Life Sciences

  • 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.

  • May 02, 2025

    Faegre Drinker Lands Patent Team From Wilson Sonsini

    Faegre Drinker Biddle & Reath LLP added a partner, an associate and two patent agents from Wilson Sonsini Goodrich & Rosati PC to bolster its intellectual property practice, the firm has announced.

  • May 02, 2025

    Goodwin Adds Scientist IP Partner From Cooley On West Coast

    A seasoned life sciences and intellectual property attorney with a doctorate in biochemistry, biophysics and molecular biology has joined Goodwin Procter LLP on the West Coast, the firm announced.

  • May 02, 2025

    23andMe Says 1.3M Customers Have Asked To Delete Data

    23andMe executives told a meeting of creditors Friday that more than 1.3 million customers have asked the DNA testing company to cancel their accounts and delete their genetic information since it entered Chapter 11.

  • May 02, 2025

    Taxation With Representation: Goodwin, Haynes Boone

    In this week's Taxation With Representation, Merck buys SpringWorks Therapeutics, Novartis AG acquires Regulus Therapeutics Inc., Sabre Corp. sells its Hospitality Solutions business to private equity shop TPG, and TWG Global and Mubadala Capital team up to bolster their investments.

Expert Analysis

  • Series

    Law School's Missed Lessons: Be An Indispensable Associate

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    While law school teaches you to research, write and think critically, it often overlooks the professional skills you will need to make yourself an essential team player when transitioning from a summer to full-time associate, say attorneys at Stinson.

  • Series

    Birding Makes Me A Better Lawyer

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    Observing and documenting birds in their natural habitats fosters patience, sharpens observational skills and provides moments of pure wonder — qualities that foster personal growth and enrich my legal career, says Allison Raley at Arnall Golden.

  • Series

    Adapting To Private Practice: From DOJ Leadership To BigLaw

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    The move from government service to private practice can feel like changing one’s identity, but as someone who has left the U.S. Department of Justice twice, I’ve learned that a successful transition requires patience, effort and the realization that the rewards of practicing law don’t come from one particular position, says Richard Donoghue at Pillsbury.

  • Fed. Circ. Ruling Reaffirms Listing Elements Separately Is Key

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    The Federal Circuit's decision last month in Regeneron v. Mylan reaffirms a critical principle in patent law: When a claim lists elements separately, the clear implication is that they are distinct elements, say attorneys at Taft.

  • State Extended Producer Responsibility Laws: Tips For Cos.

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    As states increasingly shift the onus of end-of-life product management from consumers and local governments to the businesses that produce, distribute or sell certain items, companies must track the changing landscape and evaluate the applicability of these new laws and regulations to their operations, say attorneys at Alston & Bird.

  • Law Firm Executive Orders Create A Legal Ethics Minefield

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    Recent executive orders targeting BigLaw firms create ethical dilemmas — and raise the specter of civil or criminal liability — for the government attorneys tasked with implementing them and for the law firms that choose to make agreements with the administration, say attorneys at Buchalter.

  • Firms Must Embrace Alternative Billing Models Or Fall Behind

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    As artificial intelligence tools eliminate inefficiencies and the Big Four accounting firms enter the legal market, law firms that pivot from the entrenched billable hour model to outcomes-based pricing will see a distinct competitive advantage, says attorney William Brewer.

  • Key Issues To Watch As USPTO Changes Abound

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    As 2025 continues to unfold, changes at the U.S. Patent and Trademark Office — including new leadership, operational reforms, legislative initiatives and AI-related policies — have potential to influence proceedings, including efforts to prosecute patents and adversarial proceedings before the Patent Trial and Appeal Board, say attorneys at Morgan Lewis.

  • Trending At The PTAB: A Pivot On Discretionary Denials

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    Following the U.S. Patent and Trademark Office's rescission of the 2022 Vidal memorandum and a reversion to the standards under Apple v. Fintiv, petitioners hoping to avoid discretionary denials should undertake holistic review of all Fintiv factors, rather than relying on certain fail-safe provisions, say attorneys at Finnegan.

  • How Attorneys Can Master The Art Of On-Camera Presence

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    As attorneys are increasingly presented with on-camera opportunities, they can adapt their traditional legal skills for video contexts — such as virtual client meetings, marketing content or media interviews — by understanding the medium and making intentional adjustments, says Kerry Barrett.

  • Patent Drafting Pointers From Fed. Circ. COVID Test Ruling

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    The Federal Circuit's recent decision in DNA Genotek v. Spectrum Solutions provides several best practice pointers for drafting and prosecuting patent applications, highlighting how nuances in wording can potentially limit the scope of claims or otherwise affect claim constructions, says Irah Donner at Manatt.

  • Opinion

    Congress Must Reform The PTAB To Protect Small Innovators

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    Lawmakers must reintroduce the Promoting and Respecting Economically Vital American Innovation Leadership Act or similar legislation to prevent larger companies from leveraging the Patent Trial and Appeal Board to target smaller patent holders, says Schwegman Lundberg's Russell Slifer, former deputy director of the U.S. Patent and Trademark Office.

  • Series

    Baseball Fantasy Camp Makes Me A Better Lawyer

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    With six baseball fantasy experiences under my belt, I've learned time and again that I didn't make the wrong career choice, but I've also learned that baseball lessons are life lessons, and I'm a better lawyer for my time at St. Louis Cardinals fantasy camp, says Scott Felder at Wiley.

  • Series

    Adapting To Private Practice: From Fed. Prosecutor To BigLaw

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    Making the jump from government to private practice is no small feat, but, based on my experience transitioning to a business-driven environment after 15 years as an assistant U.S. attorney, it can be incredibly rewarding and help you become a more versatile lawyer, says Michael Beckwith at Dickinson Wright.

  • What To Expect For Stem Cell Regulation Under Trump Admin

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    The new administration's push for deregulation, plus the post-Chevron legal landscape, and momentum from key political and industry players to facilitate stem cell innovation may create an opportune backdrop for a significant reduction in the U.S. Food and Drug Administration's regulatory framework for stem cells, say attorneys at Sheppard Mullin.

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