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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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The Key To Solving High Drug Costs Is Understanding Causes
One-sided views on who or what contributes to the high cost of pharmaceuticals render possible solutions much harder to discover and implement, and a better approach would be to examine history and learn why costs have increased and what legislation has and hasn't helped, says Nancy Linck at NJ Linck Consulting.
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Opinion
Legal Institutions Must Warn Against Phony Election Suits
With two weeks until the election, bar associations and courts have an urgent responsibility to warn lawyers about the consequences of filing unsubstantiated lawsuits claiming election fraud, says Elise Bean at the Carl Levin Center for Oversight and Democracy.
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Opinion
Bring Back Patent Models To Shut Down The Patent Trolls
By reintroducing the requirement that inventors submit a miniature working model of their inventions along with their patent, legislators could help to deter patent trolls, reduce frivolous litigation and support legitimate inventors in protecting their innovations, says Darin Gibby at Kilpatrick.
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Strategies To Avoid Patent Issues In AI Drug Discovery
Artificial intelligence has the potential to improve drug discovery and design, but companies should consider a variety of factors when patenting drugs created using AI systems, including guidance from the U.S. Patent and Trademark Office and methods for protecting patent eligibility, say attorneys at Ropes & Gray.
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How Cos. Can Build A Strong In-House Pro Bono Program
During this year’s pro bono celebration week, companies should consider some key pointers to grow and maintain a vibrant in-house program for attorneys to provide free legal services for the public good, says Mary Benton at Alston & Bird.
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Bristol-Myers Win Offers Lessons For Debt Security Holders
A New York federal judge's recent dismissal of a $6.4 billion lawsuit against Bristol-Myers Squibb, due to plaintiff UMB Bank's lack of standing, serves as an important reminder to debt security holders to obtain depositary proxies before pursuing litigation, say attorneys at Milbank.
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Series
Home Canning Makes Me A Better Lawyer
Making my own pickles and jams requires seeing a process through from start to finish, as does representing clients from the start of a dispute at the Patent Trial and Appeal Board through any appeals to the Federal Circuit, says attorney Kevin McNish.
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Navigating The Bankruptcy Terrain After Purdue Pharma
The U.S. Supreme Court’s June ruling in Harrington v. Purdue Pharma is having a significant impact on bankruptcies, with recent cases addressing nonconsensual third-party releases and opt-out mechanisms, and highlighting strategies practitioners can employ to avoid running afoul of the decision, say Brett Axelrod and Agostino Zammiello at Fox Rothschild.
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5 Considerations For Obviousness-Type Double Patenting
The U.S. Supreme Court’s recent denial of certiorari for In re: Cellect highlights the current state of obviousness-type double patenting based on that case and another recent Federal Circuit decision, including that ODP is not fatal, that divisional applications are protected from ODP and more, says Fabian Koenigbauer at Ice Miller.
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Patent Lessons From 7 Federal Circuit Reversals In August
The Federal Circuit’s seven vacated or reversed cases from August provide helpful clarity on obviousness-type double patenting, written description and indefiniteness, and suggest improved practices for petitioners and patent owners in inter partes review, say Denise De Mory and Li Guo at Bunsow De Mory.
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Use The Right Kind Of Feedback To Help Gen Z Attorneys
Generation Z associates bring unique perspectives and expectations to the workplace, so it’s imperative that supervising attorneys adapt their feedback approach in order to help young lawyers learn and grow — which is good for law firms, too, says Rachael Bosch at Fringe Professional Development.
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Opinion
Congress Can And Must Enact A Supreme Court Ethics Code
As public confidence in the U.S. Supreme Court dips to historic lows following reports raising conflict of interest concerns, Congress must exercise its constitutional power to enact a mandatory and enforceable code of ethics for the high court, says Muhammad Faridi, president of the New York City Bar Association.
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Series
The Pop Culture Docket: Justice Lebovits On Gilbert And Sullivan
Characters in the 19th century comic operas of Gilbert and Sullivan break the rules of good lawyering by shamelessly throwing responsible critical thought to the wind, providing hilarious lessons for lawyers and judges on how to avoid a surfeit of traps and tribulations, say acting New York Supreme Court Justice Gerald Lebovits and law student Tara Scown.
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New HHS Research Misconduct Rules Bring Seismic Changes
The U.S. Department of Health and Human Services' new rule regarding research misconduct investigations brings significant changes that focus on remediation, appeals and confidentiality, while other changes could result in institutions causing undue harm to scientists accused of such misconduct, say attorneys at Cohen Seglias.
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State Of The States' AI Legal Ethics Landscape
Over the past year, several state bar associations, as well as the American Bar Association, have released guidance on the ethical use of artificial intelligence in legal practice, all of which share overarching themes and some nuanced differences, say Eric Pacifici and Kevin Henderson at SMB Law Group.