Life Sciences

  • May 06, 2025

    Mylan Agrees To Keep Nausea Generics Off Market Until 2032

    Mylan Pharmaceuticals Inc. can enter the market in 2032 with a generic anti-nausea drug to compete with Heron Therapeutics Inc. products after the companies settled patent infringement litigation in Delaware federal court.

  • May 06, 2025

    Mistrial Declared On Punitive Damages In Bard Cancer Case

    A Georgia state judge declared a mistrial as to punitive damages Tuesday in a suit alleging C.R. Bard's ethylene oxide emissions caused a man's cancer, leaving a $20 million compensatory damages verdict in place but inviting a round of briefing on the unusual situation.

  • May 06, 2025

    Ex-CEO Can't Shake Conviction In COVID Test Kit Fraud Case

    The former chief executive of a healthcare software company who touted a $670 million COVID test kit deal that collapsed was denied acquittal Monday by a Newark federal judge who ruled the evidence was sufficient for a reasonable juror to find beyond a reasonable doubt that he had engaged in securities fraud.

  • May 06, 2025

    Trade Secrets Emerge As Path For Cos. To Protect AI Works

    Classifying creations of artificial intelligence tools as trade secrets has become a viable alternative to copyrights and patents — a shift that is presenting businesses using AI with a range of strategies and risks they must consider to protect their innovations.

  • May 06, 2025

    Trump Orders FDA To Speed Up Drug Plant Approvals

    President Donald Trump directed the U.S. Food and Drug Administration to cut the approval timelines for new manufacturing facilities by domestic drugmakers and also to pressure foreign drugmakers to comply with quality control inspections, according to a recent executive order.

  • May 06, 2025

    Gene-Editing Co. Synthego Hits Ch. 11 With Sights On A Sale

    California-based biotechnology company Synthego Corp. filed for Chapter 11 in Delaware bankruptcy court, listing up to $500 million in debt and outlining a plan to sell its assets to its prepetition lender during the proceedings.

  • May 05, 2025

    DC Circ. Has Doubts About Narcolepsy Drug Appeal

    The D.C. Circuit is now set to decide whether the U.S. Food and Drug Administration was wrong to declare a rival narcolepsy treatment not the "same drug" as another produced by Jazz Pharmaceuticals Inc., after appearing highly skeptical of the drug company's arguments that it was.

  • May 05, 2025

    Liquidia Fends Off Indication Challenge In UTC Tyvaso Fight

    A D.C. federal court has rejected United Therapeutics Corp.'s challenge to a U.S. Food and Drug Administration decision allowing Liquidia Technologies Inc. to modify a new drug application to include an additional lung disease indication for a drug competing with UTC's blockbuster lung disease drug Tyvaso.

  • May 05, 2025

    8th Circ. Backs Boehringer's Copyright Win Over Software Co.

    The Eighth Circuit upheld a district court's conclusion that Boehringer Ingelheim's veterinary arm and other companies did not infringe the copyrights of software company InfoDeli, saying in an opinion Monday that some elements of the online platforms that InfoDeli built were not entitled to protection.

  • May 05, 2025

    Regeneron, Amgen Open Drug 'Bundling' Trial In Del.

    The founder and CEO of Regeneron Inc. told a federal jury in Delaware on Monday that a major pharmacy benefit insurer told him in mid-2020 his company was wasting its time in trying to keep a cholesterol-drug supply contract, with Amgen Inc. offering a better-priced but allegedly anticompetitive multidrug portfolio.

  • May 05, 2025

    PTAB Says It's Bedtime For Sleep Apnea Patent Claims

    Patent board judges have decided to wipe out all the claims in a patent covering a method to treat sleep apnea, which were challenged by a San Diego sleep apnea outfit that says those claims reflect "97 percent" of a patent case over sleep apnea machines in Delaware federal court. 

  • May 05, 2025

    Trump Admin Urges Dismissal Of States' Abortion Pill Suit

    The Trump administration on Monday asked a Texas federal judge to dismiss a lawsuit seeking to roll back access to the abortion medication mifepristone, contending the three states pursuing the case waited too long to file and are suing in the wrong jurisdiction.

  • May 05, 2025

    Pharma Co. Escapes Investor Liver Drug Trial Suit, For Now

    Biopharmaceutical company Akero Therapeutics Inc. and its executives have escaped, for now, a proposed class action alleging they misled investors about the patient population in a clinical trial for Akero's liver disease treatment, with a California federal judge on Monday rejecting the suit's theory of motive for the defendants.

  • May 05, 2025

    Rite Aid Hits Bankruptcy Less Than A Year After Previous Ch. 11

    Drugstore chain Rite Aid Corp. reentered bankruptcy Monday less than a year after its earlier reorganization plan was approved, filing for Chapter 11 protection in New Jersey bankruptcy court with more than $1 billion in debt and plans for an asset sale.

  • May 05, 2025

    Purdue Tells Justices 'Rigid' Fed. Circ. Rule Threatens Patents

    Bankrupt OxyContin-maker Purdue Pharma LP wants the U.S. Supreme Court to revive its legal effort to use patent laws to block the release of a competing "crush-resistant" generic painkiller, challenging a Federal Circuit decision that Purdue calls too "rigid."

  • May 05, 2025

    Exactech Committee Calls Foul On Ch. 11 Voting Packages

    The official committee of unsecured creditors in Exactech Inc.'s Chapter 11 case told a Delaware bankruptcy judge that the company's solicitation packages sent to tort claimants violate court-approved procedures by requiring them to submit five separate ballots for their votes to be counted.

  • May 05, 2025

    Novartis, Incyte Settle Drug Royalty Fight On Eve Of Trial

    A Manhattan federal judge put off trial on Monday in a five-year quest by Novartis to recover what it says are $500 million in missing royalties from its agreement to commercialize an Incyte compound used to treat blood cancers, with the sides announcing they reached a settlement.

  • May 05, 2025

    High Court Won't Hear Challenge To Miss. Ban On Pot Ads

    The U.S. Supreme Court on Monday rejected an opportunity to hear a First Amendment challenge to Mississippi's policy outlawing medical marijuana advertisements, effectively preserving a circuit court decision that upheld the state's ban.

  • May 02, 2025

    Insulin Giants' Antitrust Victory On Shaky Ground At 2nd Circ.

    A major legal triumph for manufacturers of wildly popular medications treating diabetes and obesity suddenly looked precarious Friday at the Second Circuit, where judges sounded open to reviving a proposed class action alleging a multibillion-dollar conspiracy in a controversial drug-discount program.

  • May 02, 2025

    Boston Scientific, FDA Sued Over 'Unsafe' Spinal Implant

    Boston Scientific evaded safety regulations to market a defective spinal cord stimulator and the U.S. Food and Drug Administration rubber-stamped those alterations in an instance of "agency capture," according to a California federal lawsuit filed by a patient suffering from ongoing pain after the device was implanted.

  • May 02, 2025

    Plaintiffs Seek Redo Over Sterilization Co.'s Trial Tactics

    Four women who claimed a Colorado sterilization company caused their cancers asked a state court to order a new trial, arguing the business won a favorable verdict with prejudicial evidence about law firm ads and by suggesting the women are not "real victims but pawns in a scheme orchestrated by their lawyers."

  • May 02, 2025

    Tax Case Can Proceed Despite Late Name Change, Court Says

    The owner of a mail-order medical equipment company can move forward with his lawsuit against the federal government seeking to deduct a $5 million settlement payment, even though he didn't technically add his name to the case until after the deadline, the Court of Federal Claims said.

  • May 02, 2025

    Fed. Circ. Gives MSN Short Pause For Entresto Appeal

    The Federal Circuit told a Delaware federal judge on Friday to hold off entering final judgment in litigation that would delay MSN Pharmaceuticals Inc. from launching a generic version of Novartis' blockbuster heart medication Entresto.

  • May 02, 2025

    Ex-SCWorx CEO Seeks Sentencing Delay Over Restitution Row

    The former chief executive of SCWorx Corp. who was convicted of securities fraud after publicizing a $670 million COVID-19 test kit contract that never materialized told a New Jersey federal court Friday that he's seeking a one-month delay in his sentencing, citing the government's statement that it would pursue more than $140 million in restitution.

  • May 02, 2025

    CR Bard Owes $20M In Ga. Ethylene Oxide Cancer Trial

    A Georgia jury awarded $20 million in compensatory damages on Friday to a man who said his cancer was caused by exposure to ethylene oxide from C.R. Bard's medical sterilization plant, sending the case to a second phase for punitive damages.

Expert Analysis

  • Series

    Adapting To Private Practice: From SEC To BigLaw

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    As I adjusted to the multifaceted workflow of a BigLaw firm after leaving the U.S. Securities and Exchange Commission, working side by side with new colleagues on complex matters proved the fastest way to build a deep rapport and demonstrate my value, says Jennifer Lee at Jenner & Block.

  • China High Court Ruling Could Encourage Antitrust Litigation

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    Practitioners defending U.S. companies in China should take note of a Chinese Supreme Court ruling that plaintiffs can file suits based on either where the alleged action, or where the result of such action, occurred — which will promote civil litigation by minimizing procedural battles over forum selection, says Yang Yang at Leaqual Law Firm.

  • Making The Case For Rest In The Legal Profession

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    For too long, a culture of overwork has plagued the legal profession, but research shows that attorneys need rest to perform optimally and sustainably, so legal organizations and individuals must implement strategies that allow for restoration, says Marissa Alert at MDA Wellness, Carol Ross-Burnett at CRB Global, and Denise Robinson at The Still Center.

  • How Amended Rule 702 Affects Testimony In Patent Litigation

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    In 2023, Federal Rule of Evidence 702 was amended to address the apparent failure of some courts to prevent unreliable expert evidence from reaching a jury, but a statistical analysis of Daubert decisions in 2022 and 2024 shows that courts remain divided about how to apply consistent evidence standards, say attorneys at Perkins Coie.

  • What Trump's Order Means For The Legal Status Of IVF

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    An executive order signed by President Donald Trump last month signals the administration's potential intention to increase protections for in vitro fertilization services, though more concrete actions would be needed to resolve the current uncertainty around IVF access or bring about a binding legal change, says Jeanne Vance at Weintraub Tobin.

  • Mitigating Tariff Risks For Healthcare In US And Canada

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    Healthcare stakeholders should take steps to evaluate the impact of cross-border tariffs, as the historically strong ties between Canada and the U.S. demonstrate the potential for real disruption and harm to the healthcare industry in both countries, say attorneys at Norton Rose.

  • 4 Ways Women Attorneys Can Build A Legal Legacy

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    This Women’s History Month, women attorneys should consider what small, day-to-day actions they can take to help leave a lasting impact for future generations, even if it means mentoring one person or taking 10 minutes to make a plan, says Jackie Prester, a former shareholder at Baker Donelson.

  • A Judge's Pointers For Adding Spice To Dry Legal Writing

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    U.S. District Judge Fred Biery shares a few key lessons about how to go against the grain of the legal writing tradition by adding color to bland judicial opinions, such as by telling a human story and injecting literary devices where possible.

  • Preparing For Disruptions To Life Sciences Supply Chains

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    Life sciences companies must assess how new and escalating tariffs — combined with other restrictions on cross-border activity singling out pharmaceutical products and medical devices — will affect supply chains, and they should proactively prepare for antitrust and foreign direct investment regulatory review processes, say attorneys at Weil.

  • Mastering The Fundamentals Of Life Sciences Due Diligence

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    As life sciences transactions continue to gain tremendous momentum, companies participating in these transactions must conduct effective and strategic regulatory due diligence, which involves extensive amounts of information and varies by manifold factors, says Anna Zhao at GunnerCooke.

  • Beware Risks Of Arguing Multiple Constructions In IP Cases

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    Defendants accused of patent infringement often argue for different, potentially contradictory, claim constructions before district courts and the Patent Trial and Appeal Board, but the board may be clamping down on this strategy, say attorneys at Dechert.

  • What's At Stake In High Court Transgender Care Suit

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    The outcome of U.S. v. Skrmetti will have critical implications for the rights of transgender youth and their access to gender-affirming care, and will likely affect other areas of law and policy involving transgender individuals, including education, employment, healthcare and civil rights, say attorneys at ArentFox Schiff.

  • 6th Circ. Ruling Paves Path Out Of Loper Bright 'Twilight Zone'

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    The U.S. Supreme Court’s Loper Bright ruling created a twilight zone between express statutory delegations that trigger agency deference and implicit ones that do not, but the Sixth Circuit’s recent ruling in Moctezuma-Reyes v. Garland crafted a two-part test for resolving cases within this gray area, say attorneys at Wiley.

  • A Reminder On Avoiding Improper Venues In Patent Cases

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    A Texas federal court's recent decision in the Symbology and Quantum cases shows that baseless patent venue allegations may be subject to serious Rule 11 sanctions, providing venue-vetting takeaways for plaintiffs and defendants, say attorneys at Bond Schoeneck.

  • NIH Cuts To Indirect Costs May Stifle IP Generation

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    Although currently blocked by a preliminary injunction, the National Institutes of Health's new policy to cut down on indirect cost funding creates challenges for university research projects, and may hamper the development of intellectual property — which is considered an indirect cost — for years to come, say attorneys at Snell & Wilmer.

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