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Appeals Biotechnology

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

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

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

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

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

Foley Hoag LLP - White Collar Law &...

Federal District Court Upholds HHS Advisory Opinion Blocking Fertility Assistance Program

A recent decision from the United States District Court for the District of Columbia continues to give significant deference to the U.S. Department of Health and Human Services’ (HHS) interpretation of the Anti-Kickback and...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

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

McDermott Will & Emery

Small-Market Segment Can Satisfy Domestic Industry Requirement

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The US Court of Appeals for the Federal Circuit affirmed a US International Trade Commission finding, explaining that small-market segments can be significant and substantial enough to support the Commission’s domestic...more

Cooley LLP

Trends in 2024 Securities Class Actions: AI and Biotech Cases On the Rise, Second Circuit Bounces Back

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Cornerstone Research recently issued its 2024 Year in Review report examining recent trends in securities class action filings. For the second year in a row, the number of securities class action filings saw an uptick,...more

Smart & Biggar

Twice is not nice – second notice of allegation may be abusive

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On December 23, 2023, the Federal Court of Appeal (FCA) held that it was an abuse of process for Apotex to raise invalidity in defending actions under the Patented Medicines (Notice of Compliance) Regulations (Regulations)...more

McDermott Will & Emery

2023 IP Outlook: Patent Decisions Affecting Pharma and Biotech Companies

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The past year brought many developments in the life sciences patent legal space. Three decisions in particular hold potential ramifications for drug makers and patent holders in 2023. This year, the Supreme Court of the...more

McDermott Will & Emery

Intellectual Property & Health | News To Know – June 2022

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RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more

Harris Beach Murtha PLLC

Federal Circuit Denial of En Banc Rehearing in Amgen v. Sanofi Prompts New Considerations in Genus Claims

Based on the denial of rehearing and the Amgen v. Sanofi decision itself, inventors should: Claim as many separate species as possible. Attempt to fashion genus claims that have a limited number of members supported...more

Haug Partners LLP

Can Biopharma Functional Genus Patent Claims Be Resuscitated?

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An en banc rehearing petition to the Federal Circuit seeks to breathe life back into the widespread practice of patenting a genus of compounds by claiming their common functional characteristics. This claiming practice was...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Sanofi (Fed. Cir. 2021)

A little less than four years ago, the Federal Circuit rendered a decision in Amgen Inc. v. Sanofi that brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement...more

Holland & Knight LLP

Food and Beverage Law Update: December 2018

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Regulation - FDA-USDA Propose Joint Regulatory Framework for Cell-Grown Meat - On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement...more

Knobbe Martens

Ynano’s Artificial Glands

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On July 2, 2018, the Federal Circuit Court of Appeals affirmed the decision of the Patent Trial and Appeal Board holding that some of the claims relating to artificial glands and various methods of creating them were not...more

Hogan Lovells

FDA proposes streamlining combination product regulations

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On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more

Knobbe Martens

FDA Issues Refusal-to-File Letter to Alkermes for Depression Treatment

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On April 2, 2018, Irish biotech Alkermes revealed that it had received a Refusal-to-File letter from the FDA regarding its depression drug ALKS 5461. The announcement caused Alkermes shares to drop 22.4%, and adversely...more

Knobbe Martens

Inherent Anticipation for Biotechnology Inventions

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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

Carlton Fields

Food for Thought: Ninth Circuit Rejects GMO and Pesticide Bans in Three Hawaii Counties Because State and Federal Laws Preempt the...

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Alika Atay et al v. County of Maui, et al, No. 15-16466 (9th Cir., Nov. 18, 2016) - Hawai’i Papaya Indus. Assn., et al v. County of Hawaii, No. 14-17538 (9th Circ., Nov. 18, 2016) - Robert Ito Farm, Inc., et al. v. County...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit’s Application of Mayo Revives Biotech Patent

In Rapid Litig. Mgmt. Ltd v. CellzDirect, Inc., the Federal Circuit reversed a ruling of patent invalidity under Section 101, reviving a biotech patent to a method of preserving hepatocytes, liver cells, for medical use. The...more

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