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Life Sciences
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March 12, 2025
Law360 Cheat Sheet: Novartis' Fight Over Generic Entresto
Novartis has led a wide-ranging litigation campaign to block generic versions of its bestselling cardiovascular drug Entresto that has involved multidistrict litigation, trips to several circuit courts and cases against the federal government. Here, Law360 breaks down how the various cases intersect and what's still playing out.
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March 12, 2025
SEC Says Ex-Allarity Execs Concealed Doomed FDA Approval
The U.S. Securities and Exchange Commission sued three former executives of clinical-stage pharmaceutical company Allarity Therapeutics Inc. in Massachusetts federal court, alleging Wednesday that they schemed to conceal from the public that the company's new drug application for its flagship drug had no chance of gaining regulatory approval.
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March 12, 2025
Caribou Biosciences Brass Face Investor's Clinical Trials Suit
Executives and directors of Caribou Biosciences Inc. have been hit with a shareholder's derivative suit alleging that they overstated the safety and efficacy of Caribou's cell therapy and concealed that the company was at risk of being unable to fund its operations.
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March 12, 2025
COVID Test Device Maker Settles Fed. Circ. Feuds With Rival
A company that makes saliva collection devices used for COVID-19 tests says it will drop out of Federal Circuit appeals fights with Longhorn Vaccines & Diagnostics stemming from the Patent Trial and Appeal Board canceling 183 of Longhorn's patent claims as a punishment for "egregious abuse of the PTAB process."
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March 12, 2025
Publix Policies Don't Cover Opioid Claims, Court Says
Insurers for Publix have no duty to defend or indemnify the supermarket chain in dozens of public nuisance lawsuits related to the opioid crisis, a Florida federal court said Wednesday, following Publix's renewed request that the court enter a final judgment so it could proceed with appeal.
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March 12, 2025
NC Organ Procurer Sues CMS Over Hospital Waiver
A North Carolina-based organ procurement organization told a federal court Wednesday that the Centers for Medicare & Medicaid Services has violated federal law by giving a waiver to a hospital to work with another organ procurement service from a different region.
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March 12, 2025
Cannabis Tech Co. Seeks Over $1M Interest On $4.2M Verdict
A software company that won a $4.2 million judgment last year on claims that it was wrongly pushed out of a state government contract is urging a Pennsylvania federal court to award more than $1 million in pre- and postjudgment interest on the award.
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March 12, 2025
HHS To Eliminate 6 Regional Offices For Legal Staff
The U.S. Department of Health and Human Services said Tuesday it will close six out of 10 regional offices where attorneys for the agency work.
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March 12, 2025
Harvard Docs Say Gov't Censored Articles With Gender Terms
A pair of Harvard Medical School researchers sued the Trump administration in Massachusetts federal court on Wednesday, claiming their work was erased from a government-run patient safety website because their articles contained terms like "LGBTQ" and "transgender."
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March 12, 2025
Mallinckrodt Investors Ask NJ Court To Approve $46M Deal
A group of Mallinckrodt PLC investors has asked a New Jersey federal judge to grant final approval to a $46 million settlement they reached with executives and directors of the pharmaceutical company to resolve claims that they misrepresented the prospects of a drug the company developed.
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March 12, 2025
McCarter & English Wins $3.77M From Ex-Client In Billing Spat
McCarter & English LLP is entitled to nearly $3.77 million from Jarrow Formulas Inc., a nutritional supplement company that refused to pay its legal bills after losing a trade secrets trial and a subsequent malpractice claim against the firm, a Connecticut federal judge has ruled.
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March 11, 2025
Medical Device Co. Seeks Fed. Circ. Redo Over Patent Trial
A medical device manufacturer is asking a Federal Circuit panel to reconsider a decision reviving a patent infringement case against it, arguing a lower court judge was fine to allow tardy testimony from a witness who took its side.
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March 11, 2025
Kenvue Unit Can't Nix BIPA Suit Over Neutrogena Skin360 App
A Kenvue unit can't escape a proposed class action alleging it unlawfully stores facial scans of people who use its Neutrogena Skin360 tool in violation of Illinois' biometric privacy statute, after a New Jersey federal judge said those users are not "patient[s] in a healthcare setting" under the statute's healthcare exemption.
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March 11, 2025
'Paucity' Of Proof Thwarts NC State Law Claims In Gardasil MDL
A North Carolina federal judge has found that Merck did not violate state law by not including warnings about its Human Papillomavirus vaccine Gardasil, saying there was a "paucity" of evidence that the vaccines cause certain injuries to recipients.
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March 11, 2025
More ITC Patent Cases Expected After Fed. Circ. 'Sea Change'
A recent Federal Circuit decision discarding the U.S. International Trade Commission's limits on what types of domestic expenses qualify a company to bring a patent suit at the agency marks a pronounced shift that will likely spur considerably more ITC cases, attorneys say.
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March 11, 2025
Pharmacies To Appeal In Bid To Keep Making Weight Loss Drug
A group of compounding pharmacies said Monday they would appeal to the Fifth Circuit after a Texas federal judge denied an injunction that would allow compounding pharmacies to produce a lucrative weight loss drug.
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March 11, 2025
J&J Tells 3rd Circ. No Price Impact In Talc Concealment Suit
Johnson & Johnson urged the Third Circuit on Tuesday to undo class certification of investor claims that the company inflated its stock price by failing to disclose cancer risks associated with its talcum powder products, arguing that the investors could not have relied upon its alleged misrepresentations because there was no impact on the stock market's price.
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March 11, 2025
Brazilian 'Drug King' Ran Black Market Pharmacy, Feds Say
Federal prosecutors said a Brazilian national living in the United States without permission falsely portrayed himself as a pharmacist to sell members of a large Portuguese-speaking community west of Boston an array of medications, including painkillers, steroids and other controlled drugs.
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March 11, 2025
Zydus Cuts Deal With States, Tribes In Opioid Nuisance Suit
Zydus Pharmaceuticals Inc. has reached a deal in principle with states and Native American tribes that should quash claims related to the company's alleged role in exasperating the opioid crisis.
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March 11, 2025
Eli Lilly Suit Over Compounded Drugs Survives Dismissal
A Washington federal judge has trimmed Eli Lilly's lawsuit against two Seattle-area clinics and the doctors who run them for allegedly duping consumers into buying copycat versions of its diabetes and weight loss medications Mounjaro and Zepbound, nixing the pharmaceutical giant's consumer protection claim while preserving its trademark infringement and false advertising allegations.
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March 11, 2025
Alaska's RICO Claims Advance Against PBM In Opioid Suit
An Alaska federal judge has allowed most of the state's Racketeer Influenced and Corrupt Organization Act claims to move forward against pharmacy benefits manager Express Scripts for its alleged role in the opioid epidemic.
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March 11, 2025
Post Hit With False Ad Suit Over Rachael Ray Brand Pet Food
Post sells celebrity chef Rachael Ray's Nutrish brand of pet foods that are falsely labeled as being "natural" with "no artificial preservatives" despite containing citric acid, which is derived from heavy chemical processing, according to a proposed class action filed in California federal court Monday.
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March 11, 2025
Endo Sells International Pharma Biz To Knight For Up To $99M
Pharmaceutical company Endo Inc., led by Davis Polk & Wardwell LLP and Torys LLP, on Tuesday announced plans to sell its international pharmaceuticals business to Davies Ward Phillips & Vineberg LLP-advised Canadian pharmaceutical company Knight Therapeutics Inc. for up to $99 million.
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March 11, 2025
Publix's Suit Over Ga. County's Private Attys 'Beyond Reason'
Publix can't sue a metro Atlanta county to force it to drop its private attorneys who filed an opioid suit against the supermarket chain, the Georgia Court of Appeals has said, ruling that the company "fails to show what right the county has violated by its choice of counsel."
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March 11, 2025
Trump Admin Drops Suit Over COVID Nasal Spray Ads Claims
The U.S. Department of Justice quietly moved Monday to drop a Utah federal court lawsuit filed on behalf of the Federal Trade Commission accusing a sinus nasal spray company of falsely claiming its products could help prevent and treat COVID-19.
Expert Analysis
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What To Expect Next From Federal Health Tech Regulation
Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.
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Trump Rollback Of Biden Enviro Policies: What To Expect
Donald Trump's upcoming second presidential term will usher significant shifts in U.S. environmental and natural resource law and policy — and while the Biden administration is racing to secure its legacy, the incoming Trump administration is making plans to dramatically roll back most, if not all, of Biden's environmental initiatives, say attorneys at Beveridge & Diamond.
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Takeaways From State Votes On Abortion In The 2024 Election
Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.
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Key Territory-Split Licensing Lessons For Life Sciences Cos.
Territory-split deals can allow life sciences companies to maximize products' potential across a range of geographic areas, but these deals also present unique challenges requiring highly bespoke structures that can make or break the value of an asset, say attorneys at Covington.
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Legislation Most Likely To Pass In Lame Duck Session
As Congress begins its five-week post-election lame duck session, attorneys at Greenberg Traurig break down the legislative priorities and which proposals can be expected to pass.
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Justices Must Weigh Reach Of Civil RICO In Cannabis Case
Oral arguments in Medical Marijuana Inc. v. Horn suggest that a majority of the U.S. Supreme Court may agree that a truck driver's losing his job after unknowingly ingesting THC and failing a drug test does not merit a racketeering claim — but the court may not buy the other side's theory of the case either, say attorneys at Lewis Baach.
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Litigation Strategies In View Of New Double Patenting Rulings
Recent Federal Circuit decisions, including in Allergan v. MSN, raise several issues that patent owners should understand and consider addressing proactively regarding obviousness-type double patenting, at least in their prosecution strategies, say attorneys at Dentons.
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Promoting Diversity In The Selection Of ADR Neutrals
Excerpt from Practical Guidance
Choosing neutrals from diverse backgrounds is an important step in promoting inclusion in the legal profession, and it can enhance the legitimacy and public perception of alternative dispute resolution proceedings, say attorneys at Lowenstein Sandler.
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Series
Playing Ultimate Makes Us Better Lawyers
In addition to being fun, ultimate Frisbee has improved our legal careers by emphasizing the importance of professionalism, teamwork, perseverance, enthusiasm and vulnerability, say Arunabha Bhoumik and Adam Bernstein at Regeneron.
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E-Discovery Quarterly: Recent Rulings On Metadata
Several recent rulings reflect the competing considerations that arise when parties dispute the form of production for electronically stored information, underscoring that counsel must carefully consider how to produce and request reasonably usable data, say attorneys at Sidley.
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Opinion
PREVAIL Bill Is Another Misguided Attempt To Restrict PTAB
The decade-long campaign against the U.S. Patent and Trademark Office's Patent Trial and Appeal Board — currently focused on the PREVAIL Act that's slated for markup in the Senate — is not really about procedural issues, and it is not aimed at securing more accurate patentability decisions, says Clear IP's Joseph Matal, former acting director at the USPTO.
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Striking A Balance Between AI Use And Attorney Well-Being
As the legal industry increasingly adopts generative artificial intelligence tools to boost efficiency, leaders must note the hidden costs of increased productivity, and work to protect attorneys’ well-being while unlocking AI’s full potential, says Ed Sohn at Factor.
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Empathy In Mediation Offers A Soft Landing For Disputes
Experiencing a crash-landing on a recent flight underscored to me how much difference empathy makes in times of crisis or stress, including during mediation, says Eydith Kaufman at Alternative Resolution Centers.
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Series
Being An Artist Makes Me A Better Lawyer
My work as an artist has highlighted how using creativity and precision together — qualities that are equally essential in both art and law — not only improves outcomes, but also leads to more innovative and thoughtful work, says Sarah La Pearl at Segal McCambridge.
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How Judiciary Can Minimize AI Risks In Secondary Sources
Because courts’ standing orders on generative artificial intelligence and other safeguards do not address the risk of hallucinations in secondary source materials, the judiciary should consider enlisting legal publishers and database hosts to protect against AI-generated inaccuracies, say attorneys at Lankler Siffert & Wohl.