Life Sciences

  • April 01, 2024

    Inotiv Can't Toss Investor Suit Over Feds' 'Puppy Mill' Probe

    Medical research services provider Inotiv Inc. must face a proposed investor class action accusing it of failing to disclose that subsidiaries it acquired had come under investigations by the U.S. Department of Justice for animal welfare and smuggling violations, an Indiana federal judge ruled while lamenting the "appalling" mistreatment of beagles that investigators had found.

  • April 01, 2024

    Pharma Co. Beats Investor Suit Over Wrinkle Drug Approval

    A California federal judge has dismissed a lawsuit from the investors of Revance Therapeutics Inc. accusing it and several executives of concealing quality control concerns that eventually led the U.S. Food and Drug Administration to deny the company a license for its wrinkle injectable, saying the defendants may not have known the approval timeline they presented was unattainable.

  • April 01, 2024

    Apple, Intel Again Lose Fintiv APA Challenge In Calif. Court

    A California federal judge on Sunday ended Big Tech's coordinated challenge to Patent Trial and Appeal Board precedent that allows its judges to discretionarily deny patent reviews based on how proposed reviews overlap with related litigation in other forums.

  • April 01, 2024

    Optical Co. Beats Investor Suit Over Pandemic Staffing Levels

    A Georgia federal judge has permanently tossed an investor suit accusing National Vision of failing to disclose issues with its staffing levels during the pandemic, saying the investors did not adequately plead that any of the challenged statements allegedly made by the optical company were false or misleading.

  • April 01, 2024

    'Unreliable' Theory Dooms City's Acthar Antitrust Cert. Bid

    The city of Rockford has presented "unreliable" damages evidence that cannot warrant giving class treatment to its claim that pharmacy benefits manager Express Scripts engaged in a scheme to fix prices for the seizure medication Acthar, an Illinois federal judge has said.

  • April 01, 2024

    Fed. Circ. Revives Challenges To J&J Schizophrenia Drug

    A Federal Circuit panel on Monday gave generics-makers Teva Pharmaceuticals USA Inc. and Viatris Inc. a new chance to prove that a patent on Johnson & Johnson's blockbuster schizophrenia drug Invega Sustenna is invalid, saying a lower court used an "erroneously rigid" analysis when rejecting their challenge.

  • April 01, 2024

    Catching Up With Delaware's Chancery Court

    Last week, Delaware's Court of Chancery saw a $42.5 million settlement, dismissal of two big suits with two more remanded back, and new cases from shareholders of Walt Disney, Donald Trump's Truth Social, Rivian Automotive and BarkBox.

  • April 01, 2024

    Ex-Pharma Co. Exec Denies Signing Noncompete Deal

    The former director of government sales for a pharmaceutical company asked the North Carolina Business Court on Friday to knock out a breach of contract claim in a lawsuit that alleges he took trade secrets to a competitor, arguing the company has no valid noncompete agreement to back it up.

  • April 01, 2024

    J&J Opted To 'Deny' Talc-Cancer Link, Jury Told

    Johnson & Johnson opted to "deny, deny, deny" evidence linking its baby powder to ovarian cancer and continued to market it as safe to use, an attorney for the widower of a longtime baby powder user who died from cancer told jurors in Sarasota, Florida, on Monday.

  • April 01, 2024

    Gunderson-Led Contineum Joins Pipeline Eyeing $150M IPO

    Contineum Therapeutics Inc. launched plans Monday for an estimated $150 million initial public offering, represented by Gunderson Dettmer Stough Villeneuve Franklin & Hachigian LLP and underwriters counsel Sidley Austin LLP, hoping to join a nascent recovery for the IPO market.

  • April 01, 2024

    Fla. High Court Says Voters Will Choose Whether To Legalize Pot

    Florida voters will have the opportunity to legalize recreational marijuana at the ballot box this November, after the state Supreme Court on Monday rejected a challenge brought by the state's attorney general and ruled that the proposal didn't violate a state rule restricting ballot measures to only one subject.

  • April 01, 2024

    Masimo Rips Politan's New Attempt To Grab Board Seats

    Medical technology company Masimo Corp. on Monday pushed back against activist allegations of broken governance and lack of independent oversight, saying investor Politan Capital Management LP's plans to oust its current chairman and CEO contradict shareholders' best interests.

  • April 01, 2024

    Eiger BioPharmaceuticals Hits Ch. 11 With $53.1M Debt

    Eiger BioPharmaceuticals Inc. filed for Chapter 11 protection in Texas bankruptcy court Monday with $53.1 million of debt and plans to sell its assets during the case.

  • March 29, 2024

    Petition Watch: Off-Label Ads, Retiree Discrimination & PPE

    A Utah attorney has asked the U.S. Supreme Court to determine whether allegedly retaliatory IRS summonses can be quashed, and two former pharmaceutical executives are challenging the constitutionality of their convictions for marketing the off-label use of a drug. Here, Law360 looks at recently filed petitions that you might've missed.

  • March 29, 2024

    Northern Texas Judges Won't Adopt Judge-Shopping Rule

    Judges with the Northern District of Texas have opted not to make any changes to how cases are assigned, despite a recent letter from Senate Majority Leader Chuck Schumer urging the district to implement an updated policy aiming to prevent litigants from judge shopping, the district's chief judge said Friday.

  • March 29, 2024

    Hogan Lovells Vet's High Court Debut A Study In Contrasts

    Several weeks ago, when a Hogan Lovells lawyer finally delivered U.S. Supreme Court arguments after 20 years at the firm, she parsed arcane arbitration issues and her words weren't widely heard outside the courtroom. But weeks later and back at the high court podium, her words were heard nationwide when she pointedly spotlighted a judge's use of "anonymous blog posts" in a bombshell abortion ruling.

  • March 29, 2024

    Alleged 'Shadow Trader's Co-Worker Tells Jury Stocks Not Tied

    A co-worker of an ex-Medivation executive accused of "shadow trading" in rival Incyte's stock testified Friday as the first defense witness in his California federal civil trial, telling jurors that the two companies weren't competitors and that he wouldn't expect their stock prices to rise in tandem.

  • March 29, 2024

    Judge Denies Injunction For Tyvaso Drug Competitor

    A D.C. federal judge Friday denied drugmaker United Therapeutics Corp.'s attempt to preemptively block the U.S. Food and Drug Administration from approving a new competitor to its blockbuster pulmonary hypertension medication Tyvaso, saying the company was effectively seeking to challenge an agency action before the FDA made one.

  • March 29, 2024

    Fed. Circ. Tears Cancer Testing Rivals Apart In Injunction Args

    A trio of Federal Circuit judges appeared fed up Friday with a Morrison Foerster LLP attorney who they repeatedly suggested was focusing on arguments not raised to the district court judge who had blocked her client from selling certain cancer tests while facing infringement litigation.

  • March 29, 2024

    SEC Wins Extended Asset Freeze Against Biotech Co.

    A Colorado federal judge on Friday granted the U.S. Securities and Exchange Commission's request to make permanent a restraining order freezing a biotech company's assets while the case proceeds, finding that the regulator is likely to prevail in the suit.

  • March 29, 2024

    Allergan Scoffs At Sandoz Bid To Undo $39M Patent Loss

    Allergan told the Federal Circuit to reject Sandoz's fight over a $39 million verdict against it for infringing an Allergan eyelash growth drug patent, saying Sandoz's reliance on a 2014 decision involving the same drug misses the decision's central point.

  • March 29, 2024

    Judge Axes UpHealth's Claim Estimation Bid In Bankruptcy

    A Delaware bankruptcy judge denied UpHealth Holdings Inc.'s request to treat a potential liability claim as worth nothing, saying the company hadn't shown that the bankruptcy case would be hindered if a state court was left to decide the claim's value.

  • March 29, 2024

    Hedge Fund Beats Vaxart Investor's 'Short-Swing' Profits Suit

    A New York federal judge has granted a win to hedge fund Armistice Capital LLC and its managing member in a derivative suit brought by a shareholder of biotechnology company Vaxart Inc., which sought disgorgement of short-swing profits that allegedly were wrongfully obtained by the investment adviser.

  • March 29, 2024

    Del. Judge Clears Liquidia To Sell Lung-Disease Drug

    A Delaware federal judge has ruled that biochemical startup Liquidia can launch its lung disease drug after the Federal Circuit upheld a patent board ruling cutting out the remaining claims in a hypertension patent owned by United Therapeutics that was keeping the drug off the market.

  • March 29, 2024

    THL's $2.5B Deal To Buy Agiliti Sparks Chancery Suit

    A shareholder of Agiliti, a medical equipment and services provider on the cusp of being acquired and taken private by Thomas H. Lee Partners LP, has sued the healthcare company in Delaware's Court of Chancery, seeking more information about the controlling private equity stockholder's $2.5 billion buyout bid.

Expert Analysis

  • SEC Case May Expand Scope Of Insider Trading Liability

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    The U.S. Securities and Exchange Commission's first-of-its-kind enforcement action against an individual in a case involving "shadow trading" demarcates an expansion of insider trading liability to circumstances in which there is a market connection between the source of information and the issuer of the securities traded, say attorneys at Steptoe.

  • Opinion

    Waiving COVID-19 IP Protections Would Harm US Industry

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    President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.

  • Fed. Circ. Patent Decisions In 2023: An Empirical Review

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    The Federal Circuit decided 306 patent cases last year, which is still well down from the pre-pandemic norm of around 440, and on the whole the court's decisions were markedly less patentee-friendly in 2023 than in 2022, says Dan Bagatell at Perkins Coie.

  • What The Law Firm Of The Future Will Look Like

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    As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • 4 PR Pointers When Your Case Is In The News

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    Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.

  • Digging Into The Debate On FDA's Proposed Lab Test Rule

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    A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.

  • How 2023 Shaped Drug And Medical Device Legal Trends

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    2023 brought a number of positive developments for the life sciences industry, including great trial and multidistrict litigation outcomes, but also some heavy-handed regulations and other concerning developments that lay the groundwork for significant litigation, say attorneys at Faegre Drinker.

  • Opinion

    What Insurers Gain When Litigating Coverage Denials

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    Lately, insurance companies have denied coverage for lawsuits alleging liability relating to the ordinary operations of highly regulated businesses, such as those in the pharmaceutical and energy sectors — demonstrating time and again how litigation can be a vehicle for carriers to mitigate their own costs, say attorneys at Reed Smith.

  • Trending At The PTAB: 6 Areas To Watch In 2024

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    Expect further changes in a half-dozen areas in 2024 following a busy 2023 at the Patent Trial and Appeal Board, including more adjustments to the director review process and the first case to hit the Appeals Review Panel, say attorneys at Finnegan.

  • 5 Trends That Will Affect Food Litigation In 2024

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    In 2024, food and beverage companies are likely to continue to face threats of litigation relating to so-called forever chemicals, citric and malic acid, and ESG claims, but recent developments in case law have created potential avenues for defense, say Abby Meyer and Khirin Bunker at Sheppard Mullin.

  • Law Firm Strategies For Successfully Navigating 2024 Trends

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    Though law firms face the dual challenge of external and internal pressures as they enter 2024, firms willing to pivot will be able to stand out by adapting to stakeholder needs and reimagining their infrastructure, says Shireen Hilal at Maior Consultants.

  • The Most-Read Legal Industry Law360 Guest Articles Of 2023

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    A range of legal industry topics drew readers' attention in Law360's Expert Analysis section this year, from associate retention strategies to ethical billing practices.

  • Inside Higher Education's New FCA Liability Challenges

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    As the educational sector expands its use of government funding, schools are at increased risk under the False Claims Act, but recent settlements offer valuable lessons about new theories of liability they may face and specific procedures to reduce their exposure, say James Zelenay and Jeremy Ochsenbein at Gibson Dunn.

  • AI Executive Order's Life Science, Healthcare Industry Effects

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    The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.

  • 5 Most Notable Class Action Standing Cases Of 2023

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    Key appellate class action decisions this past year continued the trend of a more demanding approach to the threshold issue of standing during each phase of litigation, say attorneys at MoFo.

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