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Life Sciences
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September 09, 2025
4th Circ. Debates Whether 'Silence' In 340B Empowers States
Two states told a Fourth Circuit panel on Tuesday that "silence" in the law governing the federal government's drug discount program permits state enforcers to step in and regulate the delivery of those drugs to their communities.
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September 09, 2025
CVS Says Takeda Tried To Block Heartburn Drug Competition
Drugmaker Takeda Pharmaceutical Co. Ltd. and other entities engaged in a "horizontal conspiracy and agreement" to restrain competition in the U.S. market for the acid reflux drug Dexilant and its generic equivalents, CVS Pharmacy Inc. alleged in a complaint filed in California federal court Tuesday.
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September 09, 2025
PTAB Leader Urges Specificity In Discretionary Denial Briefs
The Patent Trial and Appeal Board's acting chief judge urged litigants Tuesday to support the arguments they make in the board's new discretionary denial process with specific details about their cases, during a panel where lawyers expressed both frustration about and praise for the system.
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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.
Expert Analysis
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Opinion
Courts Must Revitalize Robust Claim Construction
Two Federal Circuit decisions from earlier this year illustrate the rarity of robust claim construction and the underused reverse doctrine of equivalents — a dual problem that prevents courts from clearly delineating and correctly cabining the scope of rights conferred by patent claims, say attorneys at Klarquist Sparkman.
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What Gene Findings Mean For Asbestos Mesothelioma Claims
Recent advances in genetic research have provided substantial evidence that significant numbers of malignant mesothelioma cases may be caused by inherited mutations rather than asbestos exposure — a finding that could fundamentally change how defendants approach personal injury litigation over mesothelioma, say David Schwartz at Lumanity and Kirk Hartley at LSP Group.
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Series
Brazilian Jiujitsu Makes Me A Better Lawyer
Competing in Brazilian jiujitsu – often against opponents who are much larger and younger than me – has allowed me to develop a handful of useful skills that foster the resilience and adaptability necessary for a successful legal career, says Tina Dorr of Barnes & Thornburg.
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Fed. Circ. In April: Introducing New Evidence During IPR
The Federal Circuit's decision in Sage Products v. Stewart last month upheld the Patent Trial and Appeal Board's decision to allow a petitioner to rely on case-dispositive evidence beyond prior art references, affording petitioners in inter partes review proceedings greater latitude in the timing of evidence presentation, say attorneys at Knobbe Martens.
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FDA Commissioner Speech Suggests New Vision For Agency
In his first public remarks as U.S. Food and Drug Administration commissioner, Marty Makary outlined an ambitious framework for change centered around cultural restoration, scientific integrity, regulatory flexibility and selective modernization, and substantial enforcement shifts for the food and tobacco sectors, say attorneys at Arnall Golden.
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DOJ Export Declination Highlights Self-Reporting Benefits
The U.S. Department of Justice's recent decision not to prosecute a NASA contractor, despite a former employee pleading guilty to facilitating unlicensed exports, underscores the advantages available to companies that self-report sanctions violations, cooperate with investigations and implement timely remediation, say attorneys at Cleary.
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AG Watch: Texas Expands Use Of Consumer Protection Laws
In recent years under Attorney General Ken Paxton, Texas has demonstrated the breadth of its public interest authority by bringing actions in areas not traditionally associated with consumer protection law, including recent actions involving sports and public safety, say attorneys at Kelley Drye.
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Series
Power To The Paralegals: An Untapped Source For Biz Roles
Law firms looking to recruit legal business talent should consider turning to paralegals, who practice several key skills every day that prepare them to thrive in marketing and client development roles, says Vanessa Torres at Lowenstein Sandler.
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A Path Forward For Colo. Pot Products After Failed Safety Test
As cannabis products in Colorado face increasingly rigorous contamination testing, decontamination and remediation can be an alternative to destruction after a failed safety check, in certain circumstances, so understanding the nuances of these procedures is vital, say attorneys at Troutman Pepper.
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Series
Playing Poker Makes Me A Better Lawyer
Poker is a master class in psychology, risk management and strategic thinking, and I’m a better attorney because it has taught me to read my opponents, adapt when I’m dealt the unexpected and stay patient until I'm ready to reveal my hand, says Casey Kingsley at McCreadyLaw.
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What EU 'Killer Acquisition' Study Means For Pharma Deals
The European Commission’s recent study of pharmaceutical companies' acquisitions of emerging competitive threats, the first of its kind globally, has important implications for the industry, and may lead to increased awareness of merger control risks in collaborative agreements, say lawyers at Paul Weiss.
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Legal Risks For Providers Discussing Psychedelic Therapies
The emergence of psychedelic therapies as potential treatments for mental health conditions and other ailments continues to garner significant attention, but the legal landscape surrounding discussions and referrals remains fraught with complexity, creating potential risks for healthcare providers and institutions, says Kimberly Chew at Husch Blackwell.
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Series
Law School's Missed Lessons: Becoming A Firmwide MVP
Though lawyers don't have a neat metric like baseball players for measuring the value they contribute to their organizations, the sooner new attorneys learn skills frequently skipped in law school — like networking, marketing, client development and case evaluation — the more valuable, and less replaceable, they will be, says Alex Barnett at DiCello Levitt.
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Trade Secrets Would Likely See Court Protection From GenAI
The advent of generative artificial intelligence has given rise to debate about how this technology will affect intellectual property rights and trade secret protections in particular, but courts to date have protected owners when technological advances have facilitated new means for trade secret theft, say attorneys at Kilpatrick Townsend.
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A Breakdown Of Trump's Order On Drug Pricing
The Trump administration may attempt to effectuate through rulemaking a recently issued executive order on lowering drug prices, which would likely have an adverse effect on stakeholders and trigger litigation, say attorneys at Debevoise.