News & Analysis as of

Biotechnology Patents

Wolf, Greenfield & Sacks, P.C.

Unexpected Paths to IP Law with Dan Young and Colin White

For many, the journey to IP law is circuitous. And that’s undoubtedly true for Wolf Greenfield Shareholder Dan Young and Technology Specialist Colin White. Both had interesting careers outside of the legal industry before...more

Knobbe Martens

Bipartisan Law Introduced to Clarify Patent Eligibility

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For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries adjacent...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

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

Alston & Bird

Patent Case Summaries | Week Ending May 16, 2025

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The Regents of the University of California, et al. v. The Broad Institute, Inc., et al., Nos. 2022-1594, -1653 (Fed. Cir. (PTAB) May 12, 2025). Opinion by Reyna, joined by Hughes and Cunningham....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

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

Maynard Nexsen

Patenting Microbial Products: Pitfalls, Value, and Special Concerns

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The use of microorganisms in human industry is ancient, but has increased markedly in recent years. The modern recognition of the role of microbial communities in the human body has intensified innovation in fields like...more

Mintz - Tax Viewpoints

Canada Elects 2025: Tax Policies Poised to Shape Canada’s Innovation Economy

In a historic election, given the backdrop of rising tensions between Canada and the US, Canadians elected Mark Carney and his Liberal party on April 28, 2025. Although the platform released by the Liberals (the Liberal...more

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

3 Tips for Avoiding Having to File a Budapest Treaty Declaration When Prosecuting Patent Applications on Biological Materials

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other...more

American Conference Institute (ACI)

[Event] 23rd Advanced Summit on Life Sciences Patents - May 19th - 20th, New York, NY

At ACI’s 23rd Advanced Summit on Life Sciences Patents, you can expect informational overviews and thorough discussion of every facet of the industry. In a time of major legislative, regulatory, and judicial change, you can't...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

Polsinelli

Judge Connolly (D. Del.) Overturns $96 Million Molecular Diagnostics Jury Verdict, Finds Patents Invalid Under § 112

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Synopsis: In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera,...more

Goodwin

Where were biologics-related patents involved in BPCIA litigation invented?

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Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national...more

MoFo Life Sciences

Federal Circuit addresses subject matter eligibility for compositions of matter in US Synthetic v. ITC

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Earlier this month, the Federal Circuit decided a subject matter eligibility case closely watched in the pharmaceutical industry. The case involved composition-of-matter claims reciting measured results. Reversing the...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

Alston & Bird

Patent Case Summaries | Week Ending February 7, 2025

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HD Silicon Solutions LLC v. Microchip Technology, Inc., No. 2023-1397 (Fed. Cir. (PTAB) Feb. 6, 2025). Opinion by Lourie, joined by Stoll and Cunningham....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

Jones Day

No Need to Show Reasonable Expectation of Success Regarding Inherent Property

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The Federal Circuit affirmed six PTAB decisions that held unpatentable as obvious 79 claims of three Cytiva Bioprocess (“Cytiva”) challenged patents and reversed the PTAB decision upholding four claims....more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Challenges Reasonable Expectation of Success Prong of Obviousness Law Precedent in Immunogen v. Vidal

The U.S. Patent and Trademark Office has a history of attempting to challenge judicial decisions that the Office, usually for its own policy reasons, takes issue with.[1]  Recently, the Office decided to challenge the...more

Smith Anderson

Biotech Licensing Caselaw Update - 2024 Year in (Brief) Review

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Last year was a surprisingly big one for legal decisions impacting the biotechnology transactions and licensing space. Given that most biotech deals are subject to confidential alternative dispute resolution, it is unusual...more

Troutman Pepper Locke

Budding Lessons From Landmark Plant Seed Patent Battle

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The landmark legal battle over who owns the intellectual property rights in genetically modified plants is heating up. Originally published in Law360 - October 23, 2024....more

Akin Gump Strauss Hauer & Feld LLP

District Court: Factual Disputes Preclude Application of Safe Harbor to Gene Editing Technology at the Pleading Stage

The District of Delaware recently denied a motion to dismiss a patent infringement complaint involving gene editing technology that sought relief under the Safe Harbor Provision of the Hatch-Waxman Act. Specifically, the...more

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