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Life Sciences
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October 30, 2025
Fed. Circ. Explains Rule While Upholding Merck PTAB Loss
The Federal Circuit sided with generics makers Thursday and upheld the Patent Trial and Appeal Board's invalidation of claims in two Merck KGaA patents on the blockbuster multiple sclerosis drug Mavenclad, while clarifying how to treat invalidity arguments that involve overlapping inventors.
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October 30, 2025
2nd Ex-Magellan Exec Avoids Jail Over Faulty Lead Tests
A second former Magellan Diagnostics executive ducked prison time Thursday for his role in an alleged scheme to hide a defect in the company's lead-testing devices ahead of its sale in 2016.
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October 30, 2025
Lawmakers Slam Value-Based Patent Fee Proposal
Six members of the U.S. House of Representatives wrote to U.S. Secretary of Commerce Howard Lutnick on Thursday expressing concern over the proposal to charge patent holders fees based on their patent's value, saying that will harm innovation and economic growth.
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October 30, 2025
J&J's Janssen Says 3rd Circ. Should Reverse $1.6B FCA Win
Johnson & Johnson's Janssen Products LP urged the Third Circuit to overturn a $1.6 billion False Claims Act judgment over two of its HIV drugs, arguing the district court allowed whistleblowers to prove fraud based solely on "off-label" marketing rather than any false claim actually submitted to the government.
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October 30, 2025
Generic-Drug Firms Want To Fast-Track Conn. Price Cap Fight
An industry group for generic and biosimilar pharmaceutical companies has asked a Connecticut federal judge to fast-track its lawsuit seeking to block the state's new drug price cap, claiming it will suffer "imminent harm" if the case is delayed.
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October 30, 2025
McCarter & English Used Doctrine As 'Whipsaw,' Panel Hears
A biotech company on Thursday urged a New Jersey appellate panel to revive its legal malpractice suit against McCarter & English LLP, arguing that the claims were distinct from the firm's own suit seeking unpaid fees.
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October 30, 2025
Mich. Top Court Upholds Gilead Immunity In COVID Drug Case
The Michigan Supreme Court on Wednesday said it won't consider an appeal from a man who was injected with a COVID-19 treatment made by Gilead Sciences Inc. that was later recalled for containing glass shards, a few months after a lower appellate court found the company immune because of a federal health emergency law.
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October 30, 2025
Judge Unpauses 'Important' Suit Over Vax Guidelines
A Massachusetts federal judge agreed Thursday to lift a government shutdown-related stay of litigation challenging new COVID-19 vaccine recommendations for children and pregnant women, calling the case a "matter of national importance" that warrants keeping the case moving over the U.S. Department of Justice's objection.
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October 30, 2025
Novo Nordisk Bids $9B For Metsera, Jeopardizing Pfizer Deal
Metsera Inc. said Thursday that Novo Nordisk has put forth a $9 billion buyout proposal that is "superior" to its existing agreement to sell itself to Pfizer, prompting a response from Pfizer stating that it is prepared to "pursue all legal avenues" to keep its agreement intact.
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October 29, 2025
DOJ Subpoena Called 'Pressure' To Ax Gender-Affirming Care
The U.S. Department of Justice issued a subpoena to intimidate a telehealth organization into ending gender-affirming medical care, a Seattle federal judge said in a ruling that found the agency is using the guise of an investigation to further the Trump administration's stated goal of eliminating transgender and gender-diverse patients' access to healthcare.
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October 29, 2025
DexCom Misled Investors About Its Diabetes Tech, Suit Says
Medical device maker DexCom is facing a proposed investor class action in Manhattan federal court alleging the company hurt shareholders by failing to disclose changes to a glucose monitoring device affecting the reliability of the device's readings.
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October 29, 2025
Conn. Med Spa Says Ex-Workers Poaching Clients, Employees
Two former employees of a Connecticut medical spa violated their employment contract when they lured a co-worker to join them at a nearby competitor and began soliciting the spa's clients, a state court lawsuit alleges.
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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 Pot Dispute
The Georgia Court of Appeals on Wednesday backed sanctions rulings against two companies that filed 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
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.Â
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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.Â
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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 on Wednesday it will acquire Clario Holdings Inc., a provider of endpoint data solutions for clinical trials, from a shareholder group led by Astorg, 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.
Expert Analysis
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Opinion
State AGs, Not Local Officials, Should Lead Public Litigation
Local governments’ public nuisance lawsuits can raise constitutional and jurisdictional challenges, reinforcing the principle that state attorneys general — not municipalities — are best positioned to litigate on behalf of citizens when it is warranted, says former Utah Attorney General John Swallow.
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3rd Circ. Clarifies Ch. 11 3rd-Party Liability Scope Post-Purdue
A recent Third Circuit decision that tort claims against the purchaser of a debtor's business belong to the debtor's bankruptcy estate reinvigorates the use of Chapter 11 for the resolution of nondebtor liability in mass tort bankruptcies following last year's U.S. Supreme Court ruling in Purdue Pharma, say attorneys at Sullivan & Cromwell.
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Texas Suit Marks Renewed Focus On Service Kickback Theory
After a dormant period at the federal level, a theory of kickback enforcement surrounding nurse educator programs and patient support services resurfaced with a recent state court complaint filed by Texas against Eli Lilly, highlighting for drugmakers the ever-changing nature of enforcement priorities and industry landscapes, say attorneys at Sheppard Mullin.
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Series
Power To The Paralegals: How And Why Training Must Evolve
Empowering paralegals through new models of education that emphasize digital fluency, interdisciplinary collaboration and human-centered lawyering could help solve workforce challenges and the justice gap — if firms, educators and policymakers get on board, say Kristine Custodio Suero and Kelli Radnothy.
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Series
Playing Softball Makes Me A Better Lawyer
My time on the softball field has taught me lessons that also apply to success in legal work — on effective preparation, flexibility, communication and teamwork, says Sarah Abrams at Baleen Specialty.
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5 Years In, COVID-19 Fraud Enforcement Landscape Is Shifting
As the government moves pandemic fraud enforcement from small-dollar individual prosecutions to high-value corporate cases, and billions of dollars remain unaccounted for, companies and defense attorneys must take steps now to prepare for the next five years of scrutiny, says attorney David Tarras.
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Fed. Circ. In August: A Framework For AIA Derivation Disputes
In Global Health Solutions v. Selner, the Federal Circuit established how to assess derivation challenges under the America Invents Act's first-to-file system, making it easier for petitioners to determine a challenge's odds of success, say attorneys at Knobbe Martens.
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USPTO's Track One A Reliable Patent Pathway Amid Backlog
As the U.S. Patent and Trademark Office faces a backlog of unexamined utility, plant and reissue patent applications, patent applicants should consider utilizing the USPTO's Track One Program, which not only expedites the process but also increases the likelihood of working with more senior examiners, says Ryan Schermerhorn at Marshall Gerstein.
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Vanda Ruling Opens Door For Contesting FDA Drug Denials
The D.C. Circuit's recent decision in Vanda Pharmaceuticals v. U.S. Food and Drug Administration creates new opportunities and considerations for drug companies navigating the FDA approval process, establishing that litigation is an option when the FDA refuses to hold a hearing, say attorneys at Polsinelli.
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Series
Law School's Missed Lessons: Mastering Time Management
Law students typically have weeks or months to prepare for any given deadline, but the unpredictability of practicing in the real world means that lawyers must become time-management pros, ready to adapt to scheduling conflicts and unexpected assignments at any given moment, says David Thomas at Honigman.
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Rare Del. Oversight Ruling Sends Governance Wake-Up Call
An unusual ruling from the Delaware Court of Chancery recently allowed Caremark oversight claims to proceed against former executives of a company previously known as Teligent, sending a clear reminder that boards and officers must actively monitor and document oversight efforts when addressing mission-critical risks, say attorneys at WilmerHale.
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How Hyperlinks Are Changing E-Discovery Responsibilities
A recent e-discovery dispute over hyperlinked data in Hubbard v. Crow shows how courts have increasingly broadened the definition of control to account for cloud-based evidence, and why organizations must rethink preservation practices to avoid spoliation risks, says Bree Murphy at Exterro.
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Pharma Copay Programs Raise Complex Economic Questions
The growing prevalence of copay accumulator and maximizer programs in the pharmaceutical industry is drawing increased scrutiny from patients, advocacy groups, lawmakers and courts, bringing complex questions about how financial responsibility for prescription drug purchases is determined and complicating damages assessments in litigation, say analysts at Analysis Group.
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State False Claims Acts Can Help Curb Opioid Fund Fraud
State versions of the federal False Claims Act can play an important role in policing the misuse of opioid settlement funds, taking a cue from the U.S. Department of Justice’s handling of federal fraud cases involving pandemic relief funds, says Kenneth Levine at Stone & Magnanini.
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Beaming Up Lessons From William Shatner's Failed Patent Bid
In a tale that boldly goes where few celebrity inventors have gone before, William Shatner's unsuccessful attempt to patent a smartphone file organization system offers insights about potential pitfalls to avoid in patent applications, say attorneys at King & Spalding.