Life Sciences

  • March 07, 2024

    Moses & Singer Healthcare Atty Joins Day Pitney In Hartford

    Day Pitney LLP has added an experienced attorney to its Hartford office as counsel from Moses & Singer LLP in New York.

  • March 07, 2024

    Activist Caligan Sets Sights On Anika Therapeutics Again

    New York-based activist investor Caligan Partners LP disclosed a nearly 10% stake in Anika Therapeutics and nominated two director candidates, a move that comes a year after the hedge fund urged the biotech company to consider "urgent changes" to its operations and structure.

  • March 06, 2024

    Top Calif. Antitrust Atty Says Criminal Cases On The Horizon

    California is poised to start prosecuting criminal antitrust cases under a Golden State law that is "broader" than federal law, a senior assistant attorney general for the California Department of Justice said Wednesday at a San Francisco conference.

  • March 06, 2024

    Garland On AI Crime, And A Taylor Swift Tune For DOJ

    U.S. Attorney General Merrick Garland on Wednesday told a group of lawyers gathered in San Francisco that the U.S. Department of Justice is ramping up its hiring of computer scientists to fight artificial intelligence-driven crime and also revealed which Taylor Swift song he thought should be the department's anthem.

  • March 06, 2024

    Juul MDL Judge Asks Feds To Probe AI Fraud In $45.5M Deal

    A California federal judge Wednesday approved e-cigarette Juul investor Altria's $45.5 million settlement and counsel's $13.65 million fee request to resolve consumer claims in Altria's broader $235 million multidistrict settlement agreement, but said fraudulent claims submitted by AI and "click farms" are a "real problem" prosecutors should investigate.

  • March 06, 2024

    Pa. Pharma Co. Cops To Adulterated-Drug Charges

    A Pennsylvania generic drug manufacturer has pled guilty to federal charges that it sold adulterated drugs in the U.S. into interstate commerce and agreed to pay a $1.5 million penalty, the U.S. Department of Justice said Wednesday.

  • March 06, 2024

    CBP Details Apple Watch Redesign OK In Masimo Patent Row

    U.S. Customs and Border Protection has released its January decision finding that redesigned Apple Watches do not infringe Masimo Corp.'s blood oxygen monitor patents, explaining that while the new versions can access the patented feature, doing so requires "significant alteration."

  • March 06, 2024

    J&J Seeks Exit From Suit Over Stelara Exclusivity

    Johnson & Johnson told a Virginia federal court Tuesday it shouldn't have to face a proposed class action claiming it has been trying to stifle competition in the market for the immunosuppressive drug Stelara, saying there was no "scheme" to enforce its patents as the suit alleges.

  • March 06, 2024

    5th Circ. Weighs 'Very Complex' Chemo Hair Loss Dispute

    The Fifth Circuit is weighing whether two drug manufacturers had an obligation to expedite changing the label on their chemotherapy medications to warn of permanent hair loss in a case one justice describes as "a very complex situation" that will have far-reaching consequences for drugmakers and patients.

  • March 06, 2024

    PTAB Has To Rehear Challenge In Biotech Row

    A panel set up by U.S. Patent and Trademark Office Director Kathi Vidal has told the Patent Trial and Appeal Board it needs to redo its review of a fight between two biotech companies.

  • March 06, 2024

    Corporate Vet Joins Orrick's Tech Group From Wilson Sonsini

    Orrick Herrington & Sutcliffe LLP announced that a former Wilson Sonsini Goodrich & Rosati PC tech attorney with over a decade of in-house experience has joined the firm's technology companies practice as a New York-based partner.

  • March 06, 2024

    Biopharmaceutical Biz Closes $259M Upsized Funding Round

    South San Francisco, California-based clinical-stage biopharmaceutical company Alumis Inc. on Wednesday announced that it closed its upsized Series C funding round after securing $259 million from venture capital investors.

  • March 06, 2024

    Challenge To Pfizer Diversity Program Fails At 2nd Circ.

    The Second Circuit declined Wednesday to revive an advocacy group's suit claiming a Pfizer diversity fellowship unlawfully discriminated against white and Asian workers, ruling the nonprofit had no legal foothold because it wouldn't specifically identify anyone allegedly harmed.

  • March 06, 2024

    Ex-Stimwave CEO Found Guilty Of Healthcare Fraud

    A New York federal jury on Wednesday convicted the former CEO of Stimwave over allegations that the medical device maker sold an implant for chronic pain sufferers with a bogus component in order to drive up billings.

  • March 06, 2024

    Ohio Neurologist Can't Shorten His Drug Kickback Sentence

    An Ohio federal judge ruled an imprisoned neurologist cannot shorten his 30-month sentence for conspiring to collect illegal kickbacks for prescribing Nuedexta, a drug used to treat patients who have uncontrollable fits of laughter or crying, stating that his victims' vulnerability exempts him from his requested reduction.

  • March 05, 2024

    UMass, L'Oreal Fight Over Anti-Aging Cream May Be Near End

    Cosmetics brand L'Oreal and the University of Massachusetts told a Delaware federal judge they "have agreed to resolve" a purportedly ​​$200 million dispute over a method for adding an ingredient into moisturizing cream, nearly two years after a federal appeals court breathed new life into the patent case.

  • March 05, 2024

    White House To Crack Down On Illegal, Unfair Pricing

    President Joe Biden launched a new "strike force" Tuesday to stop companies from imposing unfair price hikes on consumers amid a rash of measures supporting the administration's push to boost competition and lower prices across the economy.

  • March 05, 2024

    Fed. Circ. Upholds Axing Pfizer Vax IP But Calls For More Info

    The Patent Trial and Appeal Board rightly invalidated most of a Pfizer flu vaccine patent but was too hasty in its analysis when refusing to amend the patent, the Federal Circuit said Tuesday.

  • March 05, 2024

    Gibson Dunn AI Leader On Weathering The AI Policy Blizzard

    Like a mountaineer leading a team through a snowstorm, Gibson Dunn & Crutcher LLP's artificial intelligence co-chair Cassandra L. Gaedt-Sheckter is guiding companies developing and using artificial intelligence through a blizzard of new laws and regulations coming online in Europe and the U.S., saying that assessing AI risks is the North Star to mitigating them.

  • March 05, 2024

    Pharmacist Takes Deal In Mich. Over Fatal Meningitis Outbreak

    The founder of a Massachusetts drug compounding center that was the source of a deadly meningitis outbreak has pled no contest to 11 counts of manslaughter brought by Michigan state prosecutors, the latter state's Department of Attorney General announced Tuesday.

  • March 05, 2024

    Magnolia Medical Again Sues Kurin Over Sepsis IP

    Magnolia Medical has accused Kurin of continuing to infringe patents covering its diagnostic tests for sepsis and other bloodstream infections after Kurin lost a jury trial in 2022 over a different patent, claiming its rival has a "predatory business model."

  • March 05, 2024

    CVS Again Defeats NY AG's Drug Rebate Tying Claims

    A Manhattan judge on Tuesday threw out a second New York attorney general lawsuit accusing CVS Pharmacy Inc. of illegally forcing underserved hospitals to use its claims-processing subsidiary for federal drug reimbursements, saying the government still hasn't pled viable antitrust claims.

  • March 05, 2024

    FTC Chair Decries PE's Healthcare Impacts As Probe Starts

    Federal Trade Commission Chair Lina Khan on Tuesday lamented what she deemed the "financialization" of healthcare resulting from private equity buyouts, in remarks coinciding with the launch of a multijurisdictional request for public comment on PE and other companies' growing control over the healthcare system.

  • March 05, 2024

    Avadel Told To Pay Jazz Pharma $234K Over Narcolepsy Drug IP

    A Delaware federal jury found Monday that a specialty drugmaker owes nearly $234,000 to drug manufacturer Jazz Pharmaceuticals Inc. for using a patented process behind its newer narcolepsy drug, launched last year to sales of over $28 million.

  • March 05, 2024

    GOP Sens. Voice Concern Over Biden Plan To Claim Patents

    Sen. Bill Cassidy, R-La., the top Republican on the Senate health committee, and 16 other Senate Republicans recently aired concerns with the director of the National Institutes of Health about the Biden administration's plan to "illegally" seize drug patents.

Expert Analysis

  • FOIA Exemption Questions On Redacted HHS Cannabis Letter

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    The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.

  • Fed. Circ. Ruling Seemingly Offers PTAB Deadline Immunity

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    The Federal Circuit's recent Purdue Pharma v. Collegium Pharmaceutical Inc. decision that the Patent Trial and Appeal Board had authority to issue a final written decision in a post grant review after the prescribed statutory deadline underscores how courts should consider the overall objective of the statutory scheme when balancing the classic conflict between bright-line rules and flexible standards, says Matthew Dowd at Dowd Sheffel.

  • Evaluating Retroactivity Of Mich. Drugmaker Immunity Repeal

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    In assessing whether a new Michigan law lifting drugmakers' blanket immunity from product liability suits will apply retroactively, there are four key factors that Michigan courts will likely consider, say Sherry Knutson and Brenda Sweet at Tucker Ellis.

  • 4 Legal Ethics Considerations For The New Year

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    As attorneys and clients reset for a new year, now is a good time to take a step back and review some core ethical issues that attorneys should keep front of mind in 2024, including approaching generative artificial intelligence with caution and care, and avoiding pitfalls in outside counsel guidelines, say attorneys at HWG.

  • FTC Rite Aid Order Holds Biometrics And AI Compliance Tips

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    The Federal Trade Commission's recent enforcement action against Rite Aid over its use of facial biometric technology on customers provides lessons that can be leveraged to reduce and manage the risk of regulatory scrutiny of biometrics and artificial intelligence, says David Oberly at Baker Donelson.

  • Bribery Settlement Gives Insight On DOJ Policies

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    Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.

  • SEC Case May Expand Scope Of Insider Trading Liability

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    The U.S. Securities and Exchange Commission's first-of-its-kind enforcement action against an individual in a case involving "shadow trading" demarcates an expansion of insider trading liability to circumstances in which there is a market connection between the source of information and the issuer of the securities traded, say attorneys at Steptoe.

  • Opinion

    Waiving COVID-19 IP Protections Would Harm US Industry

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    President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.

  • Fed. Circ. Patent Decisions In 2023: An Empirical Review

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    The Federal Circuit decided 306 patent cases last year, which is still well down from the pre-pandemic norm of around 440, and on the whole the court's decisions were markedly less patentee-friendly in 2023 than in 2022, says Dan Bagatell at Perkins Coie.

  • What The Law Firm Of The Future Will Look Like

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    As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

  • 4 PR Pointers When Your Case Is In The News

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    Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.

  • Digging Into The Debate On FDA's Proposed Lab Test Rule

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    A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.

  • How 2023 Shaped Drug And Medical Device Legal Trends

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    2023 brought a number of positive developments for the life sciences industry, including great trial and multidistrict litigation outcomes, but also some heavy-handed regulations and other concerning developments that lay the groundwork for significant litigation, say attorneys at Faegre Drinker.

  • Opinion

    What Insurers Gain When Litigating Coverage Denials

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    Lately, insurance companies have denied coverage for lawsuits alleging liability relating to the ordinary operations of highly regulated businesses, such as those in the pharmaceutical and energy sectors — demonstrating time and again how litigation can be a vehicle for carriers to mitigate their own costs, say attorneys at Reed Smith.

  • Trending At The PTAB: 6 Areas To Watch In 2024

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    Expect further changes in a half-dozen areas in 2024 following a busy 2023 at the Patent Trial and Appeal Board, including more adjustments to the director review process and the first case to hit the Appeals Review Panel, say attorneys at Finnegan.

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