News & Analysis as of

Pharmaceutical Patents Patent Trial and Appeal Board Appeals

Alston & Bird

Patent Case Summaries | Week Ending July 18, 2025

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Shockwave Medical, Inc. v. Cardiovascular Systems, Inc., et al., Nos. 2023-1864, -1940 (Fed. Cir. (PTAB) July 14, 2025). Opinion by Dyk, joined by Lourie and Cunningham....more

MoFo Life Sciences

Is Your Claim Open or Closed? Claim Construction Takes on a New Meaning in Eye Therapies, LLC v. Slayback Pharma, LLC

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On June 30, 2025, the Federal Circuit issued a precedential decision in Eye Therapies, LLC v. Slayback Pharma, LLC, reversing the Patent Trial and Appeal Board’s (PTAB’s) claim construction of the phrase “consisting...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

White & Case LLP

Federal Circuit Reinforces Standard for Prior Art Enablement in CRISPR Dispute

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On June 11, 2025, the U.S. Court of Appeals for the Federal Circuit decided Agilent Technologies, Inc. v. Synthego Corp. (No. 23-2186), addressing enablement of prior art references for disputed CRISPR-Cas9 gene-editing...more

Goodwin

Recent PTAB Developments for Regeneron’s Aflibercept Formulation Patent

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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

Jones Day

April 2025 Institution Rate Slips Below 45 Percent

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The PTAB has published its monthly statistics wrap up for April 2025. As expected, those statistics show a significant decline in the institution rate compared to the first six months of the fiscal year. In those first six...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

White & Case LLP

Federal Circuit Clarifies Standard for Patent Conception in Ongoing CRISPR Dispute

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On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit issued a long-awaited decision in Regents of the University of California v. Broad Institute (Nos. 22-1594, 22-1653) addressing priority for disputed...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

Wilson Sonsini Goodrich & Rosati

Method of Treatment Claim’s Limiting Preamble Must Satisfy the Written Description Requirement

On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit issued a decision in the case of In Re: Xencor, Inc. In this Appeal from the Appeals Review Panel of the Patent Trial and Appeal Board (ARP), with regard to...more

McDermott Will & Schulte

Transatlantic Terminology: Skilled Artisan Could Equate UK, US Word Meanings

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board unpatentability determination, finding that a skilled artisan would have found the term “sterile” in a UK publication to mean the same as...more

Proskauer - The Patent Playbook

Federal Circuit Affirms Stem Cell Product-by-Process Claims: Lessons in Claim Construction and Inherency from Restem LLV v. Jadi...

The Federal Circuit issued a precedential opinion on March 4, 2025, that serves as valuable guidance for product-by-process claims, particularly in the context of inherency in claim construction. In Restem, LLC v. Jadi Cell,...more

A&O Shearman

Federal Circuit Affirms PTAB Decision On Unpatentability, With The PTO Stepping In After Appellee Withdrew

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On April 15, 2025, the U.S. Court of Appeals for the Federal Circuit (“CAFC”) affirmed the Patent Trial and Appeal Board’s (“Board”) decision finding all challenged claims of Sage Products, LLC’s patents anticipated based on...more

McDonnell Boehnen Hulbert & Berghoff LLP

Recor Medical, Inc. v. Medtronic Ireland Mfg. (Fed. Cir. 2025)

The inter partes review provisions of the Leahy-Smith America Invents Act have been criticized for the propensity of the Patent Trial and Appeal Board (PTAB) to find invalid all or at least some of the challenged claims,...more

Goodwin

The Court of Appeals for the Federal Circuit’s In Re Xencor Decision: Jepson Claims Require Written Description for Their...

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On March 13, 2025, the US Court of Appeals for the Federal Circuit (Federal Circuit) issued a decision titled In Re: Xencor, Inc. (the Xencor decision). The Xencor decision affirms the decision of the Appeals Review Panel...more

Knobbe Martens

Jepson Claim Preamble Requires Written Description Support for Conventional Aspects of the Invention

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IN RE: XENCOR, INC. Before Hughes, Stark, and Schroeder (sitting by designation).  Appeal from the U.S. Patent and Trademark Office, Patent Trial and Appeal Board. To provide adequate written description for a Jepson claim,...more

Alston & Bird

Patent Case Summaries | Week Ending March 14, 2025

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CQV Co., Ltd. v. Merck Patent GmbH, No. 2023-1027 (Fed. Cir. (PTAB) Mar. 10, 2025). Opinion by Cunningham, joined by Chen and Mayer. CQV petitioned the Patent Trial and Appeal Board for post-grant review of a Merck patent...more

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