News & Analysis as of

Appeals Patent Trial and Appeal Board Pharmaceutical Industry

Goodwin

UK Court of Appeal Upholds Moderna mRNA Patent Against Pfizer/BioNTech

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On August 1, 2025, a UK Court of Appeal upheld the validity of Moderna’s European Patent No. 3,590,949 (“EP’949”) in a dispute with Pfizer and BioNTech. The decision affirmed a July 2024 UK High Court ruling finding that...more

A&O Shearman

UPC Court of Appeal clarifies approach to claim construction

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Insulet v EOFlow UPC_CoA_768/2024 (Ord_69078/2024) The Unified Patent Court (UPC) Court of Appeal has issued a significant decision that provides important guidance on the interpretation of patent claims in UPC...more

McDermott Will & Schulte

Prosecution history primacy: “Consisting essentially of” means what applicant said it meant

In a decision that underscores the primacy of prosecution history to determine claim scope, the US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s interpretation of the transitional phrase...more

Knobbe Martens

An Eye Toward Prosecution History

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EYE THERAPIES, LLC v. SLAYBACK PHARMA LLC - Before Taranto, Stoll and Scarsi (sitting by designation). The patent’s prosecution history required a restrictive interpretation of the term “consisting essentially of.”...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Eye Therapies, LLC v. Slayback Pharma, LLC

Eye Therapies, LLC v. Slayback Pharma, LLC, Appeal No. 2023-2173 (Fed. Cir. June 30, 2025) In its only precedential patent opinion last week, the Federal Circuit reviewed construction of the transitional claim phrase...more

Knobbe Martens

Speculative Plans Are Insufficient to Establish Standing in PTAB Appeals

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INCYTE CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES, INC. - Before Moore, Hughes, and Cunningham. Appeal from the Patent Trial and Appeal Board. Speculative plans for potentially infringing activity are insufficient to...more

McDonnell Boehnen Hulbert & Berghoff LLP

MSN Laboratories Private Ltd. v. Bausch Health Ireland Ltd. (Fed. Cir. 2025)

As has been noted recently (Agilent Technologies, Inc. v. Synthego Corp.), fact-based decisions from the U.S. Patent and Trademark Office (typically from the Patent Trial and Appeal Board) are reviewed under the substantial...more

Goodwin

Recent PTAB Developments for Regeneron’s Aflibercept Formulation Patent

Goodwin on

Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”)...more

Venable LLP

Court Finds bluebird bio’s Gene Therapy Zynteglo® (betibeglogene autotemcel) Does Not Infringe San Rocco Therapeutics’ Patents

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On May 16, 2025, the Court in Case No. 1:21-cv-01478 (D. Del.) granted bluebird bio’s motion for summary judgment, finding that its gene therapy Zynteglo® (betibeglogene autotemcel) does not infringe San Rocco Therapeutics‘...more

Venable LLP

Federal Circuit Affirms PTAB’s Unpatentability Findings in Gene Therapy Hemgenix® IPRs

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On May 22, 2025, the CAFC affirmed the PTAB’s (Board) Final Written Decisions in Pfizer’s IPR2021-00925 and IPR2021-00926 finding all challenged claims of uniQure’s U.S. Patent No. 9,982,248 (“the ’248 patent”) unpatentable...more

Parker Poe Adams & Bernstein LLP

Life Sciences Companies Have New Avenue to Challenge Patent Applications After Federal Court Ruling

Drugmakers and other companies in the life sciences industry seeking to invalidate patents have another arrow in their quiver thanks to a recent federal court decision....more

Wilson Sonsini Goodrich & Rosati

Federal Circuit Revives CRISPR-Cas9 Patent Priority Dispute

The CRISPR-Cas9 patent landscape remains complex and unsettled. The Federal Circuit’s latest decision in University of California v. Broad Institute1 revived the high-stakes dispute between UC2 and Broad3 over foundational...more

McDermott Will & Schulte

No Article III Appellate Standing Under the Sun

The US Court of Appeals for the Federal Circuit dismissed Incyte’s appeal of a Patent Trial & Appeal Board decision, holding that a disappointed validity challenger lacked appellate standing to challenge the Board’s final...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Pharmaceutical Patent Protections

This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development. In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: In re: Xencor, Inc.

In re: Xencor, Inc., Appeal No. 2024-1870 (Fed. Cir. Mar. 13, 2025) Our case of the week is an appeal from a decision of the Appeals Review Panel of the Patent Trial and Appeal Board, concerning Xencor’s patent application...more

WilmerHale

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

WilmerHale on

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

Alston & Bird

Patent Case Summaries | Week Ending January 10, 2025

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Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., et al., Nos. 2023-2218, -2220, -2221 (Fed. Cir. (D. Del.) Jan. 10, 2025). Opinion by Lourie, joined by Prost and Reyna. The FDA approved a New Drug Application from...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2024

Mirror Worlds Technologies, LLC v. Meta Platforms, Inc., Appeal Nos. 2022-1600, -1709 (Fed. Cir. Dec. 4, 2024) In this appeal from the United States District Court for the Southern District of New York, the Federal...more

Wilson Sonsini Goodrich & Rosati

The PTAB Review - August 2024

This issue of The PTAB Review begins by providing an analysis of how institution decisions consider declaration testimony submitted by a patent owner. Next, it summarizes proposed rulemaking from the United States Patent and...more

Goodwin

The Appeals Review Panel’s In Re Xencor Decision: The USPTO Provides Its Position on Written Description and Means-Plus-Function...

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On May 17, 2024, an Appeals Review Panel (ARP) of the United States Patent and Trademark Office (“USPTO”) released its decision in Ex parte Chamberlain (referred to in Federal Circuit proceedings as In re Xencor;...more

Knobbe Martens

Routine Optimization of Result-Effective Variable Can Bridge Gaps in Prior Art

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PFIZER INC. v. SANOFI PASTEUR INC. - Before Lourie, Bryson, and Stark.  Appeal from the Patent Trial and Appeal Board....more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Mind Your Ps and Qs, and Your PTAs Too

Last week, the Federal Circuit held that obviousness-type double patenting trumps patent term adjustment, opening the door for invalidity attacks that to date had been questionable. In re Cellect was an appeal from a...more

Knobbe Martens

Is Evidence of Generic Industry Skepticism Enough to Preclude a Finding of a Motivation to Combine?

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AURIS HEALTH, INC., v. INTUITIVE SURGICAL OPERATIONS, INC., Before Dyk, Prost, and Reyna. Appeal from the Patent Trial and Appeal Board (PTAB). Summary: Evidence of generic industry skepticism cannot, by itself, form...more

Knobbe Martens

Identical Elements Are Not Required for the Presumption of Obviousness Based on Overlapping Ranges

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ALMIRALL, LLC v. AMNEAL PHARMACEUTICALS LLC - Before Lourie, Chen, and Cunningham. Appeal from the Patent Trial and Appeal Board. Summary: Presumption of obviousness based on overlapping ranges applied where a...more

Fish & Richardson

2020 Post-Grant Report

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In a year of extraordinary change, the Patent Trial and Appeal Board (PTAB) rose to the challenge - Given the challenges of 2020 – a global pandemic, a deep economic recession, and a turbulent presidential election, among...more

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