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Life Sciences
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November 07, 2025
Sleep Apnea Device Co. Investor Says Rollout Was Botched
Medical device company Inspire Medical Systems has been hit with a proposed investor class action alleging its shares dropped by nearly a third of their value after the public learned it concealed low demand and rollout shortcomings associated with its newest sleep apnea device.
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November 07, 2025
Spurned Pfizer Turns To Antitrust Law To Reclaim Biotech
What may be a first-of-its-kind lawsuit is playing out as Pfizer Inc. turns to antitrust law to keep Novo Nordisk from usurping its bid for Metsera.
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November 07, 2025
Canadian Co. Blocked From Using 'Deep Cleansing Oil' Brand
A Pennsylvania federal judge has permanently blocked a Canadian skincare company from infringing a competitor's trademark for "Deep Cleansing Oil," after it failed to respond to the case.
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November 07, 2025
Seattle Pot Shop Slapped With Site Tracking Pixel Privacy Suit
A Seattle cannabis dispensary has been hit with a proposed class action in Washington federal court by a customer who claims the retailer shared his private information about medical marijuana appointments and pot purchases with Google and other third parties by using online browser tracking tools on its website.
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November 07, 2025
USPTO Extends Deadline For PTAB Institution Rules Feedback
The U.S. Patent and Trademark Office has provided a 15-day extension for giving feedback on proposed rules that will likely reduce the institution of certain patent challenges at the Patent Trial and Appeal Board, with Director John Squires saying "now's the time" to finalize rulemaking on discretionary denial issues.
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November 07, 2025
Jury Clears Novo Nordisk Of Medicaid Fraud Over Blood Drug
A Tacoma federal jury cleared Novo Nordisk on Friday of allegations that it defrauded Washington state's Medicaid and Medicare systems by paying kickbacks and promoting off-label use to illegally boost prescriptions of its hemophilia drug NovoSeven.
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November 07, 2025
Fla. Judge Sentences HIV Drug Fraudster To 8 Years In Prison
A Florida federal judge on Friday sentenced a man to more than eight years in prison after he pled guilty to a wire fraud-related charge in connection to a roughly $100 million HIV medication fraud scheme, referencing the harm that called into question the nation's pharmaceutical drug supply.
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November 07, 2025
Merck Wins PTAB Fight Over Blockbuster Drug, Again
Another cancer treatment patent owned by Johns Hopkins University and challenged by a Merck & Co. Inc. subsidiary didn't pass muster with the Patent Trial and Appeal Board, which on Thursday invalidated seven claims in the patent that's at issue in a disagreement between the parties.
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November 07, 2025
Taxation With Representation: Kirkland, Cravath, Paul Weiss
In this week's Taxation With Representation, consumer products giant Kimberly-Clark acquires Tylenol maker Kenvue, shale producers SM Energy and Civitas Resources announce a merger, and power management company Eaton buys Boyd Corp.'s thermal business.
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November 07, 2025
Laborie Buys Postpartum Bleeding Device For Up To $465M
Medical technology company Laborie Medical Technologies, advised by Simpson Thacher & Bartlett LLP and Cooley LLP, unveiled plans Friday to acquire a postpartum uterine bleeding device from New Jersey-based healthcare company Organon for up to $465 million.
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November 06, 2025
Pair Of Health-Focused Startups Net $423M In Combined IPOs
Two startups, spanning the diagnostics and biotechnology sectors, began trading on Thursday after raising a combined $423 million in initial public offerings, guided by three law firms, as more companies continue going public despite a historic government shutdown that has reduced staffing at the U.S. Securities and Exchange Commission.
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November 06, 2025
'Send A Message' To Novo Nordisk Over Kickbacks, Jury Told
Counsel for a whistleblower claiming Novo Nordisk paid illegal kickbacks to boost off-label prescribing of its hemophilia drug NovoSeven urged jurors during closing arguments Thursday to "send a message" to the drugmaker, saying it defrauded Washington state's Medicaid and Medicare systems out of nearly $100 million.
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November 06, 2025
CareFirst Urges Ban On J&J Character Talk At Stelara Trial
Health insurer CareFirst is asking a Virginia federal judge to bar Johnson & Johnson from promoting its "good character" to a jury that will weigh class claims of anticompetitive conduct and patent fraud to extend market protection on the blockbuster autoimmune drug Stelara.
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November 06, 2025
Lilly, Novo Nordisk Enter Obesity Drug Price Deal With Trump
Pharmaceutical giants Eli Lilly and Novo Nordisk cut a deal with the Trump administration to slash the pricing of their popular weight loss drugs in the U.S., becoming the latest to enter "most-favored-nation" pricing agreements, the White House announced Thursday.
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November 06, 2025
Texas AG Wants To Halt Kenvue $400M Shareholder Pay
Texas wants to block Johnson & Johnson consumer health spinoff Kenvue from paying $400 million to shareholders, calling it a "fraudulent transfer" amid the company, which makes Tylenol, facing "tens or hundreds of billions of dollars in liabilities" in the state's suit alleging the company hid the risk that acetaminophen could lead to autism.
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November 06, 2025
Fla. AG Says Planned Parenthood Lied About Abortion Drugs
The Florida Attorney General sued Planned Parenthood on Thursday, alleging the reproductive healthcare nonprofit misrepresented the safety of abortion drugs to women in a mass marketing campaign.
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November 06, 2025
FDA Warns Companies About Illegal Marketing Of Botox
The U.S. Food and Drug Administration has ordered the companies behind 18 websites to stop selling all Botox injectables to consumers that they have marketed as being able to treat chronic migraine, sweaty palms, overactive bladder and blepharospasm, or spasms that force one's eyelids closed.
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November 06, 2025
Squires Rebuffs Another 21 PTAB Petitions Without Comment
U.S. Patent and Trademark Office Director John Squires issued a one-page order Thursday rejecting 21 patent challenges from companies including Microsoft, Apple and Google, continuing his new practice of summarily denying such petitions with no explanation.
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November 06, 2025
3rd Circ. Won't Revive Investors' Suit Over Viatris Sale
The Third Circuit on Thursday upheld the dismissal of a proposed shareholder class action against pharmaceutical company Viatris, saying that investors hadn't plausibly alleged that they were misled about the future of the company's sold-off biosimilars business.
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November 06, 2025
Med Groups Call To Break Up 'Politicized' CDC Vax Committee
A Massachusetts doctor and a group of public health trade associations want the federal government to break up a key vaccine committee tasked with nationwide vaccine policy, arguing in an amended lawsuit Thursday that the panel has been tainted with anti-vaccine sentiment.
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November 06, 2025
Edwards Defends $945M Heart Valve Deal From FTC Challenge
Edwards Lifesciences urged a D.C. federal court to reject the Federal Trade Commission's bid to put its planned $945 million acquisition of JenaValve on hold, saying the deal will increase innovation and save the lives of thousands of people with a form of heart valve disease.
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November 06, 2025
Pfizer Matches Novo's $10B Metsera Bid, And Other Rumors
Pfizer Inc. reportedly raised its offer for Metsera Inc. to match a $10 billion bid from Novo Nordisk Inc., as a bidding war and legal squabble play out between the drugmakers. Among other deal-related rumors, Apollo Global Management Inc. reportedly dropped its bid to take private pizza chain Papa Johns International Inc., and new developments emerged as Warner Bros. Discovery Inc. weighs potential sale options.
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November 05, 2025
1st Circ. Questions Trump Admin On NIH Indirect Cost Cuts
A First Circuit panel seemed poised on Wednesday to uphold a district court decision finding that the Trump administration lacks the authority to cap indirect costs for research grants at the National Institutes of Health.
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November 05, 2025
Masimo Tells Jury It's Owed $749M In Apple Watch IP Fight
An attorney for Masimo Corp. told a California federal jury during opening statements Wednesday that Apple Inc.'s smartwatch uses his client's groundbreaking patent in the device's feature that warns about an abnormal heart rate, and that Apple should pay up to $749 million for the infringement.
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November 05, 2025
3 More Chinese Scholars Accused Of Smuggling Roundworms
Three Chinese research scholars working at a University of Michigan laboratory have been accused of conspiring with a student pursuing her doctoral degree in Wuhan, China, to smuggle roundworms into the U.S., the U.S. Department of Justice announced Wednesday.
Expert Analysis
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High Court Cert Spotlights Varying Tests For Federal Removal
A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.
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How To Increase 3rd-Party Preissuance Patent Submissions
Attorneys Marian Underweiser and Marc Ehrlich, who helped draft the America Invents Act, discuss changes that the U.S. Patent and Trademark Office could potentially implement to facilitate its hopes for increased participation in front-end patent challenges.
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Trump Air Emissions Carveouts Cloud The Regulatory Picture
President Donald Trump's new proclamations temporarily exempting key U.S. industries from air toxics standards, issued under a narrow, rarely-used provision of the Clean Air Act, will likely lead to legal challenges and tighter standards in some states, contributing to further regulatory uncertainty, say attorneys at GableGotwals.
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Series
Playing Baseball Makes Me A Better Lawyer
Playing baseball in college, and now Wiffle ball in a local league, has taught me that teamwork, mental endurance and emotional intelligence are not only important to success in the sport, but also to success as a trial attorney, says Kevan Dorsey at Swift Currie.
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What US Medicine Onshoring Means For Indian Life Sciences
Despite the Trump administration's latest moves to onshore essential medicine manufacturing, India will likely remain an indispensable component of the U.S. drug supply chain, but Indian manufacturers should prepare for stricter compliance checks, says Jashaswi Ghosh at Holon Law Partners.
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Series
Law School's Missed Lessons: Skillful Persuasion
In many ways, law school teaches us how to argue, but when the ultimate goal is to get your client what they want, being persuasive through preparation and humility is the more likely key to success, says Michael Friedland at Friedland Cianfrani.
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FCA Working Group Reboot Signals EHR Compliance Risk
The revival of the False Claims Act working group is an aggressive expansion of enforcement efforts by the Justice Department and the U.S. Department of Health and Human Services targeted toward technology-enabled fraud involving electronic health records and other data, say attorneys at ArentFox Schiff.
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Litigation Inspiration: How To Respond After A Loss
Every litigator loses a case now and then, and the sting of that loss can become a medicine that strengthens or a poison that corrodes, depending on how the attorney responds, says Bennett Rawicki at Hilgers Graben.
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While On Firmer Ground, Uncertainty Remains For SEC's ALJs
The U.S. District Court for the District of Columbia's recent opinion in Lemelson v. U.S. Securities and Exchange Commission affirmed the legitimacy of the SEC's administrative proceedings, but pointedly left unanswered the constitutional merits of tenure protection enjoyed by SEC administrative law judges — potentially the subject of future U.S. Supreme Court review, says Dean Conway at Carlton Fields.
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FDA's Hasty Policymaking Approach Faces APA Challenges
Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.
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Legal Considerations Around Ibogaine As Addiction Therapy
Recent funding approval in Texas pertaining to the use of ibogaine for the potential treatment of substance use disorders signals a growing openness to innovative addiction treatments, but also underscores the need for rigorous compliance with state and federal requirements and ethical research standards, say attorneys at Husch Blackwell.
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How Patent Attys Can Carefully Integrate LLMs Into Workflows
With artificial intelligence-powered tools now being developed specifically for the intellectual property domain, patent practitioners should monitor evolving considerations to ensure that their capabilities are enhanced — rather than diminished — by these resources, say attorneys at McDonnell Boehnen.
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The Metamorphosis Of The Major Questions Doctrine
The so-called major questions doctrine arose as a counterweight to Chevron deference over the past few decades, but invocations of the doctrine have persisted in the year since Chevron was overturned, suggesting it still has a role to play in reining in agency overreach, say attorneys at Crowell & Moring.
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New PTAB Denial Processes Grow More And More Confusing
Guidance from the U.S. Patent and Trademark Office about the Patent Trial and Appeal Board's new workload management and discretionary denial processes has been murky and inconsistent, and has been further muddled by the acting director's seemingly contradictory decisions, say attorneys at Finnegan.
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Arguing The 8th Amendment For Reduction In FCA Penalties
While False Claims Act decisions lack consistency in how high the judgment-to-damages ratio in such cases can be before it becomes unconstitutional, defense counsel should cite the Eighth Amendment's excessive fines clause in pre-trial settlement negotiations, and seek penalty decreases in post-judgment motions and on appeal, says Scott Grubman at Chilivis Grubman.