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Life Sciences
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October 29, 2025
Where PTAB Institution Reviews Stand As Squires Takes Lead
U.S. Patent and Trademark Office Director John Squires will be maintaining the agency leader's new role of gatekeeper at the Patent Trial and Appeal Board. Here's what to know about his plans and the pushback on them.
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October 29, 2025
Taro Pharma Beats Investor Suit Over $43-Per-Share Buyout
A New York federal judge tossed a proposed class action brought by minority shareholders of Taro Pharmaceutical Industries Ltd. that alleged the company and its majority shareholder misled them during the approval process for a $43-per-share buyout, finding the minority shareholders have failed to plead any actionable misstatements or omissions.
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October 29, 2025
Ga. Panel Backs Sanctions For 'Delaying Tactic' In Weed Spat
The Georgia Court of Appeals on Wednesday backed sanctions rulings against two companies that filed a slew of litigation after they were denied cannabis licenses by Georgia, only to draw out the proceedings for years before dropping their claims at "quite literally the last minute."
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October 29, 2025
FDA Unveils Plan To Speed Biosimilar Drugs To Market
The Trump administration on Wednesday said it plans to slash the cost of biologics by shortening the time required to bring a biosimilar drug to market and making it easier for patients to switch to the cheaper products.
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October 29, 2025
3 Pharmaceutical Firms Will Pay $4M To Tribes In Opioid MDL
Indivior, Sun Pharmaceuticals and Zydus Pharmaceuticals have inked deals to compensate tribes for their role in the opioid crisis, according to stipulated dismissals entered on Wednesday in Ohio federal court.
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October 29, 2025
BREAKING: Brothers Found Guilty Of $100M HIV Drug Fraud
A Florida federal jury on Wednesday convicted two Maryland brothers accused of conspiring to distribute about $100 million worth of misbranded HIV drugs, finding them guilty of fraud charges related to selling the medication with fake tracing documents.
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October 29, 2025
PE-Backed Medical Supplies Giant Medline Files For IPO
Private equity-backed medical supplies giant Medline has filed for its long-awaited initial public offering, eyeing a return to public markets four years after being taken private through a large buyout.
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October 29, 2025
'Smart Drugs' Amphetamine Suit Moves Forward Minus Execs
A Washington federal judge declined to trim claims from a former army nurse's suit alleging that Thesis "smart drugs" contained amphetamines without warning consumers, while dismissing her claims against two executives for the company.
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October 29, 2025
3 Firms Guide Thermo Fisher On $8.9B Clario Deal
Thermo Fisher Scientific Inc. said Wednesday it will acquire Clario Holdings Inc., a provider of endpoint data solutions for clinical trials, from a shareholder group led by Astorg and Nordic Capital, Novo Holdings and Cinven, for $8.875 billion in cash.
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October 28, 2025
Off-Label Prescribing Was Common, Novo Nordisk Tells Jury
A whistleblower suing drugmaker Novo Nordisk for allegedly defrauding Washington state's Medicaid system acknowledged from the witness stand Tuesday that she previously prescribed hemophilia drugs for off-label use in her own practice — despite concerns she raised in her lawsuit about other doctors' off-label prescription of Novo Nordisk's drug NovoSeven.
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October 28, 2025
Apple Spared From Some Masimo Patent Claims Before Trial
A California federal judge issued a mixed ruling in Masimo's case claiming Apple infringed its patents covering pulse oximetry technology for smartwatches, dismissing certain infringement theories but preserving other parts of the case for next week's trial.
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October 28, 2025
Perceptive Asks Chancery To Block Kindbody Ex-CEO's NY Suit
Attorneys for senior lenders to nationwide fertility clinic chain Kindbody Inc. told a Delaware vice chancellor Tuesday that amendments to a former CEO's suit against the company's controlling lenders and directors in New York triggered a right to pull the dispute into Delaware's Court of Chancery.
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October 28, 2025
Trump Admin Ordered To Halt Some Shutdown-Linked Layoffs
A California federal judge on Tuesday granted a preliminary injunction to eight unions for federal workers who lost their jobs during the government shutdown, saying they were likely to succeed on their claims that the Trump administration's actions were "political retribution" and unlawful.
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October 28, 2025
Bias Claims From Worker Who Failed Drug Test Can Proceed
A Pennsylvania federal judge narrowed, but didn't throw out, a disability bias suit from a hospital worker who said he was fired after failing a drug test because he took cannabidiol gummies for a spinal condition, saying a reasonable jury might conclude his disability earned him harsher treatment.
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October 28, 2025
Activists Drop Challenge To FDA Inaction On Menthol Cigs
A lawsuit accusing the U.S. Food and Drug Administration of slow-walking the Biden administration's proposed ban of menthol cigarettes was voluntarily dismissed, months after the Trump administration withdrew the ban entirely.
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October 28, 2025
J&J Hit With $20M Verdict In Fla. Talc Trial
A Florida jury on Tuesday awarded $20 million to the widow of a nephrologist who used Johnson & Johnson talcum powder for 50 years and died of mesothelioma, after a plaintiffs lawyer argued the company broke its "promise of purity."
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October 28, 2025
Exactech Gets Another $19M In DIP Funds Ahead Of Sale
Joint implant maker Exactech Inc. received a Delaware bankruptcy judge's permission Tuesday to borrow an additional $19.1 million in its Chapter 11 case as the company works to complete an asset sale by the end of the week.
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October 28, 2025
Ex-Philips CEO Can't Undo Finding He Misled Shareholders
A Brooklyn federal judge will not reverse a finding that a former CEO of health technology company Koninklijke Philips NV misled shareholders about the safety and compliance of a subsidiary's sleep and respiratory care products.
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October 28, 2025
Akin Beats Malpractice Claim Over Alleged IP Theft Plot
A Third Circuit panel on Tuesday refused to revive a malpractice claim against Akin Gump Strauss Hauer & Feld LLP lodged in a lawsuit that accused attorneys of manipulating patent litigation to steal a former Cornell University graduate student's DNA sequencing intellectual property.
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October 28, 2025
4th Circ. Overturns Landmark W.Va. Opioid Verdict
The Fourth Circuit on Tuesday overturned a key ruling by a West Virginia judge in the first federal bellwether in multidistrict opioid litigation that went in favor of the country's three biggest drug distributors, finding that the oversupply of opioids can create a public nuisance.
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October 28, 2025
Greenberg Traurig Adds Faegre Drinker Mass Tort Pro In NJ
Greenberg Traurig LLP added to its products liability and pharmaceutical practices in New Jersey this week with the addition of a litigator and trial attorney from Faegre Drinker Biddle & Reath LLP who specializes in complex mass tort cases.
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October 28, 2025
Texas Accuses Tylenol Makers Of Hiding Autism Danger
The Texas Attorney General's Office on Tuesday sued the makers of Tylenol, alleging they hid the risk that the drug could lead to autism while marketing acetaminophen as the safest pain relief option for pregnant women and young children.
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October 27, 2025
Whistleblower 'Horrified' By Novo Nordisk Drug Sales Tactics
The whistleblower behind a federal lawsuit accusing Novo Nordisk of paying kickbacks to doctors and patients as part of a scheme to drive sales of its hemophilia drug NovoSeven took the witness stand Monday, telling jurors she was "horrified" at how the drugmaker's marketing team targeted doctors.
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October 27, 2025
Bros. Had No Fraud Intent In HIV Drug Scam, Fla. Jury Told
Two Maryland brothers accused of orchestrating a roughly $100 million misbranded HIV drug scheme told a Florida federal jury Monday they had no intent to defraud, saying they were deceived by a co-conspirator who they made a partner in their company.
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October 27, 2025
Teva To Pay $35M In Suit Over Delayed Generic Inhalers
Teva Pharmaceuticals will pay $35 million to resolve claims from a coalition of union healthcare funds that say the company schemed to delay generic competition for its QVAR asthma inhalers, according to a motion for preliminary injunction filed in Massachusetts federal court.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Broader Eligibility For AI-Related Patents May Be Coming
A series of recent developments from the U.S. Patent and Trademark Office appears to signal that claims involving improvement in the operation of a machine learning model are now more likely to be considered patent-eligible, and that patent examiners may focus on questions of novelty and nonobviousness and less so on subject matter eligibility, say attorneys at Kilpatrick.
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Series
The Biz Court Digest: Texas, One Year In
A year after the Texas Business Court's first decision, it's clear that Texas didn't just copy Delaware and instead built something uniquely its own, combining specialization with constitutional accountability and creating a model that looks forward without losing touch with the state's democratic and statutory roots, says Chris Bankler at Jackson Walker.
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AI Product Safety Insights May Expand Foreseeability
Product liability law has long held that companies are responsible for risks they knew about or should have known about — and with AI systems now able to assess and predict hazards during the design process, companies should expect that courts will likely treat such hazards as foreseeable, says Donald Fountain at Clark Fountain.
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Series
Law School's Missed Lessons: Educating Your Community
Nearly two decades prosecuting scammers and elder fraud taught me that proactively educating the public about the risks they face and the rights they possess is essential to building trust within our communities, empowering otherwise vulnerable citizens and preventing wrongdoers from gaining a foothold, says Roger Handberg at GrayRobinson.
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Organ Transplant System Reforms Mark Regulatory Overhaul
Recent oversight, enforcement and operational developments in the U.S. organ procurement and transplantation system, alongside challenges like the federal shutdown, highlight heightened regulatory scrutiny and the need for compliance to maintain public trust, say attorneys at Hall Render.
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Adapting To USPTO's Reduction Of Examiner Interview Time
Reported changes to the U.S. Patent and Trademark Office's examiner performance appraisal plan will likely make interviews scarcer throughout the application process, potentially influencing patent allowance rates and increasing the importance of approaching each interview with a clear agenda and well-defined goals, say attorneys at Polsinelli.
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Federal Grantees May Soon Face More Limitations On Speech
If courts accept the administration’s new interpretation of preexisting case law, which attempts to graft onto grant recipients the existing limitations on government contractors' free speech, a more deferential standard may soon apply in determining whether an agency’s refusal or termination of a grant was in violation of the First Amendment, say attorneys at Venable.
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5 Crisis Lawyering Skills For An Age Of Uncertainty
As attorneys increasingly face unprecedented and pervasive situations — from prosecutions of law enforcement officials to executive orders targeting law firms — they must develop several essential competencies of effective crisis lawyering, says Ray Brescia at Albany Law School.
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Anticipating FTC's Shift On Unfair Competition Enforcement
As the Federal Trade Commission signals that it will continue to challenge unfair or deceptive acts and practices under Section 5 of the FTC Act, but with higher evidentiary standards, attorneys counseling healthcare, technology, energy or pharmaceuticals clients should note several practice tips, says Thomas Stratmann at George Mason University.
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Insights From Recent Cases On Navigating Snap Removal
Snap removal, which allows defendants to transfer state court cases to federal court before a forum defendant is properly joined and served, is viewed differently across federal circuits — but keys to making it work can be drawn from recent decisions critiquing the practice, say attorneys at Perkins Coie.
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Opinion
It's Time For The Judiciary To Fix Its Cybersecurity Problem
After recent reports that hackers have once again infiltrated federal courts’ electronic case management systems, the judiciary should strengthen its cybersecurity practices in line with executive branch standards, outlining clear roles and responsibilities for execution, says Ilona Cohen at HackerOne.
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Series
Writing Novels Makes Me A Better Lawyer
Writing my debut novel taught me to appreciate the value of critique and to never give up, no matter how long or tedious the journey, providing me with valuable skills that I now emphasize in my practice, says Daniel Buzzetta at BakerHostetler.
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SDNY OpenAI Order Clarifies Preservation Standards For AI
The Southern District of New York’s recent order in the OpenAI copyright infringement litigation, denying discovery of The New York Times' artificial intelligence technology use, clarifies that traditional preservation benchmarks apply to AI content, relieving organizations from using a “keep everything” approach, says Philip Favro at Favro Law.
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What 9th Circ.'s Rosenwald Ruling Means For Class Actions
The Ninth Circuit's recent decision in Rosenwald v. Kimberly-Clark has important implications around the Class Action Fairness Act and traditional diversity jurisdiction — both for plaintiff-side and defense-side class action litigators — and deepens the circuit split concerning the use of judicial notice to establish diversity, says Grace Schmidt at DTO Law.
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Trends In Post-Grant Practice Since USPTO Denial Guidance
Six months after the U.S. Patent and Trademark Office updated its guidance on discretionary denial of inter partes review and post-grant review, noteworthy trends in denial statistics have emerged, warranting a reassessment of strategies for parallel proceedings, says Andrew Ramos at Bayes.