyna, J.  The Court considered a petition for a writ of mandamus seeking transfer from the...more

Bradley Arant Boult Cummings LLP

A Federal Circuit Prescription to Take Away the Pain for Generics - Intellectual Property News

The Federal Circuit recently reversed a lower court’s ruling of validity under the § 112 written description requirement effectively opening the door for a number of generic drug manufacturers to enter the market with a...more

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