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Life Sciences
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July 05, 2024
3rd Circ. Preview: Ponzi Scheme, Merck Vaccine Heat Up July
The Third Circuit's July argument schedule is sizzling with several high-stakes cases, including two whistleblowers attempting to make drugmaker Merck answer for allegedly inducing the U.S. government to pay for substandard mumps vaccines.
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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.
Expert Analysis
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CSA Case Could Shift Intrastate Commercial Cannabis
In Canna Provisions v. Merrick Garland, cannabis companies argue that the Controlled Substances Act is unconstitutional as applied to intrastate commercial cannabis activity; the Massachusetts federal court's eventual decision will be important to the cannabis industry for several reasons, including that the threat of federal enforcement would disappear overnight, says Hilary Bricken at Husch Blackwell.
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How AI May Be Used In Fintech Fraud — And Fraud Detection
Recent enforcement actions in the fintech and finance industries show that the government is increasingly pursuing fraud enabled by artificial intelligence — at the same time it’s using AI innovations to enforce regulations and investigate fraud, say attorneys at ArentFox Schiff.
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What Recent Study Shows About AI's Promise For Legal Tasks
Amid both skepticism and excitement about the promise of generative artificial intelligence in legal contexts, the first randomized controlled trial studying its impact on basic lawyering tasks shows mixed but promising results, and underscores the need for attorneys to proactively engage with AI, says Daniel Schwarcz at University of Minnesota Law School.
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Fed. Circ. Patent Lesson: No Contradiction, No Indefiniteness
The Federal Circuit’s recent ruling in Maxwell v. Amperex Technology highlights the complexities of construing patent claims when seemingly contradictory limitations are present, and that when a narrowing limitation overrides a broader one, they do not necessarily contradict each other, says Roy Wepner at Kaplan Breyer.
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11th Circ. FMLA Ruling Deepens Divide Over Causation
The Eleventh Circuit's recent ruling in Lapham v. Walgreen distinguishes the circuit as the loudest advocate for the but-for causation standard for assessing Family and Medical Leave Act retaliation claims, though employers in other jurisdictions may encounter less favorable standards and the U.S. Supreme Court will likely have to address the circuit split eventually, say attorneys at Benesch.
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Decline In Same-Industry M&A Tells A Nuanced Policy Story
In light of newly available Hart-Scott-Rodino Act data suggesting that intraindustry mergers are down overall and pharmaceutical and hospital intraindustry transactions tend to face greater antitrust scrutiny than in the past, attorneys at Morgan Lewis explore whether Biden administration enforcement policies may be curbing pro-competitive strategic M&A.
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What's At Play In Rising Lanham Act Cases At The ITC
Amid an uptick in Lanham Act claims involving false advertising related to medical devices at the U.S. International Trade Commission, Brian Busey and Maryrose McLaughlin at MoFo discuss recent ITC complaints from Eli Lilly and R.J. Reynolds, Lanham Act claim limits under the Federal Food, Drug, and Cosmetic Act, and the issues practitioners face in this realm.
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BIPA's Statutory Exemptions Post-Healthcare Ruling
The Illinois Supreme Court's November opinion in Mosby v. Ingalls Memorial Hospital, which held that the Biometric Information Privacy Act's healthcare exemption also applies when information is collected from healthcare workers, is a major win for healthcare defendants that resolves an important question of statutory interpretation, say attorneys at Quinn Emanuel.
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Key Factors In Establishing Compelling Merits At The PTAB
A look at over 450 Patent Trial and Appeal Board decisions between June 2022 and now provides insights into strategies for petitioners and patent owners in establishing compelling merits arguments in post-grant proceedings, say David Holman and Tyler Liu at Sterne Kessler.
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Litigation Inspiration: A Source Of Untapped Fulfillment
As increasing numbers of attorneys struggle with stress and mental health issues, business litigators can find protection against burnout by remembering their important role in society — because fulfillment in one’s work isn’t just reserved for public interest lawyers, say Bennett Rawicki and Peter Bigelow at Hilgers Graben.
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What FTC's 'Killer Acquisition' Theory Means For Pharma Cos.
The Federal Trade Commission's recent lawsuit to block Sanofi's acquisition of a pharmaceutical treatment developed by Maze Therapeutics builds on previous enforcement actions and could indicate the agency's growing willingness to use its so-called killer acquisition theory against perceived attempts to eliminate nascent competition, say attorneys at Morgan Lewis.
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Series
Skiing Makes Me A Better Lawyer
A lifetime of skiing has helped me develop important professional skills, and taught me that embracing challenges with a spirit of adventure can allow lawyers to push boundaries, expand their capabilities and ultimately excel in their careers, says Andrea Przybysz at Tucker Ellis.
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The Road Ahead For Florida's Drug Importation Program
Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.
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Assessing CDC's Revised Guideline On Opioid Prescriptions
Kenneth Weinstein, Nicholas Van Niel and Kate Uthe at Analysis Group look at newly available data to evaluate the impact that the Centers for Disease Control and Prevention's revised opioid monitoring guideline have had on prescription trends in recent years, highlighting both specific and overall decreases.
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Think Like A Lawyer: Forget Everything You Know About IRAC
The mode of legal reasoning most students learn in law school, often called “Issue, Rule, Application, Conclusion,” or IRAC, erroneously frames analysis as a separate, discrete step, resulting in disorganized briefs and untold obfuscation — but the fix is pretty simple, says Luke Andrews at Poole Huffman.