Life Sciences

  • November 18, 2024

    MVP: Ropes & Gray's Amanda Austin

    Amanda Austin of Ropes & Gray's life sciences practice guided Pfizer through its $7 billion deal with Flagship Pioneering, advised Fulcrum Therapeutics in its blockbuster collaboration with Sanofi, and was lead counsel to Ginkgo Bioworks, earning her a spot as one of the 2024 Law360 Life Sciences MVPs.

  • November 18, 2024

    Supreme Court Turns Down 3 Patent Cases

    The U.S. Supreme Court on Monday refused to hear three patent cases dealing with patent eligibility, standing to bring infringement suits and the rules surrounding the launch of generic drugs.

  • November 15, 2024

    Eli Lilly Says HHS Ignores Drug Discount Double-Dipping

    Eli Lilly & Co. claims the U.S. Department of Health and Human Services is unlawfully blocking its efforts to crack down on hospitals the company alleges are double-dipping on medication discounts that are meant to benefit low-income patients, according to a lawsuit filed in D.C. federal court.

  • November 15, 2024

    Natera Exec Calls Guardant's Cancer Test Claims 'Dangerous'

    Natera's president of clinical diagnostics testified at trial Friday in a California federal false advertising case that Guardant Health's claims about Guardant's competing colorectal cancer test were "false and misleading" and also "dangerous."

  • November 15, 2024

    SEC-Sanctioned Accounting Firm Sued Over Pre-IPO Work

    The former public company accounting firm BF Borgers is facing a California state lawsuit by an ex-client that says it was forced to scuttle its plans for an initial public offering after the U.S. Securities and Exchange Commission accused the firm of being a "sham auditing mill."

  • November 15, 2024

    PBMs Denied Breakup Of Combined FTC Insulin Price Trial

    The Federal Trade Commission's allegations that pharmacy benefit manager giants Caremark Rx, Express Scripts and OptumRx are artificially inflating insulin prices through unfair rebate schemes will forge ahead as a single case following an in-house agency judge's refusal to break them into separate proceedings.

  • November 15, 2024

    Despite Vaccine Spotlight, RFK Jr. A Health Policy 'Unknown'

    Robert F. Kennedy Jr., President-elect Donald Trump's pick to be the nation's top health official, has made clear his unorthodox and often false views on public health issues like vaccines. But there's still plenty of policy under his potential control where his stance remains opaque, attorneys say, which could stymie their efforts to prepare for the next four years.

  • November 15, 2024

    Ariz. Judge Will Decide Proper Venue For CVS Antitrust Suit

    A federal judge concluded Thursday that he must decide whether a proposed class action accusing CVS of exploiting a Medicare loophole to charge independent pharmacies exorbitant fees belongs in arbitration, after scolding CVS's attorneys for failing to adequately develop their arguments defending an underlying delegation clause.

  • November 15, 2024

    DEA Judge Nixes Vet Group's Bid To Take Part In Pot Hearings

    An administrative law judge with the U.S. Drug Enforcement Administration on Friday denied a veterans group's bid to participate in upcoming hearings on a proposal to loosen federal restrictions on marijuana.

  • November 15, 2024

    Abbott Inks $8M Deal With Healthcare Fraudster In TM Suit

    A New York federal judge on Thursday green-lit a trademark infringement settlement in which Abbott Laboratories will receive $8 million from a Florida businessman who recently pled guilty to healthcare fraud for his role in a sprawling gray market scheme to profit off of Abbott's line of diabetic test strips meant to be sold internationally.

  • November 15, 2024

    Ayahuasca Church Urges Justices To Hear Discovery Case

    An Arizona church that uses a psychedelic substance in its ceremonies has asked the U.S. Supreme Court to reconsider lower courts' rulings directing the church to turn over members' personal information to federal drug enforcement authorities.

  • November 15, 2024

    Teva Defends Mifepristone Antitrust Case Against Corcept

    Teva Pharmaceuticals has asked a California federal judge to reject a bid to dismiss its lawsuit against the maker of a brand-name drug used to treat a rare cortisol disorder, contending its complaint plausibly alleges an illegal scheme to suppress generic competition.

  • November 15, 2024

    Attys Get 'Final Warning' In Tepezza Hearing Loss MDL

    A magistrate judge has chastised attorneys on both sides of multidistrict litigation involving claims that a thyroid eye disease treatment manufactured by Horizon Pharmaceuticals Inc. causes hearing loss, calling for an end to their "improper" conduct during depositions.

  • November 15, 2024

    HOA's Insurer Says Pool Chemical Injury Suits Aren't Covered

    A homeowners association's insurer told a Virginia federal court it needn't cover underlying lawsuits alleging a lifeguard employed by the association's contractor allowed hazardous chemicals to spread and hurt pool patrons, arguing that its commercial general liability policy excluded bodily injury as a result of pollutants.

  • November 15, 2024

    Orrick Trial Partner Joins Morgan Lewis In Boston

    Morgan Lewis & Bockius LLP announced that an experienced litigator from Orrick Herrington & Sutcliffe LLP joined the firm's Boston office as a partner, enhancing its capacity in areas such as life sciences and regulatory compliance.

  • November 15, 2024

    Pharma Biz To Pay $47M To Settle Feds' Kickback Claims

    A Florida pharmaceutical company and its chief executive have agreed to pay $47 million to settle claims that their practice of paying for certain patient tests crossed the line into being an illegal kickback to increase prescriptions of an enzyme replacement therapy, Boston federal prosecutors said on Friday.

  • November 15, 2024

    Sterilization Co. Cosmed Hits Ch. 11 Amid Cancer Claims

    Sterilization company Cosmed Group Inc. filed for Chapter 11 protection in a Texas bankruptcy court Thursday with over $100 million in liabilities, much of it related to cancer claims over the gas that it uses for sterilization.

  • November 14, 2024

    Trump's RFK Jr. Pick For HHS Draws Its Share Of Critics

    The nomination of Robert F. Kennedy Jr. — well-known for his opposition to vaccines — as the secretary of the U.S. Department of Health and Human Services is President-elect Donald Trump's latest controversial pick for his administration, and one that could disrupt the U.S. Food and Drug Administration and its mission.

  • November 14, 2024

    Senate Panel Delays Votes On Patent Eligibility And PTAB Bills

    The Senate Judiciary Committee on Thursday postponed planned votes on legislation aimed at reducing decisions that inventions are ineligible for patents and setting new limits on Patent Trial and Appeal Board challenges, but approved a bill to let the patent office collect demographic data on inventors.

  • November 14, 2024

    Judge Finds Dexcom Infringed Abbott Patent That Hung Jury

    A judge has found that Dexcom Inc. infringed a glucose monitor patent owned by an Abbott Laboratories unit, with the ruling coming after a Delaware federal jury in March said it was hung on the issue.

  • November 14, 2024

    Takeda Rips Cert. Order's 'Whale Of Assumption' At 9th Circ.

    Takeda Pharmaceutical urged the Ninth Circuit on Thursday to reverse a ruling certifying a class of third-party payors who allege Takeda and Eli Lilly & Co. hid their anti-diabetes drug's bladder-cancer risks, arguing the lower court erroneously made a "whale of an assumption" that 56.7% of prescriptions wouldn't have been written with disclosures.

  • November 14, 2024

    Boehringer Says Inhaler Antitrust Suit 'Fails On Its Face'

    Boehringer Ingelheim Pharmaceuticals Inc. and Boehringer Ingelheim International GMBH have urged a Connecticut federal judge to dismiss a proposed class action brought by health funds accusing it of monopolizing the inhaler market with improper patent listings, arguing the suit fails to allege any competitors were actually hindered by those patents.

  • November 14, 2024

    Boeing Could Sell Navigation Unit For $6B, And More Rumors

    Boeing is mulling a sale of its Jeppesen navigation unit at potential $6 billion price tag, Pfizer may be seeking billions for its hospital drug unit, and a U.S. gas station and convenience store business could be sold at a $1.5 billion value. Here, Law360 breaks down these and other notable deal rumors from the past week.

  • November 14, 2024

    Trump Picks RFK Jr. To Lead Health & Human Services

    President-elect Donald Trump announced Thursday that Robert F. Kennedy Jr., a prominent anti-vaccination activist and former presidential candidate, is his nominee to lead the U.S. Department of Health and Human Services.

  • November 13, 2024

    Guardant Atty Accuses Natera CEO Of Dishonesty At Trial

    A Guardant Health lawyer on Wednesday accused Natera's CEO of being disingenuous when he testified at trial that a Natera ad campaign was aimed at correcting misleading information Guardant promoted about its competing colorectal cancer tests, exclaiming, "It was about money, wasn't it? Can't you just be honest about that?"

Expert Analysis

  • A Midyear Forecast: Tailwinds Expected For Atty Hourly Rates

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    Hourly rates for partners, associates and support staff continued to rise in the first half of this year, and this growth shows no signs of slowing for the rest of 2024 and into next year, driven in part by the return of mergers and acquisitions and the widespread adoption of artificial intelligence, says Chuck Chandler at Valeo Partners.

  • Critical Questions Remain After High Court's Abortion Rulings

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    The U.S. Supreme Court's decisions in two major abortion-related cases this term largely preserve the status quo for now, but leave federal preemption, the Comstock Act and in vitro fertilization in limbo, say attorneys at Jenner & Block.

  • A Look At Acquisition Trends For Radiopharmaceuticals

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    As radiopharmaceutical drugs are increasingly used for the diagnosis and treatment of certain diseases, interest from Big Pharma entities is following suit, despite some questions around the drugs' capacity to expand beyond their limited niche, says Adrian Toutoungi at Taylor Wessing.

  • Opinion

    States Should Loosen Law Firm Ownership Restrictions

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    Despite growing buzz, normalized nonlawyer ownership of law firms is a distant prospect, so the legal community should focus first on liberalizing state restrictions on attorney and firm purchases of practices, which would bolster succession planning and improve access to justice, says Michael Di Gennaro at The Law Practice Exchange.

  • Navigating FDA Supply Rule Leeway For Small Dispensers

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    As the November compliance deadline for the U.S. Food and Drug Administration's new pharmaceutical distribution supply chain rules draws closer, small dispensers should understand the narrow flexibilities that are available, and the questions to consider before taking advantage of them, say attorneys at Faegre Drinker.

  • Series

    Solving Puzzles Makes Me A Better Lawyer

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    Tackling daily puzzles — like Wordle, KenKen and Connections — has bolstered my intellectual property litigation practice by helping me to exercise different mental skills, acknowledge minor but important details, and build and reinforce good habits, says Roy Wepner at Kaplan Breyer.

  • Texas Ethics Opinion Flags Hazards Of Unauthorized Practice

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    The Texas Professional Ethics Committee's recently issued proposed opinion finding that in-house counsel providing legal services to the company's clients constitutes the unauthorized practice of law is a valuable clarification given that a UPL violation — a misdemeanor in most states — carries high stakes, say Hilary Gerzhoy and Julienne Pasichow at HWG.

  • 6 Lessons From DOJ's 1st Controlled Drug Case In Telehealth

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    Following the U.S. Department of Justice’s first-ever criminal prosecution over telehealth-prescribed controlled substances in U.S. v. Ruthia He, healthcare providers should be mindful of the risks associated with restricting the physician-patient relationship when crafting new business models, says Jonathan Porter at Husch Blackwell.

  • Series

    After Chevron: Scale Tips Favor Away From HHS Agencies

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    The loss of Chevron deference may indirectly aid parties in challenging the U.S. Department of Health and Human Services' interpretations of regulations and could immediately influence several pending cases challenging HHS on technical questions and agency authority, say attorneys at Ropes & Gray.

  • 2 Options For Sackler Family After High Court Purdue Ruling

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    After the U.S. Supreme Court recently blocked Purdue Pharma's plan to shield the family that owns the company from bankruptcy lawsuits, the Sacklers face the choice to either continue litigation, or return to the bargaining table for a settlement that doesn't eliminate creditor claims, says Gregory Germain at Syracuse University.

  • In Memoriam: The Modern Administrative State

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    On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.

  • Series

    After Chevron: Expect Limited Changes In USPTO Rulemaking

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    The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.

  • How High Court Approached Time Limit On Reg Challenges

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    The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.

  • Fed. Circ. Skinny Label Ruling Guides On Infringement Claims

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    The Federal Circuit's recent decision in Amarin v. Hikma shows generic drug manufacturers must pay close attention to the statements in their abbreviated new drug application labels to put themselves in the best position in defending against an induced infringement claim, say Luke Shannon and Roshan Shrestha at Taft Stettinius.

  • 4 Takeaways From Biotech Patent Invalidity Ruling

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    The recent Patents Court decision in litigation between Advanced Cell Diagnostics and Molecular Instruments offers noteworthy commentary on issues related to experiments done in the ordinary course of business, joint importation, common general knowledge and mindset, and mosaicking for anticipation, say Nessa Khandaker and Darren Jiron at Finnegan.

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