Life Sciences

  • September 09, 2024

    Purdue Sees Another OxyContin Patent Axed

    A Delaware federal court decided on Monday that yet another patent issued to bankrupt OxyContin maker Purdue Pharma is invalid, a year and a half after a similar ruling was issued in another case about the company's efforts to assert different patents to stop the same prospective Indian manufacturer of generic painkillers.

  • September 09, 2024

    Abbott Says Illinois OT Suit Should Join Similar Case In Ohio

    Abbott Laboratories asked an Illinois federal judge Friday to send two workers' dispute over unpaid sanitary gear changes and hand washings to Ohio where a similar suit is pending, arguing that the move would promote consistent judgments across the "nearly identical" claims.

  • September 09, 2024

    House OKs Bill To Bar Contracts With Chinese Biotech Cos.

    Driven by concerns about U.S. genetic data being shared with the Chinese government, House lawmakers passed a bill on Monday to bar federal agencies from buying certain biotechnology linked to the Chinese government or from contracting with firms that use those products.

  • September 09, 2024

    FTC Backs Teva Orange Book Delisting At Fed. Circ.

    The Federal Trade Commission is continuing to back Amneal's efforts to have Teva's inhaler patents delisted from the U.S. Food and Drug Administration's Orange Book, telling the Federal Circuit that a lower court was right in determining that Teva's patents do not satisfy the registry's requirements.

  • September 09, 2024

    Biotech Execs Face Investor Suit Over Medicare Claims

    Executives and directors of biopharmaceutical company Ardelyx have been hit with a shareholder derivative suit in Massachusetts federal court alleging the company misled investors over its intentions and ability to apply for a Medicare reimbursement program for its kidney disease treatment.

  • September 09, 2024

    Generics Makers Want Mo. Sanctioned In Price-Fixing Case

    Teva Pharmaceuticals Inc., Mylan Inc. and other generic-drug makers accused by state enforcers of fixing prices have urged a Connecticut federal judge to punish the state of Missouri for failing to provide information requested by the drug companies.

  • September 09, 2024

    MBX Biosciences Seeks Up To $136M In Upcoming IPO

    Indiana-based clinical-stage biopharmaceutical company MBX Biosciences Inc. on Monday set the terms for its initial public offering, with plans to raise up to $136 million.

  • September 09, 2024

    Baltimore Strikes $80M Opioid Settlement With Teva

    Teva Pharmaceuticals will pay Baltimore $80 million to resolve claims that the company inflamed the city's opioid crisis, the city of Baltimore announced Monday ahead of a trial slated to begin next week against the remaining defendants in the Maryland state court litigation.

  • September 09, 2024

    Novo Nordisk Sues Over Ads For Diabetes, Weight Loss Drugs

    A New Jersey company violated trademark and false advertising laws by promoting drugs without a regulatory green light as being generic versions of Novo Nordisk's Ozempic and Wegovy medications, according to a lawsuit filed in New Jersey federal court.

  • September 09, 2024

    Novartis Settles Sales Rep.'s Gender Bias Suit

    A former sales representative with Novartis Pharmaceuticals Corp. has settled a lawsuit against the company alleging she faced gender-motivated retaliation after reporting a co-worker for falsifying records and hurting her sales numbers.

  • September 09, 2024

    Catching Up With Delaware's Chancery Court

    Delaware's Court of Chancery made some expensive decisions last week, ranging from a $130 million stockholder award and a freeze on $450 million in equity financing to a whopping $1 billion bill for fraud and breach of contract damages. New cases aimed at Virgin Galactic, settlements pulled in Hemisphere Media Group Inc. and court hearings involving Apollo Global Management heated up. In case you missed it, here's the roundup of news from Delaware's Court of Chancery.

  • September 09, 2024

    2nd Circ. Upholds Regeneron's Win In Remote Work Suit

    The Second Circuit rejected a former Regeneron Pharmaceuticals Inc. employee's appeal seeking to revive claims it illegally denied her a remote work situation to care for her daughter while she underwent medical care, ruling Monday that there was no evidence the company had willfully broken the law.

  • September 09, 2024

    Ore. Seeks Dismissal Of Psilocybin Disabilities Suit

    Oregon's health regulator has asked a federal judge to dismiss a lawsuit challenging aspects of the state's pioneering regulated psilocybin treatment program, saying that the program's illegality under federal law makes the lawsuit untenable.

  • September 06, 2024

    AstraZeneca Unit Owes $130M In Chancery Scuttled-Drug Suit

    The Delaware Chancery Court awarded $130 million to former shareholders of biopharmaceutical company Syntimmune in their breach of contract fight against AstraZeneca PLC unit Alexion Pharmaceuticals Inc., finding that Alexion failed to make promised payments after it acquired Syntimmune in 2018 and breached key terms of their merger agreement.

  • September 06, 2024

    Actelion Must Face Tracleer Antitrust Suit With Class Certified

    A Maryland federal judge refused Friday to toss an antitrust suit accusing Actelion Pharmaceuticals of illegally denying generics companies the samples they needed to produce generic versions of its hypertension drug Tracleer, while separately certifying a class composed of "hundreds" of insurers and self-funded employers.

  • September 06, 2024

    Biopharm Co., Directors Sued In Del. Over 'Extreme' Scheme

    A five-year run of "extreme and unconscionable self-dealing" has left 62% of Navidea BioPharmaceuticals Inc. equity in the hands of a single stockholder-director, a Delaware Court of Chancery suit has alleged, with the company now deregistered and currently without a viable product.

  • September 06, 2024

    NJ Medical Co. Claims Ex-Employees Conspired To Form Rival

    A New Jersey medical communications agency said Friday that four of its former employees and the onetime U.S. president of biopharmaceutical company PharmaEssentia used its confidential information in a scheme to form a rival firm and steal millions of dollars of work from it.

  • September 06, 2024

    Ingersoll Rand Blocks Rival From Hiring Ex-Exec In NDA Fight

    A Colorado state court has preliminarily blocked the former chief executive of a company acquired by industrial products giant Ingersoll Rand Inc. from working for rival Avantor, finding Ingersoll Rand will likely win its claims that the executive specifically agreed not to work for Avantor as a condition of the acquisition.

  • September 06, 2024

    Travel Nurse Says Emory Ended Her Contract Over Race Bias

    A travel nurse alleged in a lawsuit that Emory Healthcare Inc. unlawfully terminated her three-month contract after she complained that allowing her to administer peritoneal dialysis on Black patients without proper training would be "akin to treating those patients as guinea pigs."

  • September 06, 2024

    Goodwin-Led Cancer Biotech Eyes Roughly $200M IPO

    Drug developer Bicara Therapeutics Inc., advised by Goodwin Proctor LLP, announced on Friday plans to raise around $200 million in its initial public offering, with the proceeds going toward developing bifunctional antibodies designed to treat solid tumors.

  • September 06, 2024

    Glioblastoma Org. Wants End To Rival's Use Of 'GBM'

    The Glioblastoma Foundation has hit a competing nonprofit with a suit alleging that the group's use of the initials "GBM" in its name has ripped off its trademark and sown confusion among donors who can't tell the two organizations apart.

  • September 05, 2024

    Lawmakers, AGs Urge Justices To OK Denial Of E-Cig Apps

    A coalition of state attorneys general and a group of Democratic Congress members are backing the U.S. Food and Drug Administration in its fight to persuade the U.S. Supreme Court to overturn a decision striking down the denials of applications to market flavored vapes.

  • September 05, 2024

    Law Firms Appeal Atty Fee Denial In Opioid Settlements

    Two law firms, Goldstein & Russell PC and Kelley & Ferraro LLP, have claimed in an appeal to the Sixth Circuit that they were improperly shut out of the $2.13 billion attorney fee pool created by recent national opioid settlements with major pharmaceutical companies and pharmacy chains.

  • September 05, 2024

    Class Attys Vie To Lead Drug Co. Insider Trading Suit In Del.

    A courtroom face-off over lead stockholder counsel duties in a Delaware Chancery Court case accusing a biopharmaceutical company's directors of insider trading and fiduciary duty breaches got edgy Thursday, after one of the plaintiff-side legal teams contended that the other's case was irreparably hobbled by conflicts of interest.

  • September 05, 2024

    Lupin Infringes Exeltis Contraceptive Patents, Judge Finds

    Mumbai-based generic-pharmaceuticals company Lupin Pharmaceuticals Inc. has infringed five patents of the estrogen-free contraceptive Slynd, a Delaware federal judge said Wednesday, finding in favor of Spanish pharmaceutical company Insud Pharma and its New Jersey-based division Exeltis USA Inc. on all asserted claims.

Expert Analysis

  • Dual-Track IPO-M&A Exit Strategies For Life Science Cos.

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    A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.

  • Does Expert Testimony Aid Preliminary IPR Responses?

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    Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.

  • Are Concessions In FDA's Lab-Developed Tests Rule Enough?

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    Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

  • Rebuttal

    Double-Patenting Ruling Shows Terminal Disclaimers' Value

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    While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.

  • Series

    Swimming Makes Me A Better Lawyer

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    Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.

  • Mid-2024 FCA Enforcement And Litigation Trends To Watch

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    Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.

  • What 100 Federal Cases Suggest About Changes To Chevron

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    With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.

  • Why High Court May Have Rejected IP Obviousness Appeal

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    Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.

  • Microplastics At The Crossroads Of Regulation And Litigation

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    Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.

  • The Fed. Circ. In April: Hurdles Remain For Generics

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    The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.

  • Tylenol MDL Highlights Expert Admissibility Headaches

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    A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.

  • Don't Use The Same Template For Every Client Alert

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    As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.

  • Don't Fall On That Hill: Keys To Testifying Before Congress

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    Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.

  • Online Portal Helps Fortify Feds' Unfair Health Practices Fight

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    The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.

  • Series

    Walking With My Dog Makes Me A Better Lawyer

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    Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.

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