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Life Sciences
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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."
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September 17, 2025
Purdue Can Pay CEO Ch. 11 Bonus After Trimming Comp
A New York bankruptcy judge Wednesday approved a nearly $3 million incentive program for Purdue Pharma's chief executive after he agreed to reduce his total compensation by $500,000.
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September 16, 2025
Exactech Enters $8M Deal To Resolve Implant Failure Claims
Orthopedic implant-maker Exactech Inc. agreed to pay $8 million to resolve allegations it marketed and sold faulty components of its knee-replacement systems that were to be used on patients on Medicare, Medicaid and U.S. Department of Veterans Affairs assistance, federal prosecutors in Maryland and Alabama announced Tuesday.
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September 16, 2025
Merck Says Vaccine Case 'Poor Vehicle' For Antitrust Review
Merck & Co. told the U.S. Supreme Court to reject a bid from physicians looking to revive antitrust claims over submissions the pharmaceutical giant made to federal regulators concerning its mumps vaccine, arguing that the case is "an exceptionally poor vehicle" for review.
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September 16, 2025
BrainStorm Can't Shed Investors' ALS Treatment Trial Claims
Biopharmaceutical company BrainStorm Cell Therapeutics Inc. must face a proposed investor class alleging it misrepresented feedback from the U.S. Food and Drug Administration regarding clinical trials for an ALS product candidate that failed to get approval, though a Manhattan federal judge has tossed the suit's insider trading allegations and certain fraud claims.
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September 16, 2025
The Patent Workforce Is Attracting Fewer Attys, More Agents
The pool of patent practitioners registered with the U.S. Patent and Trademark Office has undergone a dramatic shift over the past few decades, with the number of attorneys taking the bar exam decreasing at the same time more patent agents are entering the field.
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September 16, 2025
Jazz Can't Escape Antitrust Claims Over Sleep Disorder IP
A Delaware federal judge has refused to let Jazz Pharmaceuticals dodge antitrust claims that it wrongly listed a patent covering a way to distribute a narcolepsy drug in the U.S. Food and Drug Administration's Orange Book.
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September 16, 2025
CVS Caremark Takes $290M Overbilling Judgment To 3rd Circ.
CVS's pharmacy benefits manager will appeal a judgment against the company that was recently increased from $95 million to $290 million in a suit alleging it overbilled Medicare Part D-sponsored drugs, according to a notice of appeal filed in Pennsylvania federal court.
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September 16, 2025
FTC Chair Pledges 'Action' Against Late Merger Fixes
Federal Trade Commission Chairman Andrew Ferguson vowed Tuesday to take unspecified "action" against tactics by merging companies to propose fixes only after antitrust enforcers bring a transaction challenge, a strategy he called "bad for the system."
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September 16, 2025
Jones Day Adds FDA Regulatory Expert As Of Counsel In DC
Jones Day on Tuesday announced the arrival of an attorney who brings over a decade of experience at the U.S. Food and Drug Administration advising on drug regulation.
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September 16, 2025
For Cahill Atty, Rare Disease Pro Bono Work Is Personal
John MacGregor of Cahill Gordon & Reindel LLP didn't have any experience in healthcare law before taking on a pro bono client that supports people with a rare form of epilepsy. MacGregor's son is one of them.
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September 16, 2025
VarmX Partners With Biotech CSL In Deal Worth Up To $2.2B
European life sciences venture capital firm EQT Life Sciences on Tuesday announced that its portfolio company VarmX, a Netherlands-based biotech, has entered into an exclusive option agreement to be bought by global biotech CSL in a deal worth up to $2.2 billion.
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September 15, 2025
Jazz Loses Bid To Block Avadel From Seeking Sleep Drug OK
Jazz Pharmaceuticals Inc. cannot block Avadel CNS Pharmaceuticals LLC from seeking U.S. Food and Drug Administration approval for its sleep disorder treatment, a Delaware federal judge ruled, saying the act of seeking FDA approval is not an infringing activity that can be enjoined.
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September 15, 2025
AbbVie Settles Rinvoq Litigation, Blocks Generics Until 2037
AbbVie Inc. has settled litigation with drug manufacturers, blocking generic versions of its immunosuppressant Rinvoq drug from the market for just over a decade and closing out litigation that accused generic-drug makers of infringing a slew of its patents.
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September 15, 2025
Ch. 11 Plan Faces Blowback From 23andMe Breach Claimants
More than 30,000 individuals who elected to pursue arbitration rather than sign on to a proposed class settlement over a data breach at 23andMe are urging a Missouri bankruptcy judge to reject the DNA testing company's notice of its reorganization plan, arguing that the disclosure provides misleading and inflated information about the company's agreement with these claimants.
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September 15, 2025
Bayer Urges 9th Circ. Not To Revive Tevra Flea, Tick Meds Suit
Bayer is urging the Ninth Circuit not to grant a new trial over claims that it locked up the market for pet flea and tick treatment, saying the only evidence that rival Tevra showed a jury at trial was "highly dubious."
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September 15, 2025
Ex-PTAB Leader Reflects On USPTO After Leaving Agency
One of the Patent Trial and Appeal Board's most senior judges has left the U.S. Patent and Trademark Office after more than 13 years, and soon after joining private practice she spoke with Law360 about her history at the agency and the current dynamics playing out at the office.
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September 15, 2025
Investor Says $16M Ouraring Fight Shouldn't Go To Finland
An early investor in the Oura health and fitness tracker is fighting Ouraring Inc.'s attempt to send his $16 million dispute to arbitration in Finland, saying there is no underlying agreement to arbitrate and his lawsuit should stay in California federal court.
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September 15, 2025
Stewart Says New Policies Seek Fairness For Patent Owners
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart said Monday the numerous changes to patent reviews she has implemented are intended to provide "more balance and fairness" for patent owners, and bring the reviews "back to how they were originally intended."
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September 15, 2025
Eli Lilly Fights $278M Drug Royalties Ruling At 9th Circ.
Eli Lilly urged the Ninth Circuit at a hearing on Monday to reverse a finding that it owes an Arizona company $278 million from insulin-brands sales under their royalty agreement, arguing it is off the hook because Eli Lilly only used that company's technology in manufacturing, not in the final product.
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September 15, 2025
Corcept Can't Escape Teva's Mifepristone Antitrust Suit
Corcept Therapeutics must face most of Teva Pharmaceuticals' lawsuit alleging it suppressed generic competition for its brand-name medication used to treat a rare cortisol disorder, a California federal judge ruled, saying the claims are not time-barred and Teva has adequately alleged unlawful monopolization.
Expert Analysis
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Discretionary Denial Rulings May Spur Calls For PTAB Reform
The U.S. Patent and Trademark Office's recent decision in iRhythm Technologies v. Welch Allyn, denying inter partes review based on the patent owner's settled expectations that the patent would not be challenged, could motivate patent holders to seek Patent Trial and Appeal Board reform to preserve patent quality without burdening owners, say attorneys at Dechert.
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Comparing New Neural Data Privacy Laws In 4 States
Although no federal law yet addresses neural privacy comprehensively, the combined effect of recent state laws in Colorado, California, Montana and Connecticut is already shaping the regulatory future, but a multistate compliance strategy has quickly become a gating item for those experimenting with neuro-enabled workplace tools, says Kristen Mathews at Cooley.
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Spinoff Transaction Considerations For Biotech M&A
Amid current market challenges, boards and management teams of biotech companies can consider several strategies for maximizing value should a spinoff opportunity arise, but not without significant advance planning and careful implementation, particularly in cases that might qualify as tax-free, say attorneys at Paul Hastings.
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Opinion
Senate's 41% Litigation Finance Tax Would Hurt Legal System
The Senate’s latest version of the Big Beautiful Bill Act would impose a 41% tax on the litigation finance industry, but the tax is totally disconnected from the concerns it purports to address, and it would set the country back to a time when small plaintiffs had little recourse against big defendants, says Anthony Sebok at Cardozo School of Law.
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Psychedelic Treatment Regs May Be At A Tipping Point
Recent scientific and public attention suggest that development of psychedelics as treatment for some conditions may be at a tipping point, which could bring on more rapid change and opportunities for stakeholders who may in the future benefit from greater access to safe and effective psychedelic medicines, say attorneys at King & Spalding.
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Tips For Litigating Apex Doctrine Disputes Amid Controversy
Litigants once took for granted that deposition requests of high-ranking corporate officers required a greater showing of need than for lower-level witnesses, but the apex doctrine has proven controversial in recent years, and fights over such depositions will be won by creative lawyers adapting their arguments to this particular moment, say attorneys at Hangley Aronchick.
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Series
Performing As A Clown Makes Me A Better Lawyer
To say that being a clown in the Macy’s Thanksgiving Day Parade has changed my legal career would truly be an understatement — by creating an opening to converse on a unique topic, it has allowed me to connect with clients, counsel and even judges on a deeper level, says Charles Tatelbaum at Tripp Scott.
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A Midyear Tuneup For Your Trade Secret Portfolio
Halfway through 2025, now is a good time for companies to thoroughly evaluate their trade secret portfolios and follow eight steps to reassess protection processes for confidential information, says Robert Jensen at Wolf Greenfield.
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Focusing On Fluoride: From FDA To Class Action
A class action filed two days after the U.S. Food and Drug Administration announced plans to remove ingestible fluoride prescription drug products for children from the market may be the tip of the iceberg in terms of the connection between government pronouncements on safety and their immediate use as evidence in lawsuits, says Rachel Turow at Skadden.
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Series
Law School's Missed Lessons: Rejecting Biz Dev Myths
Law schools don’t spend sufficient time dispelling certain myths that prevent young lawyers from exploring new business opportunities, but by dismissing these misguided beliefs, even an introverted first-year associate with a small network of contacts can find long-term success, says Ronald Levine at Herrick Feinstein.
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Move Beyond Surface-Level Edits To Master Legal Writing
Recent instances in which attorneys filed briefs containing artificial intelligence hallucinations offer a stark reminder that effective revision isn’t just about superficial details like grammar — it requires attorneys to critically engage with their writing and analyze their rhetorical choices, says Ivy Grey at WordRake.
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Observations On 5 Years Of Non-Notified CFIUS Inquiries
Since 2020, the Committee on Foreign Investment in the United States has identified and investigated covered cross-border transactions not formally notified to CFIUS, and a look at data from 50 non-notified matters during that time reveals the general dynamics of this enforcement function, say attorneys at Cooley.
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9th Circ. Has Muddied Waters Of Article III Pleading Standard
District courts in the Ninth Circuit continue to apply a defunct and especially forgiving pleading standard to questions of Article III standing, and the circuit court itself has only perpetuated this confusion — making it an attractive forum for disputes that have no rightful place in federal court, say attorneys at Gibson Dunn.
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An Underused Tariff Exemption For Medical Product Importers
Medical device importers may be able to reduce tariff exposure by leveraging an often-overlooked Nairobi Protocol duty exemption for products specially designed to benefit those with qualifying medical conditions, says Samuel Finkelstein at LMD Trade Law.
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Series
Competing In Modern Pentathlon Makes Me A Better Lawyer
Opening myself up to new experiences through competing in modern Olympic pentathlon has shrunk the appearance of my daily work annoyances and helps me improve my patience, manage crises better and remember that acquiring new skills requires working through your early mistakes, says attorney Mary Zoldak.