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Patent Trial and Appeal Board Life Sciences

Jones Day

Discretionary Denial of IPR Institution Due to Advanced Hatch-Waxman Litigation

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In a recent decision, the Patent Trial and Appeals Board (“PTAB”) exercised its discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review (“IPR”) after applying the Fintiv factors, despite Petitioner’s...more

Jones Day

Physical Products Cannot Form Basis of an IPR

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On May 1, 2025, the Patent Trial and Appeal Board (PTAB) denied institution of inter partes review (IPR) of U.S. Patent No. 11,140,841 in the case of Aardevo North America, LLC v. Agventure B.V. The patent in question, owned...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 & Emery

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

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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

Haug Partners LLP

In CRISPR Patent Dispute, the Federal Circuit Clarifies the Conception and Written Description Standards

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On May 12, 2025, the Federal Circuit issued a decision in Regents of the Univ. of California v. Broad Inst., Inc.1 concerning the ongoing priority dispute relating to competing inventor groups for the CRISPR-Cas9 eukaryotic...more

Knobbe Martens

CRISPR Dispute Heats Up With Recent Federal Court Decision

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On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit (CAFC) revived the Regents of the University of California’s (Regents) challenge to the Broad Institute’s CRISPR-Cas9 patents, overturning a 2022 decision by...more

Knobbe Martens

Keeping PACE With CRISPR

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AGILENT TECHNOLOGIES, INC. v. SYNTHEGO CORP. - Before Prost, Linn, and Reyna. Appeal from the Patent Trial and Appeal Board. Obviousness does not require all claimed limitations to be expressly disclosed in a primary prior...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

McDermott Will & Emery

In Determining Subject Matter Eligibility, the Name of the Game Is the Claim

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In a decision underscoring the distinct standards governing enablement under §§ 102 and 112, the US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s finding that a prior art reference was...more

McDermott Will & Emery

CRISPR Clarity: Enablement Is Analyzed Differently Under §§ 102 and 112

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In a decision underscoring the distinct standards governing enablement under §§ 102 and 112, the US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s finding that a prior art reference was...more

A&O Shearman

Federal Circuit Affirms Patent Trial And Appeal Board Decision, Finding Claims Of Patents Covering CRISPR Guide RNA Technology As...

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On June 11, 2025, the United States Court of Appeals for the Federal Circuit affirmed the Patent Trial and Appeal Board (PTAB) decision invalidating two patents owned by Agilent Technologies. The patents at issue, U.S. Patent...more

Jones Day

Federal Circuit: Plans for Future Activity Created a Substantial Risk of Future Infringement

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Restem filed a petition for inter partes review of U.S. Patent No. 9,803,176, directed to stem cells obtained from umbilical cord tissue and isolated through a two-step process to create a specific cell marker expression...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

DLA Piper

What is a “Clear and Unmistakable” Prosecution History Disclaimer?

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The Federal Circuit’s March 21, 2025 decision in Maquet Cardiovascular LLC v. Abiomed Inc. et al. (No. 2023-2045) and the recent Patent Trial and Appeal Board (PTAB) Delegated Rehearing Panel decision in SynAffix B.V. v....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

Irwin IP LLP

CAFC Cleaves ‘Conception’ from ‘Reduction to Practice’: Conception Requires Neither Certainty Invention Will Work Nor Successful...

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Regents of the Univ. of California v. Broad Inst., Inc., No. 2022-1594, 2025 WL 1363125 (Fed. Cir. May 12, 2025) - On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit vacated the Patent Trial and Appeals...more

McDermott Will & Emery

Take That Conception Out of the Oven – It’s CRISPR Even If the Cook Doesn’t Know

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Addressing the distinction between conception and reduction to practice and the requirement for written description in the unpredictable arts, the US Court of Appeals for the Federal Circuit explained that proof of conception...more

Foley Hoag LLP

A Super CRISPR Week – the Week of May 12, 2025: Patent Battles, Clinical Milestones, and Next-Gen Tools

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Key Takeaways: Federal Circuit Reopens CRISPR-Cas9 Priority Fight. The CAFC vacated the PTAB’s earlier ruling that UC lacked prior conception of CRISPR-Cas9 in eukaryotic cells, remanding the interference for reconsideration...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: The Regents of the University of California v. The Broad Institute

The Regents of the University of California v. The Broad Institute, Inc., Appeal Nos. 2022-1594, -1653 (Fed. Cir. May 12, 2025) Must an inventor know their invention will work to demonstrate that they “conceived” of it? ...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

Morrison & Foerster LLP

Federal Circuit Vacates and Remands in Long-Pending Dispute over CRISPR IP

Those hoping the Court of Appeals for the Federal Circuit would finally resolve priority in the long-pending dispute between the University of California and the Broad Institute will have to wait a little longer. Oral...more

Robins Kaplan LLP

New ANDA Cases

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Federal district court cases that are filed pursuant to the Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more

Jones Day

Expert Testimony Supporting POPR Can Be An Effective Strategy

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It is relatively uncommon for parties to submit expert declarations in the preliminary-response phase of an IPR proceeding, but recently the Patent Owner in Imperative Care, Inc. v. Inari Medical, Inc. effectively used that...more

Venable LLP

Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximab-pvvr) / Riabni™ (rituximab-arrx) - April...

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Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

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