Life Sciences

  • June 24, 2024

    Altria Subsidiary Allowed To Sell Menthol-Flavored Vapes

    Altria Group Inc. subsidiary NJOY has secured permission from the U.S. Food and Drug Administration to sell four menthol-flavored vapes, marking the first time any kind of flavored e-cigarette has secured federal approval.

  • June 24, 2024

    Biotech Co. Hits Ch. 11 With Plans For Sale And 'Reboot'

    Virginia-based synthetic biology products maker Solar Biotech Inc. filed for Chapter 11 bankruptcy in Delaware with plans to sell its assets, saying a difficult capital market, the loss of a major client and the pandemic drained its cash and caused it to furlough employees.

  • June 24, 2024

    Justices Pass On Rutgers COVID-19 Vax Mandate Case

    The U.S. Supreme Court declined on Monday to review a split Third Circuit ruling that Rutgers University students cannot challenge the school's COVID-19 vaccine policy because, under the high court's 1905 precedent in Jacobson v. Massachusetts, there is no fundamental right to refuse vaccinations.

  • June 21, 2024

    Drug Cos., IP Attys Back Cellect In High Court Efforts

    A petition by patent litigation outfit Cellect that is looking to persuade the U.S. Supreme Court to wade into a double patenting dispute has drawn support from even more lawyers as well as a handful of major drugmakers and small tech companies like Sonos.

  • June 21, 2024

    Drugmakers Decline To Drop Patent Listings After FTC Letters

    The eight pharmaceutical companies that the Federal Trade Commission warned in April may have improperly listed patents for its products in a key federal database have chosen not to remove any patents or otherwise alter their listings, according to a document released Friday.

  • June 21, 2024

    After Fed. Circ. Win, Bausch Sues Alvogen Over Drug Patents

    Bausch's Salix Pharmaceuticals has launched a lawsuit against Alvogen's Norwich Pharmaceuticals unit in a New Jersey federal court, claiming that its planned generic version of Xifaxan, a blockbuster diarrhea and brain disorder drug, infringes a set of patents.

  • June 21, 2024

    Pay-For-Delay Drug Case Not Time-Barred, UK Tribunal Says

    The U.K. Competition Appeal Tribunal refused Friday to apply a much more restrictive statute of limitations that would toss government claims that Danish pharmaceutical company Lundbeck Ltd. and generic drug manufacturers anticompetitively agreed to delay generic competition to an antidepressant.

  • June 21, 2024

    Ex-CEO Found Liable For $1 Now Seeks Atty Fees For Del. Suit

    The ex-CEO of a biopharma company who was found liable in 2021 for breaching his fiduciary duties but ordered to pay just $1 in damages after Delaware's Court of Chancery found that no real harm had been done is now suing for his attorney's fees and court costs.

  • June 21, 2024

    Costco Sued Over PFAS In Kirkland Brand Baby Wipes

    Costco is facing a proposed class action over its fragrance-free "natural" baby wipes, which consumers claim are made with toxic levels of forever chemicals, rendering them unsafe for use on children.

  • June 21, 2024

    8 Firms To Lead 4 IPOs Totaling $806M As Action Heats Up

    Eight law firms are slated to guide four initial public offerings estimated to raise a combined $806 million during the week of June 24, potentially closing a slow month for new listings with a bang.

  • June 21, 2024

    Taxation With Representation: Travers Smith, Potamitis Vekris

    In this week's Taxation With Representation, RSK Group Ltd. gets a £500 million ($632 million) investment, Boston Scientific Corp. acquires Silk Road Medical Inc., Masdar takes a part of Terna Energy SA, and Tate & Lyle PLC buys CP Kelco from JM Huber Corp.

  • June 20, 2024

    Ex-DEA Heads Echo GOP AGs' Call For Pot Rescheduling Hearing

    A group of former U.S. Drug Enforcement Administration leaders and Republican attorneys general have formally requested administrative hearings on the U.S. attorney general's proposal to reschedule cannabis, according to separate letters sent this week that distinctly echo each other.

  • June 20, 2024

    Patent Owners, Challengers Spar Over PTAB Rule Proposal

    The U.S. Patent and Trademark Office's scaled-back package of Patent Trial and Appeal Board rules has drawn a mixed reaction from legal and industry groups, which offered praise and concern about both the proposal and the topics it does not address.

  • June 20, 2024

    Eli Lilly Launches Round Of Diabetes Drug Suits

    Eli Lilly on Thursday hit various compounding pharmacies and medical spas in five states and the District of Columbia with suits saying that they trick consumers into thinking that they sell Eli Lilly medications that treat diabetes and obesity when actually they are copycats and are untested by the U.S. Food and Drug Administration.

  • June 20, 2024

    Spinal Implant Maker Can Liquidate Under Ch. 11 Plan

    A Delaware bankruptcy judge agreed Thursday to approve the Chapter 11 liquidation and wind-down plan of biotechnology developer InVivo, which reported it landed a buyer for its spinal cord implant technology following an unsuccessful bankruptcy auction.

  • June 20, 2024

    11th Circ. Upholds $2.5M Pelvic Mesh Verdict, Rules Suit Timely

    The Eleventh Circuit on Thursday refused to throw out a woman's $2.5 million victory against Coloplast Corp. in a suit alleging she was implanted with defective pelvic mesh, saying the evidence does not support a conclusion that her claim was filed too late.

  • June 20, 2024

    No Access To Ethics Docs For Ex-NJ Official Yet, Judge Rules

    A New Jersey judge has rejected a bid by a former Garden State health official asking the court to compel the state and its ethics commission to produce documents related to claims he was fired in 2020 for raising concerns over the earmarking of COVID-19 tests for relatives of a state administration official, according to Wednesday orders.

  • June 20, 2024

    No Atty, No Case: Judge Tosses Attack On Psychedelics Ban

    A federal judge in Washington state threw out a challenge to the U.S. Drug Enforcement Administration's efforts to ban two psychedelic substances in an order Thursday that chided a psychedelic research company for doing "an end run" around requirements that corporations be represented by an attorney.

  • June 20, 2024

    HHS Drug Pricing Program Flouts Constitution, Boehringer Says

    An "unprecedented" new Medicare price negotiation program deprives drugmakers of their constitutional rights and forces them to make declarations on issues of public concern that reflect poorly on them, Boehringer Ingelheim Pharmaceuticals Inc. argued Thursday in Connecticut federal court as it echoed the industry chorus seeking to strike the initiative.

  • June 20, 2024

    11th Circ. Nixes J&J Sunscreen Benzene MDL Settlement

    The Eleventh Circuit on Thursday vacated an order granting approval to a settlement resolving claims that Johnson & Johnson sold sunscreens containing benzene, saying a pair of circuit court decisions since the approval mean the deal needs another look.

  • June 20, 2024

    Theravance, Mylan Say Chinese Co. Copied COPD Drug

    Theravance Biopharma and Mylan Specialty have sued a Chinese drugmaker, alleging it copied Yupelri, one of its chronic obstructive pulmonary disease drugs, and infringed several patents in the process.

  • June 20, 2024

    USPTO's AI-Assisted Inventions Guidance Irks ABA IP Section

    The U.S. Patent and Trademark Office's guidance on when inventions developed using artificial intelligence can be patented generated criticism from the American Bar Association's Section of Intellectual Property Law, expressing concern that it could be detrimental as it "casts doubt on inventorship through general acts of human direction."

  • June 20, 2024

    11th Circ. Backs Stryker's Defeat Of Fired Worker's Leave Suit

    The Eleventh Circuit refused Thursday to revive a suit claiming medical technology company Stryker illegally fired a worker on leave awaiting the birth of his child, ruling that because the leave didn't formally kick in until the child was born, his termination was fair game.

  • June 18, 2024

    High Court Petition Asks Justices: What's A 'Willful' Kickback?

    Does a "willful" act under federal anti-kickback law require a defendant to know that the conduct violates the law? That's the question a whistleblower is asking the U.S. Supreme Court to answer in order to resolve what the petition calls a circuit split on a key question of federal fraud prosecutions.

  • June 18, 2024

    Company, States Battle In Court Over At-Home Rape Kits

    A fight is brewing in federal and state courts between a company that purports to be the nation's only purveyor of self-administered sexual assault DNA collection kits and state attorneys general who believe it is misleading sexual assault victims.

Expert Analysis

  • Strategies For Challenging A Fla. Grand Jury Report's Release

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    A Florida grand jury’s recent report on potential wrongdoing related to COVID-19 vaccines should serve as a reminder to attorneys to review the myriad legal mechanisms available to challenge the lawfulness of a grand jury report’s publication and expunge the names of their clients, says Cary Aronovitz at Holland & Knight.

  • Patent Lessons From 8 Federal Circuit Reversals In March

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    A number of Federal Circuit patent decisions last month reversed or vacated underlying rulings, providing guidance regarding the definiteness of a claim that include multiple limitations of different scopes, the importance of adequate jury instruction, the proper scope of the precedent, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

  • A Look At Ex Parte Seizures 8 Years Post-DTSA

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    In the eight years since the Defend Trade Secrets Act was enacted, not much has changed for jurisprudence on ex parte seizures, but a few seminal rulings show that there still isn’t a bright line on what qualifies as extraordinary circumstances warranting a seizure, say attorneys at Finnegan.

  • Series

    Whitewater Kayaking Makes Me A Better Lawyer

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    Whether it's seeing clients and their issues from a new perspective, or staying nimble in a moment of intense challenge, the lessons learned from whitewater kayaking transcend the rapids of a river and prepare attorneys for the courtroom and beyond, says Matthew Kent at Alston & Bird.

  • AI In The Operating Room: Liability Issues For Device Makers

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    As healthcare providers consider medical devices that use artificial intelligence — including systems to help surgeons make decisions in the operating room — and lobby to shift liability to device manufacturers, companies making these products must review potential product liability risks and important design considerations for such equipment, say attorneys at Troutman Pepper.

  • Del. Lessons For Director-Nominees On Sharing With Activists

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    The Delaware Chancery Court's recent decision in Icahn Partners v. deSouza finding that a director wasn't permitted to share certain privileged information with the activist stockholders that nominated him shows the need for companies to consider imposing appropriate confidentiality requirements on directors, say attorneys at Sullivan & Cromwell.

  • 10 Years After Alice, Predictability Debate Lingers

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    A decade after the U.S. Supreme Court’s Alice ruling, critics continue to argue that the subject matter eligibility framework it established yields inconsistent results, but that contention is disproved by affirmance data from the Federal Circuit, district courts and the Patent Trial and Appeal Board, say Dennis Abdelnour and David Thomas at Honigman.

  • This Earth Day, Consider How Your Firm Can Go Greener

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    As Earth Day approaches, law firms and attorneys should consider adopting more sustainable practices to reduce their carbon footprint — from minimizing single-use plastics to purchasing carbon offsets for air travel — which ultimately can also reduce costs for clients, say M’Lynn Phillips and Lisa Walters at IMS Legal Strategies.

  • Questions Persist After Ruling Skirts $925M TCPA Award Issue

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    After an Oregon federal court's recent Wakefield v. ViSalus ruling that the doctrine of constitutional avoidance precluded it from deciding whether a $925 million Telephone Consumer Protection Act damages award was constitutionally sound, further guidance is needed on when statutory damages violate due process, says Michael Klotz at O'Melveny.

  • Benzene Contamination Concerns: Drugmakers' Next Steps

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    After a citizen petition to the U.S. Food and Drug Administration and a flurry of class actions over benzene contamination in benzoyl peroxide acne products, affected manufacturers should consider a thoughtful approach that includes assembling internal data and possibly contacting the FDA for product-specific discussions, say attorneys at Morgan Lewis.

  • Opinion

    States Should Follow Federal Lead On Expert Evidence Rules

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    The recently amended Federal Rule of Evidence 702 will help ensure expert testimony in federal courts reflects adequate data and reliable methods properly applied to a given case, and state courts — home to the overwhelming majority of U.S. litigation — should adopt similar changes, says retired attorney Michael Harrington.

  • The Pros And Cons Of NIST's Proposed March-In Framework

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    Recent comments for and against the National Institute of Standards and Technology’s proposed guidance on march-in rights — which permit the government to seize federally funded patents — highlight how the framework may promote competition, but could also pose a risk to contractors and universities, say Nick Lee and Paul Ragusa at Baker Botts.

  • Opinion

    Federal MDL Rule Benefits From Public Comments

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    The new Federal Rule of Civil Procedure concerning multidistrict litigation that was approved this week by the Advisory Committee on Civil Rules incorporates ideas from public comments that will aid both plaintiffs and defense attorneys — and if ultimately adopted, the rule should promote efficient, merits-driven MDL case management, say Robert Johnston and Gary Feldon at Hollingsworth.

  • Practicing Law With Parkinson's Disease

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    This Parkinson’s Awareness Month, Adam Siegler at Greenberg Traurig discusses his experience working as a lawyer with Parkinson’s disease, sharing both lessons on how to cope with a diagnosis and advice for supporting colleagues who live with the disease.

  • When Trade Secret Protection And Nat'l Security Converge

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    The Trump administration's anti-espionage program focused on China is over, but federal enforcement efforts to protect trade secrets and U.S. national security continue, and companies doing business in high-risk jurisdictions need to maintain their compliance programs to avoid the risk of being caught in the crosshairs of an investigation, say attorneys at Baker McKenzie.

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