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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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Trump's 2nd Term Puts Merger Remedies Back On The Table
In contrast with the Biden administration, the second Trump administration has signaled a renewed willingness to resolve merger enforcement concerns through remedies from the outset, particularly when the proposed fix is structural, clearly addresses the harm and does not require burdensome oversight, say attorneys at Cooley.
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Patent Ambiguity Persists After Justices Nix Eligibility Appeal
The Supreme Court recently declined to revisit the contentious framework governing patent eligibility by denying certiorari in Audio Evolution Diagnostics v. U.S., suggesting a necessary recalibration of both patent application and litigation strategies, say attorneys at Skadden.
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Texas Med Spas Must Prepare For 2 New State Laws
Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.
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Fed. Circ. In June: Transitional Phrases In Patent Claims
The Federal Circuit's recent decision in Eye Therapies v. Slayback Pharma takes on the rarely addressed topic of transitional phrases in patent claims, providing some useful lessons regarding restating claim language and broadly distinguishing prior art, say attorneys at Knobbe Martens.
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Series
Playing Soccer Makes Me A Better Lawyer
Soccer has become a key contributor to how I approach my work, and the lessons I’ve learned on the pitch about leadership, adaptability, resilience and communication make me better at what I do every day in my legal career, says Whitney O’Byrne at MoFo.
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Strategies For Cos. Navigating US-Indian Pharma Partnerships
Recent policy adjustments implemented by the U.S. government present both new opportunities and heightened regulatory scrutiny for the Indian life sciences industry, amplifying the importance of collaboration between the Indian and U.S. pharmaceutical sectors, say Bryant Godfrey at Foley Hoag and Jashaswi Ghosh at Holon Law Partners.
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DOJ-HHS Collab Crystallizes Focus On Health Enforcement
The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.
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Series
Law School's Missed Lessons: Learning From Failure
While law school often focuses on the importance of precision, correctness and perfection, mistakes are inevitable in real-world practice — but failure is not the opposite of progress, and real talent comes from the ability to recover, rethink and reshape, says Brooke Pauley at Tucker Ellis.
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23andMe Fine Signals ICO's New GDPR Enforcement Focus
Many of the cybersecurity failures identified by the Information Commissioner’s Office in its investigation of 23andMe, recently resulting in a £2.3 million fine, were basic lapses, but the ICO's focus on several new U.K. General Data Protection Regulation considerations will likely carry into the future, say lawyers at Womble Bond.
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Eye Drop Ruling Clarifies Importance Of Patent Phrasing
The Federal Circuit's recent ruling in Eye Therapies v. Slayback, rejecting the Patent Trial and Appeal Board's interpretation of "consisting essentially of," highlights the importance of using clear and consistent terms throughout a patent's filing history to shield it against future challenges, says Liliana Di Nola-Baron at Panitch Schwarze.
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How The Healthline Privacy Settlement Redefines Ad Tech Use
The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.
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How Sweeping Budget Bill Shakes Up Health Industry
With the recently passed One Big Beautiful Bill Act marking one of the most significant overhauls of federal health policy since the passage of the Affordable Care Act, providers, managed care organizations and life sciences companies must now shift focus from policy review to implementation planning, say advisers at Holland & Knight.
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Series
Adapting To Private Practice: From ATF Director To BigLaw
As a two-time boomerang partner, returning to BigLaw after stints as a U.S. attorney and the director of the Bureau of Alcohol, Tobacco, Firearms and Explosives, people ask me how I know when to move on, but there’s no single answer — just clearly set your priorities, says Steven Dettelbach at BakerHostetler.
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A Look At Key 5th Circ. White Collar Rulings So Far This Year
In the first half of 2025, the Fifth Circuit has decided numerous cases of particular import to white collar practitioners, which collectively underscore the critical importance of meticulous recordbuilding, procedural compliance and strategic litigation choices at every stage of a case, says Joe Magliolo at Jackson Walker.
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High Court Cert Spotlights Varying Tests For Federal Removal
A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.