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Inventions Life Sciences

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

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

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

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

Jones Day

Innovative Insights: Legal Updates in Life Sciences | First Quarter 2025

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Artificial intelligence is revolutionizing life science R&D (particularly in the realm of drug discovery) and challenging the traditional "human inventorship" requirement for U.S. patents. Recent guidance from the USPTO...more

Jones Day

Blurring the Line Between the Dry and Wet Lab: Joint Inventorship in AI-Assisted Life Science Inventions

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In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

PTAB Year in Review – PTAB Trends in 2024: Challenges to Genus Claims

In the biotechnology and chemical spaces, genus claims are often sought by patent applicants to protect not only a specific product of interest, but also as a means to protect against others making related products that...more

Foley & Lardner LLP

Beyond the Polanyi Paradox: How Human-Aware AI Unlocks Creativity And Breakthrough Discoveries

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Artificial intelligence (AI) has transformed scientific research and innovation, yet as previously discussed, the Polanyi Paradox remains a significant obstacle to using AI to generate creative solutions or breakthrough...more

MoFo Life Sciences

Navigating Inventorship in the Era of AI-Assisted Drug Discovery

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This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Fenwick & West LLP

What is the IP Risk Profile in AI Drug Discovery?

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The scientific benefits and legal risks of AI-driven drug discovery are consequential. But recent IP law decisions allude to a general concept that IP rights will not be awarded if AI completely or significantly replaces...more

Mayer Brown

Patents, Native People, and Traditional Communities: World Intellectual Property Organization (WIPO) Signs Historic Treaty

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Following more than two decades of negotiation, WIPO member states have inked the first-of-its-kind international treaty addressing the connection between “Intellectual Property, Genetic Resources, and Associated Traditional...more

MoFo Life Sciences

At-Home Diagnostics Articles: Non-Lab Diagnostics: Supply, Manufacturing, And Distribution Agreements

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The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services...more

Polsinelli

Regeneron v Novartis and Vetter: Walker Process Client Update

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In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in...more

American Conference Institute (ACI)

[Event] 22nd Advanced Summit on Life Sciences - May 29th - 30th, New York, NY

Hosted by American Conference Institute, the 22nd Advanced Summit on Life Sciences Patents returns for another exciting year with curated programming that will provide practical insights on how to maximize your patent term...more

Goodwin

USPTO’s New Guidance on AI-Assisted Inventions: The Impact on the Use of AI in the Life Sciences

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On February 12, 2024, the US Patent Office and Trademark Office (USPTO) released the Inventorship Guidance for AI-assisted Inventions (the Guidance). ...more

Axinn, Veltrop & Harkrider LLP

Over-Sweetening the Pot? When Selling a Product Bars Patenting the Manufacturing Process Under the AIA

The America Invents Act ("AIA") bars a person from obtaining a patent when the “claimed invention” had been “on sale” more than one year before the filing date of the patent. 35 U.S.C. § 102(a)(1). Acesulfame potassium...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit IP Appeals: Summaries of Key 2023 Decisions (8th Edition): Amgen Inc. v. Sanofi, 598 U.S. 594 (2023)

The Supreme Court’s lone patent case from last term does not break new ground on enablement law. The Court’s core holdings—that a patent specification must enable the full scope of the claimed invention and therefore that...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: January 2024

The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more

Jones Day

Federal Agencies Seeking Patent Seizure Authority Through Draft NIST Guidance

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The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Weighs in on Relevance of Primary Reference’s Intended Purpose to a POSITA’s Motivation to Combine

In Medtronic, Inc., Medtronic Vascular, Inc., v. Teleflex Innovations S.A.R.L., the case addresses the weight the Patent Trial and Appeal Board (PTAB) should give to the intended purpose of a primary reference when evaluating...more

Goodwin

Federal Government Releases Proposed Guidance for Exercising “March-In” Rights Under the Bayh-Dole Act: Implications for...

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On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The Bayh-Dole march-in...more

Seyfarth Shaw LLP

Pill Politics: Unveiling Biden’s Bold Blueprint for Affordable Drugs

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On December 7, 2023, the Biden administration announced a blueprint for a framework that may be a tough pill to swallow for the pharmaceutical industry. This framework suggests that drug prices should be a crucial factor in...more

Knobbe Martens

Recent Developments in Medical Casts

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On October 5, 2023, the World Intellectual Property Organization published Cast21’s PCT application related to its alternative cast device – a 3D-printed exoskeleton created from a medical-grade resin.  Cast21’s device seeks...more

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