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Life Sciences
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October 14, 2025
Skinny Labels, Orange Book Take Center Stage In IP Talks
Patent litigators focused on pharmaceuticals and biotechnology met Tuesday to work through the biggest issues in their industries, including possible reform to skinny label law, frustration with position-switching in litigation, concerns about when to list patents in the U.S. Food and Drug Administration's Orange Book and data on the relatively low impact of new policies at the U.S. Patent and Trademark Office.
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October 14, 2025
Full 3rd Circ. Won't Rethink $45M CareDx False Ad Case
The Third Circuit on Tuesday turned down medical testing company CareDx's request to have a full panel mull whether to reinstate a $45 million jury award in a false advertisement case over genetic testing technology against rival Natera.
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October 14, 2025
Relief Concerns Grow As Sectoral Tariff Actions Build
Importers' hopes for relief from industrywide tariffs are lagging alongside the trade deals President Donald Trump is trying to broker for some goods, while the administration's accelerated rollout of sectoral levies is also stoking concerns the government may be hamstringing its onshoring goals.
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October 14, 2025
Embryo Loss Class Claims Hinge On Calif. Suit, Judge Says
A Connecticut federal judge may pause a proposed class action blaming CooperSurgical Inc. for embryo losses during in vitro fertilization until a class certification motion is decided in a first-filed case in California, but the plaintiff will have until the end of the month to decide if she wants to proceed with only her direct claims instead.
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October 14, 2025
6th Circ. Won't Revive Allergy Tester's Antitrust Case
The Sixth Circuit refused to revive an allergy testing and treatment company's antitrust case accusing an insurer and a medical group of conspiring to squeeze it out of the market, after finding that doctors are the ones being directly harmed by the alleged activity.
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October 14, 2025
Meet HHS General Counsel Michael Stuart
Michael Stuart, a former chief federal prosecutor for West Virginia, has been confirmed by the U.S. Senate to serve as general counsel for the Department of Health and Human Services, where he has promised to make healthcare fraud enforcement a priority.
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October 14, 2025
Attempts To Revive Stroke Treatment Patents Fail At Fed. Circ.
The Federal Circuit on Tuesday tossed without analysis a challenge to Patent Trial and Appeal Board rulings that invalidated patents covering a stroke treatment system, letting stand one of the decisions deemed precedential by a former U.S. Patent and Trademark Office director.
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October 14, 2025
Freshfields Guides J&J's Planned Orthopedics Unit Spinoff
Johnson & Johnson said Tuesday it intends to separate its orthopedics business into a stand-alone company within the next 18 to 24 months, with Freshfields LLP advising on the planned spinoff of the unit.
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October 14, 2025
Ōura Valuation Soars To $11B After $900M Financing Round
Fitness-tracking ring maker Ōura on Tuesday revealed it had reached a roughly $11 billion valuation after securing over $900 million in a funding round, which it says will help it develop new technologies, speed up artificial intelligence and product innovation, and expand global distribution.
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October 14, 2025
Catching Up With Delaware's Chancery Court
Last week at the Delaware Chancery Court, Vice Chancellor Lori W. Will ruled that Carlos Vasallo remains the CEO of Caribevision TV Network LLC, finding that majority investors' attempt to remove him under a defective 2019 agreement was invalid for lack of proper notice.
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October 14, 2025
Blood Test Co. Can't Escape Willful Infringement Claims
A company that makes diagnostic medical tests has been denied a bid to escape from a medical research firm's claims that it willfully infringed patents when a judge held that reading the allegations in combination creates a plausible basis that the company had knowledge of the patents.
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October 14, 2025
Covington, Sidley Guide $700M BioCryst Allergic Disease Deal
BioCryst Pharmaceuticals Inc. will purchase Astria Therapeutics Inc., a biopharmaceutical company focused on therapies for allergic and immunologic diseases, in a cash and stock deal worth about $700 million, the companies announced Tuesday.
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October 14, 2025
High Court Won't Hear FDA Stem Cell Regulation Fight
The U.S. Supreme Court on Tuesday declined to review a circuit court holding that a stem cell treatment derived from a patient's own tissue is subject to Food, Drug and Cosmetic Act regulations.
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October 10, 2025
Some Cases Advance In Latest Stewart Discretionary Rulings
Deputy U.S. Patent and Trademark Office Director Coke Morgan Stewart rejected 37 Patent Trial and Appeal Board petitions Friday night, but allowed 17 challenges to proceed.
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October 10, 2025
Zantac MDL Suits Were Impropely Tossed, 11th Circ. Told
Consumers urged the Eleventh Circuit on Friday to revive their claims in a multidistrict litigation alleging that the main ingredient in the heartburn medication Zantac causes cancer, saying the court overseeing the case improperly sided with drugmakers' experts and preempted more claims from coming forward.
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October 10, 2025
Federal Worker Unions Press For Immediate Block Of Layoffs
Unions representing federal workers urged a California federal court Friday to immediately block the Trump administration from laying off workers amid the government shutdown as the administration acknowledged it had begun issuing reduction-in-force notices to thousands of employees.
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October 10, 2025
AstraZeneca Strikes 'Most Favored Nation' Price Deal
Pharmaceutical giant AstraZeneca on Friday cut a deal with the Trump administration to reduce drug prices in the United States, agreeing to provide its medications for Medicaid beneficiaries at discount prices.
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October 10, 2025
ATyr Pharma Faces Investor Suit Over Failed Drug Trial
Rare disease biotech aTyr Pharma Inc. and its CEO have been hit with a proposed shareholder class action accusing them of misleading the public about the efficacy of aTyr's lung disease treatment for several months before announcing its trial had not yielded favorable results.
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October 10, 2025
Profs Say Apple Used Copyrighted Material For AI Training
Two neuroscientists have sued Apple in California federal court, claiming it made use of their copyrighted materials to train its artificial intelligence model Apple Intelligence.
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October 10, 2025
Covington, Goodwin Guide Bristol Myers' $1.5B Orbital Buy
Bristol Myers Squibb plans to acquire privately held Orbital Therapeutics for $1.5 billion in cash, aiming to expand its pipeline in cell- and RNA-based therapies for autoimmune diseases, the companies announced Friday.
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October 10, 2025
Pharma Co. Escapes Suit Over Ex-CEO's Alleged Misconduct
Exscientia PLC on Friday won dismissal of a proposed class action related to the termination of its CEO after claims emerged that he participated in inappropriate workplace relationships, with the court finding the investors failed to show that the company's statements about its culture and governance were anything more than puffery.
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October 10, 2025
Clinical Trial Co. Settles Severance Fight With Ex-VP
A clinical research company has agreed to shutter a lawsuit from an ex-executive who claimed his requests for severance went ignored following his resignation, according to a Friday filing in North Carolina federal court.
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October 10, 2025
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen Paddington Bear's creators and Studio Canal sue the company behind Spitting Image, Blackpool Football Club's former owner Owen Oyston bring a fresh claim against the club, and Mishcon de Reya sue a Saudi investment group.
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October 09, 2025
Justices Urged To Clarify Patent Validity In Entresto Case
Generic-drug makers, academics and others are urging the U.S. Supreme Court to take a case involving Novartis' blockbuster cardiovascular drug Entresto, saying the justices must bring consistency to conflicting Federal Circuit precedent on the role of later technology in assessing patent validity.
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October 09, 2025
Biotronik Wants Full 9th Circ. Review Of Whistleblower Ruling
Biotronik Inc. urged the full Ninth Circuit to review a panel ruling that revived a whistleblower suit alleging the company used unlawful compensation tactics to boost heart-device sales, saying it should have been tossed based on prior disclosures in news articles.
Expert Analysis
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A Simple Way Courts Can Help Attys Avoid AI Hallucinations
As attorneys increasingly rely on generative artificial intelligence for legal research, courts should consider expanding online quality control programs to flag potential hallucinations — permitting counsel to correct mistakes and sparing judges the burden of imposing sanctions, say attorneys at Lankler Siffert & Wohl and Connors.
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DOJ Consumer Branch's End Leaves FDA Litigation Questions
With the dissolution of the U.S. Department of Justice's Consumer Protection Branch set to occur by Sept. 30, companies must carefully monitor how responsibility is reallocated for civil and criminal enforcement cases related to products regulated by the U.S. Food and Drug Administration, say attorneys at Foley & Lardner.
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The Evolving Legal Landscape For THC-Infused Beverages
A recent Eighth Circuit ruling, holding that states may restrict the sale of intoxicating hemp-derived products without violating federal law, combined with ongoing regulatory uncertainty at both the federal and state levels, could alter the trajectory of the THC-infused beverage market, say attorneys at Pashman Stein.
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Series
Creating Botanical Art Makes Me A Better Lawyer
Pressing and framing plants that I grow has shown me that pursuing an endeavor that brings you joy can lead to surprising benefits for a legal career, including mental clarity, perspective and even a bit of humility, says Douglas Selph at Morris Manning.
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Opinion
The Legal Education Status Quo Is No Longer Tenable
As underscored by the fallout from California’s February bar exam, legal education and licensure are tethered to outdated systems, and the industry must implement several key reforms to remain relevant and responsive to 21st century legal needs, says Matthew Nehmer at The Colleges of Law.
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2nd Circ. Reinforces Consensus On Vacating Foreign Awards
In Molecular Dynamics v. Spectrum Dynamics Medical, the Second Circuit recently affirmed that federal district courts do not possess subject matter jurisdiction to vacate foreign arbitral awards, strengthening this consensus across the circuits most active in recognition and enforcement actions, says Ed Mullins at Reed Smith.
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E-Discovery Quarterly: Rulings On Relevance Redactions
In recent cases addressing redactions that parties sought to apply based on the relevance of information — as opposed to considerations of privilege — courts have generally limited a party’s ability to withhold nonresponsive or irrelevant material, providing a few lessons for discovery strategy, say attorneys at Sidley.
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How DOJ's New Data Security Rules Leave HIPAA In The Dust
The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.
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Opinion
Section 1983 Has Promise After End Of Nationwide Injunctions
After the U.S. Supreme Court recently struck down the practice of nationwide injunctions in Trump v. Casa, Section 1983 civil rights suits can provide a better pathway to hold the government accountable — but this will require reforms to qualified immunity, says Marc Levin at the Council on Criminal Justice.
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Trump's 2nd Term Puts Merger Remedies Back On The Table
In contrast with the Biden administration, the second Trump administration has signaled a renewed willingness to resolve merger enforcement concerns through remedies from the outset, particularly when the proposed fix is structural, clearly addresses the harm and does not require burdensome oversight, say attorneys at Cooley.
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Patent Ambiguity Persists After Justices Nix Eligibility Appeal
The Supreme Court recently declined to revisit the contentious framework governing patent eligibility by denying certiorari in Audio Evolution Diagnostics v. U.S., suggesting a necessary recalibration of both patent application and litigation strategies, say attorneys at Skadden.
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Texas Med Spas Must Prepare For 2 New State Laws
Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.
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Fed. Circ. In June: Transitional Phrases In Patent Claims
The Federal Circuit's recent decision in Eye Therapies v. Slayback Pharma takes on the rarely addressed topic of transitional phrases in patent claims, providing some useful lessons regarding restating claim language and broadly distinguishing prior art, say attorneys at Knobbe Martens.
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Series
Playing Soccer Makes Me A Better Lawyer
Soccer has become a key contributor to how I approach my work, and the lessons I’ve learned on the pitch about leadership, adaptability, resilience and communication make me better at what I do every day in my legal career, says Whitney O’Byrne at MoFo.
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Strategies For Cos. Navigating US-Indian Pharma Partnerships
Recent policy adjustments implemented by the U.S. government present both new opportunities and heightened regulatory scrutiny for the Indian life sciences industry, amplifying the importance of collaboration between the Indian and U.S. pharmaceutical sectors, say Bryant Godfrey at Foley Hoag and Jashaswi Ghosh at Holon Law Partners.