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Life Sciences
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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.
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September 15, 2025
Exactech Gets OK For Ch. 11 Plan Ditching Sponsor Deal
A Delaware bankruptcy judge on Monday approved Exactech's Chapter 11 sale and liquidation plan that drops a previous deal with the joint implant maker's equity sponsor in favor of funding the pursuit of potential legal claims against the sponsor on behalf of creditors.
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September 15, 2025
Novartis, Monte Rosa Ink Up To $5.7B 'Molecular Glue' Deal
Novartis is placing a potential $5.7 billion bet on Monte Rosa Therapeutics, a clinical-stage biotech company, to develop new treatments for immune-related diseases, Monte Rosa said on Monday.Â
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September 12, 2025
Ex-Investor Relations Exec Gets 15 Months For Inside Trades
A former managing director for LifeSci Advisors LLC was sentenced to 15 months in prison on Friday for passing confidential information about several of the investor relations firm's clients to two friends who used it to make over $500,000 in illicit profits.
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September 12, 2025
AbbVie Can't Halt Miss. Discount Drug Law, 5th Circ. Says
AbbVie and other pharmaceutical manufacturers that participate in Medicaid cannot preliminarily block a Mississippi law barring their interference with the distribution of discounted prescriptions to pharmacies serving low-income patients, the Fifth Circuit ruled Friday, saying the drugmakers haven't shown that the statute likely effectuates a taking of their property.
Expert Analysis
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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.
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7 Ways To Fetch Patents In The World Of Working Animals
Though developers rarely file patents related to working animals, and animal training techniques are generally considered unpatentable, certain aspects of training and developing animals may be ripe for patent protection, say Matthew Avery at Baker Botts, Makenzi Galvan at Perkins Coie and Lute Yang at Orrick.
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9th Circ.'s Kickback Ruling Strengthens A Prosecutorial Tool
The Ninth Circuit's decision last month in U.S. v. Schena, interpreting the Eliminating Kickbacks in Recovery Act to prohibit kickback conduct between the principal and individuals who do not directly interact with patients, serves as a wake-up call to the booming clinical laboratory testing industry, say attorneys at Kendall Brill.
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Series
Law School's Missed Lessons: How To Make A Deal
Preparing lawyers for the nuances of a transactional practice is not a strong suit for most law schools, but, in practice, there are six principles that can help young M&A lawyers become seasoned, trusted deal advisers, says Chuck Morton at Venable.
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From Clerkship To Law Firm: 5 Transition Tips For Associates
Excerpt from
Transitioning from a judicial clerkship to an associate position at a law firm may seem daunting, but by using knowledge gained while clerking, being mindful of key differences and taking advantage of professional development opportunities, these attorneys can flourish in private practice, say attorneys at Lowenstein Sandler.
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9th Circ.'s Trade Secrets Ruling Is A Win For DTSA Plaintiffs
The Ninth Circuit's recent decision in Quintara v. Ruifeng shifts the balance in federal trade secret litigation toward a more flexible, discovery-driven process, meaning that plaintiffs may be more likely to pursue claims under the Defend Trade Secrets Act, and early motions to strike or dismiss will face steep odds, say attorneys at Cooley.
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Associates Can Earn Credibility By Investing In Relationships
As the class of 2025 prepares to join law firms this fall, new associates must adapt to office dynamics and establish credible reputations — which require quiet, consistent relationship-building skills as much as legal acumen, says Kyle Forges at Bast Amron.
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Puzzling Out When Similar Insurance Claims Are Related
A recent decision in Virginia federal court shows that more than identical allegations of negligent business practices across two lawsuits may be necessary to satisfy the strict definition of relatedness under claims-made liability insurance policies, say attorneys at Hunton.
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A Shifting Trend In FDA Form 483 Disclosure Obligations
A New York federal court's Checkpoint Therapeutics decision extends a recent streak of dismissals of securities class actions alleging that pharmaceutical companies failed to disclose U.S. Food and Drug Administration Form 483 inspection reports, providing critical guidance for companies during the FDA approval process, say attorneys at Alston & Bird.
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Trending At The PTAB: IPR Memo And Its Fed. Circ. Backdrop
There are new rules for when and how evidence other than patents or printed publications can be considered in inter partes reviews, and while this change is intended to reflect current Federal Circuit precedent, the U.S. Patent and Trademark Office's memo seems to acknowledge tension with last month's Shockwave decision, say attorneys at Finnegan.