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Life Sciences
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August 25, 2025
Generic-Drugs Group Asks 9th Circ. To Nix Pay-For-Delay Law
A trade group for generic drugmakers urged the Ninth Circuit to fully scrap a California law banning brand pharmaceutical companies from paying to delay generics competition, in a brief targeting both the law's in-state features upheld by a district court and the extraterritorial reach the state wants revived.
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August 25, 2025
AbbVie Nabs Depression Drug From Gilgamesh In $1.2B Deal
Covington & Burling LLP-advised biotech company AbbVie on Monday announced plans to acquire Ropes & Gray LLP-led Gilgamesh Pharmaceuticals' lead investigational candidate, which targets the treatment of patients with moderate to severe major depressive disorder, for up to $1.2 billion.
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August 25, 2025
Pfizer Says FDA Blocked Tumor Warnings For Depo-Provera
Pfizer said Friday that plaintiffs' claims in the multidistrict litigation over a link between brain tumors and the hormonal contraceptive Depo-Provera are preempted by federal law because the drugmaker asked the U.S. Food and Drug Administration for permission to change the drug's label to add tumor warnings but was rejected.
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August 22, 2025
Texas, Fla. Want In On Abortion Medication Challenge
Texas and Florida have asked a Lone Star State federal court to allow them to intervene in litigation challenging federal approvals for the abortion medication mifepristone, arguing that their interests may "no longer be adequately represented" by Missouri, Kansas and Idaho, which are currently leading the suit.
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August 22, 2025
USPTO Allows Discretionary Denials For 3-Year-Old Patents
A top Patent Trial and Appeal Board judge Friday rejected challenges to GenghisComm Holdings LLC patents issued as recently as 2022, as part of the three discretionary review decisions issued over the last week.Â
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August 22, 2025
Chicago Feds Create New Healthcare Fraud Section
The U.S. attorney's office in Chicago announced Friday it has created a section within its Criminal Division dedicated solely to prosecuting healthcare fraud, which the U.S. Department of Justice has identified as a fraud enforcement priority.
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August 22, 2025
Altria Unit Says FDA Stonewalled On Flavored E-Cig Approvals
A subsidiary of tobacco giant Altria has filed a new lawsuit in Louisiana federal court against U.S. health regulators it alleges unlawfully delayed processing the company's applications to market flavored e-cigarettes for almost three years.
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August 22, 2025
Ex-Pharma Exec Leaked Bankruptcy Deliberations, Suit Says
BioCurity Pharmaceuticals Inc. and its advisers sued a former officer of the company, alleging that she broke a nondisclosure agreement to disparage the advisers and leak the company's bankruptcy deliberations to its shareholders.
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August 22, 2025
Supplement Co. Says Insurer Failed To Pay $2.1M Claim
The parent company of sports nutrition and supplement website Bodybuilding.com told an Idaho federal court that a Berkley unit failed to fully pay for property damage and business income loss after a water pipe burst at the Boise-based data center hosting the website's servers.
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August 22, 2025
SEC Sues 5 For Insider Trading Before Chinook-Novartis Deal
The U.S. Securities and Exchange Commission filed suit on Friday against five individuals for allegedly engaging in insider trading involving Chinook Therapeutics stock ahead of its $3.5 billion acquisition by Novartis, resulting in wrongful gains of more than $500,000 from their trades using material nonpublic information.
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August 22, 2025
House Oversight Chair Presses DOJ On Chinese Vape Surge
The Republican head of the U.S. House of Representatives Committee on Oversight and Government Reform is asking the U.S. Department of Justice for an update on how it is combating the import of illicit vape products from China.
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August 22, 2025
NJ Judge Halts Ex-CEO's Sentencing After Habba Ruling
Citing a federal court ruling that the Garden State's U.S. attorney is serving unlawfully, a New Jersey federal judge issued an order Friday postponing indefinitely the sentencing of the ex-chief executive of SCWorx Corp., who had promoted a $670 million COVID-19 test kit deal that later fell apart.
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August 22, 2025
Marketer Who Eyed US Fentanyl 'Grand Lab' Gets 15 Years
A Manhattan federal judge on Friday sentenced a Chinese marketing manager to 15 years in prison after a jury convicted her of scheming to secretly send large quantities of precursor chemicals into the United States for the production of fentanyl.
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August 21, 2025
Cannabis Cos. Face $2.9M IT Judgment After Unable To Pay Attys
Subsidiaries of Canadian cannabis company Halo Collective Inc. were hit with a nearly $2.9 million judgment over claims that they infringed on a Colorado-based firm's patents, losing the litigation after their attorneys withdrew because they could "no longer pay."
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August 21, 2025
UPenn Gene Therapy Patent Survives Sarepta's PTAB Challenge
The Patent Trial and Appeal Board on Thursday declined to wipe out a claim in a University of Pennsylvania gene therapy patent, denying a win to Sarepta Therapeutics Inc., which is fighting an infringement case in Delaware federal court.
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August 21, 2025
Del. Judge Outlines Misconduct Behind Amgen's $50M Relief
A Delaware federal judge overruled German biotech company Lindis's $50 million patent infringement win against Amgen, finding an inventor purposefully withheld harmful information from the U.S. Patent and Trademark Office, according to an opinion made public Wednesday.
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August 21, 2025
Fertility Co. Says Deception Suit 'Mischaracterizes' Test
A fertility clinic chain is urging a Colorado federal judge to toss a proposed class action accusing it of deceptively marketing genetic tests of embryos, saying the claims are time-barred, lack required expert backing and specificity, and don't identify any actionable misstatements.
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August 21, 2025
GTCR Deal A 'Smokescreen' For Coatings Merger, FTC Says
GTCR BC Holdings LLC's $627 million bid to buy the nation's largest medical device coatings company is a blatant attempt to overwhelmingly dominate an already highly concentrated market, and the "smokescreen" of a partial divestiture shouldn't convince anyone otherwise, the Federal Trade Commission told an Illinois federal judge Thursday.
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August 21, 2025
CVS, Drugmakers Illegally Inflated Insulin Prices, City Claims
Drugmakers Eli Lilly and Co., Novo Nordisk Inc. and Sanofi-Aventis US LLC, pharmacy benefit managers CVS Caremark, Express Scripts and Optum Rx, and others have been hit with civil racketeering and state unfair trade practices law claims by the city of Torrington, Connecticut, over an alleged scheme to inflate insulin prices.
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August 21, 2025
High Court Allows Trump Admin To Cancel $783M In NIH Grants
The U.S. Supreme Court on Thursday allowed the Trump administration to resume the mass termination of scientific grants, overturning rulings by lower courts that had kept the funds flowing to universities and other recipients.Â
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August 20, 2025
Masimo Targets CBP Over Latest Apple Watch Import Ruling
Masimo sued U.S. Customs and Border Protection in D.C. federal court Wednesday, arguing the agency defied the law by issuing a ruling that found a newly redesigned version of Apple's smartwatches is not subject to an import ban in the companies' patent dispute.
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August 20, 2025
Masimo's 'Empty Voting' Suit Against Founder Gets Green Light
A California federal judge has rejected a bid to dismiss Masimo Corp.'s suit alleging the medical technology company's founder and an investment firm manipulated a shareholder vote through an "empty voting" scheme, finding there is enough evidence at this point to show the pair formed an undisclosed insider group under federal securities laws.
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August 20, 2025
Talphera Beats Investors' Bid To Save Slogan Suit At 9th Circ.
The Ninth Circuit on Wednesday refused to revive a proposed shareholder class action accusing Talphera Inc. of misleading investors about the simplicity of administering the pharmaceutical company's "Tongue and Done" opioid, saying in a published opinion that no reasonable investor would "blindly" accept the slogan without considering other information.
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August 20, 2025
Feds Lose Bid To Seal In Vax Patent Case Against Moderna
The U.S. government has failed to show why names and contact information of certain U.S. Department of the Army employees should be hidden in an mRNA vaccine developer's $5 billion patent suit over Moderna's COVID-19 vaccines, a federal judge has found.
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August 20, 2025
Texas AG Threatens Suit Over Orgs. Mailing Abortion Pills
Texas Attorney General Ken Paxton has sent cease-and-desist letters to three organizations he's accused of shipping abortion drugs to women in the state in violation of state and federal laws.
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.