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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 $278MÂ 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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Enablement Standard Insights From Fed. Circ. Agilent Ruling
The Federal Circuit's recent enablement standard decision in Agilent v. Synthego underscores three critical takeaways for patent practitioners, including reaffirmation that the enablement inquiry under Section 102 of the Patent Act is distinct from the inquiry under Section 112, say attorneys at MoFo.
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Series
Teaching Trial Advocacy Makes Us Better Lawyers
Teaching trial advocacy skills to other lawyers makes us better litigators because it makes us question our default methods, connect to young attorneys with new perspectives and focus on the needs of the real people at the heart of every trial, say Reuben Guttman, Veronica Finkelstein and Joleen Youngers.
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The Crucial Question Left Unanswered In EpicentRx Decision
The California Supreme Court recently issued its long-awaited decision in EpicentRx Inc. v. Superior Court, resolving a dispute regarding the enforceability of forum selection clauses, but the question remains whether private companies can trust that courts will continue to consistently enforce forum selection clauses in corporate charters, says John Yow at Yow PC.
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Federal AI Action Plan Marks A Shift For Health And Bio Fields
The Trump administration's recent artificial intelligence action plan significantly expands federal commitments across biomedical agencies, defining a pivotal moment for attorneys and others involved in research collaborations, managing regulatory compliance and AI-related intellectual property, says Mehrin Masud-Elias at Arnold & Porter.
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Preparing For DEA Rescheduling Of 2 Research Chemicals
A recent decision to allow the U.S. Drug Enforcement Administration to reclassify two research psychedelics in Schedule I under the Controlled Substances Act may pose significant barriers to scientific study, including stringent registration requirements, heightened security protocols and burdensome reporting obligations, say Kimberly Chew at Husch Blackwell and Jackie von Salm at Psilera.
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Why EpicentRx Ruling Is A Major Win For Business Certainty
The California Supreme Court's recent decision in EpicentRx v. Superior Court removes a significant source of uncertainty that plagued commercial litigation in California by clarifying that forum selection clauses shouldn't be invalidated solely because the selected forum lacks the right to a jury trial, say attorneys at Clark Hill.
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A Change In Big Pharma Response To FTC Delisting Warnings
While the effect of Federal Trade Commission notices to pharmaceutical companies about allegedly improper patent listings in the U.S. Food and Drug Administration's Orange Book had been de minimis through the end of last year, July data shows an increase in delistings, say Ratib Ali and Celia Lu at Competition Dynamics.
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As Product Recalls Rise, So Do The Stakes For The Bar
Recent recall announcements affecting over 800,000 Ford vehicles highlight how product recalls have become more frequent, complex and safety-critical than ever, raising key practice questions for counsel, and raising the stakes in product liability litigation, says Ken Fulginiti at Fulginiti Law.
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Series
Adapting To Private Practice: From Texas AUSA To BigLaw
As I learned when I transitioned from an assistant U.S. attorney to a BigLaw partner, the move from government to private practice is not without its hurdles, but it offers immense potential for growth and the opportunity to use highly transferable skills developed in public service, says Jeffery Vaden at Bracewell.
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Data Undermines USPTO's 'Settled Expectations' Doctrine
An analysis of inter partes review proceedings filed since 2012 appears to refute the U.S. Patent and Trademark Office's recent stance that patent owners develop a strong settled expectation that their patents will not be challenged after being in force for six years, say Jonathan DeFosse and Samuel Smith at Sheppard Mullin, and Kenzo Kasai at NGB Corp.
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Advice For 1st-Gen Lawyers Entering The Legal Profession
Nikki Hurtado at The Ferraro Law Firm tells her story of being a first-generation lawyer and how others who begin their professional journeys without the benefit of playbooks handed down by relatives can turn this disadvantage into their greatest strength.
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High Court E-Cig Ruling Opens Door For FDA Challenges
There will likely be more challenges to marketing denial orders brought before the Fifth Circuit following the Supreme Court's recent ruling in U.S. Food and Drug Administration v. R.J. Reynolds Vapor Co., where litigants have generally had greater success, say attorneys at Troutman Pepper.
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Fed. Circ. In July: Instability In IPR Requirements
The Federal Circuit's decision in Shockwave v. Cardiovascular last month provided an important, albeit short-lived, clarification to the type of evidence that can be used in an inter partes review challenge, say attorneys at Knobbe Martens.
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Structuring Noncompetes In License And Collaboration Deals
As companies grappling with coming patent cliffs look to mergers and acquisitions to compensate, contracting parties assessing biopharma license and collaboration agreements should prepare to agree on noncompetes that ensure the parties' respective objectives are met and that their incentives are aligned, both under their collaboration and beyond, says Jeff Jay at Freshfields.
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Series
Coaching Cheerleading Makes Me A Better Lawyer
At first glance, cheerleading and litigation may seem like worlds apart, but both require precision, adaptability, leadership and the ability to stay composed under pressure — all of which have sharpened how I approach my work in the emotionally complex world of mass torts and personal injury, says Rashanda Bruce at Robins Kaplan.