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Life Sciences
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April 12, 2024
US-based MSD Broke Ban On Using 'Merck' In UK, Court Finds
U.S.-based Merck Sharp & Dohme LLC's use of the "Merck" name on websites and social media breached the terms of a court order barring it from using the name in the U.K. to protect German drugmaker Merck KGaA's rights, a London court ruled Friday.
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April 12, 2024
Zoll Says 'Cookie-Cutter' Hack Claims Don't Show Harm
Zoll Medical Corp. is asking a Boston federal judge to toss a proposed class action brought by medical device customers whose personal information was released during a ransomware attack last year and an earlier data breach in 2019, arguing the consumers weren't actually injured.
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April 12, 2024
EU Approves Biotech Co. Illumina's Plan To Divest Grail
European Union antitrust authorities on Friday approved Illumina's plan to sell off Grail, the latest development in a saga that saw the biotech company reverse course and agree to offload the cancer-screening company after authorities claimed the reacquisition was completed "unlawfully."
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April 12, 2024
Asbury Park Escapes Pot Co.'s Zoning Board Conspiracy Suit
A New Jersey federal court has dismissed a medical cannabis company's suit alleging Asbury Park and its zoning board conspired with a rival to block it from operating a treatment center, saying the complaint fails to support its allegations of the scheme.
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April 11, 2024
Sandoz Says Feds Misclassified Generics As 'Innovator Drugs'
Pharmaceutical company Sandoz Inc. sued the Centers for Medicare & Medicaid Services in Washington, D.C., federal court on Wednesday, alleging the agency ignored the company's objection to classifying two of its generics as "innovator drugs," which could impact Sandoz's rebate obligations under Medicaid.
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April 11, 2024
Fed. Circ. Blocks Alvogen Generic Of Bausch Diarrhea Drug
The Federal Circuit upheld a decision Thursday that prevents Alvogen from releasing a generic version of Bausch Health's blockbuster diarrhea and brain disease drug Xifaxan until 2029, rejecting Alvogen's bid to launch sooner because it was cleared of infringing some patents.
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April 11, 2024
FDA Commissioner Says Congress Must Act On Hemp, CBD
The commissioner of the U.S. Food and Drug Administration said Thursday that the agency did not consider hemp-derived CBD safe enough to be sold lawfully as a dietary supplement, and urged Congress to create a new pathway to regulate the substance.
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April 11, 2024
9th Circ. Nixes 'Super Snap Removals' In Dexcom Suits
The Ninth Circuit won't let Dexcom Inc. remove three suits alleging its glucose monitoring system is defective to federal court, saying its "super snap removal" motions were premature as they were filed before any of the cases actually commenced.
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April 11, 2024
Birth Control Injury Claims Barred From Conn., Court Told
Connecticut state courts have no basis to exercise jurisdiction over three of the four companies targeted in product liability lawsuits brought by 103 women who claim their Filshie Clip birth control devices migrated within their bodies and caused injuries, counsel for the defendants told a Waterbury judge Thursday.
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April 11, 2024
Deals Rumor Mill: US Steel, Germany's Stada, Paramount
The DOJ opens a probe into Nippon’s proposed $14.9 billion takeover of US Steel, German drugmaker Stada explores a sale, and Paramount and Skydance are hashing out potential deal terms. Here, Law360 breaks down these and other notable deal rumors from the past week.
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April 11, 2024
Del. Justices OK Denial Of Icahn-Illumina Midcase Appeal Bid
Billionaire investor Carl Icahn may not put his Chancery Court litigation against biotechnology company Illumina Inc.'s board on hold for a review of a decision that struck portions of the complaint that were based on confidential information, Delaware's Supreme Court said Thursday, upholding the lower court's rejection of the midcase appeal.
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April 11, 2024
Medtronic Can't Ditch Ex-Sales Rep's Retaliation Claim
Medical device maker Medtronic can't avoid a whistleblower retaliation claim by a former sales rep who says he was pushed out after reporting what he suspected to be a kickback scheme to the U.S. Food and Drug Administration, a federal judge said Wednesday.
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April 11, 2024
Kirkland, Jones Day Build $787.5M Sale Of Steris' Dental Unit
Medical device company Steris, advised by Jones Day, on Thursday announced plans to sell its dental segment to Kirkland & Ellis LLP-advised middle market private equity shop Peak Rock Capital for $787.5 million.
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April 11, 2024
Life Sciences Group Of The Year: Sullivan & Cromwell
Sullivan & Cromwell LLP helped Bayer defeat Merck in litigation over asbestos-containing talc liability and guided mega pharma deals such as Pfizer's $43 billion acquisition of Seagen and Amgen's $27.8 billion acquisition of Horizon Therapeutics, earning the firm a spot among Law360's 2023 Life Sciences Groups of the Year.
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April 10, 2024
Pfizer Unit Cuts $39M Deal Ending Effexor Antitrust Claims
A proposed class of direct buyers asked a New Jersey federal judge on Tuesday to approve a $39 million settlement to end allegations that Pfizer Inc. unit Wyeth engaged in a scheme with Teva Pharmaceuticals to delay generic competition for the antidepressant drug Effexor XR.
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April 10, 2024
DOJ Hits Regeneron With False Claims Act Suit Over Eylea
The federal government has brought a False Claims Act intervenor complaint in Massachusetts against Regeneron, alleging the pharmaceutical giant fraudulently withheld information from its Medicare reports seeking reimbursement for its drug Eylea, the U.S. Department of Justice announced Wednesday.
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April 10, 2024
Del. Justices Probe Validity Of Advance Notice Bylaws
The appeal of a Delaware Chancery Court decision voiding a biopharmaceutical company's "onerous" advance notice requirements for director nominations while upholding the rejection of an activist shareholder's nominees boiled down to one basic legal question at Delaware's Supreme Court Wednesday: Is this a facial or an as-applied challenge?
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April 10, 2024
9th Circ. Mostly Affirms Industry Ban For COVID PPE Delays
A Ninth Circuit panel on Tuesday largely upheld a district court's ruling requiring personal protective equipment suppliers to pay over $3 million after finding that they misrepresented the shipping times of hand sanitizer products at the start of the COVID-19 pandemic, while reversing the Federal Trade Commission's injunction against one of the companies' owners.
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April 10, 2024
Dems Introduce Bill To Codify Policy Barring Judge Shopping
Senate Majority Leader Chuck Schumer, D-N.Y., along with 37 other Democratic and two independent senators, introduced legislation on Wednesday to codify the new Judicial Conference of the United States policy against judge shopping after pushback from Republicans and a Texas court.
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April 10, 2024
4th Circ. Sides With CMS' Definition Of 'Line-Extension Drug'
The Fourth Circuit on Wednesday affirmed a summary judgment ruling in favor of the Centers for Medicare & Medicaid Services in a rule challenge by Vanda Pharmaceuticals, which took issue with the agency's criteria for what constitutes a line-extension drug.
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April 10, 2024
Skadden, Fenwick Lead $4.9B Alpine Immune Sciences Sale
Biotechnology company Alpine Immune Sciences Inc., advised by Fenwick & West LLP, on Wednesday revealed that it has agreed to be bought by Vertex Pharmaceuticals Inc., led by Skadden Arps Slate Meagher & Flom LLP, in a $4.9 billion cash deal.
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April 10, 2024
Pharmacy Gets Eli Lilly's Mounjaro Suit Tossed
A Florida federal judge has thrown out Eli Lilly & Co.'s suit accusing an online pharmacy of wrongly selling a compounded version of its drug Mounjaro, saying Eli Lilly was "using state law to enforce the terms of" federal law.
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April 10, 2024
Justices Asked To Ban FCA Suits Relying On Patent Reviews
Valeant Pharmaceuticals is going to the U.S. Supreme Court to argue that information cited in Patent Trial and Appeal Board reviews cannot later be used by whistleblowers in False Claims Act lawsuits.
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April 10, 2024
Moderna Says Pfizer Is PTAB 'Tea-Leaf-Reading' In Vax IP Row
Moderna Inc. asked a Boston federal judge to deny Pfizer Inc.'s bid to pause a COVID-19 vaccine patent trial while the Patent Trial and Appeal Board reviews the validity of two of the three patents at issue.
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April 10, 2024
1st Circ. Says Appellant's Death Erases Conviction
The First Circuit has vacated the stock fraud conviction of a biotech executive who died in prison, aligning itself with all the other federal circuits in adopting the longstanding principle that a defendant's death during a direct appeal of a conviction wipes out all the criminal proceedings from their inception.
Expert Analysis
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Series
ESG Around The World: Canada
In Canada, multiple statutes, regulations, common law and industry guidance address environmental, social and governance considerations, with debate over ESG in the business realm potentially growing on the horizon, say attorneys at Blakes.
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5 Legal Considerations For Psychedelic Therapy Sector
With multiple developments signaling the rise of psychedelic-assisted psychotherapy, it is imperative that clinicians understand unique legal nuances ranging from corporate formation to specialized insurance coverage, say Kimberly Chew and Natasha Sumner at Husch Blackwell.
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Lessons From Country Singer's Personal Service Saga
Recent reports that country singer Luke Combs won a judgment against a Florida woman who didn’t receive notice of the counterfeit suit against her should serve as a reminder for attorneys on best practices for effectuating service by electronic means, say attorneys at Jenner & Block.
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A Potential Proactive Tool For Public-Private Joint Ventures
In the current environment of heightened antitrust enforcement, the National Cooperative Research and Production Act seems tailor-made for the collaborative work among competitors encouraged by the Biden administration's infrastructure and green energy funding legislation, say Jeetander Dulani and Susan Ebner at Stinson.
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Patent Prosecution Carries Consequences For Later Litigation
The Federal Circuit's recent Mylan v. Actelon holding, along with three other 2023 decisions, underscores the continued need for patent prosecutors to make note of potential claim construction issues that may arise in subsequent litigation, says Steven Wood at Hunton.
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10 Global Antitrust Trends To Anticipate In 2024
Proactive navigation of the antitrust enforcement environment remains crucial this year as legal policy and tools evolve to meet intensifying global economic complexity, including geopolitical tensions, trade realignment, market volatility and inflation, say attorneys at Freshfields.
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Global Cartel Enforcement Looks Set To Intensify In 2024
The cartel enforcement winds may strengthen this year, with the U.S. Department of Justice, as well as regulators in other countries, placing a renewed focus on pursuing international cartels and more traditional, hard-core cartel conduct, say attorneys at Simpson Thacher.
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Series
Baking Bread Makes Me A Better Lawyer
After many years practicing law, and a few years baking bread, I have learned that there are a few keys to success in both endeavors, including the assembly of a nourishing and resilient culture, and the ability to learn from failure and exercise patience, says Rick Robinson at Reed Smith.
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Supreme Court Amgen Ruling's Major Effect On Enablement
The U.S. Supreme Court's Amgen v. Sanofi invalidity holding continues to significantly affect technologies and all aspects of the patent system by providing confidence in the Federal Circuit's approach and a clearer understanding on enforceability and the disclosure needed for compliance, say Irena Royzman and Daniel Williams at Kramer Levin.
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Federal Courts And AI Standing Orders: Safety Or Overkill?
Several district court judges have issued standing orders regulating the use of artificial intelligence in their courts, but courts should consider following ordinary notice and comment procedures before implementing sweeping mandates that could be unnecessarily burdensome and counterproductive, say attorneys at Curtis.
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7 E-Discovery Predictions For 2024 And Beyond
The legal and technical issues of e-discovery now affect virtually every lawsuit, and in the year to come, practitioners can expect practices and policies to evolve in a number of ways, from the expanded use of relevancy redactions to mandated information security provisions in protective orders, say attorneys at Littler.
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Top Considerations For Retailers Using AI To Combat Theft
The Federal Trade Commission's recent enforcement action against Rite Aid indicates a significant evolution in the landscape surrounding biometric information and artificial intelligence data collection by retailers, meaning retailers should take reasonable measures to prevent harm to customers, say attorneys at Dentons.
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2 FCPA Settlements Illuminate Self-Disclosure, Disgorgement
Two of last year’s Foreign Corrupt Practices Act settlements — with biomedical company Lifecore and mining company Corsa Coal — suggest that the government will be much more flexible in negotiating disgorgement amounts if an entity voluntarily self-discloses misconduct, say Michael Gilbert and Lucas Amodio at Sheppard Mullin.
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Opinion
Anti-Kickback Statute Does Not Require But-For Causation
A proper interpretation of the Anti-Kickback Statute clearly indicates that but-for causation is not required for False Claims Act Liability, and courts that hold otherwise will make it significantly easier for fraudsters to avoid accountability, says Kenneth Capesius at Baron & Budd.
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5 Litigation Funding Trends To Note In 2024
Over the next year and beyond, litigation funding will continue to evolve in ways that affect attorneys and the larger litigation landscape, from the growth of a secondary market for funded claims, to rising interest rates restricting the availability of capital, says Jeffery Lula at GLS Capital.