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Life Sciences
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January 15, 2025
Novartis Wins Temporary Stay Of MSN's Generic Heart Drug
The D.C. Circuit late Wednesday temporarily halted the U.S. Food and Drug Administration's approval of MSN Pharmaceuticals' generic version of Novartis' blockbuster heart failure drug Entresto, just after federal judges in D.C. and Delaware declined to block the launch of MSN's product.
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January 15, 2025
Gilead, Feds Resolve HIV Drug Patent Dispute Amid Appeal
Gilead Sciences and the federal government have agreed to dismiss all claims and counterclaims in a yearslong intellectual property and contract battle over HIV prevention drugs Truvada and Descovy, according to stipulations of voluntary dismissal filed Wednesday in both the Federal Circuit and Delaware federal court.
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January 15, 2025
Robo Surgery Co. Caused $140M In Lost Profits, Jury Told
Surgical Instrument Service suffered lost profits of up to $140 million because Intuitive Surgical Inc. blocked it from providing a service that extends the life of an Intuitive da Vinci surgery robot component, an economist told jurors Wednesday in a trial over claims Intuitive abuses its market power.
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January 15, 2025
Quest Diagnostics Gets Meta Data-Share Suit Tossed For Now
Quest Diagnostics got allegations that it unlawfully shared patient data with Meta Platforms through ad tracking software dismissed Tuesday, after persuading a New Jersey federal judge to reconsider his earlier ruling that allowed an eavesdropping claim under California's Invasion of Privacy Act to go forward.
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January 15, 2025
SEC Dings Pharma Co., Ex-CFO Over Prescription Scheme
The U.S. Securities and Exchange Commission announced it has settled claims against bankrupt DMK Pharmaceuticals Corp. and its ex-chief financial officer over their alleged role in a fraudulent scheme to generate revenues using illegal prescriptions for horse medications.
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January 15, 2025
Abbott's Toddler Nutrition Drinks Aren't Healthy, Parents Claim
A trio of parents filed a proposed false advertising class action in Illinois federal court Tuesday alleging Abbott Laboratories touts its toddler drinks sold under the Similac brand as nutritionally proper for children ages 12 months to 36 months, even though the products contain added sugar which is harmful to health.
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January 15, 2025
Justices Asked If Zoning Immunity Can Pass To Private Entity
The Georgia Supreme Court on Wednesday considered whether a hospital authority could transfer its exemption from municipal zoning ordinances to a private buyer in a dispute over whether a hospital site can become an addiction rehabilitation center.
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January 15, 2025
Del. Justices Mull 'Reasonable' Effort Duty In Drug Biz Deal
An attorney for former stockholders of Ception Therapeutics Inc. told Delaware's top court on Wednesday that a now-retired vice chancellor "asked the wrong question" in dismissing a suit alleging breaches of an agreement to use commercially reasonable efforts before abandoning a new drug prospect.
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January 15, 2025
DOJ Reports $2.9B Haul Under FCA, Largest In 3 Years
Litigation under the False Claims Act generated a little over $2.9 billion in settlements and judgments in the most recent fiscal year, a 5% bump over 2023's total and the most in three years, according to data released Wednesday by the U.S. Department of Justice.
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January 15, 2025
3rd Circ. Preview: NFL Concussion Benefits Fight Tops January
The case of late NFL players' family members who say they shouldn't have to exhume their loved ones' remains to receive benefits from the national concussion settlement takes center stage in the Third Circuit's January argument session.
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January 15, 2025
Chinese Execs Sent Fentanyl Precursor To NY, Jury Told
A novel fentanyl-trafficking case went to trial in New York federal court on Wednesday, with prosecutors arguing that two Chinese chemical executives inked a multimillion-dollar deal to export the raw materials for the drug to a Manhattan lab in 2023.
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January 15, 2025
Former FDA Official Joins King & Spalding Life Sciences Team
King & Spalding on Wednesday announced that a former U.S. Food and Drug Administration official has joined the firm's government matters and regulation practice group after an eight-year stint at the agency.
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January 15, 2025
FDA Bans Red Dye No. 3, Citing Cancer Link In Animal Studies
The U.S. Food and Drug Administration on Wednesday said that it is banning the use of a red dye, Red No. 3, which gives food and drinks a bright red color but has also been linked to cancer in animals.
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January 15, 2025
Holland & Knight Adds Ex-GOP Rep. To Policy Advisory Team
Holland & Knight LLP has hired seven-term Indiana Republican Congressman Larry Bucshon as a senior policy adviser.
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January 15, 2025
Justices Say Nixing Federal Claims Ends Federal Jurisdiction
The U.S. Supreme Court on Wednesday said a proposed class action over alleged mislabeling of prescription dog food was appropriately sent back to state court, holding that once the plaintiff dropped her federal claims, the federal courts no longer had jurisdiction.
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January 14, 2025
Abbott, Novartis Settle HIV Test Patent Beef Ahead Of Trial
Abbott Laboratories, Novartis and Grifols have reached a settlement in a yearslong battle over a patent covering a method for replicating DNA, putting to rest the litigation less than a month before it was set to go to trial, according to an entry in Illinois federal court posted Monday.
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January 14, 2025
Conn. City Hits PBMs And Pharma Cos. With Insulin Pricing Suit
A city partway between New Haven and Hartford took pharmacy benefit managers and drug makers including CVS Health Corp., Eli Lilly and Co. and Novo Nordisk Inc. to Connecticut federal court on Monday, alleging that they conspired to keep diabetes medications and insulin at needlessly high prices.
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January 14, 2025
Latham Grabs Top Spot For 2024 IPOs By Large Margin
Latham & Watkins LLP guided more initial public offerings than any law firm in 2024, capturing a diverse mix of large listings for companies that seized opportunities to go public as the broader IPO market inched toward recovery, new data shows.
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January 14, 2025
Fed. Circ. Judge Asks What's The Rush In Eylea Biosimilar Case
Counsel for Amgen and a Federal Circuit judge got into a back-and-forth Tuesday concerning the pace of an appeal over a denied injunction on Regeneron's biosimilar of Eylea, with the judge wondering why the attorney was so eager to move things along.
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January 14, 2025
Chancery Hits Co. With $2.9M Atty Fee Bill As Sanction
A California medical device molding company that sought millions from a merger partner for breaches of contract in Delaware's Court of Chancery came away Tuesday with awards of $104,000 for its claims and $2.9 million in attorney fees as a sanction for contempt and spoliation by Symbient Product Development LLC founder Scott Castanon.
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January 14, 2025
Cannabis Reformers Split After DEA Judge Cancels Hearings
The cannabis legal and business world was divided Tuesday after a U.S. Drug Enforcement Administration judge hit pause on widely anticipated and historic public hearings on the merits of a proposal to loosen federal restrictions on marijuana.
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January 14, 2025
Dispute Over Eli Lilly Weight Loss Drug Reignited
Compounding pharmacies have reignited a suit against the U.S. Food and Drug Administration over the removal of a lucrative weight loss drug from the shortage list, with a Texas federal judge ordering both sides to turn in briefing on injunctive relief during a Tuesday hearing.
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January 14, 2025
SEC Sues Elon Musk Over Late Twitter Buy-Up Disclosure
Elon Musk violated securities laws by failing to timely disclose his initial buy-up of Twitter stock ahead of his $44 billion acquisition of the company, allowing him to purchase shares at artificially low prices, the U.S. Securities and Exchange Commission alleged in a D.C. federal lawsuit filed Tuesday.
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January 14, 2025
Eli Lilly Says Colo. Clinic Selling Deceptive Weight Loss Drug
Eli Lilly & Co. has sued a Denver health clinic for allegedly selling "unapproved and potentially dangerous" drugs marketed to treat type 2 diabetes and obesity, which the pharmaceutical company said could give consumers the false impression that its U.S. Food and Drug Administration-approved medications don't work.
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January 14, 2025
TikTok Says NC Can't Fault Platform For Being 'Too Engaging'
TikTok Inc. has asked for an early exit from the North Carolina attorney general's lawsuit accusing the video platform of harming young users, saying it has no significant ties to the Tar Heel state and the AG's office can't otherwise build a case around its platform being "too engaging."
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Series
Playing Rugby Makes Me A Better Lawyer
My experience playing rugby, including a near-fatal accident, has influenced my legal practice on a professional, organizational and personal level by showing me the importance of maintaining empathy, fostering team empowerment and embracing the art of preparation, says James Gillenwater at Greenberg Traurig.
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Looking Back At 2024's Noteworthy State AG Litigation
State attorneys general across the U.S. took bold steps in 2024 to address unlawful activities by corporations in several areas, including privacy and data security, financial transparency, children's internet safety, and other overall consumer protection claims, say attorneys at Troutman Pepper.
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Opinion
No, Litigation Funders Are Not 'Fleeing' The District Of Del.
A recent study claimed that litigation funders have “fled” Delaware federal court due to a standing order requiring disclosure of third-party financing, but responsible funders have no problem litigating in this jurisdiction, and many other factors could explain the decline in filings, say Will Freeman and Sarah Tsou at Omni Bridgeway.
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Patent Policy Changes To Track Under New Gov't Leadership
The new federal government will likely bring pivotal shifts in U.S. patent policy through legislation and initiatives that reflect a renewed focus on strengthening intellectual property rights, fostering innovation and enhancing the nation's competitive edge, says PK Chakrabarti at Butzel Long.
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Liability Risk For AI In Medical Devices Demands Greater Care
As regulators push for legal reform surrounding artificial intelligence and cases implicating product liability for AI in medical technology continue to rise, manufacturers must adapt and implement new strategies to accommodate evolving risks, say attorneys at Crowell & Moring.
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5 E-Discovery Predictions For 2025 And Beyond
In the year to come, e-discovery will be shaped by new and emerging trends, from the adoption of artificial intelligence provisions in protective orders, to the proliferation of emojis as a source of evidence in contemporary litigation, say attorneys at Littler.
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4 Trade Secret Developments To Follow This Year
Significant developments in trade secret law are likely in 2025, and areas to watch include protection of AI-related innovations, the fate of the Federal Trade Commission's noncompete ban, and questions of the federal Defend Trade Secrets Act's extraterritorial reach, say attorneys at Faegre Drinker.
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Republican Trifecta Amplifies Risks For Cos. In 3 Key Areas
Expected coordination between a Republican Congress and presidential administration may expose companies to simultaneous criminal, civil and congressional investigations, particularly with regard to supply chain risks in certain industries, government contracting and cross-border investment, say attorneys at Morgan Lewis.
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7 Ways 2nd Trump Administration May Affect Partner Hiring
President-elect Donald Trump's return to the White House will likely have a number of downstream effects on partner hiring in the legal industry, from accelerated hiring timelines to increased vetting of prospective employees, say recruiters at Macrae.
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How Trump 2.0 May Change Business In Latin America
Companies in Latin America should expect to face more trade restrictions, tighter economic sanctions and enhanced corruption risks, as the incoming administration shifts focus to certain non-U.S. actors, most notably China, says Matteson Ellis at Miller & Chevalier.
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Opinion
Courts Must Curb The Drug Price Negotiation Program
The Inflation Reduction Act's drug price negotiation program upends incentive structures that drive medical innovation, and courts must act appropriately to avoid devastating consequences for American healthcare and the pharmaceutical industry, says Jeff Stier at the Consumer Choice Center.
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E-Discovery Quarterly: Rulings On Custodian Selection
Several recent rulings make clear that the proportionality of additional proposed custodians will depend on whether the custodians have unique relevant documents, and producing parties should consider whether information already in the record will show that they have relevant documents that otherwise might not be produced, say attorneys at Sidley.
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Series
Exercising On My Peloton Bike Makes Me A Better Lawyer
While I originally came to the Peloton bike for exercise, one cycling instructor’s teachings have come to serve as a road map for practicing law thoughtfully and mindfully, which has opened opportunities for growth and change in my career, says Andrea Kirshenbaum at Littler.
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5 Drug And Device Developments That Shaped 2024
The last year saw significant legal developments affecting drug and device manufacturers, with landmark decisions and regulatory changes that require vigilance and agility from the industry, say attorneys at Faegre Drinker.
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How To Manage During A Trade Dispute With USMCA Partners
Companies can try to minimize the potential impacts of future tariffs on Mexican and Canadian goods, and uncertainty about future trade relations, by evaluating supply chains, considering how they may be modified, and engaging with the new administration over exemptions and the upcoming review of the U.S.-Mexico-Canada Agreement, say attorneys at Holland & Knight.