Life Sciences

  • October 07, 2024

    5 Decisions To Know By Outgoing Mass. Chief Judge

    Chief Massachusetts U.S. District Judge F. Dennis Saylor IV, who announced Monday that he will step back from full-time judicial service next summer, has presided over numerous significant cases in recent years, including a dispute over the U.S. Securities and Exchange Commission's disgorgement powers and a birth defects suit against GlaxoSmithKline.

  • October 07, 2024

    Trio Of 1st Circ. Criminal Cases Turned Away By Top Court

    The U.S. Supreme Court on Monday declined to review three white collar cases on appeal from the First Circuit, including challenges to a cryptocurrency founder's conviction for investor theft and an Illinois attorney's fraud and money laundering conspiracy verdict.

  • October 07, 2024

    Justices Won't Hear Kickback Statute 'Willfulness' Case

    The U.S. Supreme Court on Monday declined to consider whether a "willful" act under federal anti-kickback law requires a defendant to know their actions violate the law.

  • October 07, 2024

    High Court Rejects Pleas To Hear 7 Patent Cases

    The U.S. Supreme Court on Monday turned down seven petitions seeking review of decisions in patent cases, including appeals dealing with double patenting, patent eligibility and Patent Trial and Appeal Board procedures.

  • October 07, 2024

    High Court Won't Look At Alabama Frozen Embryo Decision

    The U.S. Supreme Court on Monday said it won't consider a challenge to a first-of-its-kind Alabama state court ruling that frozen embryos are legally children.

  • October 07, 2024

    Justices Won't Hear Shkreli's Bid To Undo $64M Disgorgement

    The U.S. Supreme Court refused Monday to review former pharmaceutical executive Martin Shkreli's challenge of a disgorgement order requiring him to pay up to $64 million for an alleged scheme to increase the price of a life-saving drug by 4,000%.

  • October 04, 2024

    Top 5 Supreme Court Cases To Watch This Fall

    The U.S. Supreme Court will hear several cases in its October 2024 term that could further refine the new administrative law landscape, establish constitutional rights to gender-affirming care for transgender minors and affect how the federal government regulates water, air and weapons. Here, Law360 looks at five of the most important cases on the Supreme Court's docket so far.

  • October 04, 2024

    NJ, Ethics Board Must Hand Over Docs In Retaliation Fight

    A New Jersey state judge has ordered the state and its ethics commission to hand over to an ex-state health official internal documents in his lawsuit alleging that he was wrongly fired in 2020 for raising concerns about the earmarking of COVID-19 tests for relatives of another state official.

  • October 04, 2024

    DOJ Charges Execs, Sales Reps Over Texas 'Pill Mills' Sales

    Tens of millions of opioid pills ended up in the black market by way of pharmaceutical distribution executives and sales representatives who targeted a Houston "hot zone" for drug diversion, the U.S. Department of Justice said in unsealing several indictments in Texas, Florida, Missouri and North Carolina.

  • October 04, 2024

    Regeneron Can't Ax Willful Infringement In COVID Patent Case

    Regeneron Pharmaceuticals Inc. cannot boot a willful infringement claim from Allele Biotech's patent suit over the development of COVID-19 vaccines and treatments, a New York federal judge ruled Friday, saying it was up to Regeneron to establish that Allele failed to show the defendant had presuit knowledge of the patent.

  • October 04, 2024

    Healthcare Co. Inks Deal In DOL Equal Pay Investigation

    A healthcare diagnostics company has agreed to pay nearly $60,000 to the U.S. Department of Labor to end an agency probe over concerns that a New Jersey manufacturing facility undercompensated female employees compared to their male colleagues.

  • October 04, 2024

    There May Not Be Life On Mars, But There Could Be IP

    The rapidly expanding space tourism industry is raising a vast universe of potential intellectual property issues. Experts say most of the laws governing extraterrestrial IP are as unexplored as space itself.

  • October 04, 2024

    UK Litigation Roundup: Here's What You Missed In London

    This past week in London has seen GMB Union sued by the makers of Tetley Tea after a staff walkout in September, boxer Mike Tyson hit with legal action from a marketing company and the Met Police face a misuse of private data claim from a woman who had a relationship with an undercover police officer. Here, Law360 looks at these and other new claims in the U.K.

  • October 04, 2024

    High Court Takes Up E-Cig 'Forum Shopping' Appeal

    The U.S. Supreme Court on Friday agreed to review a Fifth Circuit ruling that allowed out-of-circuit e-cigarette manufacturers to seek judicial review before the New Orleans-based court so long as the petition is joined by a seller located in the circuit.

  • October 04, 2024

    High Court Will Hear TCPA Case Over Online Junk Faxes

    The U.S. Supreme Court said Friday it will review whether district courts must follow a Federal Communications Commission ruling that the Telephone Consumer Protection Act does not prohibit junk faxes that are received only via electronic inboxes.

  • October 03, 2024

    Gilead Makes Generic HIV Drug Plan, Advocates Urge Expansion

    Gilead Sciences Inc. this week announced a plan to allow six drugmakers to produce generic lenacapavir to help combat the HIV pandemic in 120 lower-income countries, an initiative that won praise as a welcome step Thursday, although advocacy groups urged the company to expand the effort.

  • October 03, 2024

    Boston Pharma Co. Drops Another Moderna Patent Suit

    A Boston pharmaceutical developer once again has agreed to drop a patent lawsuit against Moderna over its popular coronavirus vaccines after losing a claim construction ruling in front of Delaware's top judge.

  • October 03, 2024

    Del. Vice Chancellor Slams Fee Terms In Advancement Case

    A Delaware vice chancellor balked Thursday at "success fee" terms in a fee advancement case that she suggested made the clients a "human shield" in litigation over attorney expenses in connection with a New Jersey legal malpractice case.

  • October 03, 2024

    Trulieve Sues Fla. Republican Party Over Anti-Weed Ads

    Trulieve, which is Florida's largest medical marijuana company and the principal backer of a ballot initiative to legalize cannabis in the Sunshine State, has sued the state's Republican Party and a pair of television stations for defamation, alleging that they ran misleading anti-weed ads.

  • October 03, 2024

    FibroGen Suit Alleging Disclosure Failures Tossed In Del.

    Biopharmaceutical company FibroGen has beaten a stockholder derivative lawsuit in Delaware's Chancery Court that accused the business and its top officers of fiduciary breaches and insider trading related to its flagship anemia drug, which was once projected to bring in $3.5 billion for the drugmaker before regulators refused to approve its use in the U.S.

  • October 03, 2024

    12 Lawyers Who Are The Future Of The Supreme Court Bar

    One attorney hasn't lost a single U.S. Supreme Court case she's argued, or even a single justice's vote. One attorney is perhaps "the preeminent SCOTUS advocate." And one may soon become U.S. solicitor general, despite acknowledging there are "judges out there who don't like me." All three are among a dozen lawyers in the vanguard of the Supreme Court bar's next generation, poised to follow in the footsteps of the bar's current icons.

  • October 03, 2024

    Stanford Profs Deny Roche's Trade Secret Theft Accusations

    Three Stanford University oncology professors sued by subsidiaries of F. Hoffmann-La Roche AG for allegedly stealing confidential information about cancer-detecting technology have denied the accusations, saying in California federal court that Roche's purported trade secrets were not secret, and even if they were, Roche does not own them.

  • October 03, 2024

    Texas Takes Aim At Insulin Manufacturers For Price-Gouging

    Texas sued several major insulin manufacturers and pharmacy benefit managers in Texas state court on Thursday, accusing the companies of running quid pro quo deals to bump insulin prices by as much as 1,000% and violating Texas laws around deceptive trade practices.

  • October 03, 2024

    Flint Water Judge Wishes Public Knew Case Complexity

    A Michigan federal judge on Thursday gave the final approval to a $25 million settlement to end claims from a class of Flint adults and businesses accusing a firm of failing to properly alert officials about the dangers of the city's water, noting that the case took years to resolve because it involved complicated legal issues.

  • October 03, 2024

    NJ Contractors Accused Of $10M Fraud In Lead Removal Work

    A New Jersey construction company billed the city of Newark $10.2 million for replacing 1,500 lead water service lines but never did the work, instead concocting false evidence to show new copper pipes had been installed, federal authorities said Thursday in announcing the arrests of the chief executive and a foreperson.

Expert Analysis

  • Vertex Suit Highlights Issues For Pharma Fertility Support

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    Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.

  • Opinion

    CMS' New 'Breakthrough' Device Policy Shows Little Promise

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    The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.

  • New Lessons On Managing Earnout Provision Risks

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    Earnout provisions can be a useful tool for bridging valuation gaps in M&A, particularly in developmental-stage pharmaceutical transactions, but the Delaware Chancery Court’s recent decision in Shareholder Representative Services v. Alexion sheds new light on the inherent risks and best practices for managing them, say attorneys at Cleary.

  • 3 Patent Considerations For America's New Quantum Hub

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    Recent developments signal an incredibly bright future for Chicago as the new home of quantum computing, and it is crucial that these innovators — whose technology has the potential to transform many industries — prioritize intellectual property strategy, says Andrew Velzen at McDonnell Boehnen.

  • A Preview Of AI Priorities Under The Next President

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    For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.

  • How Companies Are Approaching Insider Trading Policies

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    An analysis of insider trading policies recently disclosed by 49 S&P 500 companies under a new U.S. Securities and Exchange Commission rule reveals that while specific provisions vary from company to company, certain common themes are emerging, say attorneys at Gibson Dunn.

  • 11 Patent Cases To Watch At Fed. Circ. And High Court

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    As we head into fall, there are 11 patent cases to monitor, touching on a range of issues that could affect patent strategy, such as biotech innovation, administrative rulemaking and patent eligibility, say Edward Lanquist and Wesley Barbee at Baker Donelson.

  • Opinion

    3rd. Circ. Got It Right On Cancer Warning Claims Preemption

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    The Third Circuit's recent, eminently sensible ruling in a failure-to-warn case against Roundup manufacturer Monsanto, holding that the Federal Insecticide, Fungicide and Rodenticide Act preempts state law claims, provides a road map that other courts should adopt, says Lawrence Ebner at the Atlantic Legal Foundation.

  • Opinion

    To Lower Drug Prices, Harris Must Address Patent Thickets

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    If Vice President Kamala Harris is serious about her pledge to address high drug prices, she must begin by closing loopholes that allow pharmaceutical companies to develop patent thickets that can deter generic or biosimilar companies from entering the market, says Tahir Amin at the Initiative for Medicines, Access & Knowledge.

  • How Methods Are Evolving In Textualist Interpretations

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    Textualists at the U.S. Supreme Court are increasingly considering new methods such as corpus linguistics and surveys to evaluate what a statute's text communicates to an ordinary reader, while lower courts even mull large language models like ChatGPT as supplements, says Kevin Tobia at Georgetown Law.

  • Trending At The PTAB: Obviousness In Director Reviews

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    Three July decisions from the U.S. Patent and Trademark Office favoring petitioners indicate a willingness by the director to review substantive issues, such as obviousness, particularly in cases where the director believes the Patent Trial and Appeal Board provided incorrect or inadequate rationale to support its decisions, say attorneys at Finnegan.

  • Why Attorneys Should Consider Community Leadership Roles

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    Volunteering and nonprofit board service are complementary to, but distinct from, traditional pro bono work, and taking on these community leadership roles can produce dividends for lawyers, their firms and the nonprofit causes they support, says Katie Beacham at Kilpatrick.

  • Opinion

    Agencies Should Reward Corporate Cyber Victim Cooperation

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    The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.

  • Firms Must Offer A Trifecta Of Services In Post-Chevron World

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    After the U.S. Supreme Court’s Loper Bright Enterprises v. Raimondo decision overturning Chevron deference, law firms will need to integrate litigation, lobbying and communications functions to keep up with the ramifications of the ruling and provide adequate counsel quickly, says Neil Hare at Dentons.

  • Takeaways From UPC's Amgen Patent Invalidity Analysis

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    The Unified Patent Court Central Division's decision in Regeneron v. Amgen to revoke a patent for lack of inventive step is particularly clear in its reasoning and highlights the risks to patentees of the new court's central revocation powers, say Jane Evenson and Caitlin Heard at CMS.

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