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Life Sciences
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September 08, 2025
NY AG To Fight Texas Bid To Enforce Abortion Ban Ruling
New York Attorney General Letitia James on Monday moved to intervene in a lawsuit brought by the state of Texas that seeks to enforce a money judgment against a New York doctor for providing abortion-inducing drugs to a woman via telemedicine in the Lone Star state.
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September 08, 2025
Oura Domestic Labor Investment Won Import Ban, ITC Says
The U.S. International Trade Commission has found that Ouraring Inc.'s commitments in the U.S. to producing its smart ring warranted the agency's decision to block Ultrahuman and RingConn from importing products it held infringed a wearable computing device patent.
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September 08, 2025
FisherBroyles Can't Nix Stem Cell Patent Malpractice Claim
A California judge on Monday denied FisherBroyles LLP's motion to toss a claim in a $10 million malpractice suit brought against it by a stem cell treatment center, ruling the firm missed a deadline to file the motion.
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September 08, 2025
Whisper Not Enough To Sustain Worker's Harassment Suit
A Pennsylvania federal judge tossed a Merck Sharp & Dohme worker's suit Monday claiming his boss sexually harassed him by whispering in his ear at a staff meeting, ruling the singular incident did not create a hostile work environment at the pharmaceutical company.
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September 08, 2025
Trump Returns To High Court In Foreign Aid Freeze Dispute
President Donald Trump asked the U.S. Supreme Court on Monday to pause a lower court's order requiring the administration to release roughly $4 billion in frozen foreign aid, claiming the ruling interferes with his attempt to lawfully rescind the funding.
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September 08, 2025
FibroGen To Pay SEC $1.25M Over Drug Mistatements
Biopharmaceutical company FibroGen Inc. has agreed to pay a $1.25 million penalty to the U.S. Securities and Exchange Commission to resolve claims that its former chief medical officer fudged results for its primary drug, Roxadustat, which treats anemia in kidney disease patients.
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September 08, 2025
Catching Up With Delaware's Chancery Court
Last week at the Delaware Court of Chancery, a bankruptcy administrator for a generic drugmaker formerly known as Teligent was told he can proceed with duty of oversight claims against most former officers and directors of the company, who the administrator said was complicit in the company's collapse. In an opinion, the Court of Chancery cites its 1996 decision In re Caremark International Inc. Derivative Litigation, which refined director duties of care and oversight.
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September 08, 2025
23andMe's Ch. 11 Sale Flouted State Privacy Law, Calif. Says
The state of California has asked a Missouri federal judge to undo the $305 million bankruptcy sale of consumer DNA testing group 23andMe, arguing it sidestepped state consumer data protections.
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September 05, 2025
DC Circ. Won't Halt Order Releasing Billions In Foreign Aid
Both a divided D.C. Circuit panel and a district court judge Friday refused to hit pause on the judge's recent order requiring the Trump administration to release billions of dollars in frozen foreign aid.
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September 05, 2025
Stewart Tackles Markets, Injunctions In Newest PTAB Reviews
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart released 14 institution decisions in the last week, providing more insight on the scope of settled expectations and the impact of a district court preliminary injunction.
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September 05, 2025
Federal Agencies Push To Toss Masimo's Apple Watch Suit
U.S. Customs and Border Protection and the U.S. International Trade Commission have again urged a federal judge to throw out Masimo's suit seeking to block a decision allowing imports of redesigned Apple Watches, saying Congress barred court review of such findings.
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September 05, 2025
2nd Circ. Backs Ex-Pfizer Worker's Insider Trading Conviction
The Second Circuit on Friday affirmed a former Pfizer Inc. statistician's insider trading conviction for making $272,000 in options trades from nonpublic news about the success of trials for the COVID-19 therapy drug Paxlovid, rejecting his arguments that prosecutors improperly shifted their legal theory at trial and pursued the case in the wrong venue.
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September 05, 2025
DOJ Pushes To DQ Attorney Over Conflict In Fraud Case
Federal prosecutors in Georgia are seeking to disqualify an attorney from representing a defendant accused of making false statements in relation to a criminal fraud investigation of Hi-Tech Pharmaceuticals Inc., arguing the lawyer was previously disqualified from representing the company's CEO for a conflict and that "the same is true now."
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September 05, 2025
Merck Shakes Off Some Claims From Cholesterol Drugs Suit
A New Jersey federal judge has partly granted a request from Merck & Co. to dismiss claims brought by Humana over an alleged anticompetitive scheme to control distribution of cholesterol drugs Zetia and Vytorin, tossing several proposed theories of monopolization but allowing unjust enrichment claims and state law antitrust claims to survive.
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September 05, 2025
Vein Tech Maker Wants Suit Over DOJ Kickback Probe Tossed
Vein disease device maker Inari Medical Inc. and its former top brass have asked a New York federal judge to toss a proposed investor class action over claims the company's share price fell after it disclosed an investigation into its compliance with federal anti-kickback laws, arguing the suit fails to allege any specific kickbacks or false statements.
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September 05, 2025
FDA Explains Rejection Of MDMA Therapy For Treating PTSD
The U.S. Food and Drug Administration rejected a historic new drug application to treat post-traumatic stress disorder with the psychedelic MDMA due to concerns with the drug's safety and effectiveness and with the design of the clinical trials behind the bid, according to an agency letter made public Thursday.
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September 05, 2025
Casper Can't Escape Innovator-Liability Drug Label Suit
A California federal judge won't let Casper Pharma LLC escape an innovator-liability suit alleging that its failure to provide adequate warnings on its gout treatment led to the death of a man who used its generic version.
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September 05, 2025
Conn. Biotech Hits Ch. 11 With $2.7M Debt After Patent Suit
A Connecticut biotech company has filed a voluntary Chapter 11 petition claiming at least $2.7 million in liabilities, mostly debts to Quinn Emanuel Urquhart & Sullivan LLP and Verrill Dana LLP, after both law firms represented it in a since-settled Massachusetts stem cell patent lawsuit.
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September 05, 2025
Motley Rice Fights OptumRx DQ Bid In Utah Opioid Suit
Pharmacy benefit manager OptumRx cannot disqualify Motley Rice LLC from representing Utah in a lawsuit over the opioid crisis, since any information the firm obtained during its involvement in earlier government investigations is available to all other parties in the multidistrict litigation and so isn't confidential, the state has told a federal court.
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September 04, 2025
Feds Seek Stay On Court Order Releasing Foreign Aid Billions
The Trump administration urged the D.C. Circuit on Thursday to stay a federal judge's order that it release billions in frozen foreign aid pending its appeal, saying the disbursement will likely be "impossible" to recover according to the international aid organization plaintiffs' "own description of their financial condition."
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September 04, 2025
Split 3rd Circ. Rejects Janssen, Bristol Myers Pricing Appeal
A split Third Circuit panel Thursday shot down another challenge to the Medicare drug pricing negotiation, this time rejecting a consolidated appeal from Bristol Myers Squibb and Janssen and upholding a lower court's finding that the program is indeed voluntary and therefore constitutional.
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September 04, 2025
Doc Tells 1st Circ. Acquitted Conduct Marred Drug Sentence
A Massachusetts psychiatrist convicted over an alleged scheme to import and dispense nonapproved forms of addiction medication on Thursday told the First Circuit the trial judge wrongly ran afoul of limitations on the consideration of acquitted conduct in federal sentencings when handing him a three-year prison term.
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September 04, 2025
4th Circ. Affirms Gardasil's Vaccine Table Inclusion
A unanimous Fourth Circuit panel affirmed Thursday that adding the human papillomavirus vaccine Gardasil to the Vaccine Act's injury table did not violate the U.S. Constitution, rejecting three plaintiffs' arguments that the Secretary of Health and Human Services lacks the authority to make additions to the table without an act of Congress.
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September 04, 2025
Generic Drug Org Backs MSN In High Court Entresto Appeal
The Association for Accessible Medicines has thrown its weight behind MSN Pharmaceuticals in the company's U.S. Supreme Court challenge to a Federal Circuit decision blocking its generic version of Novartis' blockbuster cardiovascular drug Entresto, saying Wednesday that the appeals court took the wrong approach to patent validity.
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September 04, 2025
GSK Adds Moderna's New COVID Vaccine To Del. IP Suit
GlaxoSmithKline Biologicals is broadening its patent infringement suit against Moderna Inc. to include the latter's new family of COVID-19 vaccines, mNEXSPIKE.
Expert Analysis
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What FCA Liability Looks Like In The Cybersecurity Realm
Two recent settlements highlight how whistleblowers and the U.S. Department of Justice have been utilizing the False Claims Act to allege fraud predicated on violations of cybersecurity standards — timely lessons given new bipartisan legislation introducing potential FCA liability for artificial intelligence use, say attorneys Rachel Rose and Julie Bracker.
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Foreign Sovereign Entities Should Heed 9th Circ. IP Ruling
After the Ninth Circuit recently held that four Chinese state-controlled companies were not immune from criminal indictment for alleged economic espionage, foreign sovereign-controlled entities should assess whether their operations and affiliation with their parent states qualify for sovereign immunity under the common law, say attorneys at Cleary.
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How Attorneys Can Become Change Agents For Racial Equity
As the administration targets diversity, equity and inclusion efforts and law firms consider pulling back from their programs, lawyers who care about racial equity and justice can employ four strategies to create microspaces of justice, which can then be parlayed into drivers of transformational change, says Susan Sturm at Columbia Law School.
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CMS Guidance May Complicate Drug Pricing, Trigger Lawsuits
Recent draft guidance from the Centers for Medicare & Medicaid Services proposes to expand the scope of what counts as the same qualifying single-source drug, which would significantly alter the timeline for modified drugs facing price controls and would likely draw legal challenges from innovator drug companies, say attorneys at Debevoise.
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Strategies For Litigating In The Unified Patent Court
Since opening its gates two years ago, the European Unified Patent Court has transformed the patent litigation landscape and global litigation strategies, but parties seeking to take advantage of the court's robust processes must be prepared for the front-loaded character of UPC proceedings, say attorneys at McDermott.
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Series
Running Marathons Makes Me A Better Lawyer
After almost five years of running marathons, I’ve learned that both the race itself and the training process sharpen skills that directly translate to the practice of law, including discipline, dedication, endurance, problem-solving and mental toughness, says Lauren Meadows at Swift Currie.
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Series
Law School's Missed Lessons: Supporting A Trial Team
While students often practice as lead trial attorneys in law school, such an opportunity likely won’t arise until a few years into practice, so junior associates should focus on honing skills that are essential to supporting a trial team, including organization, adaptability and humility, says Lucy Zelina at Tucker Ellis.
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Compliance Essentials To Mitigate AI Crime Enforcement Risk
As artificial intelligence systems move closer to accurately mimicking human decision-making, companies must understand how the U.S. Department of Justice might prosecute them for crimes committed by AI tools — and how to mitigate enforcement risks, say attorneys at Paul Hastings.
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Series
Adapting To Private Practice: From US Attorney To BigLaw
When I transitioned to private practice after government service — most recently as the U.S. attorney for the Eastern District of Virginia — I learned there are more similarities between the two jobs than many realize, with both disciplines requiring resourcefulness, zealous advocacy and foresight, says Zach Terwilliger at V&E.
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Most-Favored Nation Drug Pricing Could Shake Up US Pharma
Recent moves from the executive and legislative branches represent a serious attempt to revive and refine the first Trump administration's most-favored-nations model for drug pricing, though implementation could bring unintended consequences for pharmaceutical manufacturers and will likely draw significant legal opposition, say attorneys at Morgan Lewis.
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The Ins And Outs Of Consensual Judicial References
As parties consider the possibility of judicial reference to resolve complex disputes, it is critical to understand how the process works, why it's gaining traction, and why carefully crafted agreements make all the difference, say attorneys at Pillsbury.
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Opinion
Congress Must Restore IP Protection To Drive US Innovation
Congress should pass the RESTORE Patent Rights Act to enforce patent holders' exclusive rights and encourage American innovation, and undo the decades of patent rights erosion caused by the U.S. Supreme Court's 2006 decision in eBay v. MercExchange, says former Chief U.S. Circuit Judge Paul Michel.
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How Focus On Menopause Care Is Fueling Innovation, Access
Recent legislative developments concerning the growing field of menopause care are creating opportunities for increased investment and innovation in the space as they increase access to education and coverage, say attorneys at Kirkland.
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Opinion
The BigLaw Settlements Are About Risk, Not Profit
The nine Am Law 100 firms that settled with the Trump administration likely did so because of the personal risk faced by equity partners in today's billion‑dollar national practices, enabled by an ethics rule primed for modernization, says Adam Forest at Scale.
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Neb.'s Cannabis Regulatory Void Poses Operational Risks
With the Nebraska Legislature recently declining to advance any cannabis legislation, leaving the state without a regulatory framework for voter-passed initiatives, the risks of operating without clear rules will likely affect patients, providers and caregivers, says John Cartier at Omnus Law.