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Life Sciences
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July 05, 2024
Top Federal Tax Cases To Watch In The 2nd Half Of 2024
In the coming months, the U.S. Treasury and the IRS will defend rules designed to go after what they consider as abusive tax practices, including the economic substance doctrine, the Corporate Transparency Act and the moratorium on employee retention tax credits. Here, Law360 looks at key federal tax cases to watch in the rest of 2024.
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July 05, 2024
A&O Shearman-Led GSK Signs €1.4B Deal For Vaccines
British pharma giant GlaxoSmithKline has amended its collaboration agreement with German biopharmaceutical company CureVac to acquire full rights to develop, manufacture and commercialize globally the candidate vaccines for influenza and COVID-19 in an approximately €1.4 billion ($1.5 billion) deal.
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July 03, 2024
HHS Scores Early Win In Boehringer's Medicare Pricing Suit
A Connecticut federal judge on Wednesday sided with the U.S. Department of Health and Human Services in Boehringer Ingelheim's challenge to a new Medicare drug price negotiation program, rejecting the pharmaceutical company's claim that the program is unconstitutional.
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July 03, 2024
Humana Drops 6th Circ. Remand Bid In Ohio Collusion Suit
Humana is being dismissed from Ohio's lawsuit accusing pharmacy benefit managers and insurers of conspiring to inflate prescription prices through international subsidiaries after the company reached a settlement agreement in June.
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July 03, 2024
Roche Says Stanford Profs Stole Cancer Detection Tech
Roche Molecular Systems has accused Stanford University and several faculty members of swiping its proprietary cancer detection technology and secretly founding a new company with it, according to a suit filed in California federal court.
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July 03, 2024
Revived Skinny Label Case Is A Warning For Generics
The Federal Circuit has made clear that generic-drug companies need to pay close attention to public statements when advertising drugs that still have patent-protected uses, even if their so-called skinny labels properly avoid references to those carved-out indications, attorneys say.
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July 03, 2024
Appeals Board Tosses Revived License Breach Dispute
The Civilian Board of Contract Appeals has again tossed a dispute, previously revived by the Federal Circuit, alleging the U.S. Food and Drug Administration breached a software company's end-user license agreement, saying it lacks jurisdiction to enforce the agreement.
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July 03, 2024
Cooley DQ'd From IP Case Over Atty's Past Patent Work
Cooley LLP was disqualified on Wednesday from representing a pharmaceutical customer-support software company against patent infringement claims in Delaware, with the district court citing a Cooley partner's prior work representing the plaintiff and Cooley's refusal to screen its attorney.
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July 03, 2024
Penile Implant Doc Seeks $7M Atty Fees, Costs In $18M IP Win
A urologist who won $18.3 million in royalties and damages after a jury found a rival stole his penile implant trade secrets and infringed his intellectual property asked a California federal judge for $6.5 million in attorney fees and $614,000 in costs, saying he is owed the funds as the prevailing party in the litigation.
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July 03, 2024
4 Mass. Rulings You Might Have Missed In June
Massachusetts state courts last month dealt with thorny contract disputes, mistakenly disclosed emails between a defendant and an attorney, and a company's overtime policy change that may not have been spelled out to workers.
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July 03, 2024
1st Circ. Hands Hearing Loss Biotech Win In Stock-Drop Suit
A panel of the First Circuit declined to revive an investor class action alleging that a hearing loss treatment company and some of its executives concealed disappointing clinical trial results, saying there was no evidence the company had knowingly made false statements about the trial.
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July 03, 2024
Cerevel Investors Allege Insider Trades Pre-$8.7B AbbVie Deal
A pension fund shareholder of Cerevel Therapeutics Holdings Inc. has sued the biopharmaceutical company in Delaware's Court of Chancery, seeking documents to investigate potential fiduciary duty breaches and possible insider trading shortly before the company announced its pending $8.7 billion merger with AbbVie Inc.
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July 03, 2024
After Chevron Deference: What Lawyers Need To Know
This term, the U.S. Supreme Court overturned Chevron deference, a precedent established 40 years ago that said when judges could defer to federal agencies' interpretations of law in rulemaking. Here, catch up with Law360's coverage of what is likely to happen next.
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July 03, 2024
Chancery Tosses Challenge To $3B AstraZeneca Viela Bio Sale
AstraZeneca PLC and a U.K. affiliate beat late Tuesday a Delaware Court of Chancery stockholder suit accusing the company of orchestrating an underpriced, $3 billion sale of clinical stage biopharmaceutical venture Viela Bio Inc. in order to clear the way for AstraZeneca's purchase of a larger competitor.
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July 03, 2024
Quest Diagnostics Paying $985M For OMERS' LifeLabs
Canadian law firm McCarthy Tétrault LLP is guiding New Jersey-based Quest Diagnostics on a newly inked deal to buy LifeLabs from the Ontario Municipal Employees Retirement System, or OMERS, for about $985 million, Quest said Wednesday.
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July 02, 2024
FTC Investigating Teva Inhaler Patent Listings, Report Says
The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals after it refused to remove inhaler patents from a key federal database, according to a Washington Post report citing confidential agency documents.
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July 02, 2024
Chamber, Pharma Slam Colorado Drug Price Controls
The U.S. Chamber of Commerce and a prominent pharmaceutical industry group have urged a Colorado federal court to bar a state review board from setting price controls on prescription drugs, arguing that the practice is "irreconcilable" with federal patent law.
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July 02, 2024
Biotech Biz Co-Directors Sue Each Other In Del., Cite Breaches
A California-based biotech company once researching a new class of antiviral therapy for COVID-19 is now the subject of dissolution proceedings in Delaware's Court of Chancery, after the company's two directors filed dueling lawsuits alleging fiduciary duty breaches and a board-level stalemate.
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July 02, 2024
Pharma Co. Scores Exit In Investor Suit Over Primate Imports
A Massachusetts federal judge tossed every claim in a proposed class action claiming that pharmaceutical company Charles River Laboratories and its executives concealed their involvement in the illegal importation of nonhuman primates for research, ruling that the disputed statements are not false or misleading.
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July 02, 2024
McKinsey Wants To Arbitrate Ex-Partner's Defamation Suit
McKinsey & Co. has urged a New York state judge to send to arbitration or dismiss a former partner's defamation lawsuit alleging the consulting giant tried to make him a scapegoat for purported evidence destruction amid a U.S. Department of Justice probe into McKinsey's work with opioid makers.
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July 02, 2024
Beasley Allen Slams J&J's DQ Bid 'Check-Up' In Talc Tort
The Beasley Allen Law Firm and Johnson & Johnson continue to spar over the firm and attorney Andy Birchfield's role in long-running federal and state mass torts over talcum powder injuries, with the firm calling out J&J on Tuesday for "prodding" the New Jersey courts to boot the lawyers from the litigation.
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July 02, 2024
High Court Agrees To Review FDA's Flavored E-Cig Denial
The U.S. Supreme Court on Tuesday granted the U.S. Food and Drug Administration's petition to review a Fifth Circuit decision overturning its denial of a flavored e-cigarette marketing application.
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July 01, 2024
High Court's 1-2 Punch Sets Up Long-Standing Regs For KO
By ending its term with a stinging combination against federal agencies, the U.S. Supreme Court's conservative bloc left behind a bruised bureaucracy and a regulatory system that's now vulnerable to a barrage of incoming attacks.
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July 01, 2024
UC Riverside Profs Win Combined $6.1M In Retaliation Trial
Two former University of California, Riverside professors were awarded a total of $6.1 million in damages by a jury that found they were retaliated against in violation of the California Whistleblower Protection Act after making official complaints about alleged misdeeds their supervisor was engaging in, including misuse of government funds.
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July 01, 2024
State AGs Get Stay Lifted In Generic Drug Pricing Litigation
A Connecticut federal judge on Monday agreed to lift a partial discovery stay in a trio of generic drug pricing antitrust suits led by the attorneys general of New York and Connecticut, according to a short, text-only order posted to each of the case dockets.
Expert Analysis
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Opinion
USPTO's Proposed Disclaimer Rule Would Harm Inventors
The U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers will make the patent system less available to inventors and will unfairly favor defendants in litigation, say Stephen Schreiner at Carmichael IP and Sarah Tsou at Omni Bridgeway.
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Series
Being An EMT Makes Me A Better Lawyer
While some of my experiences as an emergency medical technician have been unusually painful and searing, the skills I’ve learned — such as triage, empathy and preparedness — are just as useful in my work as a restructuring lawyer, says Marshall Huebner at Davis Polk.
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Mitigating Incarceration's Impacts On Foreign Nationals
Sentencing arguments that highlighted the disparate impact incarceration would have on a British national recently sentenced for insider training by a New York district court, when compared to similarly situated U.S. citizens, provide an example of the advocacy needed to avoid or mitigate problems unique to noncitizen defendants, say attorneys at Lankler Siffert.
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Contract Disputes Recap: Saying What Needs To Be Said
Edward Arnold and Bret Marfut at Seyfarth Shaw examine three recent decisions that delve into the meaning and effect of contractual releases, and demonstrate the importance of ensuring that releases, as written, do what the parties intend.
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Lessons On Challenging Class Plaintiffs' Expert Testimony
In class actions seeking damages, plaintiffs are increasingly using expert opinions to establish predominance, but several recent rulings from California federal courts shed light on how defendants can respond, say Jennifer Romano and Raija Horstman at Crowell & Moring.
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Exploring An Alternative Model Of Litigation Finance
A new model of litigation finance, most aptly described as insurance-backed litigation funding, differs from traditional funding in two key ways, and the process of securing it involves three primary steps, say Bob Koneck, Christopher Le Neve Foster and Richard Butters at Atlantic Global Risk LLC.
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Del. IP Ruling May Mark Limitation-By-Limitation Analysis Shift
A Delaware federal court's recent ruling in Lindis Biotech v. Amgen, which involved complex technology where the complaint contained neither facts nor a specific allegation directed to a claim limitation, might spark a shift away from requiring a limitation-by-limitation analysis, say Ted Mathias and Ian Swan at Axinn.
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Cell Therapy Cos. Must Beware Limits Of Patent Safe Harbors
Though developers of gene and cell therapy products commonly assume that a legal safe harbor protects them from patent infringement suits, recent case law shows that not all preapproval uses of patented technology are necessarily protected, say Natasha Daughtrey and Joshua Weinger at Goodwin.
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Series
Teaching Yoga Makes Me A Better Lawyer
Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.
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How Clinical Trials Affect Patentability In US And Europe
A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.
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A Vision For Economic Clerkships In The Legal System
As courts handle increasingly complex damages analyses involving vast amounts of data, an economic clerkship program — integrating early-career economists into the judicial system — could improve legal outcomes and provide essential training to clerks, say Mona Birjandi at Data for Decisions and Matt Farber at Secretariat.
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Opinion
State-Regulated Cannabis Can Thrive Without Section 280E
Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Opinion
Feds' Biotech Enforcement Efforts Are Too Heavy-Handed
The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.