News & Analysis as of

Biotechnology Patents

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

Fish & Richardson

The Not-So-Safe Harbor for Research Tools: Lessons From the District of Delaware

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In BlueAllele Corp. v. Intellia Therapeutics, Inc., 2024 U.S. Dist. Lexis 222094 (D. Del. Dec. 9, 2024)1, the District of Delaware addressed several issues relevant to the safe harbor defense in Hatch-Waxman litigation. ...more

Wolf, Greenfield & Sacks, P.C.

A Look Ahead: Key Intellectual Property Legal Developments in 2024 - and What to Expect in 2025

From potential legal challenges to Chinese biopharma supply chains, Europe’s new Unified Patent Court (UPC), landmark decisions in life sciences, pharma’s Orange Book listings, design patent rejections, and likely shifts at...more

Wolf, Greenfield & Sacks, P.C.

A Conversation with Phil Hamzik

Phil Hamzik is an Associate in Wolf Greenfield’s Pharmaceutical Practice. From protecting key platform technologies to advising on drug product life cycle management, Phil works closely with pharmaceutical and biotechnology...more

Goodwin

Accord Biopharma Announces FDA Approval of IMULDOSA (ustekinumab-srlf)

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​​​​​​​On October 14, 2024, Accord BioPharma, Inc. announced that the FDA has approved IMULDOSA (ustekinumab-srlf), a biosimilar to Johnson & Johnson’s STELARA (ustekinumab), indicated for the treatment of chronic...more

Goodwin

GlaxoSmithKline and Northwestern Sue Moderna for Patent Infringement in Trio of Lawsuits

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Last week, GlaxoSmithKline and Northwestern University filed separate lawsuits against Moderna, accusing its mRNA-based vaccines of patent infringement....more

Patterson Belknap Webb & Tyler LLP

X Doesn’t Mark the Spot: Judge Halpern Denies a Motion for Summary Judgment That Alleged Failure to Comply with Marking Statute

On October 4, 2024, District Judge Philip M. Halpern (S.D.N.Y.) denied Defendant Regeneron Pharmaceuticals Inc. (“Regeneron”)’s Motion for Summary Judgment that (1) Allele was not entitled to any pre-suit infringement damages...more

Orrick, Herrington & Sutcliffe LLP

Developing and Patenting AI Inventions: 5 Things for Biotech Companies to Consider

As AI tools become more prevalent in the life sciences, biotechnology companies need to evaluate AI’s impact on their ability to protect the results of their research. Recent U.S. Patent and Trademark Office (PTO) guidance...more

MoFo Life Sciences

Federal Circuit Clarifies Scope Of Obviousness-Type Double Patenting In Allergan USA V. MSN Laboratories

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On August 13, 2024, the U.S. Court of Appeals for the Federal Circuit issued a welcomed decision to patentees in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061 (Fed. Cir. 2024) clarifying the scope of...more

Kilpatrick

7 Key Takeaways - The Federal Circuit's New § 112 Attack on Biotechnology: Diagnosis and Prescription

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Kilpatrick attorneys Yifan Mao and Stuart Pollack recently attended the 20th annual KTIPS (Kilpatrick Townsend Intellectual Property Seminar) to discuss the “The Federal Circuit’s New § 112 Attack on Biotechnology: Diagnosis...more

Foley & Lardner LLP

Patenting Power Plays For AI Drug Discovery

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In April 2024, BioPharmaTrend published a comprehensive review of the past and current state of artificial intelligence (AI) drug discovery, using the 2012 advent of modern deep learning as a starting point. The review...more

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