Life Sciences

  • December 03, 2024

    Vidal Aimed To Put USPTO Rulemaking In The Spotlight

    Kathi Vidal's tenure as director of the U.S. Patent and Trademark Office has been marked by dedication to making the agency's decisions and processes more transparent, attorneys said ahead of her mid-December departure.

  • December 03, 2024

    FDA Issues Guidance On Potential Infant Formula Shortages

    The U.S. Food and Drug Administration has put forth draft guidance on how the country's infant food manufacturers should tell the agency about permanent or temporary stoppages in the making of infant formula, several years after an outbreak and a national shortage.

  • December 03, 2024

    4 Mass. State Court Rulings You May Have Missed In Nov.

    An age discrimination case was undone by the fine print of an employment agreement, while an "utterly inadequate" document search led to a five-figure sanctions order, among other notable recent decisions in Massachusetts state court.

  • December 03, 2024

    VA Announces Study On MDMA-Assisted Therapy For Vets

    The U.S. Department of Veterans Affairs announced Tuesday it will fund a study on psychedelic-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder, alongside researchers from Brown University and Yale University.

  • December 02, 2024

    House COVID-19 Probe Points to China 'Lab Leak'

    The Republican-led House Select Subcommittee on the Coronavirus Pandemic published the results of its two-year investigation into the origins of the COVID-19 pandemic Monday, concluding that COVID-19 "most likely" emerged from a laboratory in Wuhan, China, and heavily criticizing the Biden administration, Anthony Fauci and left-leaning organizations for their responses.

  • December 02, 2024

    Judge Isn't Seeing 'Good Faith' Compliance In Probiotic Feud

    A Maryland federal judge said Monday that a drug company is, yet again, failing to make "good faith substantial compliance" with the terms of an injunction that followed a $15 million jury verdict in a dispute over a proprietary probiotic formula.

  • December 02, 2024

    Justices Seem Inclined To Back FDA Block Of Flavored Vapes

    U.S. Supreme Court justices on Monday seemed skeptical of arguments by an e-cigarette company that the U.S. Food and Drug Administration acted unfairly in rejecting its applications to market its flavored vaping products, with several justices supporting the FDA's position that the company knew it had to counterbalance the risk of its products appealing to kids.

  • December 02, 2024

    Investor Alleges Medical Device Co. Misled On FDA Clearance

    The executives and directors of dialysis equipment company Outset Medical Inc. have been hit with a shareholder derivative suit in California federal court alleging they allowed the company to market its product without proper clearance from the U.S. Food and Drug Administration.

  • December 02, 2024

    Hagens Berman Sued For Slice Of Atty Fee From Effexor Deal

    A pharmaceutical reseller's in-house counsel and founder lodged a breach of contract suit against Hagens Berman in Mississippi federal court, accusing the law firm of refusing to pay him his share of a $13 million attorney fees award stemming from an antitrust class settlement with Pfizer Inc. unit Wyeth.

  • December 02, 2024

    Chancery OKs $21M Deal To End Gene Co. Class Suit

    A $21 million settlement of stockholder challenges to a blank check company's take-public merger with clinical data and genomics company Sema4 Holdings in July 2021 won Delaware Court of Chancery approval Monday, with nearly $4.1 million carved out for attorney fees.

  • December 02, 2024

    Fla. Tribe Sues Eli Lilly, CVS, Others Over Insulin Price-Fixing

    The Miccosukee Tribe in Florida is alleging drugmakers like Eli Lilly & Co. and pharmacy benefit managers like CVS illegally conspired to limit competition and artificially inflate the price of insulin drugs, according to a new lawsuit filed in New Jersey federal court.

  • December 02, 2024

    Heritage's $10M Generic Drugs Deal With AGs Gets 1st OK

    A Connecticut federal judge gave his initial approval on Monday to Heritage Pharmaceuticals Inc.'s $10 million settlement agreement with state attorneys general to resolve allegations it took part in an anticompetitive, price-fixing scheme focused on generic drugs.

  • December 02, 2024

    DEA Asserts Its Role As Proponent Of Pot Rescheduling Plan

    The Drug Enforcement Administration on Monday affirmed it was acting as the proponent of a proposal to loosen federal restrictions on marijuana, and the administrative law judge said supporters of rescheduling would not get an opportunity to cross-examine DEA witnesses.

  • December 02, 2024

    Ex-Parexel Worker Says Vax Rule Lacked 'Informed Consent'

    A former employee of clinical research firm Parexel International says the company's COVID-19 vaccine requirement was a breach of contract because she and other workers did not have the option of giving informed consent for what she calls an "experimental medical treatment," according to a lawsuit filed in Massachusetts state court.

  • December 02, 2024

    Shipping Industry Braces For Waves Of New Trump Tariffs

    After a holiday weekend marked by a fresh round of tariff threats from President-elect Donald Trump, the shipping and logistics industry is beginning to feel the heat, warning companies to prepare for massive upheaval if Trump follows through.

  • December 02, 2024

    Co-Worker's Affair Isn't Harassment, Research Co. Tells Court

    A clinical research company urged a Georgia federal judge to toss a former employee's suit claiming the business failed to take action when a co-worker made sexual comments about her father and began an affair with him, arguing the conduct isn't protected by federal civil rights law.

  • November 27, 2024

    A Look Back At Years Of Zantac Litigation: Timeline

    After the U.S. Food and Drug Administration raised a red flag five years ago that heartburn drug Zantac and its generics contained levels of a chemical that could cause cancer, litigation kicked off in federal and state courts. Here, Law360 presents a timeline of the lawsuits, trials and settlements that ensued.

  • November 27, 2024

    PTAB Finds Hormone Treatment Patent Claims Invalid

    The Patent Trial and Appeal Board has found Neurocrine Biosciences Inc. was able to show that all the claims in a patent owned by biotechnology company Spruce Biosciences Inc. relating to the treatment of a hormonal disorder were invalid.

  • November 27, 2024

    Deloitte Posed As Consultant To Steal Vax Software, Suit Says

    An inventor has accused Deloitte Consulting LLP in New York federal court of stealing her proprietary vaccination management system and securing a multimillion-dollar government contract for rolling out COVID-19 vaccines, saying the firm colluded with the Centers for Disease Control and Prevention to pilfer the technology.

  • November 27, 2024

    PBM Says Opioid Ruling Ignored High Court's Privilege Stance

    A special master's ruling that internal audit records from Express Scripts Inc. are not protected by attorney-client privilege should be overturned because it contradicts nearly 40 years of U.S. Supreme Court precedent, the pharmacy benefit manager told an Ohio federal court overseeing multidistrict opioid litigation.

  • November 27, 2024

    Nonprofit Warns 3rd Circ. Against 'Abuse' In Merck Vax Case

    The anti-monopoly think tank Open Markets Institute urged the full Third Circuit to rethink a panel's immunization of Merck & Co. Inc. from antitrust claims over its mumps vaccine, arguing in an amicus brief that the doctrine cementing the right to petition the government doesn't justify the use of courts and administration as a "competitive weapon."

  • November 27, 2024

    Amid Claims Of Bias, DEA To Kick Off Historic Pot Hearing

    The Drug Enforcement Administration's administrative law tribunal will hold a preliminary hearing Monday on the U.S. Department of Justice's proposal to relax restrictions on marijuana, kicking off a historic process that has already been marked by allegations of agency bias.

  • November 27, 2024

    Up Next At The High Court: Transgender Care, Holocaust Art

    The U.S. Supreme Court will return to the bench Monday for its December arguments session, which will include blockbuster questions about the constitutionality of state laws banning gender-affirming care for transgender minors and whether Hungary can be held liable for property stolen during World War II.

  • November 27, 2024

    Hospital Sued For Firing Tech Who Reported Lax Drugmaking

    A pharmacy technician claims in Illinois state court that she was fired from Lurie Children's Hospital in Chicago for making complaints both internally and to state regulators that the medications for pediatric patients were being compounded in an unsanitary manner and that the facilities weren't being properly cleaned.

  • November 27, 2024

    Congressional Dems Urge Biden For More Cannabis Reform

    Congressional Democrats are urging President Joe Biden to use his executive authority to take further action on marijuana reforms during the waning weeks of his administration.

Expert Analysis

  • What Trump's Next Term May Mean For Biz Immigration

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    Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.

  • Racing Patents To The Fed. Circ.: Collateral Estoppel Lessons

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    As more and more parties find themselves in two different forums addressing the same issues and then competing in a race to the Federal Circuit, certain strategies can help despite unanswered questions on when Patent Trial and Appeal Board determinations trigger collateral estoppel, say attorneys at Akin.

  • Series

    Circus Arts Make Me A Better Lawyer

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    Performing circus arts has strengthened my ability to be more thoughtful, confident and grounded, all of which has enhanced my legal practice and allowed me to serve clients in a more meaningful way, says Bailey McGowan at Stinson.

  • 3 Ways To Train Junior Lawyers In 30 Minutes Or Less

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    Today’s junior lawyers are experiencing a skills gap due to pandemic-era disruptions, but firms can help bring them up to speed by offering high-impact skill building content in bite-sized, interactive training sessions, say Stacey Schwartz at Katten, Diane Costigan at Winston & Strawn and Lauren Tierney at Freshfields.

  • How AstraZeneca Ruling Could Change Dosage Patent Claims

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    If affirmed on appeal, the rationale employed by the Delaware federal court in Wyeth v. AstraZeneca to find "unit dosage"-related patent claims invalid could lead to a significant paradigm shift in how active-ingredient-focused patent applications are drafted and litigated, say Matthew Zapadka and John Schneible at Arnall Golden.

  • Failed W.Va. Patent Challenge Reveals Secret Prior Art's Risks

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    A West Virginia federal court's recent ruling — that references used by a patent challenger to establish an ordinarily skilled artisan's existing knowledge must be published before a patent's filing — may discourage claim construction challenges based on secret prior art and steer drafters away from externally defined terms, says Brianna Potter at Baker Botts.

  • Navigating Decentralized Clinical Trials With FDA's Guidance

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    The U.S. Food and Drug Administration's recently finalized guidance on conducting decentralized clinical trials, while not legally binding, can serve as a road map for sponsors, investigators and others to ensure trial integrity and participant safety, say attorneys at Phillips Lytle.

  • The Bar Needs More Clarity On The Discovery Objection Rule

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    Almost 10 years after Federal Rule of Civil Procedure 34 was amended, attorneys still seem confused about what they should include in objections to discovery requests, and until the rules committee provides additional clarity, practitioners must beware the steep costs of noncompliance, says Tristan Ellis at Shanies Law Office.

  • How Patent Landscape Analysis Drives Business Growth

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    Keegan Caldwell at Caldwell Law explores how patent landscape analysis serves as a key driver of sustainable growth — examining how its components, strategic advantages and implementation best practices are reshaping innovation leadership.

  • In Terror Case, DC Circ. Must Weigh Justices' Twitter Ruling

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    When the D.C. Circuit hears oral argument in AstraZeneca UK v. Atchley, how the court interprets the U.S. Supreme Court's 2023 ruling in Twitter v. Taamneh will have a significant impact on future claims brought under the Anti-Terrorism Act and Justice Against Sponsors of Terrorism Act, say attorneys at Lewis Baach.

  • Marching In On Orange Book Drugs May Have Limited Effect

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    Statistical analysis shows that marching in on Orange Book drug patent holders to require additional licensees would have a relatively minimal impact on drug prices, and should be weighed against the harms it could have on pharmaceutical innovation, say researchers at Competition Dynamics.

  • Series

    Being A Navy Reservist Makes Me A Better Lawyer

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    Serving this country in uniform has not only been one of the greatest honors of my life, but it has also provided me with opportunities to broaden my legal acumen and interpersonal skills in ways that have indelibly contributed to my civilian practice, says Phillip Smith at Weinberg Wheeler.

  • Incoming Admin May Shake Up Life Sciences Regulation

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    Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.

  • Next Steps In The $2.8B Blue Cross Payout To Providers

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    Healthcare providers deciding whether to participate in Blue Cross Blue Shield network's recent $2.8 billion antitrust class action settlement must weigh key recovery factors, including provider type and litigation cost, say attorneys at Hall Render.

  • So You Want To Move Your Law Practice To Canada, Eh?

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    Google searches for how to move to Canada have surged in the wake of the U.S. presidential election, and if you’re an attorney considering a move to the Great White North, you’ll need to understand how the practice of law differs across the border, says David Postel at Henein Hutchison.

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