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Life Sciences
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September 03, 2024
HQ Specialty Looks To Fix Patent Flaws After Delaware Trial
HQ Specialty Pharma Corp. said Tuesday that it will correct flaws in its patent for an injectable calcium supplement that led a federal jury in Delaware to find it partially invalid last week and then will seek a court order to stop generic-drug maker Fresenius Kabi USA LLC from selling its allegedly infringing product.
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September 03, 2024
Teva Patents Don't Belong In Orange Book, Fed. Circ. Told
Amneal Pharmaceuticals Inc. is urging the Federal Circuit to preserve a lower court decision ejecting inhaler device patents from an important government database, arguing that the delisting, won in an infringement lawsuit from Teva Pharmaceuticals USA Inc., properly separated out device patents from drug patents.
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September 03, 2024
Aesthetic Laser Co. Tells Jury Of Rival's 'Corporate Raid'
Medical aesthetic business Cynosure told a Boston federal jury Tuesday that two former employees and an industry rival launched a "calculated corporate raid" by poaching dozens of sales and marketing personnel, violating a host of noncompete and non-solicitation agreements while the departing workers pocketed trade secrets on their way out the door.
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September 03, 2024
3rd Circ.: Biotech Must Pay Royalties Despite Expired Patents
A cancer drug biotechnology company must pay royalties to a research firm despite the expiration of the applicable patents, a Third Circuit panel ruled in a precedential decision Tuesday, concluding that the biotech's royalty obligation is calculated differently than the one in a U.S. Supreme Court case it cited.
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September 03, 2024
Gov't Backs 9th Circ. Bid To Revive Invisalign Monopoly Case
The U.S. Department of Justice has told the Ninth Circuit that a lower court applied the wrong standard when tossing a pair of class actions accusing the maker of Invisalign of monopolizing markets for clear dental aligners and teeth scanners.
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September 03, 2024
Aspire Biopharma Inks SPAC Deal At $316M Valuation
Aspire Biopharma Inc., advised by Sichenzia Ross Ference Carmel LLP, on Tuesday announced that it will go public through a merger with special purpose acquisition company PowerUp Acquisition Corp., led by Dykema Gossett PLLC, in a transaction that values the business at a pre-money equity value of roughly $316 million.
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September 03, 2024
Catching Up With Delaware's Chancery Court
Last week in Delaware's court of equity, an iconic rock band got a new member, former President Donald Trump's social media company escaped a contempt ruling, and litigation grew over Illumina Inc.'s $8 billion reacquisition of cancer-testing company Grail Inc. New cases touched on intellectual property, mergers, share transfers and dump trucks. In case you missed it, here's the latest from Delaware's Court of Chancery.
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September 03, 2024
Scientist Says Yale Medical School Ruined $28M 'Life's Work'
An accounting issue at Yale School of Medicine caused a liquid nitrogen supply to become disconnected from an incubator that housed thousands of genetic materials comprising an employee's "life's work," destroying research funded by a total of $28 million in grants and private money, according to a lawsuit in Connecticut state court.
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September 03, 2024
Glenmark Hit With $50M Suit Over Potassium Pill Death
A proposed class of buyers is suing Glenmark Pharmaceuticals Inc. for more than $50 million, alleging that the company's extended-release potassium chloride capsules are defective and instead deliver the potassium too fast, which resulted in the death of the lead plaintiff's mother.
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September 03, 2024
Semnur Pharmaceuticals To Go Public Via $2.5B SPAC Merger
Paul Hastings LLP-advised Semnur Pharmaceuticals Inc. on Tuesday unveiled plans to go public via a merger with Winston & Strawn LLP-led blank check company Denali Capital Acquisition Corp. in a deal that gives the pharmaceutical company a pre-transaction equity value of $2.5 billion.
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September 03, 2024
Hogan Lovells Tech Transactions Ace Returns To Weil In SF
Weil Gotshal & Manges LLP is expanding its California team, announcing Tuesday it is welcoming back a technology transactions expert, most recently with Hogan Lovells, as a partner in its recently opened San Francisco office.
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August 30, 2024
McKesson, Others To Pay Benefit Plans $300M In Opioid Deal
McKesson Corp., Cardinal Health Inc. and Cencora Inc. have agreed to pay a group of benefit plans a combined $300 million to resolve allegations that the drug distributors fanned the flames of the opioid epidemic, according to a filing Friday in Ohio federal court.
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August 30, 2024
Calif. Legislature OKs Ban On 6 Food Dyes In Public Schools
California's State Legislature on Thursday passed the nation's first-ever bill aimed at banning public schools in the state from serving foods to children that contain Red 40 and other synthetic food dyes, sending the law to the governor's desk.
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August 30, 2024
Doctor In Matthew Perry's Death Makes 1st Court Appearance
A physician charged in actor Matthew Perry's death made his initial appearance in Los Angeles federal court Friday and was allowed to remain free on a $50,000 unsecured bond pending his expected guilty plea to one count of conspiracy to distribute ketamine.
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August 30, 2024
Wheeling & Appealing: The Latest Must-Know Appellate Action
Appeals courts have awakened from summertime slumber and crammed their early autumn calendars with arguments of national significance, which Law360 previews in this edition of Wheeling & Appealing. We're also recapping August's top appellate decisions, exploring new polling about U.S. Supreme Court opinions and testing your knowledge of Fifth Circuit history.
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August 30, 2024
Align Tech Cuts $27.5M Antitrust Deal With 1.45M Consumers
A proposed class of nearly 1.45 million SmileDirectClub teeth-aligner buyers urged a California federal judge Thursday to preliminarily sign off on Align Technologies Inc.'s $27.5 million cash and coupon settlement to resolve antitrust claims alleging the company colluded with the now-bankrupt SmileDirecClub to illegally restrict competition.
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August 30, 2024
Nebraska Expected To Vote On Medical Marijuana Legalization
Medical marijuana advocates have met the requirements to put a legalization question before Nebraska voters on Election Day this November, the secretary of state announced Friday.
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August 30, 2024
Period Tracker App Users Seek Class Cert. In Data-Selling Suit
Users of the menstrual cycle tracking app Flo Health Inc. are seeking class certification in their suit against Flo, Google and Meta, telling a California federal judge the proposed class would include millions of users whose personal health information was sold to the ad giants without consent.
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August 30, 2024
Philips Accuses SoClean Of Discovery Delay In CPAP Recall
Koninklijke Philips NV says SoClean Inc. is unduly delaying claims that the company should contribute to Philips' $1 billion settlement over breathing machine foam by insisting on a wall between discovery materials in two related multidistrict litigations.
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August 30, 2024
Cancer Detection Co. Valued At $375M In SPAC Merger
Blank check company Mountain Crest Acquisition Corp. V, advised by Loeb & Loeb LLP, announced that it has agreed to merge with and take public Korean cancer diagnosis technology company CubeBio Co. Ltd., led by Nelson Mullins Riley & Scarborough LLP, in a deal valued at $375 million.
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August 30, 2024
Fall IPO Pickup Could Be A Prelude For 2025 Recovery
More companies are preparing to go public after Labor Day, signaling a modest increase in initial public offerings that capital markets advisers say could presage a stronger recovery in 2025, assuming next year brings more clarity regarding interest-rate policy and the result of the presidential election.
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August 29, 2024
Pa. Justices To Examine Axing Of 'Red Book' Drug Pricing
The Supreme Court of Pennsylvania has agreed to review a decision tossing the "Red Book" pricing values used by the state's Bureau of Workers' Compensation to calculate reimbursement for prescription drug costs.
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August 29, 2024
Jury Clears Ore. Hospital That Implanted FDA-Flagged Mesh
A state jury cleared an Oregon hospital system and a surgeon of liability Wednesday over a patient's claims that prolapse mesh was implanted almost two weeks after the U.S. Food and Drug Administration ordered its maker to stop selling it.
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August 29, 2024
Lannett Says Areva Reneged On Cancer-Drug Deal After Ch. 11
Lannett Pharmaceuticals hit generic-drug maker Areva Pharmaceuticals with a contract suit in Delaware's Court of Chancery on Thursday, accusing Areva of breaching their 2022 agreement that gave Lannett exclusive rights to distribute Areva's injectable anticancer drug after Lannett emerged from a prepackaged Chapter 11 bankruptcy.
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August 29, 2024
Comer Tells PBMs To Correct Record On Role In Drug Pricing
Rep. James Comer, R-Ky., chair of the House Oversight and Accountability Committee, is demanding that the heads of three major pharmacy benefit managers "correct the record" on their testimony made before his committee in July about their roles in drug pricing, including company claims that the PBMs don't steer customers to in-house pharmacies and that they allow non-affiliated pharmacies to negotiate contracts.
Expert Analysis
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Microplastics At The Crossroads Of Regulation And Litigation
Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.
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The Fed. Circ. In April: Hurdles Remain For Generics
The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Tylenol MDL Highlights Expert Admissibility Headaches
A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.
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Don't Use The Same Template For Every Client Alert
As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.
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Don't Fall On That Hill: Keys To Testifying Before Congress
Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.
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Online Portal Helps Fortify Feds' Unfair Health Practices Fight
The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.
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Series
Walking With My Dog Makes Me A Better Lawyer
Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.
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Think Like A Lawyer: Follow The Iron Rule Of Trial Logic
Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.
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The Art Of Asking: Leveraging Your Contacts For Referrals
Though attorneys may hesitate to ask for referral recommendations to generate new business, research shows that people want to help others they know, like and trust, so consider who in your network you should approach and how to make the ask, says Rebecca Hnatowski at Edwards Advisory.
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Trending At The PTAB: Permissible New Reply Arguments
In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.
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Wave Of Final Rules Reflects Race Against CRA Deadline
The flurry of final rules now leaping off the Federal Register press — some of which will affect entire industries and millions of Americans — shows President Joe Biden's determination to protect his regulatory legacy from reversal by the next Congress, given the impending statutory look-back period under the Congressional Review Act, say attorneys at Jenner & Block.
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'Beauty From Within' Trend Poses Regulatory Risks For Cos.
Companies capitalizing on the current trend in oral supplements touting cosmetic benefits must note that a product claim that would be acceptable for an externally applied cosmetic may draw much stronger scrutiny from the U.S. Food and Drug Administration when applied to a supplement, say Natalie Rainer and Katherine Staba at K&L Gates.
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McKesson May Change How AKS-Based FCA Claims Are Pled
The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.
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Series
Being An Equestrian Makes Me A Better Lawyer
Beyond getting experience thinking on my feet and tackling stressful situations, the skills I've gained from horseback riding have considerable overlap with the skills used to practice law, particularly in terms of team building, continuing education, and making an effort to reset and recharge, says Kerry Irwin at Moore & Van Allen.
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7th Circ. Mootness Fee Case May Curb Frivolous Merger Suits
On April 15, the Seventh Circuit in Jorge Alcarez v. Akorn Inc. mapped out a framework for courts to consider mootness fees paid to individual shareholders after the voluntary dismissal of a challenge to a public company merger, which could encourage objections to mootness fees and reduce the number of frivolous merger challenges filed, say attorneys at Skadden.