Life Sciences

  • August 04, 2025

    Ex-FDA Chief Of Staff Joins Hogan Lovells' Pharma Team

    The former chief of staff at the U.S. Food and Drug Administration, who most recently was a senior policy adviser there in the commissioner's office, has joined Hogan Lovells' Washington, D.C., team as a partner, the firm announced Monday.

  • August 01, 2025

    Meta Illegally Recorded Flo Users' Data, Calif. Jury Finds

    A California federal jury Friday found Meta Platforms Inc. liable for violating the state's wiretap law by using a data analytics tool to retrieve sensitive health data from users of the popular menstrual tracking app Flo, in what plaintiffs' counsel called "one of the first times" a major tech company has been held accountable for such practices. 

  • August 01, 2025

    Wheeling & Appealing: Midyear Highlights For Every Circuit

    In this special edition of Wheeling & Appealing, we're spotlighting key decisions and developments in every circuit court during the first half of 2025, while also previewing August's most intriguing oral arguments, including a remarkably "fierce" showdown between Edible Arrangements and 1-800-Flowers with millions of dollars in attorney fees on the line.

  • August 01, 2025

    IP Owners Largely Win In Stewart's Newest Discretion Orders

    Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart dismissed most of the 50 petitions for inter partes review addressed in her latest decisions over discretionary denials at the Patent Trial and Appeal Board.

  • August 01, 2025

    USPTO Tightens Rules On Patent Challengers' Arguments

    Patent challengers at the Patent Trial and Appeal Board will no longer be able to skirt a requirement that they must identify where all the elements of the patent are found in prior art patents or printed publications, according to a notice from the U.S. Patent and Trademark Office.

  • August 01, 2025

    AGs Sue Trump Over 'Onslaught Of Pressure' On Trans Care

    The Trump administration has improperly "weaponized" federal laws against drug misbranding, false claims and female genital mutilation as part of a pressure campaign to undermine state protections for gender-affirming care, a coalition of state attorneys general argued in a new suit Friday.

  • August 01, 2025

    En Banc 9th Circ. Backs LA Schools In Vax Mandate Fight

    A majority en banc Ninth Circuit has affirmed a lower court's decision upholding Los Angeles Unified School District's COVID-19 vaccine mandate for employees, while two partially dissenting judges disagreed with the majority's conclusion that the policy passes constitutional muster.

  • August 01, 2025

    States Urge High Court To Keep NIH Grant Funds Flowing

    A coalition of 16 states pressed the U.S. Supreme Court on Friday to reject the Trump administration's push to resume the mass termination of scientific research grants, saying a district judge had authority to pause the cuts.

  • August 01, 2025

    Monthly Merger Review Snapshot

    The U.S. Department of Justice abandoned its challenge of a corporate travel management deal, while lawmakers are calling for scrutiny of the agency's recent decision to settle a different case, and the Federal Trade Commission agreed to nix the requirements placed on a pair of oil and gas deals.

  • August 01, 2025

    OptumRx Moves To DQ Motley Rice In Utah Opioid Case

    Pharmacy benefit manager OptumRx has moved to disqualify Motley Rice LLC from representing the state of Utah in an opioid crisis lawsuit, claiming the firm clearly violated ethical rules by investigating OptumRx on behalf of government entities, then suing OptumRx in a private capacity.

  • August 01, 2025

    J&J Unit's Catheter Rival Scores Injunction After $442M Win

    A California federal judge will block Johnson & Johnson's Biosense Webster from refusing clinical support for its Carto cardio mapping systems from hospitals that use competitors' cardiac catheters, requiring the company to institute nondiscriminatory pricing for its services at hospitals regardless of which products they use.

  • July 31, 2025

    Hospitals Want To Duck Pharmacy Career Match Program Suit

    A professional pharmacy organization and a group of teaching hospitals teed up motions to dismiss Wednesday against proposed class action allegations that they conspired to restrict wages and benefits by funneling new pharmacists through a job-matching program, telling a Maryland federal judge that there's no sign of an agreement.

  • July 31, 2025

    Biotech Co. Beats Investor Suit Over Antifungal Drug Recall

    Biotechnology company Scynexis Inc. has won dismissal, for now, of a proposed investor class action alleging that it triggered a 34% share decline by knowingly misleading investors about manufacturing compliance issues that led to a drug recall, with the court finding the allegations the company should have known and disclosed issues only show "fraud by hindsight."

  • July 31, 2025

    Robotic Surgery Co.'s Antitrust Appeal Backed At 9th Circ.

    Surgical Instrument Service Co. Inc. has received backing at the Ninth Circuit from a trade association and others groups as it looks to revive its case accusing Intuitive Surgical Inc. of blocking third parties from refurbishing components for its popular da Vinci surgery robot.

  • July 31, 2025

    18 GOP Sens. Urge Trump To Fill IP Negotiator Post

    Eighteen Republican U.S. senators urged President Donald Trump to appoint someone to the vacant role of chief innovation and intellectual property negotiator of the U.S. Trade Representative in order to work to remove what they called "market-distorting price controls" in the pharmaceutical industry.

  • July 31, 2025

    HHS Plans To Test Rebates In 340B Drug Pricing Program

    The Trump administration on Thursday announced plans for a pilot project that would allow certain drugmakers to abandon upfront discounts in the 340B program and instead require hospitals to apply for rebates, testing an idea that would fundamentally reshape the long-running program.

  • July 31, 2025

    Honeywell Ex-GC Claims Age Bias Led To Firing At 55

    A Honeywell International Inc. former vice president and general counsel accused the Charlotte-based conglomerate of age discrimination, telling a North Carolina federal court that she was fired for turning 55.

  • July 31, 2025

    ITC Ends Dermatology Needle Import Ban After Settlement

    The International Trade Commission has lifted a ban on certain imports of skin treatment devices that infringed patents owned by a South Korean dermatologist's needle business after it settled with a rival.

  • July 31, 2025

    J&J Fired Sales Worker Who Reported Pay Issue, Suit Says

    Johnson & Johnson wrongly credited a former executive sales representative's sales to another worker, leading to lost earned commissions, and then fired him once he complained, the former employee said in a suit in Texas federal court.

  • July 30, 2025

    3rd Circ. Won't Upend Investors' Class Cert. In J&J Talc Suit

    A split Third Circuit on Wednesday upheld a New Jersey federal judge's class certification order in a Johnson & Johnson investor action alleging the company artificially inflated its stock price by failing to disclose cancer risks associated with its talcum powder products, finding the lower court did not err in concluding that common issues predominate in the suit.

  • July 30, 2025

    Flo Likely To Get Health Privacy Claim Tossed In Meta Case

    The California federal judge overseeing a trial on allegations that Flo Health and Meta Platforms Inc. violated the privacy of millions of women who used Flo's period tracker app said Wednesday he'd likely toss the California Confidentiality of Medical Information Act claim, saying the lack of evidence is an "unsurmountable" problem.

  • July 30, 2025

    Illumina To Pay $9.8M To Resolve Cybersecurity Qui Tam Case

    Biotechnology company Illumina Inc. has agreed to pay $9.8 million in a settlement with the U.S. Department of Justice to put to rest a first-of-its-kind False Claims Act suit alleging the company violated cybersecurity regulations for medical devices, according to an announcement Wednesday.

  • July 30, 2025

    No Philly Clause Is Valid In Med Mal Case, Pa. Panel Says

    A Pennsylvania appellate panel said Wednesday that a contract a patient signed before surgery mandating that any legal actions must be heard in Bucks County is valid and enforceable, affirming a trial court's transfer of the medical malpractice suit from plaintiff-friendly Philadelphia County.

  • July 30, 2025

    CVS Can't Arbitrate RICO Suit Over Alleged 'No Generic' Policy

    CVS effectively forfeited its arbitration rights in proposed class action litigation accusing it of conspiring to block Medicare beneficiaries from accessing generic versions of prescription drugs, a Pennsylvania federal judge ruled in denying the company's bid to enforce an arbitration agreement.

  • July 30, 2025

    FDA's Vaccine Chief Is Out After Loyalty To Trump Questioned

    Dr. Vinay Prasad's tenure as the top vaccine regulator at the U.S. Food and Drug Administration ended abruptly this week following intense criticism from conservative activists who questioned his loyalty to President Donald Trump.

Expert Analysis

  • 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.

  • Firms Still Have Lateral Market Advantage, But Risks Persist

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    Partner and associate mobility data from the fourth quarter of 2024 shows that we’re in a new, stable era of lateral hiring where firms have the edge, but leaders should proceed cautiously, looking beyond expected revenue and compensation analyses for potential risks, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.

  • 10 Practical Takeaways From FDA's Biopharma AI Guidance

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    Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.

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