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Life Sciences
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July 30, 2024
AIDS Org Sues Express Scripts For PBM Monopoly
The world's largest HIV/AIDS healthcare organization is joining the slew of litigants suing pharmacy benefit manager Express Scripts, claiming in a new complaint that the pharmacy giant has leveraged monopoly power in Louisiana to suppress competition among independent specialty pharmacies that focus on rare and complex medical conditions.
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July 30, 2024
Judge Wants Device Warning Answers From Mich. Justices
A Michigan federal judge ruled Tuesday that medical device manufacturer NuVasive Inc. must face a patient suit alleging its limb-lengthening device caused metal poisoning, while also asking the Michigan Supreme Court to break its silence on medical manufacturers' duty to warn patients directly.
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July 30, 2024
Chancery Rejects Forte-Camac Deal As 'Not Fair' To Class
A Delaware Chancery Court judge on Tuesday rejected a settlement between Forte Biosciences Inc. and Camac Partners LLC that would have ended the activist investor's class action over Forte's alleged board entrenchment, finding that the proposed deal gave Camac "unique and personal benefits" that weren't shared with the rest of the class.
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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.
Expert Analysis
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Big Business May Come To Rue The Post-Administrative State
Many have framed the U.S. Supreme Court’s recent decisions overturning Chevron deference and extending the window to challenge regulations as big wins for big business, but sand in the gears of agency rulemaking may be a double-edged sword, creating prolonged uncertainty that impedes businesses’ ability to plan for the future, says Todd Baker at Columbia University.
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Opinion
Proposed Terminal Disclaimers Rule Harms Colleges, Startups
Universities and startups are ill-suited to follow the U.S. Patent and Trademark Office’s recently proposed rule on terminal disclaimers due to their necessity of filing patent applications early prior to contacting outside entities for funds and resources, say attorneys at Sterne Kessler.
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A Midyear Forecast: Tailwinds Expected For Atty Hourly Rates
Hourly rates for partners, associates and support staff continued to rise in the first half of this year, and this growth shows no signs of slowing for the rest of 2024 and into next year, driven in part by the return of mergers and acquisitions and the widespread adoption of artificial intelligence, says Chuck Chandler at Valeo Partners.
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Critical Questions Remain After High Court's Abortion Rulings
The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.
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A Look At Acquisition Trends For Radiopharmaceuticals
As radiopharmaceutical drugs are increasingly used for the diagnosis and treatment of certain diseases, interest from Big Pharma entities is following suit, despite some questions around the drugs' capacity to expand beyond their limited niche, says Adrian Toutoungi at Taylor Wessing.
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Opinion
States Should Loosen Law Firm Ownership Restrictions
Despite growing buzz, normalized nonlawyer ownership of law firms is a distant prospect, so the legal community should focus first on liberalizing state restrictions on attorney and firm purchases of practices, which would bolster succession planning and improve access to justice, says Michael Di Gennaro at The Law Practice Exchange.
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Navigating FDA Supply Rule Leeway For Small Dispensers
As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.
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Series
Solving Puzzles Makes Me A Better Lawyer
Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.
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Texas Ethics Opinion Flags Hazards Of Unauthorized Practice
The Texas Professional Ethics Committee's recently issued proposed opinion finding that in-house counsel providing legal services to the company's clients constitutes the unauthorized practice of law is a valuable clarification given that a UPL violation — a misdemeanor in most states — carries high stakes, say Hilary Gerzhoy and Julienne Pasichow at HWG.
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6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth
Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.
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Series
After Chevron: Scale Tips Favor Away From HHS Agencies
The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.
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2 Options For Sackler Family After High Court Purdue Ruling
After the U.S. Supreme Court recently blocked Purdue Pharma's plan to shield the family that owns the company from bankruptcy lawsuits, the Sacklers face the choice to either continue litigation, or return to the bargaining table for a settlement that doesn't eliminate creditor claims, says Gregory Germain at Syracuse University.
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.
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Series
After Chevron: Expect Limited Changes In USPTO Rulemaking
The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.
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How High Court Approached Time Limit On Reg Challenges
The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.