Life Sciences

  • May 06, 2025

    Post-Ch. 11 Rite Aid Trustee Asks To Take Over Insurance Suit

    A trust tied to Rite-Aid's previous bankruptcy exit plan has asked a New Jersey bankruptcy judge for permission to take over for Rite Aid in an adversary case seeking insurance money related to opioid claims.

  • May 06, 2025

    Medical Device Co. SeaStar Seeks Toss Of Shareholder Suit

    SeaStar Medical Inc. has urged a Colorado federal judge to toss a proposed class action alleging the healthcare company misled investors about potential regulatory risks and compliance deficiencies, arguing the amended complaint "attempts to create the illusion of factual particularity through a façade of prolixity."

  • May 06, 2025

    Quarles & Brady Adds New IP, Real Estate Partners

    Quarles & Brady LLP has welcomed a Milwaukee-based intellectual property litigator from Quinn Emanuel Urquhart & Sullivan LLP and a Phoenix-based real estate and public finance attorney from Ice Miller LLP.

  • May 06, 2025

    Fed. Circ. Asks What Law Applies For Sleep Drug Injunction

    The Federal Circuit lifted an injunction Tuesday that had placed limits on Avadel CNS Pharmaceuticals' clinical trials for sleep disorder treatments, but sent the infringement case back to Delaware to determine whether a future injunction should be governed by the Hatch-Waxman Act.

  • May 06, 2025

    Haemonetics Sues Terumo Over Plasma Tech Patents

    A Massachusetts-based developer of blood- and plasma-related medical technology has accused a Colorado-based competitor of infringing four of its plasma collection patents with two variations of a donation system that got approval from the U.S. Food and Drug Administration in 2022 and 2024.

  • 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.

Expert Analysis

  • FDA's Red No. 3 Ban Reshapes Food Safety Legal Landscape

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    The U.S. Food and Drug Administration's recent ban on Red No. 3 represents more than the end of a controversial dye — it signals a shift in regulatory priorities, consumer expectations, intellectual property strategy, compliance considerations and litigation risk, says Dino Haloulos at Foley Mansfield.

  • Scope And Nature Of Judicial Relief Will Affect Loper's Impact

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    The practical result of post-Loper Bright rulings against regulatory actions will depend on the relief courts grant — and there has been controversy in these types of cases over whether the ruling is applied just to the parties or nationwide, and whether the action can be left in place while it's corrected, says Steven Gordon at Holland & Knight.

  • The Implications Of E-Cigarette Cos. Taking Suits To 5th Circ.

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    The U.S. Supreme Court recently heard oral arguments in U.S. Food and Drug Administration v. R.J. Reynolds over the definition of an "adversely affected" person under the Tobacco Control Act, and the justices' ruling will have important and potentially wide-ranging implications for forum shopping claims, says Trillium Chang at Zuckerman Spaeder.

  • Series

    Adventure Photography Makes Me A Better Lawyer

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    Photographing nature everywhere from Siberia to Cuba and Iceland to Rwanda provides me with a constant reminder to refresh, refocus and rethink the legal issues that my clients face, says Richard Birmingham at Davis Wright.

  • What Vinyl Acetate's Prop 65 Listing Means For Cos.

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    California's recent move to add vinyl acetate to the Proposition 65 list of carcinogens, with enforcement starting later this year, will have sweeping compliance and risk implications for businesses in the retail, food and beverage, paint, adhesive, industrial manufacturing, and personal care product industries, say attorneys at Alston & Bird.

  • Fed. Circ. Inherency Ruling Refines Obviousness Framework

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    The Federal Circuit's December decision in Cytiva v. JSR has definitively eliminated the requirement of "reasonable expectation of success" analysis for inherent properties in obviousness determinations, while providing some key clarifications for patent practitioners, says Lawrence Kass at Steptoe.

  • Navigating The Potential End Of GLP-1 Drug Shortages

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    The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.

  • High Court Could Further Limit Deference With TCPA Fax Case

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    The Supreme Court's decision to hear McLaughlin Chiropractic Associates v. McKesson, a case involving alleged junk faxes that centers whether district courts are bound by Federal Communications Commission rules, offers the court a chance to possibly further limit the judicial deference afforded to federal agency interpretations of statutes, says Samantha Duke at Rumberger Kirk.

  • 5 Ways To Create Effective Mock Assignments For Associates

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    In order to effectively develop associates’ critical thinking skills, firms should design mock assignments that contain a few key ingredients, from messy fact patterns to actionable feedback, says Abdi Shayesteh at AltaClaro.

  • Calif. Cannabis Decision Deepens Commerce Clause Divide

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    In Peridot Tree v. Sacramento, the Eastern District of California joined a growing minority of courts that have found the dormant commerce clause inapplicable to state-regulated marijuana, and the Ninth Circuit will soon provide important guidance on this issue, say attorneys at Perkins Coie.

  • Opinion

    IVF Suits Highlight Need For Better Legal Frameworks

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    The high number of in vitro fertilization embryo losses underscores the need for more cohesive legal and regulatory guidance related to human errors, property versus personhood, and liability, says Jeff Korek at Gersowitz Libo.

  • Recent Suits Show Antitrust Agencies' Focus On HSR Review

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    The U.S. Department of Justice's suit this month against KKR for inaccurate and incomplete premerger filings, along with other recent cases, highlights the agency's increasing scrutiny of Hart-Scott-Rodino Act compliance for private equity firms, say attorneys at Willkie.

  • The 7th Circ.'s Top 10 Civil Opinions Of 2024

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    Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2024, and explain how they may affect issues related to mass arbitration, consumer fraud, class certification and more.

  • Royal Canin Ruling Won't Transform Removal Jurisdiction

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    The U.S. Supreme Court's ruling in Royal Canin USA v. Wullschleger means that federal district courts must now remand whenever an amended complaint excises grounds for federal jurisdiction — but given existing litigation strategy and case law trends, this may ultimately preserve, rather than alter, the status quo, say attorneys at Norton Rose.

  • Lessons From The Pharma Industry On Patent Cliffs

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    In the next five years, patents for drugs that have generated billions in global sales are set to expire, and companies that view this imminent patent cliff as an opportunity for strategic renewal rather than a challenge will be best positioned to maintain market leadership, says Keegan Caldwell at Caldwell Law.

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