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Life Sciences
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May 07, 2025
Device Seller Asks For Probation In $2.4M Tax Evasion Case
The septuagenarian owner of a Florida medical device company who pled guilty to evading $2.4 million in taxes asked a federal district court Wednesday for his sentence to entail home probation and not prison, given his health challenges and payments he already made to the Internal Revenue Service.
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May 07, 2025
Orrick Hires Boston Duo For Life Sciences Practice
Orrick Herrington & Sutcliffe LLP has added a pair of life sciences and tech company advisors from Wilson Sonsini Goodrich & Rosati PC as Boston partners, the firm said Wednesday.
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May 07, 2025
Masimo Unloads Embattled Audio Unit In $350M Sale
Samsung Electronics subsidiary Harman International has agreed to acquire Masimo Corp.'s consumer audio division, Sound United, for $350 million in cash, with Masimo taking a financial hit on the business it acquired three years ago for about $1 billion.
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May 06, 2025
Post-Ch. 11 Rite Aid Trustee Asks To Take Over Insurance Suit
A trust tied to Rite-Aid's previous bankruptcy exit plan has asked a New Jersey bankruptcy judge for permission to take over for Rite Aid in an adversary case seeking insurance money related to opioid claims.
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May 06, 2025
Medical Device Co. SeaStar Seeks Toss Of Shareholder Suit
SeaStar Medical Inc. has urged a Colorado federal judge to toss a proposed class action alleging the healthcare company misled investors about potential regulatory risks and compliance deficiencies, arguing the amended complaint "attempts to create the illusion of factual particularity through a façade of prolixity."
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May 06, 2025
Quarles & Brady Adds New IP, Real Estate Partners
Quarles & Brady LLP has welcomed a Milwaukee-based intellectual property litigator from Quinn Emanuel Urquhart & Sullivan LLP and a Phoenix-based real estate and public finance attorney from Ice Miller LLP.
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May 06, 2025
Fed. Circ. Asks What Law Applies For Sleep Drug Injunction
The Federal Circuit lifted an injunction Tuesday that had placed limits on Avadel CNS Pharmaceuticals' clinical trials for sleep disorder treatments, but sent the infringement case back to Delaware to determine whether a future injunction should be governed by the Hatch-Waxman Act.
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May 06, 2025
Haemonetics Sues Terumo Over Plasma Tech Patents
A Massachusetts-based developer of blood- and plasma-related medical technology has accused a Colorado-based competitor of infringing four of its plasma collection patents with two variations of a donation system that got approval from the U.S. Food and Drug Administration in 2022 and 2024.
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May 06, 2025
Mylan Agrees To Keep Nausea Generics Off Market Until 2032
Mylan Pharmaceuticals Inc. can enter the market in 2032 with a generic anti-nausea drug to compete with Heron Therapeutics Inc. products after the companies settled patent infringement litigation in Delaware federal court.
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May 06, 2025
Mistrial Declared On Punitive Damages In Bard Cancer Case
A Georgia state judge declared a mistrial as to punitive damages Tuesday in a suit alleging C.R. Bard's ethylene oxide emissions caused a man's cancer, leaving a $20 million compensatory damages verdict in place but inviting a round of briefing on the unusual situation.
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May 06, 2025
Ex-CEO Can't Shake Conviction In COVID Test Kit Fraud Case
The former chief executive of a healthcare software company who touted a $670 million COVID test kit deal that collapsed was denied acquittal Monday by a Newark federal judge who ruled the evidence was sufficient for a reasonable juror to find beyond a reasonable doubt that he had engaged in securities fraud.
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May 06, 2025
Trade Secrets Emerge As Path For Cos. To Protect AI Works
Classifying creations of artificial intelligence tools as trade secrets has become a viable alternative to copyrights and patents — a shift that is presenting businesses using AI with a range of strategies and risks they must consider to protect their innovations.
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May 06, 2025
Trump Orders FDA To Speed Up Drug Plant Approvals
President Donald Trump directed the U.S. Food and Drug Administration to cut the approval timelines for new manufacturing facilities by domestic drugmakers and also to pressure foreign drugmakers to comply with quality control inspections, according to a recent executive order.
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May 06, 2025
Gene-Editing Co. Synthego Hits Ch. 11 With Sights On A Sale
California-based biotechnology company Synthego Corp. filed for Chapter 11 in Delaware bankruptcy court, listing up to $500 million in debt and outlining a plan to sell its assets to its prepetition lender during the proceedings.
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May 05, 2025
DC Circ. Has Doubts About Narcolepsy Drug Appeal
The D.C. Circuit is now set to decide whether the U.S. Food and Drug Administration was wrong to declare a rival narcolepsy treatment not the "same drug" as another produced by Jazz Pharmaceuticals Inc., after appearing highly skeptical of the drug company's arguments that it was.
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May 05, 2025
Liquidia Fends Off Indication Challenge In UTC Tyvaso Fight
A D.C. federal court has rejected United Therapeutics Corp.'s challenge to a U.S. Food and Drug Administration decision allowing Liquidia Technologies Inc. to modify a new drug application to include an additional lung disease indication for a drug competing with UTC's blockbuster lung disease drug Tyvaso.
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May 05, 2025
8th Circ. Backs Boehringer's Copyright Win Over Software Co.
The Eighth Circuit upheld a district court's conclusion that Boehringer Ingelheim's veterinary arm and other companies did not infringe the copyrights of software company InfoDeli, saying in an opinion Monday that some elements of the online platforms that InfoDeli built were not entitled to protection.
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May 05, 2025
Regeneron, Amgen Open Drug 'Bundling' Trial In Del.
The founder and CEO of Regeneron Inc. told a federal jury in Delaware on Monday that a major pharmacy benefit insurer told him in mid-2020 his company was wasting its time in trying to keep a cholesterol-drug supply contract, with Amgen Inc. offering a better-priced but allegedly anticompetitive multidrug portfolio.
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May 05, 2025
PTAB Says It's Bedtime For Sleep Apnea Patent Claims
Patent board judges have decided to wipe out all the claims in a patent covering a method to treat sleep apnea, which were challenged by a San Diego sleep apnea outfit that says those claims reflect "97 percent" of a patent case over sleep apnea machines in Delaware federal court.
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May 05, 2025
Trump Admin Urges Dismissal Of States' Abortion Pill Suit
The Trump administration on Monday asked a Texas federal judge to dismiss a lawsuit seeking to roll back access to the abortion medication mifepristone, contending the three states pursuing the case waited too long to file and are suing in the wrong jurisdiction.
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May 05, 2025
Pharma Co. Escapes Investor Liver Drug Trial Suit, For Now
Biopharmaceutical company Akero Therapeutics Inc. and its executives have escaped, for now, a proposed class action alleging they misled investors about the patient population in a clinical trial for Akero's liver disease treatment, with a California federal judge on Monday rejecting the suit's theory of motive for the defendants.
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May 05, 2025
Rite Aid Hits Bankruptcy Less Than A Year After Previous Ch. 11
Drugstore chain Rite Aid Corp. reentered bankruptcy Monday less than a year after its earlier reorganization plan was approved, filing for Chapter 11 protection in New Jersey bankruptcy court with more than $1 billion in debt and plans for an asset sale.
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May 05, 2025
Purdue Tells Justices 'Rigid' Fed. Circ. Rule Threatens Patents
Bankrupt OxyContin-maker Purdue Pharma LP wants the U.S. Supreme Court to revive its legal effort to use patent laws to block the release of a competing "crush-resistant" generic painkiller, challenging a Federal Circuit decision that Purdue calls too "rigid."
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May 05, 2025
Exactech Committee Calls Foul On Ch. 11 Voting Packages
The official committee of unsecured creditors in Exactech Inc.'s Chapter 11 case told a Delaware bankruptcy judge that the company's solicitation packages sent to tort claimants violate court-approved procedures by requiring them to submit five separate ballots for their votes to be counted.
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May 05, 2025
Novartis, Incyte Settle Drug Royalty Fight On Eve Of Trial
A Manhattan federal judge put off trial on Monday in a five-year quest by Novartis to recover what it says are $500 million in missing royalties from its agreement to commercialize an Incyte compound used to treat blood cancers, with the sides announcing they reached a settlement.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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4 Legislative Proposals Reflect Growing Scrutiny Of Pharma IP
Bipartisan legislative momentum in Congress, including a recent package of bills targeting exclusivity strategies that delay generic and biosimilar competition, signals growing scrutiny of life sciences intellectual property strategies, so biologics companies and investors must pay attention to new strategic, compliance and litigation risks, says Olga Berson at Thompson Coburn.
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Series
Adapting To Private Practice: From NY Fed To BigLaw
While the move to private practice brings a learning curve, it also brings chances to learn new skills and grow your network, requiring a clear understanding of how your skills can complement and contribute to a firm's existing practice, and where you can add new value, says Meghann Donahue at Covington.
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7 Considerations For Conducting Drug Clinical Trials Abroad
With continuing cuts to U.S. Food and Drug Administration staffing motivating some pharmaceutical companies to consider developing drugs abroad, it's important to understand the additional risks and compliance requirements associated with conducting clinical studies in other countries, say attorneys at Morgan Lewis.
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Top 3 Litigation Finance Deal-Killers, And How To Avoid Them
Like all transactions, litigation finance deals can sometimes collapse, but understanding the most common reasons for failure, including a lack of trust or a misunderstanding of deal terms, can help both parties avoid problems, say Rebecca Berrebi at Avenue 33 and Boris Ziser at Schulte Roth.
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5th Circ. Ruling Is Latest Signal Of Shaky Qui Tam Landscape
In his recent concurring opinion in U.S. v. Peripheral Vascular Associates, a Fifth Circuit judge joined a growing list of jurists suggesting that the False Claims Act's whistleblower provisions are unconstitutional, underscoring that acceptance of qui tam relators can no longer be taken for granted, say attorneys at Miller & Chevalier.
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How Attys Can Use A Therapy Model To Help Triggered Clients
Attorneys can lean on key principles from a psychotherapeutic paradigm known as the "Internal Family Systems" model to help manage triggered clients and get settlement negotiations back on track, says Jennifer Gibbs at Zelle.
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3 Steps For In-House Counsel To Assess Litigation Claims
Before a potential economic downturn, in-house attorneys should investigate whether their company is sitting on hidden litigation claims that could unlock large recoveries to help the business withstand tough times, says Will Burgess at Hilgers Graben.
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J&J's Failed 3rd Try Casts Doubt On Use Of 'Texas Two-Step'
A Texas bankruptcy court recently rejected Johnson & Johnson's third attempt to use Chapter 11 to resolve liabilities from allegations of injuries from using talcum powder, suggesting that the U.S. Supreme Court's limitations on nondebtor releases, from 2024's Purdue Pharma ruling, may prove difficult to evade, say attorneys at Cadwalader.
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Series
Teaching College Students Makes Me A Better Lawyer
Serving as an adjunct college professor has taught me the importance of building rapport, communicating effectively, and persuading individuals to critically analyze the difference between what they think and what they know — principles that have helped to improve my practice of law, says Sheria Clarke at Nelson Mullins.
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Why Attys Should Get Familiar With Quantum Computing
Quantum computing is projected to pose significant updates to current practices in cryptography, making the issue relevant to policymakers and the legal profession generally, particularly when it comes to data storage, privacy regulations and pharmaceutical industry market changes, say professors at the University of San Francisco.
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Series
Adapting To Private Practice: From DOJ Enviro To Mid-Law
Practitioners leaving a longtime government role for private practice — as when I departed the U.S. Department of Justice’s environmental enforcement division — should prioritize finding a firm that shares their principles, values their experience and will invest in their transition, says John Cruden at Beveridge & Diamond.
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Legal Ethics Considerations For Law Firm Pro Bono Deals
If a law firm enters into a pro bono deal with the Trump administration in exchange for avoiding or removing an executive order, it has an ethical obligation to create a written settlement agreement with specific terms, which would mitigate some potential conflict of interest problems, says Andrew Altschul at Buchanan Angeli.
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Reproductive Health Under Trump So Far, And What's Next
Based on priorities stated so far, the Trump administration will likely continue to weaken Biden-era policies that protect reproductive health, with abortion, in vitro fertilization and contraception all being issues to watch closely amid a post-Dobbs shift, say attorneys at McDermott.
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Series
Playing Football Made Me A Better Lawyer
While my football career ended over 15 years ago, the lessons the sport taught me about grit, accountability and resilience have stayed with me and will continue to help me succeed as an attorney, says Bert McBride at Trenam.
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10 Arbitrations And A 5th Circ. Ruling Flag Arb. Clause Risks
The ongoing arbitral saga of Sullivan v. Feldman, which has engendered proceedings before 10 different arbitrators in Texas and Louisiana along with last month's Fifth Circuit opinion, showcases both the risks and limitations of arbitration clauses in retainer agreements for resolving attorney-client disputes, says Christopher Blazejewski at Sherin and Lodgen.