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Life Sciences
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September 09, 2025
Zantac Buyers Will Appeal Sanofi Dismissal From Conn. Suit
Hundreds of out-of-state purchasers of the heartburn drug ranitidine, the generic form of Zantac, have signaled plans to appeal a Connecticut judge's dismissal of negligent design claims against Sanofi-Aventis U.S. LLC, challenging the conclusion that they had no right to sue the company in the Constitution State.
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September 09, 2025
Omni Must Pay Atty Fees Over 'Troubling' Conduct In FCA Suit
A Massachusetts federal judge has ordered a medical practice to pay legal fees to a lab it accused of False Claims Act violations, ruling its claims were "clearly vexatious" because the provider knowingly ordered medically unnecessary tests to support its suit.
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September 09, 2025
MAHA Report Calls For Increased Scrutiny Of Drug Advertising
The Trump administration on Tuesday pledged to ramp up federal oversight of drug advertising, update dietary guidelines and slash unnecessary regulations as part of its strategy to boost the health of America's children and curb the rise in childhood chronic disease.
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September 09, 2025
Gilgo Beach DNA Evidence Ruling May Propel New Methods
A recent ruling from the New York judge overseeing the Gilgo Beach serial killer case finding that the newer DNA testing method known as whole genome sequencing clears rigorous admissibility standards is a laudable decision that could help solve cold cases, according to proponents of the technology.
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September 09, 2025
Sandoz, Regeneron Settle Eye Drug Patent Claims
Sandoz Inc. and Regeneron Pharmaceuticals Inc. have reached a settlement to resolve patent claims Regeneron had asserted over a biosimilar alternative to its Eylea ophthalmic disorder drug.
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September 09, 2025
Particle's Antitrust Battle With Epic: 3 Things To Know
Epic Systems Corp. must face allegations it violated federal law by attempting to monopolize a segment of the electronic health records market to the exclusion of competitor Particle Health Inc. Here's what you need to know about the case.
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September 09, 2025
Roberts Pauses Foreign Aid Distribution For Now
Chief Justice John Roberts on Tuesday temporarily stayed a lower court's order requiring the Trump administration to release roughly $4 billion in frozen foreign aid while the U.S. Supreme Court considers a longer-term solution.
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September 09, 2025
Kidney Care Co. Strive Health Secures $550M In New Funding
Kidney care company Strive Health, led by Goodwin Procter LLP, on Tuesday revealed that it has completed a $550 million capital raise, which will be used to help the company enhance its "value-based" care model through advanced technology such as artificial intelligence-driven tools and analytics.
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September 09, 2025
DOJ, FTC Urged To Probe Drugmakers' Rebate Models
The American Hospital Association asked the Trump administration to investigate whether major pharmaceutical companies violated antitrust laws as they push out new rebate models for a program that offers discounted drugs to healthcare providers serving low-income patients.
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September 09, 2025
3rd Circ. Told Cigna's 'Private Label' Stelara May Alter Market
A Johnson & Johnson subsidiary told a Third Circuit panel it would be "difficult" to calculate its potential monetary losses if a Cigna subsidiary were to launch its own version of an anti-inflammatory treatment, particularly if it permanently changed the market by giving the insurance giant a "private label" version that pharmacies would give preference over the original.
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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.
Expert Analysis
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Opinion
High Court Must Overrule Outdated Patent Eligibility Doctrine
A certiorari petition should directly ask the U.S. Supreme Court to correct its 1972 patent decision in Gottschalk v. Benson, the critical point where patent eligibility law veered from the statutory text toward judicial policymaking, says Robert Greenspoon at Dunlap Bennett.
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Series
Playing The Violin Makes Me A Better Lawyer
Playing violin in a string quartet reminds me that flexibility, ambition, strong listening skills, thoughtful leadership and intentional collaboration are all keys to a successful legal practice, says Julie Park at MoFo.
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The State Of AI Adoption In The Patent Field
The use of generative artificial intelligence in patent-related practices has lagged behind early predictions, which may be explained by a number of core concerns that organizations must address before seriously considering adoption, say attorney Michael Drapkin and leadership coach Michael Colacchio.
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Purdue Case Could Transform Patent Obviousness Analyses
If accepted for review by the U.S. Supreme Court, Purdue Pharma v. Accord Healthcare — concerning whether Purdue's abuse-deterrent opioid formulation patents were invalid as obvious — could significantly shift how courts weigh secondary considerations in patent obviousness analyses, say attorneys at Lathrop.
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Federal Regs Order May Spell Harsher FDCA Enforcement
A recent executive order aimed at reducing criminal prosecutions of those who unknowingly violate complex federal regulations may actually lead to more aggressive felony indictments under the Federal Food, Drug and Cosmetic Act, but companies and executives can mitigate risks by following several key principals, say attorneys at McGuireWoods.
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Series
Law School's Missed Lessons: Practicing Self-Care
Law schools don’t teach the mental, physical and emotional health maintenance tools necessary to deal with the profession's many demands, but practicing self-care is an important key to success that can help to improve focus, manage stress and reduce burnout, says Rachel Leonard at MG+M.
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ABA Opinion Makes It A Bit Easier To Drop A 'Hot Potato'
The American Bar Association's recent ethics opinion clarifies when attorneys may terminate clients without good cause, though courts may still disqualify a lawyer who drops a client like a hot potato, so sending a closeout letter is always a best practice, say attorneys at Thompson Hine.
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IRhythm IPR Denial Raises Key PTAB Discretion Questions
By giving the passage of time a dispositive role in denying institution of five inter partes review petitions filed by iRhythm Technologies, the U.S. Patent and Trademark Office has upended the strategic considerations for filing and defending against IPRs, disclosing prior art during prosecution, and engaging in licensing negotiations, say attorneys at Dentons.
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Canadian Suit Offers Disclosure Lesson For US Cannabis Cos.
A Canadian class action asserting that Aurora Cannabis failed to warn consumers about the risk of developing cannabinoid hyperemesis syndrome may spawn copycat filings in the U.S., and is a cautionary tale for cannabis and hemp industries to prioritize risk disclosure, says Ian Stewart at Wilson Elser.
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Opinion
IPR Denial In IRhythm Should Not Set A Blanket Rule
Though the Patent Trial and Appeal Board's discretionary denial in iRhythm v. Welch Allyn last month raised concerns that mere knowledge of a patent could bar inter partes review institution, a closer look at the facts and reasoning reveals why this case's holdings should not be reflexively applied to all petitioners, says David McCombs at Haynes Boone.
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What High Court's Tenn. Trans Care Ruling Means Nationally
The U.S. Supreme Court's decision in U.S. v. Skrmetti, upholding a Tennessee ban on gender-affirming medical care for minors, is fairly limited in scope and closely tailored to the specific language of Tennessee's law, but it may have implications for challenges to similar laws in other states, say attorneys at Hall Render.
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How Trump's Trade Policies Are Shaping Foreign Investment
Five months into the Trump administration, investors are beginning to see the concrete effects of the president’s America First Investment Policy as it presents new opportunities for clearing transactions more quickly, while sustaining risk aversion related to Chinese trade and potentially creating different political risks, say attorneys at Covington.
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Series
My Opera And Baseball Careers Make Me A Better Lawyer
Though participating in opera and the world of professional baseball often pulls me away from the office, my avocations improve my legal career by helping me perform under scrutiny, prioritize team success, and maintain joy and perspective at work, says Adam Unger at Herrick Feinstein.
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Opinion
Subject Matter Eligibility Test Should Return To Preemption
Subject matter eligibility has posed challenges for patentees due to courts' arbitrary and confusing reasoning, but adopting a two-part preemption test could align the applicant, the U.S. Patent and Trademark Office and the courts, says Manav Das at McDonnell Boehnen.
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8 Ways Lawyers Can Protect The Rule Of Law In Their Work
Whether they are concerned with judicial independence, regulatory predictability or client confidence, lawyers can take specific meaningful actions on their own when traditional structures are too slow or too compromised to respond, says Angeli Patel at the Berkeley Center of Law and Business.