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Life Sciences
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March 27, 2025
Vaping Interests Take Challenge To FDA Rule To 5th Circ.
A coalition of vaping interests challenging the U.S. Food and Drug Administration's marketing and recordkeeping regulations has taken the dispute to the Fifth Circuit after a lower district judge tossed the lawsuit, which claimed many in the industry were prohibited from seeking FDA approval for multiple products at once because of the high cost of applying.
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March 27, 2025
Fertility Co. Wants To Pull Device Maker Into Negligence Suit
A fertility products company wants two other companies to share potential liability from a Connecticut state lawsuit alleging that a recalled culture medium was responsible for the loss of embryos a couple were planning to use for in vitro fertilization.
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March 27, 2025
Texas Judge 'Disturbed' By Filings In Weight Loss Drug Case
A Texas federal judge had stern words for a group of compounding pharmacies while refusing to allow them to manufacture Eli Lilly's lucrative weight loss drug, saying he was "increasingly exasperated" with the pharmacies' attempts to dictate how he manages the case.
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March 27, 2025
Fed. Circ. Revives Recor's PTAB Challenge To Medtronic IP
The Federal Circuit on Thursday revived medical technology company Recor Medical's challenge to a Medtronic Ireland Manufacturing patent on a way to treat heart and renal failure, telling the Patent Trial and Appeal Board to once again review the fight.
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March 27, 2025
Fitch Even Sues Ex-IP Client In Effort To End Malpractice Case
Fitch Even Tabin & Flannery LLP has launched a lawsuit asking an Illinois federal court to declare that the co-founder of a former client isn't the inventor behind a prenatal test patent, which the firm said would put a stop to a malpractice case against it in state court.
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March 27, 2025
Oura Gets Samsung's Preemptive IP Strike Tossed, For Now
Samsung Electronics cannot yet seek a declaration that its Galaxy Ring brand of wearable, health-tracking devices does not infringe Oura Health's smart ring patents, a California federal judge ruled Thursday, saying Samsung hasn't shown the Finnish company is threatening to sue for infringement.
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March 27, 2025
Ga. Therapy Clinic Accused Of Refusing OT Payments
A Georgia mental health clinic was sued Wednesday by a former aide who alleged that she was forced to resign her position with the company last year when it refused to give her thousands of dollars of overtime pay she claims she was owed.
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March 27, 2025
Eli Lilly Says Michigan AG's Insulin Pricing Probe Is Baseless
Michigan Attorney General Dana Nessel's case for investigating Eli Lilly's insulin prices is based on fundamentally flawed premises, such as comparing what consumers pay in Michigan to Canada, the drugmaker has told the Michigan Supreme Court in a new brief.
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March 27, 2025
Walgreens To Pay $2.8M For Alleged Medicaid Overcharges
Walgreens will pay $2.8 million under an agreement with federal prosecutors to settle allegations that it submitted inflated prices for some generic medications to Medicaid programs in Massachusetts and Georgia.
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March 27, 2025
Mich. Judge Deflects Criticism Of Atty Fees In $53M Flint Deal
A Michigan federal judge on Thursday defended her decision to grant a third of a $53 million settlement to attorney fees for lawyers who represented Flint claimants who alleged a water firm prolonged the water crisis, saying many members of the public don't understand the complexities of the case.
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March 27, 2025
Fox Rothschild Brings On McCarter & English IP Ace In NJ
Fox Rothschild LLP grew its Princeton, New Jersey, office this week with the addition of an intellectual property partner from McCarter & English LLP specializing in patent prosecution for medical devices, technology-enabled hardware and more.
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March 27, 2025
Texas Law Firm Must Face 2nd Firm's Paxil Fees Suit
A Texas appellate court affirmed Thursday that a law firm battling its former co-counsel over the proceeds of lawsuits concerning the antidepressant drug Paxil can't use the state's anti-SLAPP statute to avoid a breach of contract claim but tossed an award of $100,000 in attorney fees.
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March 27, 2025
Top EU Court Urged To Uphold €60M Teva Pay-For-Delay Fine
An adviser to the European Union's top court said Thursday that it should uphold €60.5 million ($70.7 million) in fines against Teva and its subsidiary Cephalon for an alleged conspiracy to keep a generic version of Provigil off the shelves.
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March 27, 2025
1st Circ. Denies Gov't Bid To Enforce Funding Freeze
The First Circuit has declined to interfere with a Rhode Island federal judge's order that the government continue releasing federal funds while the Trump administration appeals a ruling blocking its efforts to enforce the freeze.
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March 27, 2025
HHS To Cut 10,000 Jobs As RFK Jr. Reorganizes Agency
The U.S. Department of Health and Human Services said Thursday that it would lay off 10,000 employees as part of a "dramatic" plan to restructure the agency and downsize its workforce by about 24%.
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March 26, 2025
Sotomayor Urges Caution On Nondelegation Doctrine Revamp
U.S. Supreme Court Justice Sonia Sotomayor cautioned her colleagues during oral arguments Wednesday against using a challenge to the Federal Communications Commission's administration of a broadband subsidy program as a way to resurrect the long-dormant nondelegation doctrine. Several conservative justices, however, seemed willing to disregard that admonition.
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March 26, 2025
7 Firms Compete To Lead Novo Nordisk Securities Suit
Levi & Korsinsky LLP, Pomerantz LLP and the Rosen Law Firm PA are among seven law firms vying to lead proposed class claims accusing Novo Nordisk A/S of misleading investors about a clinical trial for an obesity drug.
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March 26, 2025
23andMe Says Ch. 11 Privacy Ombudsman Not Required
DNA testing company 23andMe Inc.'s customer data will be protected in Chapter 11, its attorneys told a Missouri bankruptcy judge Wednesday as it argued that the appointment of a consumer privacy ombudsman is not required.
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March 26, 2025
Full Fed. Circ. Won't Look At Injunction On MSN's Generic Drug
The full Federal Circuit won't revisit a panel's January order barring MSN Laboratories Pvt. Ltd. from launching a generic version of Novartis' bestseller, the cardiovascular drug Entresto, as part of a flurry of moves in litigation related to the treatment.
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March 26, 2025
Drugmaker Execs Hid Approval Process Roadblocks, Suit Says
A Sage Therapeutics Inc. investor sued the company's executives in New York federal court Wednesday alleging they hid significant setbacks affecting the regulatory approval for its drug candidates intended to treat mood disorders and other conditions including Parkinson's and Alzheimer's diseases.
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March 26, 2025
Women Make Up 13% Of Attys In Front Of The PTAB
Women account for 13% of attorneys appearing in front of the Patent Trial and Appeal Board in post-grant proceedings going back to the board's founding in 2012 despite comprising up to 30% of all patent attorneys, according to a report from the PTAB Bar Association.
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March 26, 2025
Walgreens, Kroger Claim Takeda Cut Illegal TWi Generics Deal
Walgreens, Kroger, Albertsons and H-E-B hit Takeda and TWi Pharmaceuticals with an antitrust suit in California federal court Tuesday, accusing the pharmaceutical companies of conspiring to delay the release of the generic version of Takeda's heartburn medication Dexilant, causing the retailers to pay more for the brand-name drug.
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March 26, 2025
Del. Justices Back Axing Suit Over $3B AstraZeneca Viela Sale
The Delaware Supreme Court on Wednesday upheld without elaboration the dismissal of a Court of Chancery lawsuit accusing AstraZeneca PLC of lining up a conflicted, underpriced $3 billion sale of clinical stage biopharmaceutical venture Viela Bio Inc.
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March 26, 2025
AGs Seek 1st OK For $39M Apotex Deal In Price-Fixing Case
A coalition of 50 state attorneys general on Wednesday asked a Connecticut federal judge to accept a $39.1 million deal settling claims that pharmaceutical company Apotex Corp. schemed with others to fix generic-drug prices, with 70% earmarked for a restitution fund and 30% for consumer notices and attorney fees.
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March 26, 2025
False COVID Cure Claims No Longer Feds' 'Current Priority'
The Trump administration has abandoned another case targeting allegedly false claims that an over-the-counter product could treat, or even cure, COVID-19 by dropping its case against a one-man herbal tea operation.
Expert Analysis
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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.
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Justices Mull Sex-Based Classification In Trans Law Case
After the U.S. Supreme Court heard oral argument in U.S. v. Skrmetti this week, it appears that the fate of the Tennessee law at the center of the case — a law banning gender-affirming healthcare for transgender adolescents — will hinge on whether the majority read the statute as imposing a sex-based classification, says Alexandra Crandall at Dickinson Wright.
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Series
Gardening Makes Me A Better Lawyer
Beyond its practical and therapeutic benefits, gardening has bolstered important attributes that also apply to my litigation practice, including persistence, patience, grit and authenticity, says Christopher Viceconte at Gibbons.
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Litigation Inspiration: Reframing Document Review
For attorneys — new ones especially — there is much fulfillment to find in document review by reflecting on how important, interesting and pleasant it can be, says Bennett Rawicki at Hilgers Graben.
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Key Takeaways From FDA's Latest Social Media Warnings
The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.
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Expect More State Scrutiny Of PE In Healthcare M&A
While a California bill that called for increased antitrust scrutiny of many healthcare private equity transactions was recently vetoed by the governor, state legislatures are likely to continue introducing similar laws, particularly if the Trump administration eases federal enforcement, say attorneys at Morgan Lewis.