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Life Sciences
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April 02, 2025
MSN Denied More Relief For 'Falling Sky' In Entresto Dispute
A Delaware federal judge on Wednesday denied MSN Pharmaceuticals Inc.'s effort to pause a judgment delaying its generic version of a blockbuster Novartis heart medication, finding the court had already granted the company's previous request for relief and wouldn't do so again "for essentially the same falling sky."
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April 02, 2025
Garmin Beats Fitness Tracker Patent Suit, For Now
A Michigan federal judge has tossed, for now, a suit accusing Garmin International Inc. of infringing a CardiacSense Ltd. fitness tracker patent after finding the claims aren't eligible for patent protection, but the judge left room for an amended complaint to be filed.
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April 02, 2025
CVS Asserts DOJ's Opioid Prescription Suit Lacks Facts
CVS Pharmacy Inc. has told a Rhode Island federal judge that most of the U.S. Department of Justice's claims that it knowingly filed invalid prescriptions for opioids should be tossed, saying the agency failed to adequately allege the company willfully put profits over safety.
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April 02, 2025
Bidi Vapor Says FDA Denial Of E-Cig Was Unlawful
Vape company Bidi Vapor LLC urged the Eleventh Circuit on Wednesday to reverse a U.S. Food and Drug Administration decision denying its application to market a disposable e-cigarette, saying the agency acted unlawfully and ignored evidence the company presented.
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April 02, 2025
Orthodontic Software Co. Hit With Data Breach Class Action
An orthodontic software company has been hit with a proposed class action in Georgia federal court over a November data breach in which the names, birth dates, medical records, insurance information, payment card data and Social Security numbers of its clients' patients were stolen by hackers.
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April 02, 2025
Justices Broaden RICO Reach To Personal Injuries
The U.S. Supreme Court on Wednesday expanded the type of civil actions that can be brought under a federal racketeering statute, asserting that claims stemming from personal injuries are redressable if they can be shown to have caused economic harm.
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April 02, 2025
Supreme Court Backs FDA Block Of Flavored Vapes
The U.S. Supreme Court on Wednesday overruled a determination that the U.S. Food and Drug Administration acted arbitrarily when it rejected an e-cigarette company's applications to market flavored vape products.
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April 01, 2025
FDA Beats Challenge To Approval Of Elanco's Cattle Gas Drug
The U.S. Food and Drug Administration has defeated an administrative challenge to its approval of Elanco Health's drug meant to reduce ammonia gas emissions from beef cattle and their waste, with a California federal judge ruling Tuesday that the agency reasonably evaluated its safety based on a wide array of studies.
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April 01, 2025
Takeda Antitrust Trial Over Actos Generics Set For July
A New York federal court refused a bid from Takeda Pharmaceuticals Co. to escape a long-running case accusing it of unlawfully delaying generic versions of its diabetes treatment Actos and scheduled a trial to start in July.
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April 01, 2025
Fla. Defends Sandoz Price-Fixing Settlement Terms
Florida defended its deal with Sandoz Inc. on Monday, saying the other states suing the generic-drug maker over price-fixing have no right to object to the settlement, which does not require court approval and does not affect the states objecting to it.
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April 01, 2025
Two More Pharmacies Hit With Eli Lilly Weight Loss Drug Suits
Eli Lilly and Co. filed another round of lawsuits Tuesday accusing compounding pharmacies of selling copycat versions of its weight loss and diabetes medications, saying in New Jersey and Delaware federal courts that two online pharmacies are deceiving consumers about their knockoff products.
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April 01, 2025
No Inequitable Conduct From Fresenius Foe, Judge Says
German medical giant Fresenius has failed to convince a Delaware federal judge that any foul play could be found in the prosecution of a patent involved in a fight over selling IV bags filled with calcium supplements, used to treat hypocalcemia.
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April 01, 2025
Ex-Biotech CEO Wrongly Sentenced To 7 Years, DC Circ. Told
A former biotech executive who pled guilty to misleading investors about a blood-based COVID-19 test urged the D.C. Circuit to order a redo of his seven-year prison sentence on Tuesday, telling an appeals panel that the trial court miscalculated the sentencing guidelines.
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April 01, 2025
IBM And J&J Beat 'Speculative' Data Breach Suit, For Now
A New York federal judge has tossed with leave to amend a proposed class action alleging IBM and Johnson & Johnson's healthcare arm failed to safeguard sensitive health information of thousands of patients before a 2023 data breach, finding the purported harm is "entirely speculative" as currently alleged.
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April 01, 2025
Talc Claimants Tell 3rd Circ. Whittaker Couldn't File Ch. 11
Talc injury claimants on Tuesday asked the Third Circuit to dismiss Whittaker Clark & Daniels' Chapter 11 case, saying a South Carolina state judge had given control of the talc supplier to a receiver six weeks before the company filed for bankruptcy.
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April 01, 2025
FDA Cuts Prompt Biotech Players To Rethink Deal Strategies
Funding cuts at the U.S. Department of Health and Human Services are sending ripples of concern through the biotech industry, as attorneys advise companies to consider a wider breadth of strategic alternatives amid fears of regulatory delays.
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March 31, 2025
Texas Judge Deems Lab-Test Rule Outside FDA Authority
A Texas federal judge on Monday vacated a new U.S. Food and Drug Administration rule that would have brought lab-developed tests under its regulatory authority as "medical devices," finding that the move exceeded the agency's statutory authority and defied "common sense."
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March 31, 2025
Former Stimlabs Exec Must Face Trade Secrets Claims
A former biomedical technology company executive must face claims that she absconded with thousands of internal files containing valuable product information in the days and weeks leading up to her ouster last year, a Georgia federal judge ruled.
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March 31, 2025
Ex-Blood Bank Atty Goes Back To Ballard Spahr In Phoenix
Ballard Spahr LLP has picked up a former in-house intellectual property lawyer from nonprofit blood bank Vitalant who had worked at the law firm a little over a decade ago.
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March 31, 2025
Nasdaq's Tighter IPO Rules Raise Bar For Small Companies
Nasdaq is seeking to weed out volatile stocks by tightening listing standards for small companies conducting initial public offerings or uplistings, although lawyers caution that new rules could prompt capital-hungry companies to pursue other listing strategies, including reverse mergers.
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March 31, 2025
Buyer Class Of Surgical Robots Is Certified In Antitrust Fight
A California federal judge on Monday certified a class of thousands of hospitals alleging Intuitive Surgical monopolized the market for robotic surgical tools by blocking third-party repairs and tying services to robot purchases, finding the case raises common antitrust questions that can be resolved on a classwide basis.
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March 31, 2025
J&J Talc Spinoff's Ch. 11 Case Gets Tossed, Erasing $9B Deal
A Texas bankruptcy judge rejected Johnson & Johnson's third attempt to use Chapter 11 to settle thousands of claims that its products caused cancer, dismissing J&J unit Red River Talc's Chapter 11 case on Monday and throwing out a roughly $9 billion bankruptcy deal over issues with the company's voting procedures and third-party releases.
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March 31, 2025
Despite 'Admirable' Effort, Vertex Kickback Challenge Fails
A D.C. federal judge dealt a loss on Monday to gene therapy drugmaker Vertex Pharmaceuticals, ruling in favor of a U.S. Department of Health and Human Services advisory opinion that found the company's fertility preservation program could potentially violate the Anti-Kickback Statute.
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March 31, 2025
Pierson Ferdinand Adds Taylor English Health Pro In Atlanta
Pierson Ferdinand LLP announced Monday that it has hired a former Taylor English Duma LLP partner who specializes in mergers and acquisitions and also has sleep medicine expertise to strengthen its healthcare practice.
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March 31, 2025
Cleary Gains 5-Atty Latham Team Known For Big IP Wins
Cleary Gottlieb Steen & Hamilton LLP has welcomed a bi-coastal team of five intellectual property litigators from Latham & Watkins LLP, lauding their history leading "many of the most high-profile and complex patent and trade secrets cases of the last decade" in a statement Monday.
Expert Analysis
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Looking For Patterns In Pharmaceuticals' Use Of AI Patents
Merging data from the U.S. Patent and Trademark Office's artificial intelligence patent dataset and the U.S. Food and Drug Administration's Orange Book sheds light on pharmaceutical patents involving AI technology, as well as trends in the industry's use of this technology, says Kiefer Ahn at NERA.
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The State Of USPTO Rulemaking At The End Of Vidal's Term
As U.S. Patent and Trademark Office director, Kathi Vidal placed a particular emphasis on formal rulemaking — so as she returns to private practice this week, attorneys at Irell take stock of which of her proposals made it across the finish line, and where the rest stand on the cusp of a new administration.
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2024 IPO Market Trends, And What To Expect Next Year
The initial public offering market returned to historically typical levels on a deal count basis in 2024 but continued to lag based on proceeds raised due to a larger number of smaller IPOs this year, and signs point to continued ongoing momentum in the next year, say attorneys at Paul Hastings.
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What 2024 Trends In Marketing, Comms Hiring Mean For 2025
The state of hiring in legal industry marketing, business development and communications over the past 12 months was marked by a number of trends — from changes in the C-suite to lateral move challenges — providing clues for what’s to come in the year ahead, says Ben Curle at Ambition.
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How Trump's Tariff Promises May Play Out In 2nd Term
While it is unclear which of President-elect Donald Trump's promised tariffs he intends to actually implement in January, lessons from his first administration, laws governing executive action and U.S. trade agreements together paint a picture of what may be possible, say attorneys at Butzel.
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Series
Group Running Makes Me A Better Lawyer
The combination of physical fitness and community connection derived from running with a group of business leaders has, among other things, helped me to stay grounded, improve my communication skills, and develop a deeper empathy for clients and colleagues, says Jessica Shpall Rosen at Greenwald Doherty.
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Opinion
6 Changes I Would Make If I Ran A Law School
Reuben Guttman at Guttman Buschner identifies several key issues plaguing law schools and discusses potential solutions, such as opting out of the rankings game and mandating courses in basic writing skills.
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Predictions For Trump Antitrust Enforcement Of Life Sciences
Key life sciences antitrust issues of the past two administrations may indicate the direction of enforcement during President-elect Donald Trump's second term, including in areas such as drug prices, killer acquisitions and merger remedies, say attorneys at Ropes & Gray.
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Nutraceutical Patent Insights As Market Heats Up
Companies entering the expanding nutraceutical market and seeking patents to protect their innovations should evaluate successful nutraceutical claim language and common patent challenges in this field, say attorneys at Sterne Kessler.
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Firms Still Have The Edge In Lateral Hiring, But Buyer Beware
Partner mobility data suggests that the third quarter of this year continued to be a buyer’s market, with the average candidate demanding less compensation for a larger book of business — but moving into the fourth quarter, firms should slow down their hiring process to minimize risks, say officers at Decipher Investigative Intelligence.
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What 2024 Election Means For Drugs, Medicare And Medicaid
With Republicans running the White House, U.S. House of Representatives and U.S. Senate, the incoming administration is likely to provide pathways — through new initiatives and others returning from Trump's previous presidency — for a range of potential changes to drug pricing, Medicare and Medicaid, say attorneys at Morgan Lewis.
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Think Like A Lawyer: 1 Type Of Case Complexity Stands Out
In contrast to some cases that appear complex due to voluminous evidence or esoteric subject matter, a different kind of complexity involves tangled legal and factual questions, each with a range of possible outcomes, which require a “sliding scale” approach instead of syllogistic reasoning, says Luke Andrews at Poole Huffman.
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What Bisphenol S Prop 65 Listing Will Mean For Industry
The imminent addition of bisphenol S — a chemical used in millions of products — to California's Proposition 65 list will have sweeping compliance and litigation implications for companies in the retail, food and beverage, paper, manufacturing and personal care product industries, say attorneys at Alston & Bird.
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Fed. Circ. Ruling Shows Importance Of Trial Expert Specificity
The Federal Circuit’s recent ruling in NexStep v. Comcast highlights how even a persuasive expert’s failure to fully explain the basis of their opinion at trial can turn a winning patent infringement argument into a losing one, say attorneys at Barnes & Thornburg.
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Think Like A Lawyer: Note 3 Simple Types Of Legal Complexity
Cases can appear complex for several reasons — due to the number of issues, the volume of factual and evidentiary sources, and the sophistication of those sources — but the same basic technique can help lawyers tame their arguments into a simple and persuasive message, says Luke Andrews at Poole Huffman.