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Life Sciences
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July 30, 2024
Psychedelics And The Law: A Midyear Review
A groundbreaking effort to secure federal approval for a psychedelic medication hit an unexpected snag. Religious groups asserting the right to access controlled substances had mixed success in federal court. Physicians seeking to administer psilocybin to terminally ill patients will finally have their day in court. Here are the major developments in psychedelics law from the first half of 2024.
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July 30, 2024
DOD Contractors Must Face Suit Over 'Made In U.S.A.' Label
A pair of whistleblowers who claim that tourniquets and other medical equipment sold to the U.S. Department of Defense was mislabeled as "made in U.S.A." can continue with most of their False Claims Act suit against two contractors, a Pennsylvania federal judge said.
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July 30, 2024
Litigator Rejoins Faegre Drinker From Medical Device Co.
Faegre Drinker Biddle & Reath LLP's newest lateral hire is stepping back into private practice after two years as associate general counsel for orthopedic implant company Exactech, and should be a familiar face around the firm's Indianapolis office.
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July 30, 2024
What Mass. Attys Will Be Watching In The 2nd Half Of 2024
Two potentially sweeping Massachusetts high court rulings and a long-awaited employment bill lingering in the State House are among the issues Bay State attorneys say they are monitoring closely heading into the latter half of 2024.
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July 29, 2024
Genzyme Says Sarepta's Dystrophy Gene Therapy Infringes IP
Sanofi's biotechnology company Genzyme Corp. hauled Sarepta Therapeutics into Delaware federal court on Friday, alleging Sarepta's gene therapy treatment for Duchenne muscular dystrophy infringed two of its patents for manufacturing certain therapeutics.
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July 29, 2024
Medical Co. Can't Get Alleged Fraudulent Arbitral Award Nixed
A New York federal judge has declined to vacate an arbitral award issued by a Swiss tribunal to a Singapore company in a dispute over a medical imaging joint venture, rejecting arguments that an agreement struck by the parties meant that a New York court could decide the issue.
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July 29, 2024
NIST Lays Out 200+ Ways To Tackle Generative AI Risks
The National Institute of Standards and Technology has recommended hundreds of actions that can be taken to address issues of data privacy, intellectual property, environmental impact and more raised by generative artificial intelligence.
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July 29, 2024
Wash. Says At-Home Rape Kit Law Targets Harm, Not Speech
Washington pushed back against a company's bid to pause enforcement of a ban on the sale of "DIY" DNA collection kits to sexual assault survivors, saying the prohibition is meant to prevent victims from being tricked into thinking the kit results will stand up in court.
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July 29, 2024
Gilstrap Finds Nothing Between The Lines Of Barcode Patents
A handful of barcode scanning patents issued to prolific litigant Leigh Rothschild met their fate in Texas, with U.S. District Judge Rodney Gilstrap deciding they "recite no more than generic computer operations."
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July 29, 2024
Vaccine Co. Was Sanctioned For Deliberately Hiding Testing
U.S. Patent and Trademark Office Director Kathi Vidal backed sanctions for Longhorn Vaccines & Diagnostics' "egregious abuse" of the Patent Trial and Appeal Board system because of the patent owner's "deliberate scheme to hide" harmful evidence from the board, she said in an opinion made public Friday.
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July 29, 2024
Boehringer Appeals HHS Win In Medicare Drug Price Suit
Boehringer Ingelheim Pharmaceuticals Inc. notified a Connecticut federal court Friday that it will appeal its loss in a lawsuit challenging a new Medicare drug price negotiation program on the grounds that it unlawfully compels the pharmaceutical giant to declare prices "fair," takes its property and imposes an excessive fine.
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July 29, 2024
Kirkland-Led Amulet Closes $1.2B Health-Focused Fund
Kirkland & Ellis LLP-advised private equity shop Amulet Capital Partners LP on Monday announced that it successfully closed its third healthcare-focused private equity fund with roughly $1.2 billion in tow.
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July 29, 2024
Legalization Org Taps Cannabis Atty As New Treasurer
The pro-legalization advocacy organization Marijuana Policy Project announced Monday that a preeminent member of the cannabis bar had been tapped as the group's newest treasurer.
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July 29, 2024
GSK Settles Ill. Zantac Cancer Suit
GlaxoSmithKline said Monday it has settled a lawsuit brought by an Illinois man who took the heartburn medication Zantac or its generic counterpart for more than 20 years and claimed the drug caused his prostate cancer.
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July 29, 2024
Firm, Ex-Client Brief Conn. High Court In Punitive Award Case
McCarter & English LLP and ex-client Jarrow Formulas Inc. are weighing in as the Connecticut Supreme Court decides whether a federal court can award law firms punitive damages in suits for breach of contract, as the firm seeks a punitive payout after winning multimillion-dollar judgments in a contract dispute.
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July 29, 2024
Catching Up With Delaware's Chancery Court
Litigation linked to Elon Musk sparked several filings in Delaware's Court of Chancery last week, including a call for sanctions and hand-wringing about a proposed multibillion-dollar attorney fee. Here, Law360 looks at this and other highlights from last week in Delaware's Chancery Court.
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July 29, 2024
Ex-Pharma Exec Seeks Leniency After SEC Contempt Plea
A former pharmaceutical executive is hoping to avoid jail after his use of an alias to circumvent a U.S. Securities and Exchange Commission ban on finance work landed him a criminal contempt conviction, while Boston federal prosecutors are seeking up to 10 months in prison.
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July 26, 2024
'Low-Grade Lawyering': Quinn Emanuel Attys Draw Judge's Ire
A California federal judge considering Guardant Health's sanctions bid in a false advertising case against rival Natera said Friday that representations to the court by Natera's attorneys from Quinn Emanuel Urquhart & Sullivan LLP regarding a proposed expert witness were "less than forthright" and "pretty low-grade lawyering."
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July 26, 2024
Apple Commits To White House Guidelines For Responsible AI
Apple Inc. has signed onto the Biden administration's voluntary guidelines for "responsible" artificial intelligence innovation, joining the likes of Amazon.com Inc., Google LLC, Microsoft Corp. and a dozen other leading tech companies, the White House announced Friday.
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July 26, 2024
Product Liability Cases To Watch 2024: A Midyear Report
Litigation over claims that social media addict children and harm mental health continues to hold attorneys' attention, along with claims that "forever chemicals" are a source of cancer.
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July 26, 2024
Del. Court Won't Let Generic Co. Walk Back Invalidity Promise
Generic-drug maker Mankind Pharma is bound to its promise not to challenge the validity of a patent covering Allergan's glaucoma drug Lumigan after a federal judge in Delaware shot down its argument that recent rulings on obviousness-type double patenting altered the litigation landscape.
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July 26, 2024
Indivior To Pay $86M To Settle Opioid Claims By 5 States
Indivior will pay $86 million to settle claims by a group of state attorneys general over the drugmaker's alleged contributions to the American opioid crisis.
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July 26, 2024
Hearing Set Over Bid To Recuse Judge In Philly Zantac Cases
A Philadelphia judge will hear arguments next month over a recusal motion filed by plaintiffs' counsel in the city's Zantac mass tort program that argues the judge should remove himself from the proceedings after he disclosed his wife is a partner at Reed Smith, which represents GlaxoSmithKline, a manufacturer of the drug.
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July 26, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen U.K. band The 1975 face action by Future Sound Asia after its performance in Malaysia resulted in a festival's cancelation, Spectrum Insurance hit by The Motoring Organization following their dispute over information misuse, and a former police constable pursue defamation against a colleague for allegedly instigating a campaign of harassment against her. Here, Law360 looks at these and other new claims in the U.K.
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July 25, 2024
3rd Circ. Again Tosses J&J Talc Unit's 'Texas Two-Step' Ch. 11
The Third Circuit on Thursday affirmed the dismissal of the reworked Chapter 11 case of Johnson & Johnson's talc unit that used a controversial "Texas two-step" maneuver, saying the company still hasn't displayed the financial distress required to justify bankruptcy protection.
Expert Analysis
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What 100 Federal Cases Suggest About Changes To Chevron
With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.
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Why High Court May Have Rejected IP Obviousness Appeal
Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.
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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.