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Life Sciences
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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
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."
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January 14, 2025
MIT Bio Lab Can't Use Anti-SLAPP To Duck Defamation Suit
The Massachusetts Appeals Court on Tuesday ruled that the state's anti-SLAPP statute could not stop a suit brought by the former head of an MIT-affiliated biomedical research lab who stepped down amid a finding that he harassed a subordinate, though several of his claims were axed nonetheless.
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January 14, 2025
Mass. AG Says Insulin Makers, Middlemen Colluded On Costs
Insulin makers Eli Lilly, Sanofi and Novo Nordisk conspired with pharmacy benefit managers OptumRX, Express Scripts and CVS Caremark to jack up prices by as much as 1,000%, the Massachusetts attorney general alleged in a suit.
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January 13, 2025
Robo-Surgery Part Reset Is Reliable, Expert Tells Antitrust Jury
A mechanical engineering expert who testified Monday in an antitrust trial in California federal court over claims that Intuitive Surgical Inc. abuses its market power by blocking hospitals from extending the life of a surgical robot part said the extension procedure was "thorough" and "reliable."
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January 13, 2025
Ozempic Maker Says Atlanta Clinic Misuses TM To Sell Meds
Novo Nordisk, the pharmaceutical company that makes weight loss drugs Ozempic, Rybelsus and Wegovy, filed suit against an Atlanta anti-aging treatment center in Georgia federal court Friday, alleging trademark infringement, false advertising, unfair competition and deceptive trade practices.
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January 13, 2025
5 Firms Steer Up-To-$750M Sale Of Life Molecular Imaging
Radiopharmaceutical-focused company Lantheus Holdings Inc. announced plans Monday to buy Life Molecular Imaging Ltd. for up to $750 million in a deal built by five law firms.
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January 13, 2025
Acting USPTO Chief Won't Review Seed IP Challenge Denial
The acting leader of the U.S. Patent and Trademark Office shot down a bid by a Cambridge, Massachusetts, gene-editing startup to review decisions rejecting its challenges to patents covering purportedly novel corn seeds developed by a unit of DowDuPont spin-off Corteva.
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January 13, 2025
Goodwin Procter Adds NY IP Attys From Fenwick, Desmarais
Goodwin Procter LLP announced Monday that it was expanding its intellectual property practice in New York with two scientifically talented lawyers, one from Fenwick & West LLP, the other from Desmarais LLP.
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January 13, 2025
Lilly To Buy Scorpion Cancer Program For Up To $2.5B
Ropes & Gray LLP-led Eli Lilly and Co. said Monday it has agreed to purchase a precision breast cancer program of biotechnology company Scorpion Therapeutics Inc. for up to $2.5 billion.
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January 13, 2025
PBMs' Federal Work Irrelevant To Opioid Suit, Mich. AG Says
Michigan's attorney general urged a federal judge Friday to send a case accusing pharmacy benefit managers of stoking the opioid crisis back to the state court where it was originally filed, saying there is nothing federal about the claims.
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January 13, 2025
Cravath-Led J&J Paying $14.6B For Neuropsychiatric Drug Co.
Johnson & Johnson said Monday it has agreed to purchase Intra-Cellular Therapies Inc., a biopharmaceutical company focused on therapies for neuropsychiatric and neurological disorders, for approximately $14.6 billion.
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January 13, 2025
Feds Say NC Medical Biz Owner Overbilled For Nutrient Drinks
A North Carolina businessman who ran a durable medical equipment business under multiple names overbilled the state's Medicaid program $1.85 million for special enteral nutritional formulas used to treat inherited metabolic disorders when he was actually just providing people common nutritional shakes like Ensure, the federal government said.
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January 13, 2025
Supreme Court Turns Away IP Safe Harbor Dispute
The U.S. Supreme Court on Monday said it won't consider whether the Federal Circuit has overexpanded a safe harbor for drug development, in litigation where Meril Life Sciences escaped allegations that it infringed Edwards Lifesciences' heart valve patents.
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January 13, 2025
Nvidia's Healthcare Ambitions Grow In New Partnerships
Nvidia announced Monday that it has inked four new healthcare partnerships, a move that comes on the first day of the annual J.P. Morgan Healthcare Conference in San Francisco.
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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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.
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Rejoinder Strategy After Allergan Double-Patenting Case
A closer look at last year's Allergan v. MSN case at the Federal Circuit highlights the importance of rejoinder during patent prosecution in view of the risks associated with obviousness-type double patenting based on later-filed applications in the same patent family, say attorneys at BCLP.
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Takeaways From 2024's Emerging IP Licensing Trends
Themes in intellectual property licensing from the past year – including artificial intelligence; risk management; and name, image and likeness rights – highlight key considerations for navigating an evolving landscape, say attorneys at Ballard Spahr.