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Life Sciences
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February 14, 2025
Judge Upholds Pay-For-Delay Ban Law, But Only In Calif.
A California federal judge has upheld part of a new state law that the Association for Accessible Medicines alleged unlawfully restricted "reverse payment" settlements between makers of brand-name and generic drugs, finding that the law's attempt to regulate deals outside of California runs afoul of the Constitution, but is otherwise valid.
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February 14, 2025
Camston Wrather Files For Ch. 7 With Over $100M In Debt
California-based sustainable resource recovery company Camston Wrather LLC has filed for Chapter 7 bankruptcy listing liabilities between $100 million and $500 million along with up to $50 million in assets, citing insufficient funding to continue operations.
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February 14, 2025
Tariffs On Drugs And Chips May Not Bring Makers Stateside
The White House's planned tariffs on semiconductors, computer chips and pharmaceuticals are likely to raise prices for consumers and businesses, but won't necessarily lead to the president's stated goal of growing domestic manufacturing, attorneys and others told Law360.
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February 14, 2025
2nd Judge Blocks Trump Trans Health Order, Chides DOJ Atty
A Washington federal judge put a second temporary block on President Donald Trump's executive order targeting funding for gender-affirming care for people younger than 19, at a Seattle hearing where the judge said she was extremely frustrated with a federal government attorney's inability to answer questions about the order's discriminatory impact on transgender youth.
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February 13, 2025
Mallinckrodt Fails To Halt Airgas' Generic Nitric Oxide Drug
A Delaware federal judge has rejected Mallinckrodt Pharmaceuticals' attempt to block French industrial gas company Airgas Healthcare from selling a generic version of its inhaled nitric oxide treatment, saying Mallinckrodt didn't show enough evidence that Airgas infringed its patents or that it would suffer irreparable harm.
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February 13, 2025
DC Judge Affirms Approval Of Teva's Generic Sleep Drug
A D.C. federal judge upheld the U.S. Food and Drug Administration's approval of Teva's generic version of Vanda's sleep-walking treatment tasimelteon, ruling Thursday that omitting Braille on the labeling is permissible as it would be "aberrant" to allow safe variations in a drug's substance but not for labeling.
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February 13, 2025
Long-Term Zantac Use Raised Cancer Risks, Jury Hears
Chronic ranitidine ingestion was a factor in the development of prostate cancer in two men who are retrying their claims over the active ingredient in Boehringer Ingelheim's over-the-counter Zantac medication, the University of South Carolina's chief urologist testified in Illinois on Thursday.
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February 13, 2025
Maryland Judge Blocks Trump's Orders On Trans Healthcare
A Maryland federal judge on Thursday temporarily blocked the Trump administration from restricting gender-affirming care for people under the age of 19 and required the administration to keep in place federal funding for healthcare providers that provide transgender care.
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February 13, 2025
Merck Investor Sues Over Gardasil China Market Projections
Pharmaceutical giant Merck & Co. Inc. has been hit with a proposed shareholder class action alleging it overstated global demand for its human papillomavirus vaccine Gardasil, damaging investors when it revealed earlier this month it would not meet its revenue projections for the vaccine and paused shipments to China.
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February 13, 2025
9th Circ. Upholds DEA Denial Of Psilocybin Petition
The Ninth Circuit on Thursday affirmed the U.S. Drug Enforcement Administration's rejection of a Seattle physician's request to treat terminally ill patients with psilocybin.
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February 13, 2025
Musk's $97B OpenAI Bid Dubbed A 'Stunt' Amid Other Rumors
After a Wall Street Journal report on Monday revealed that a consortium of investors led by Elon Musk was offering $97.4 billion to buy the nonprofit that controls OpenAI, rumors began to swirl regarding the true intentions behind the billionaire's bid.
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February 13, 2025
Robert F. Kennedy Jr. Confirmed, Sworn In As HHS Secretary
Robert F. Kennedy Jr. is officially the nation's top healthcare official.
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February 13, 2025
Paul Hastings, Cooley Lead Obesity-Focused Aardvark's IPO
Obesity-focused Aardvark Therapeutics Inc. began trading Thursday after pricing a $94 million initial public offering at the bottom of its range, represented by Paul Hastings LLP and underwriters' counsel Cooley LLP, joining a string of biotechnology firms to go public recently.
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February 13, 2025
Greenberg Traurig Adds Goodwin Life Sciences Pro In Texas
Greenberg Traurig LLP has expanded its life sciences and technology practice with a shareholder in Austin, Texas, who has extensive expertise in handling cross-border deals and came aboard from Goodwin Procter LLP.
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February 12, 2025
Judge Finds No Infringement In Alcon's Eye Drop Patent Suit
Alcon Inc. has failed to persuade a Delaware federal court to block the release of a generic glaucoma treatment that would compete with a brand of eye drops the company sells.
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February 12, 2025
Bausch Health Beats Suit Over 'Faking' Financial Stability
Pharmaceutical company Bausch Health Cos. Inc. and its top brass have beaten, for now, a proposed class action accusing them of misleading shareholders about threats to the company's financial stability, with a New Jersey federal judge finding Wednesday that most of the challenged statements in the complaint are inactionable.
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February 12, 2025
Supply Co. Files Failsafe $387M Suit Amid Threat Of Dismissal
A medical supply procurement company has re-upped claims that a pharmaceutical middleman cut it out of a billion-dollar deal with the U.K. government to sell COVID-19 tests after newly unveiled information threatened to derail the long-running litigation.
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February 12, 2025
Aurion Tells Del. Justices IPO Delayed Amid Investor Battle
Cell therapy venture Aurion Biotech told Delaware's Supreme Court on Wednesday that it has delayed a planned initial public offering now at the center of an appeal from a January Court of Chancery ruling that rejected a top investor's challenge to a reverse stock split.
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February 12, 2025
Labcorp Can't Score New Trial After $384M Patent Loss
Clinical lab giant Labcorp has failed to land a new trial in front of U.S. District Judge Alan Albright after a $384.4 million patent infringement judgment against it in a case over a method for testing for genetic disorders during pregnancy.
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February 12, 2025
Paraquat Plaintiffs Urge 7th Circ. To Revive MDL Suits
Four plaintiffs who were set for bellwether trials in multidistrict litigation targeting the herbicide paraquat argued Wednesday that the Seventh Circuit should unwind their summary judgment losses because the district court's ruling was based on "core misunderstandings" about their expert's evidentiary requirements.
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February 12, 2025
RI Judge Won't Pause Order To Unfreeze Funds Amid Appeal
A Rhode Island federal judge refused Wednesday to pause a court order blocking a freeze on funding for federal grants and programs while the Trump administration appeals the ruling to the First Circuit.
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February 12, 2025
Ga. Judge Trims Untimely Paragard IUD Claims From MDL
The Georgia federal judge overseeing the sprawling multidistrict litigation over alleged defects in Paragard intrauterine devices agreed Tuesday to dismiss as untimely dozens of claims against Teva Pharmaceutical and Cooper Cos. from patients in eight states.
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February 12, 2025
Boston's Opioid Damages Claims Tossed As Too Late
Boston waited too long to sue a group of drug benefits intermediaries over their alleged roles in the opioid crisis, a Massachusetts federal judge said in dismissing the city's complaint Tuesday.
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February 11, 2025
Wash. Health Privacy Law Debuts In Amazon Tracking Suit
A Washington resident has launched the first claims under the state's groundbreaking health privacy law, as part of a proposed class action accusing Amazon of unlawfully harvesting location data from tens of millions of mobile phone users through third-party apps that are running the company's software development kit.
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February 11, 2025
Medtronic, Axonics Agree To End Bladder Control Patent Fight
A California federal judge on Tuesday agreed to permanently dismiss Medtronic's long-running dispute accusing Axonics of infringing its patents related to its bladder and bowel control device, three months after Medtronic sought a new trial in the case following a verdict where a federal jury found no infringement by Axonics.
Expert Analysis
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What Nearshoring Growth In Americas Means For Patents
With the new U.S. administration potentially focused on implementing draconian trade restrictions, nearshoring in the Americas is expected to grow, and patent prosecution attorneys will be kept on their toes as the patent landscape from country to country continues to evolve, says Ernest Huang at Procopio.
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Takeaways From FDA's Updated Confirmatory Trial Guidance
The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may help motivate the industry to complete confirmatory trials, say attorneys at Sheppard Mullin.
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The Most Important Schedule I Drug Regulatory Shifts Of 2024
In 2024, psychedelics and cannabis emerged as focal points in medical research, marking a pivotal year in their legal and regulatory journey, but these developments presented both opportunities and challenges within this evolving field, say Kimberly Chew at Husch Blackwell and Stephen Kim at Avicanna.
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Series
Coaching Little League Makes Me A Better Lawyer
While coaching poorly played Little League Baseball early in the morning doesn't sound like a good time, I love it — and the experience has taught me valuable lessons about imperfection, compassion and acceptance that have helped me grow as a person and as a lawyer, says Alex Barnett at DiCello Levitt.
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5 Litigation Funding Trends To Note In 2025
Lawyers and their clients must be prepared to navigate an evolving litigation funding market in 2025, made more complicated by a new administration and the increasing overall cost of litigation, says Jeffery Lula at GLS Capital.
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A Look At FDA's Plans To Establish New OTC Drug Category
The U.S. Food and Drug Administration's recently finalized rule, creating a new over-the-counter pathway for drugs when patients satisfy certain conditions, may be useful for off-patent drugs with established safety records, though switching to OTC comes with additional costs and considerations, say attorneys at Skadden.
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The Fed. Circ. In 2024: 5 Major Rulings To Know
In 2024, the Federal Circuit provided a number of important clarifications to distinct areas of patent law – including design patent obviousness, expert testimony admissions and patent term adjustments – all of which are poised to have an influence going forward, say attorneys at Knobbe Martens.
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Rethinking Litigation Risk And What It Really Means To Win
Attorneys have a tendency to overestimate litigation risk before summary judgment and underestimate risk after it, but an eight-stage litigation framework can clarify risk at different points and help litigators reassess what true success looks like in any particular case, says Joshua Libling at Arcadia Finance.
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How DOGE's Bite Can Live Up To Its Bark
All signs suggest that the Department of Government Efficiency will be an important part of the new Trump administration, with ample tools at its disposal to effectuate change, particularly with an attentive Republican-controlled Congress, say attorneys at K&L Gates.
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US-China Deal Considerations Amid Cross-Border Uncertainty
With China seemingly set to respond to the incoming U.S. administration's call for strategic decoupling and tariffs, companies on both sides of the Pacific should explore deals and internal changes to mitigate risks and overcome hurdles to their strategic plans, say attorneys at Covington.
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Considering The Status Of The US Doctrine Of Patent Misuse
A recent Ninth Circuit decision and a U.K. Court of Appeal decision demonstrate the impact that the U.S. Supreme Court's 2015 decision in Kimble v. Marvel Entertainment has had on the principle that post-patent-expiration royalty payments amount to patent misuse, not only in the U.S. but in English courts as well, say attorneys at Covington.
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Series
Playing Rugby Makes Me A Better Lawyer
My experience playing rugby, including a near-fatal accident, has influenced my legal practice on a professional, organizational and personal level by showing me the importance of maintaining empathy, fostering team empowerment and embracing the art of preparation, says James Gillenwater at Greenberg Traurig.
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Looking Back At 2024's Noteworthy State AG Litigation
State attorneys general across the U.S. took bold steps in 2024 to address unlawful activities by corporations in several areas, including privacy and data security, financial transparency, children's internet safety, and other overall consumer protection claims, say attorneys at Troutman Pepper.
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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.