News & Analysis as of

Life Sciences Intellectual Property Litigation

White & Case LLP

Federal Circuit Reinforces Standard for Prior Art Enablement in CRISPR Dispute

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On June 11, 2025, the U.S. Court of Appeals for the Federal Circuit decided Agilent Technologies, Inc. v. Synthego Corp. (No. 23-2186), addressing enablement of prior art references for disputed CRISPR-Cas9 gene-editing...more

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

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

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As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...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...

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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

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

Robins Kaplan LLP

New ANDA Cases

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Federal district court cases that are filed pursuant to the Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more

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

[Webinar] mRNA Patent Wars Update: Litigations Expand and Key Rulings Expected in 2025 - May 14th, 2:00 pm ET

Partner Dan Shores will present a webinar titled "mRNA Patent Wars Update: Litigations Expand and Key Rulings Expected in 2025" for Medmarc, the leading expert in the products liability risks facing medical technology and...more

Robins Kaplan LLP

Taiho Pharma Co. v. MSN Labs Private Ltd.

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Lonsurf® (tipiracil) - Case Name: Taiho Pharma Co. v. MSN Labs Private Ltd., No. 19-2342-JLH (D. Del. Jan. 23, 2025) (Hall, J.)  Drug Product and Patent(s)-in-Suit: Lonsurf® (tipiracil); U.S. Patent No. 10,457,666 (“the ’666...more

Robins Kaplan LLP

Mallinckrodt Pharms. Ireland Ltd. v. Airgas Therapeutics LLC

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INOMax® (nitric oxide) - Case Name: Mallinckrodt Pharms. Ireland Ltd. v. Airgas Therapeutics LLC, Civ. No. 22-1648-RGA, 2025 WL 472557 (D. Del. Feb. 12, 2025) (Andrews, J.)  Drug Product and Patent(s)-in-Suit: INOMax® (nitric...more

Jones Day

Expert Testimony Supporting POPR Can Be An Effective Strategy

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It is relatively uncommon for parties to submit expert declarations in the preliminary-response phase of an IPR proceeding, but recently the Patent Owner in Imperative Care, Inc. v. Inari Medical, Inc. effectively used that...more

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

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Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Troutman Pepper Locke

Trade Dress Disputes Continue To Be a Bitter Pill in Pharma

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A recent federal court decision highlights the delicate balance between U.S. Food and Drug Administration (FDA) guidance and trade dress protections for drugs administered in a tablet or capsule form. Last month, a district...more

Goodwin

GSK and Pfizer Stipulate to Dismissal of RSV Vaccines Lawsuit

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On April 3, 2025, GlaxoSmithKline (GSK) and Pfizer filed a stipulation to dismiss with prejudice GSK’s litigation in the United States District Court for the District of Delaware....more

Fenwick & West LLP

Navigating and Litigating 'Commercially Reasonable Efforts' Provisions: Considerations and Strategies for Tech & Life Sciences...

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Commercially reasonable efforts (CRE) provisions are a common feature in technology and life sciences agreements, particularly in development collaborations, licensing deals, and milestone-based contracts. ...more

Goodwin

The Court of Appeals for the Federal Circuit’s In Re Xencor Decision: Jepson Claims Require Written Description for Their...

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On March 13, 2025, the US Court of Appeals for the Federal Circuit (Federal Circuit) issued a decision titled In Re: Xencor, Inc. (the Xencor decision). The Xencor decision affirms the decision of the Appeals Review Panel...more

Knobbe Martens

An Obvious Solution to an Unknown Problem?

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IMMUNOGEN, INC. v. STEWART - Before Lourie, Dyk, and Prost. Appeal from the United States District Court for the Eastern District of Virginia. A solution to a problem can be obvious even when the problem itself was unknown in...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

Benesch

Insulet Corp. May Have to Choose Between $452 Million Jury Award or Permanently Blocking Competitor From Utilizing Its Trade...

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After receiving a jury verdict awarding $452 million in damages against a rival company for misappropriation of trade secrets, the prevailing party, Insulet Corp., may have to choose between portions of the damages award or...more

McDonnell Boehnen Hulbert & Berghoff LLP

DNA Genotek Inc. v. Spectrum Solutions LLC (Fed. Cir. 2025)

Sometimes important contributions to innovation can come from the mundane rather than the extraordinary. One (perhaps apocryphal) example comes from the story of the early development of television by Philo Farnsworth (the...more

McDermott Will & Emery

Inventor’s Motivation to Combine Does Not Control Obviousness

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The US Court of Appeals for the Federal Circuit affirmed a district court decision rejecting claims of a patent application directed to a dosing regimen for a cancer treatment, finding the claims to be obvious where the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Five Years Ago Today . . .

On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear."  At...more

McDonnell Boehnen Hulbert & Berghoff LLP

Immunogen, Inc. v. Stewart (Fed. Cir. 2025)

After creating something of a frisson due to the apprehension that the Federal Circuit might be convinced to re-evaluate whether it was a necessary element for establishing obviousness for the skilled artisan to have had a...more

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