Life Sciences

  • September 22, 2025

    5th Circ.'s 340B Ruling 'Limited,' Pharma Cos. Tell 4th Circ.

    The Fifth Circuit's recent refusal to block a Mississippi law regulating the delivery of discounted drugs to rural providers can't be wielded by West Virginia in its battle over the law's constitutionality because of the distinctions between the two state laws, a coalition of pharmaceutical companies told the Fourth Circuit.

  • September 22, 2025

    In-House Judge Won't Pause FTC's Heart Valve Deal Challenge

    An administrative law judge refused to pause the Federal Trade Commission's in-house case challenging Edwards Lifesciences Corp.'s planned $945 million purchase of JenaValve Technology Inc. until after a ruling in the related federal court case.

  • September 22, 2025

    J&J Ruling Misapplied Goldman Precedent, 3rd Circ. Told

    The U.S. Chamber of Commerce and other business organizations are supporting Johnson & Johnson's call for the full Third Circuit to reconsider a ruling that the groups argue could "saddle" companies with investor class-action suits through the misapplication of a recent U.S. Supreme Court ruling. 

  • September 22, 2025

    Catching Up With Delaware's Chancery Court

    Last week, Match.com secured approval for a $30M settlement over its 2019 reverse spinoff from IAC, and Vice Chancellor Morgan T. Zurn urged decorum among Delaware lawyers, comparing recent legal turmoil to dark times in British monarchy history. Here's the latest from the Chancery Court.

  • September 22, 2025

    CVS's Omnicare Hits Ch. 11 After $949M FCA Judgment

    Omnicare LLC, CVS Health's subsidiary that provides pharmacy services for long-term care facilities, filed for Chapter 11 bankruptcy relief Monday in Texas following a $949 million judgment against Omnicare and CVS issued by a New York federal judge earlier this year.

  • September 22, 2025

    Wachtell, Paul Weiss Advise On Pfizer's $7.3B Obesity Path

    Pfizer Inc. will acquire Metsera Inc. for $4.9 billion in cash, as the U.S. pharmaceutical giant bets on the biotech firm's experimental treatments for obesity and cardiometabolic diseases, the companies said Monday. 

  • September 22, 2025

    ProPhase COVID-19 Testing Units Hit Ch. 11 In NJ

    Biotechnology company ProPhase Labs Inc. put three of its COVID-19 laboratory testing subsidiaries in Chapter 11 bankruptcy Monday in New Jersey with combined liabilities of more than $13 million, saying it has been underpaid by insurance companies.

  • September 21, 2025

    Chinese Exec Who Shipped Fentanyl Ingredients Gets 25 Yrs

    A Manhattan federal judge on Friday sentenced a Chinese national and chemical company executive to 25 years in prison for shipping large quantities of fentanyl ingredients to the U.S., citing the defendant's "egregious, callous" disregard for the deaths caused by the drugs he helped create.

  • September 19, 2025

    Stewart Issues Mixed Bag Of Referrals, Denied Petitions

    Coke Morgan Stewart issued some of her final decisions as acting director of the U.S. Patent and Trademark Office, discretionarily denying a host of petitions for Patent Trial and Appeal Board review, while also referring a group of Apple Inc.'s petitions to the board for scrutiny.

  • September 19, 2025

    Call For Gov't Cut Of University Patent Cash Spurs Concern

    Commerce Secretary Howard Lutnick's comments that the government should get as much as half of the revenue that universities generate from patents developed with federal funding have caused worry among industry groups and attorneys, who say it would inhibit efforts to commercialize publicly funded inventions.

  • September 19, 2025

    Goodwin, Latham Steer E-Commerce Co. Pattern's $300M IPO

    Top Amazon.com reseller Pattern Group Inc. kicked off its public-market trading debut on the Nasdaq on Friday with a $300 million initial public offering guided by Goodwin Procter LLP, and Latham & Watkins LLP represented the underwriters, which include Goldman Sachs & Co. LLC and J.P. Morgan.

  • September 19, 2025

    PTAB Invalidates Johns Hopkins Patent In Keytruda Fight

    The Patent Trial and Appeal Board has invalidated an anti-cancer therapy patent owned by Johns Hopkins University, handing a win to challenger Merck Sharp & Dohme LLC in a larger fight relating to Merck's Keytruda treatment.

  • September 19, 2025

    DA In Gilgo Beach Killings Case Talks Advances In DNA Use

    Law360 sat down with Suffolk County, New York, District Attorney Ray Tierney, who is prosecuting architect Rex Heuermann on charges that he murdered seven women on Long Island, to discuss the use of a newer form of DNA testing that has passed rigorous admissibility standards for the first time, among other aspects of the case.

  • September 19, 2025

    Moderna Wants Fed. Circ. Reversal Of Vax Patent Invalidation

    Moderna has told the Federal Circuit that the Patent Trial and Appeal Board got it wrong when it found that the success of the inventions behind two of its COVID-19 vaccine patents challenged by Pfizer and BioNTech didn't outweigh the evidence they were invalid as obvious.

  • September 19, 2025

    Rite Aid Gets OK To Seek Votes On Dual-Track Ch. 11 Plan

    A New Jersey bankruptcy judge on Friday approved drugstore chain Rite Aid's bid to take votes on a Chapter 11 plan as the debtor weighs whether to complete a deal with McKesson Corp. or formally seek to dismiss its bankruptcy case.

  • September 19, 2025

    CDC Panel Urges Caution On COVID Vax, Punts On Hep B

    A panel of advisers at the Centers for Disease Control and Prevention on Friday voted unanimously to recommend that people receiving the COVID-19 vaccine this season do so only after discussing it with their health providers.

  • September 18, 2025

    Federal Vaccine Panel Votes To Tweak MMRV Recommendation

    A panel of federal vaccine advisers on Thursday changed its recommendation for a long-used vaccine for children but allowed a key government program to continue paying for the shots.

  • September 18, 2025

    Cytokinetics Investor Sues Over Heart Drug Approval Claims

    Biopharmaceutical company Cytokinetics and its CEO have been hit with a proposed investor class action in California federal court alleging they made false and misleading statements about the regulatory timeline for one of the company's new drugs, which caused a share price drop when the truth came to light.

  • September 18, 2025

    Brothers Blame Associate For $90M HIV Drug Fraud Scheme

    Two Maryland brothers accused of selling $90 million worth of mislabeled HIV drugs told a Florida federal jury on Thursday that their charges stem from an associate hired for his pharmaceutical industry connections, but who instead lied about the medication's black market origins and told them it was purchased legitimately.

  • September 18, 2025

    HHS Shutters Miami Organ Donor Org. For 'Unsafe' Practices

    Federal health officials have decertified a Miami-based organ procurement organization that arranges organ donations after an investigation found a pattern of "unsafe" practices, marking the first time the federal government has revoked the certification of such a group, according to an announcement Thursday from Health Secretary Robert F. Kennedy Jr. 

  • September 18, 2025

    Senate Confirms Squires To Lead USPTO

    The U.S. Senate on Thursday confirmed Dilworth Paxson LLP partner John Squires to serve as the next U.S. Patent and Trademark Office director.

  • September 18, 2025

    Senate Confirms Trump's Pick To Lead DOL Benefits Arm

    The Senate confirmed fiduciary liability insurance expert Daniel Aronowitz on Thursday to lead the U.S. Department of Labor's employee benefits division, which oversees regulation and enforcement of employer-provided health and retirement plans.

  • September 18, 2025

    Steptoe Adds Jones Day Biotech Patent Pro To NY Office

    Steptoe LLP has bolstered its intellectual property practice with an attorney arriving from Jones Day with multinational experience advising biotech and biopharmaceutical companies on patent issues.

  • September 18, 2025

    Colibri Wants Full Fed. Circ. To Rethink Medtronic Patent Case

    Colibri Heart Valve LLC wants the full Federal Circuit to review a panel's ruling overturning a patent infringement judgment of more than $125 million against Medtronic's CoreValve unit, saying the panel wrongly applied a reading of the law that is too broad.

  • September 18, 2025

    NJ City Makes 3rd Escape From Pot Co.'s Zoning Suit

    For the third time, a New Jersey federal judge has dismissed claims from a would-be cannabis dispensary alleging the city of Asbury Park and its zoning board conspired to deny its application for a medical marijuana store.

Expert Analysis

  • Purdue Case Could Transform Patent Obviousness Analyses

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    If accepted for review by the U.S. Supreme Court, Purdue Pharma v. Accord Healthcare — concerning whether Purdue's abuse-deterrent opioid formulation patents were invalid as obvious — could significantly shift how courts weigh secondary considerations in patent obviousness analyses, say attorneys at Lathrop.

  • Federal Regs Order May Spell Harsher FDCA Enforcement

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    A recent executive order aimed at reducing criminal prosecutions of those who unknowingly violate complex federal regulations may actually lead to more aggressive felony indictments under the Federal Food, Drug and Cosmetic Act, but companies and executives can mitigate risks by following several key principals, say attorneys at McGuireWoods.

  • Series

    Law School's Missed Lessons: Practicing Self-Care

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    Law schools don’t teach the mental, physical and emotional health maintenance tools necessary to deal with the profession's many demands, but practicing self-care is an important key to success that can help to improve focus, manage stress and reduce burnout, says Rachel Leonard​​​​​​​ at MG+M.

  • ABA Opinion Makes It A Bit Easier To Drop A 'Hot Potato'

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    The American Bar Association's recent ethics opinion clarifies when attorneys may terminate clients without good cause, though courts may still disqualify a lawyer who drops a client like a hot potato, so sending a closeout letter is always a best practice, say attorneys at Thompson Hine.

  • IRhythm IPR Denial Raises Key PTAB Discretion Questions

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    By giving the passage of time a dispositive role in denying institution of five inter partes review petitions filed by iRhythm Technologies, the U.S. Patent and Trademark Office has upended the strategic considerations for filing and defending against IPRs, disclosing prior art during prosecution, and engaging in licensing negotiations, say attorneys at Dentons.

  • Canadian Suit Offers Disclosure Lesson For US Cannabis Cos.

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    A Canadian class action asserting that Aurora Cannabis failed to warn consumers about the risk of developing cannabinoid hyperemesis syndrome may spawn copycat filings in the U.S., and is a cautionary tale for cannabis and hemp industries to prioritize risk disclosure, says Ian Stewart at Wilson Elser.

  • Opinion

    IPR Denial In IRhythm Should Not Set A Blanket Rule

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    Though the Patent Trial and Appeal Board's discretionary denial in iRhythm v. Welch Allyn last month raised concerns that mere knowledge of a patent could bar inter partes review institution, a closer look at the facts and reasoning reveals why this case's holdings should not be reflexively applied to all petitioners, says David McCombs at Haynes Boone.

  • What High Court's Tenn. Trans Care Ruling Means Nationally

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    The U.S. Supreme Court's decision in U.S. v. Skrmetti, upholding a Tennessee ban on gender-affirming medical care for minors, is fairly limited in scope and closely tailored to the specific language of Tennessee's law, but it may have implications for challenges to similar laws in other states, say attorneys at Hall Render.

  • How Trump's Trade Policies Are Shaping Foreign Investment

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    Five months into the Trump administration, investors are beginning to see the concrete effects of the president’s America First Investment Policy as it presents new opportunities for clearing transactions more quickly, while sustaining risk aversion related to Chinese trade and potentially creating different political risks, say attorneys at Covington.

  • Series

    My Opera And Baseball Careers Make Me A Better Lawyer

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    Though participating in opera and the world of professional baseball often pulls me away from the office, my avocations improve my legal career by helping me perform under scrutiny, prioritize team success, and maintain joy and perspective at work, says Adam Unger at Herrick Feinstein.

  • Opinion

    Subject Matter Eligibility Test Should Return To Preemption

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    Subject matter eligibility has posed challenges for patentees due to courts' arbitrary and confusing reasoning, but adopting a two-part preemption test could align the applicant, the U.S. Patent and Trademark Office and the courts, says Manav Das at McDonnell Boehnen.

  • 8 Ways Lawyers Can Protect The Rule Of Law In Their Work

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    Whether they are concerned with judicial independence, regulatory predictability or client confidence, lawyers can take specific meaningful actions on their own when traditional structures are too slow or too compromised to respond, says Angeli Patel at the Berkeley Center of Law and Business.

  • Is SEC Moving Away From Parallel Insider Trading Cases?

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    The U.S. Securities and Exchange Commission's apparent lack of follow-up in four recent criminal cases of insider trading brought by the Justice Department suggests the SEC may be reconsidering the expense and effort of bringing parallel civil charges for insider trading, say attorneys at Dentons.

  • Rising Enforcement Stakes For Pharma Telehealth Platforms

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    Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.

  • Series

    Law School's Missed Lessons: Communicating With Clients

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    Law school curricula often overlook client communication procedures, and those who actively teach this crucial facet of the practice can create exceptional client satisfaction and success, says Patrick Hanson at Wiggam Law.

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