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Life Sciences
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September 19, 2025
PTAB Invalidates Johns Hopkins Patent In Keytruda Fight
The Patent Trial and Appeal Board has invalidated an anti-cancer therapy patent owned by Johns Hopkins University, handing a win to challenger Merck Sharp & Dohme LLC in a larger fight relating to Merck's Keytruda treatment.
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September 19, 2025
DA In Gilgo Beach Killings Case Talks Advances In DNA Use
Law360 sat down with Suffolk County, New York, District Attorney Ray Tierney, who is prosecuting architect Rex Heuermann on charges that he murdered seven women on Long Island, to discuss the use of a newer form of DNA testing that has passed rigorous admissibility standards for the first time, among other aspects of the case.
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September 19, 2025
Moderna Wants Fed. Circ. Reversal Of Vax Patent Invalidation
Moderna has told the Federal Circuit that the Patent Trial and Appeal Board got it wrong when it found that the success of the inventions behind two of its COVID-19 vaccine patents challenged by Pfizer and BioNTech didn't outweigh the evidence they were invalid as obvious.
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September 19, 2025
Rite Aid Gets OK To Seek Votes On Dual-Track Ch. 11 Plan
A New Jersey bankruptcy judge on Friday approved drugstore chain Rite Aid's bid to take votes on a Chapter 11 plan as the debtor weighs whether to complete a deal with McKesson Corp. or formally seek to dismiss its bankruptcy case.
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September 19, 2025
CDC Panel Urges Caution On COVID Vax, Punts On Hep B
A panel of advisers at the Centers for Disease Control and Prevention on Friday voted unanimously to recommend that people receiving the COVID-19 vaccine this season do so only after discussing it with their health providers.
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September 18, 2025
Federal Vaccine Panel Votes To Tweak MMRV Recommendation
A panel of federal vaccine advisers on Thursday changed its recommendation for a long-used vaccine for children but allowed a key government program to continue paying for the shots.
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September 18, 2025
Cytokinetics Investor Sues Over Heart Drug Approval Claims
Biopharmaceutical company Cytokinetics and its CEO have been hit with a proposed investor class action in California federal court alleging they made false and misleading statements about the regulatory timeline for one of the company's new drugs, which caused a share price drop when the truth came to light.
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September 18, 2025
Brothers Blame Associate For $90M HIV Drug Fraud Scheme
Two Maryland brothers accused of selling $90 million worth of mislabeled HIV drugs told a Florida federal jury on Thursday that their charges stem from an associate hired for his pharmaceutical industry connections, but who instead lied about the medication's black market origins and told them it was purchased legitimately.
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September 18, 2025
HHS Shutters Miami Organ Donor Org. For 'Unsafe' Practices
Federal health officials have decertified a Miami-based organ procurement organization that arranges organ donations after an investigation found a pattern of "unsafe" practices, marking the first time the federal government has revoked the certification of such a group, according to an announcement Thursday from Health Secretary Robert F. Kennedy Jr.
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September 18, 2025
Senate Confirms Squires To Lead USPTO
The U.S. Senate on Thursday confirmed Dilworth Paxson LLP partner John Squires to serve as the next U.S. Patent and Trademark Office director.
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September 18, 2025
Senate Confirms Trump's Pick To Lead DOL Benefits Arm
The Senate confirmed fiduciary liability insurance expert Daniel Aronowitz on Thursday to lead the U.S. Department of Labor's employee benefits division, which oversees regulation and enforcement of employer-provided health and retirement plans.
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September 18, 2025
Steptoe Adds Jones Day Biotech Patent Pro To NY Office
Steptoe LLP has bolstered its intellectual property practice with an attorney arriving from Jones Day with multinational experience advising biotech and biopharmaceutical companies on patent issues.
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September 18, 2025
Colibri Wants Full Fed. Circ. To Rethink Medtronic Patent Case
Colibri Heart Valve LLC wants the full Federal Circuit to review a panel's ruling overturning a patent infringement judgment of more than $125 million against Medtronic's CoreValve unit, saying the panel wrongly applied a reading of the law that is too broad.
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September 18, 2025
NJ City Makes 3rd Escape From Pot Co.'s Zoning Suit
For the third time, a New Jersey federal judge has dismissed claims from a would-be cannabis dispensary alleging the city of Asbury Park and its zoning board conspired to deny its application for a medical marijuana store.
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September 18, 2025
Dorsey & Whitney IP Atty Joins Foley Hoag In Denver
Foley Hoag LLP announced the addition of its first intellectual property partner in the West with the hire of a longtime Dorsey & Whitney LLP attorney in its fast-growing Denver office.
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September 18, 2025
Montreal-Based Corp. Atty Moves To Akerman's NY Office
Akerman LLP has announced that a former Quebec-based partner at the Canadian business law firm Davies Ward Phillips & Vineberg LLP is returning to New York to join its corporate practice group.
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September 18, 2025
Japanese Glycine Exporter Hit With 86% Antidumping Duty
The U.S. Department of Commerce issued a notice Thursday indicating a Japanese supplier of glycine faces a more than 86% antidumping duty rate, saying the company failed to cooperate with the federal government's investigation.
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September 18, 2025
Group Of US Investors To Buy TikTok, Plus More Rumors
A consortium of big-name buyers including Oracle, Silver Lake and Andreessen Horowitz are rumored to be taking a majority stake in TikTok after a long search to find the app a U.S. owner; Paramount Skydance is reportedly ready to make an offer for Warner Bros. Discovery; and private equity shop CVC is close to inking a $1.5 billion deal to acquire web-hosting provider Namecheap. Here, Law360 breaks down these and other deal rumors from the past week.
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September 18, 2025
Valitic Soap Is Unapproved Drug, Class Of Buyers Claims
A proposed class of soap buyers is suing the maker of Valitic soap in New York federal court, alleging that it is an illegal drug as it claims to be able to treat dark spots, acne and other skin conditions without U.S. Food and Drug Administration approval.
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September 17, 2025
J&J Whistleblowers Defend $1.6B False Claims Act Win
Whistleblowers filed a brief Wednesday in the Third Circuit in a closely watched False Claims Act appeal involving a $1.6 billion judgment against Johnson & Johnson unit Janssen as well as the constitutionality of the FCA's "qui tam" whistleblower provisions, arguing that the act's lawfulness has been settled by its "unbroken 162-year history."
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September 17, 2025
Chancery Mulls Limited Discovery In $8.7B Cerevel Sale Suit
A Delaware vice chancellor said Wednesday he is considering denial of a motion to dismiss as well as limited plaintiff discovery in a suit accusing Cerevel Therapeutics Holdings Inc. insiders of lining up a secondary stock sale ahead of the biopharma's disclosure of a proposed $8.7 billion sale to AbbVie.
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September 17, 2025
FDA Says Vape Manufacturer Lying About Marketing Approval
The U.S. Food and Drug Administration on Tuesday sued manufacturers of flavored vapes in New Jersey federal court to seek an end to their sales, saying that they are falsely representing that their products had received marketing approval.
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September 17, 2025
Don Jr.-Backed Patent Co. Hires Nokia Licensing Exec
SIM IP, the newest venture by high-profile patent monetizer Erich Spangenberg, has brought on Nokia's chief licensing officer to serve as managing director.
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September 17, 2025
Missouri AG Can Seek Unredacted Trans Care Records
The Missouri attorney general can demand that a hospital turn over unredacted records on patients getting transgender care as part of a probe of a whistleblower complaint, a state appeals court held Tuesday.
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September 17, 2025
Ex-CDC Head Says RFK Jr. Urged Vax Schedule Rubber Stamp
Susan Monarez, the former head of the Centers for Disease Control and Prevention, told federal lawmakers on Wednesday she was abruptly fired just weeks into her tenure for "holding the line on scientific integrity."
Expert Analysis
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What EU 'Killer Acquisition' Study Means For Pharma Deals
The European Commission’s recent study of pharmaceutical companies' acquisitions of emerging competitive threats, the first of its kind globally, has important implications for the industry, and may lead to increased awareness of merger control risks in collaborative agreements, say lawyers at Paul Weiss.
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Legal Risks For Providers Discussing Psychedelic Therapies
The emergence of psychedelic therapies as potential treatments for mental health conditions and other ailments continues to garner significant attention, but the legal landscape surrounding discussions and referrals remains fraught with complexity, creating potential risks for healthcare providers and institutions, says Kimberly Chew at Husch Blackwell.
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Series
Law School's Missed Lessons: Becoming A Firmwide MVP
Though lawyers don't have a neat metric like baseball players for measuring the value they contribute to their organizations, the sooner new attorneys learn skills frequently skipped in law school — like networking, marketing, client development and case evaluation — the more valuable, and less replaceable, they will be, says Alex Barnett at DiCello Levitt.
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Trade Secrets Would Likely See Court Protection From GenAI
The advent of generative artificial intelligence has given rise to debate about how this technology will affect intellectual property rights and trade secret protections in particular, but courts to date have protected owners when technological advances have facilitated new means for trade secret theft, say attorneys at Kilpatrick Townsend.
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A Breakdown Of Trump's Order On Drug Pricing
The Trump administration may attempt to effectuate through rulemaking a recently issued executive order on lowering drug prices, which would likely have an adverse effect on stakeholders and trigger litigation, say attorneys at Debevoise.
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Cosmetic Co. Considerations As More States Target PFAS
In the first quarter of the year, seven states introduced or passed legislation focused on banning the sale of cosmetics that contain PFAS, making it necessary for businesses to adjust their product testing and supply chain practices, product formulations, marketing strategies, and more, say attorneys at Alston & Bird.
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Del. Bill Reflects Nat'l Tug-Of-War Between Cannabis, Alcohol
As Delaware's bill targeting hemp-derived THC beverages and ingestible products moves through the general assembly, it reads like a local regulatory fix — but in reality, it's a microcosm of a national power struggle playing out state-by-state across the cannabis frontier, says attorney Peter Murphy.
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$38M Law Firm Settlement Highlights 'Unworthy Client' Perils
A recent settlement of claims against law firm Eckert Seamans for allegedly abetting a Ponzi scheme underscores the continuing threat of clients who seek to exploit their lawyers in perpetrating fraud, and the critical importance of preemptive measures to avoid these clients, say attorneys at Lockton Companies.
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Maintaining Legal Compliance For GenAI In Life Sciences
As companies continue to implement generative artificial intelligence to enhance all phases of drug discovery, they must remain mindful of legal, regulatory and practical considerations as best practices in this space emerge and evolve, say attorneys at Sullivan & Cromwell.
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Trending At The PTAB: The Influence Of Litigation Arguments
Recent decisions from the Patent Trial and Appeal Board shed light on the varying extent to which the board considers patent owners' district court arguments, particularly with respect to the meaning of claim terms, say attorneys at Finnegan.
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Series
Teaching Business Law Makes Me A Better Lawyer
Teaching business law to college students has rekindled my sense of purpose as a lawyer — I am more mindful of the importance of the rule of law and the benefits of our common law system, which helps me maintain a clearer perspective on work, says David Feldman at Feldman Legal Advisors.
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Deregulation Memo Presents Risks, Opportunities For Cos.
A recent Trump administration memo providing direction to agencies tasked with rescinding regulations under an earlier executive order — without undergoing the typical notice-and-review process — will likely create much uncertainty for businesses, though they may be able to engage with agencies to shape the regulatory agenda, say attorneys at Blank Rome.
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Series
Law School's Missed Lessons: Mastering Discovery
The discovery process and the rules that govern it are often absent from law school curricula, but developing a solid grasp of the particulars can give any new attorney a leg up in their practice, says Jordan Davies at Knowles Gallant.
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Maneuvering The Weeds Of Cannabis Vertical Integration
The conversation around vertical integration has taken on new urgency as the cannabis market expands, despite federal reform remaining a distant dream, so the best strategy for cannabis operators is to approach vertical integration on a state-by-state basis, say attorneys at Sweetspot Brands.
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Opinion
The IRS Shouldn't Go To War Over Harvard's Tax Exemption
If the Internal Revenue Service revokes Harvard's tax-exempt status for violating established public policy — a position unsupported by currently available information — the precedent set by surviving the inevitable court challenge could undercut the autonomy and distinctiveness of the charitable sector, says Johnny Rex Buckles at Houston Law Center.