News & Analysis as of

CRISPR

ArentFox Schiff

FDA Greenlights Commercialization of Gene-Edited Pig Resistant to Devastating Swine Disease PRRSV

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On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease....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...

Irwin IP LLP on

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

Foley Hoag LLP on

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

McDonnell Boehnen Hulbert & Berghoff LLP

Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2025) - Update

Only a few days after the one-year anniversary of hearing oral argument, the Federal Circuit handed down its decision in Regents of the University of California v. Broad Institute, Inc. on Monday. The opinion reviewed the...more

Morrison & Foerster LLP - Class Dismissed

APHIS Reinstates Legacy Biotechnology Regulations: Implications for CRISPR-Edited Plants

USDA Animal and Plant Health Inspection Service (APHIS) announced on January 23, 2025, that it is reinstating its legacy notification procedure as of February 7, 2025, providing a streamlined alternative to permits for...more

Rothwell, Figg, Ernst & Manbeck, P.C.

CRISPR and Agriculture

Modern gene-editing technology, such as CRISPR/Cas technology, represents a ground-breaking advancement that has transformed our genetic engineering capabilities and has enormous potential for revolutionising medicine, food...more

Proskauer - Minding Your Business

Troubling Trend of “Self” Revocation In the CRISPR Space Continues in Europe

Less than two months after CVC made the surprising move to revoke two of its seminal European CRISPR patents, Sigma-Aldrich has done it too. While the facts that led to Sigma’s “self” revocation may be different than CVC’s,...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 9, November 2024

Welcome to our ninth 2024 issue of Decoded - our technology law insights e-newsletter. How are States Using Generative Artificial Intelligence? and Employee AI Adoption Cools Globally - Why this is important: As...more

Proskauer - Minding Your Business

To Be Or Not To Be: Self-Revocation of Seminal European Patents Creates New Uncertainty In CRISPR IP Space

There is no shortage of surprises and twists in the decade-long fight over the control of dominant IP in the CRISPR space. The newest one is the self-revocation of two seminal CRISPR patents in Europe by the team led by two...more

Rothwell, Figg, Ernst & Manbeck, P.C.

The Future of Food: Regulatory and Patent Landscape of Genome Editing in Food Technology

Our current food system is facing a myriad of critical challenges. The United Nations predicts that the world population will reach 9.3 billion people by 2050, which means that we will need to produce 60% more food to feed...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 5, June 2024

We are pleased to announce that several of the firm’s practice groups and attorneys were recognized in the 2024 edition of Chambers USA, a directory of leading law firms and attorneys. Chambers and Partners annually...more

Spilman Thomas & Battle, PLLC

Decoded Technology Law Insights, V 5, Issue 3, April 2024

Using AI to Build Cyber Resilience for Critical Infrastructure - "Cyber resilience serves as a literal survival strategy, offering a framework to detect threats, understand attacks, recover swiftly, and adapt to...more

Goodwin

Women’s History Month Spotlight: Emmanuelle Charpentier and Jennifer Doudna

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In honor of Women’s History Month, Big Molecule Watch recognizes Emmanuelle Charpentier and Jennifer Doudna, who won the Nobel Prize for a method for genome editing, commonly called CRISPR or “molecular scissors”. By sharing...more

WilmerHale

Recent Appellate Decision Overturns Revocations of Broad Institute CRISPR-Cas9 Patents

WilmerHale on

This past Thursday, the Board of Appeals of the European Patent Office released the minutes of oral proceedings in which the Board rendered a decision in closely watched appeals relating to Broad patents directed to...more

MoFo Life Sciences

Update February 2024 On Commission Plans Liberalization Of New Genomic Techniques (NGTS) In The EU

MoFo Life Sciences on

On February 7, 2024, the European Parliament approved the draft regulating plants obtained by certain new genomic techniques (NGT) like CRISPR-Cas. The members of the European Parliament (MEPs) voted to divide NGT plants into...more

Morrison & Foerster LLP

New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants

On February 22, 2024, FDA released a final guidance detailing how foods derived from genome-edited plants fall into FDA’s existing food safety framework and outlining two voluntary consultation processes for developers. The...more

Jones Day

Ban on European Patents for Plants Engineered by "New Genomic Techniques" Nearing Reality

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The European Parliament has adopted an amended European Commission proposal to regulate plants engineered using techniques such as CRISPR/Cas and ban any patenting of plants, plant parts, material, genetic information, or...more

Goodwin

CRISPR Regulatory Updates

Goodwin on

On December 15, 2023, Vertex announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the conditional approval of CASGEVY (exagamglogene autotemcel...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 10, December 2023

Revisiting…Are Automakers Making Sufficient Efforts to Protect Customer Data? As a follow-up to our previous article and webinar, “Are Automakers Making Sufficient Efforts to Protect Customer Data?", we are addressing the...more

Goodwin

FDA Approves First Cell-Based Therapies for Treatment of Sickle Cell Disease

Goodwin on

On December 8, 2023, the FDA approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older—Vertex’s CASGEVY and Bluebird’s LYFGENIA.  SCD is a group of inherited...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Gene Therapy Approvals Gain Steam in 2023: FDA Approves First Gene Therapies for Sickle Cell Disease

In a long-awaited milestone in the gene therapy space, the Food and Drug Administration (FDA) approved two gene therapies to cure sickle cell disease (SCD). Soon thereafter these approvals, a key licensing agreement was...more

Foley & Lardner LLP

FDA Approves Two Gene Therapies to Treat Sickle Cell Disease Including a CRISPR-Based Therapy

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Share on Twitter Print Share Back to top On December 8, 2023 the U.S. Food and Drug Administration (FDA) approved Casgevy and Lyfgenia, both cell-based gene therapies for the treatment of sickle cell disease in patients 12...more

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