Life Sciences

  • December 05, 2024

    Gov't Efficiency Push Is A 'New Day,' House Speaker Says

    House Speaker Mike Johnson, R-La., spoke excitedly Thursday about the new government efficiency operation helmed by billionaire Elon Musk and former presidential candidate Vivek Ramaswamy and touted the budding bipartisan lineup of a congressional caucus that will work with it.

  • December 06, 2024

    FINRA Fines Firm $900K Over SPAC Underwriting Fee Issues

    The Financial Industry Regulatory Authority has fined New York-based LifeSci Capital LLC nearly $1 million over claims that it received and failed to disclose unfair and unreasonable fees for an initial public offering it underwrote.

  • December 05, 2024

    Abbott Accused Of 'Last-Ditch Effort' To Halt Formula Suit

    Investors accusing Abbott Laboratories leaders of concealing known safety issues related to recalled infant formula urged an Illinois federal judge to reject the company's bid to stay the case because it belatedly formed a special litigation committee to investigate the allegations two years into the litigation.

  • December 05, 2024

    Quest Ex-Workers Ask 3rd Circ. To Revive 401(k) Suit

    Ex-workers for Quest Diagnostics Inc. urged the Third Circuit to revive their suit alleging mismanagement of their $5 billion 401(k) retirement plan, arguing a lower court shouldn't have handed Quest an early win on claims the company failed to properly monitor investment offerings.

  • December 05, 2024

    SpaceX Seeks Astronomical $350B Value, And More Rumors

    SpaceX is in discussions for a transaction that could value the rocket and spacecraft maker at about $350 billion, the private equity owner of Crunch Fitness could sell the health club at a $1.5 billion value, and the management group looking to buy the Japanese owner of 7-Eleven may launch an IPO. Here, Law360 breaks down these and other notable deal rumors from the past week.

  • December 05, 2024

    FDA Warns 115 Retailers Over Unauthorized E-Cigarettes

    The U.S. Food and Drug Administration has issued warning letters to 115 retailers across the country for selling unauthorized e-cigarettes that appeal to youths, the agency said Thursday.

  • December 05, 2024

    Insulet Wins $452M In Trade Secret Theft Trial

    A Massachusetts federal jury has awarded Insulet Corp. $452 million after concluding that a South Korean company stole its trade secrets for a wearable insulin patch pump, marking one of the largest trade secrets verdicts of the decade.

  • December 04, 2024

    Withers IP Partners Hop To Sullivan & Worcester

    Sullivan & Worcester LLP has said the Boston firm picked up a team of five intellectual property lawyers, including two partners, from Withers who have expertise in filing patents and working on deals for biotech startups. 

  • December 04, 2024

    Novartis Fails To Stop Generic Drug Release At Fed. Circ.

    Novartis could not persuade Federal Circuit judges to grant an injunction Wednesday protecting its blockbuster heart failure medication from facing generic competition, with the appeals court backing a Delaware federal judge's opinion that it was unlikely that one of the generic drug's ingredients is "amorphous."

  • December 04, 2024

    Jackson's 'Quite Worried' About Equal Protection Precedent

    The U.S. Supreme Court's Republican-appointed justices' apparent willingness Wednesday to rule that a Tennessee law banning gender-affirming healthcare for transgender minors didn't rely on sex-based classifications worried Justice Ketanji Brown Jackson, who warned that such a decision would undermine decades of the court's equal protection clause precedent.

  • December 04, 2024

    JSR Wins As Fed. Circ. Axes Cytiva Antibody Isolation Patents

    In a precedential opinion, the Federal Circuit held Wednesday that all the claims that JSR Corp. challenged in three Cytiva Bioprocess antibody isolation patents are invalid as obvious, backing the Patent Trial and Appeal Board's invalidation of many claims while reversing its decision to uphold others.

  • December 04, 2024

    Colo. Co.'s Alleged Kickback Scheme Ends In $2M Settlements

    A Colorado neuromonitoring company, its founder and two others have agreed to pay more than $2 million to end a False Claims Act lawsuit alleging they participated in a kickback scheme to get surgeons to order neuromonitoring services covered by federal programs.

  • December 04, 2024

    DEA Judge Sets Pot Rescheduling Hearings

    The Drug Enforcement Administration will kick off six weeks of hearings in late January on the merits of the attorney general's proposal to loosen restrictions on marijuana, an agency administrative law judge said Wednesday.

  • December 04, 2024

    Fed. Circ. Judge Condemns 'Nonsense' Law In Antibody Fight

    U.S. Circuit Judge Todd Hughes called the Federal Circuit's case law on interpreting preambles in patent claims "nonsense" on Wednesday, expressing frustration as a panel tried to work through whether Xencor Inc.'s antibody patent application was too broad.

  • December 04, 2024

    Takeda Exec Duped Beau Into $2M Fraud, Jury Told

    A Massachusetts man is accusing his wife, a former Takeda Pharmaceuticals vice president, of playing "puppet master" by tricking him into joining a scheme to steal millions from the drug company through fake invoices.

  • December 04, 2024

    Justices Seem To Back Ban On Transgender Youth Care

    The U.S. Supreme Court's conservative majority on Wednesday seemed poised to greenlight a Tennessee ban on minors receiving gender-affirming care, despite arguments from the court's liberal block that finding the law constitutional would fly in the face of the court's equal-protection precedents.

  • December 03, 2024

    Mich. AG Deal, NIH 4th Circ. Win And X Corp Bid In HIPAA Row

    Michigan's attorney general has agreed not to hold a Christian healthcare provider accountable to certain antidiscrimination protections related to gender and sexuality while the provider challenges them in court. Meanwhile, a New York federal judge decided to keep the largest anesthesiology provider in the U.S. on the hook for antitrust claims over its noncompete agreements with clinicians.

  • December 03, 2024

    Calif. Unveils Reproductive Rights Bills To Prep For Trump

    California lawmakers plan to introduce a pair of bills aimed at protecting access to abortion in the Golden State as Donald Trump returns to office, according to an announcement made Monday, the first day of a special legislative session called by Gov. Gavin Newsom.

  • December 03, 2024

    SEC Says Biopharma's Cooperation Helped It Avoid Penalty

    A Houston biopharmaceutical company accused of misleading investors about the regulatory status of two cancer drugs agreed to settle the U.S. Securities and Exchange Commission's action against it on Tuesday without paying a dime, in recognition of what the SEC said was the company's self-reporting and cooperation with investigators.

  • December 03, 2024

    J&J's Neosporin Forever Discolored Man's Groin, Suit Says

    Johnson & Johnson and its consumer health spinoff were sued in California state court over claims that Neosporin antibiotic ointment badly infected a Los Angeles man's scrotum and permanently discolored his groin.

  • December 03, 2024

    $1B Sandoz Placeholder Bid Needs More Support, Judge Says

    A Connecticut federal judge on Tuesday said he cannot force Novartis spinoff Sandoz Inc. to set aside a $1 billion litigation placeholder in a generic drug pricing lawsuit without hearing whether the state attorney general can enforce possible orders in other states where the pharmaceutical company keeps assets.

  • December 03, 2024

    USPTO Abandons Polarizing Proposal Over Double Patenting

    The U.S. Patent and Trademark Office has withdrawn an extremely controversial proposal tied to double patenting, citing "resource constraints" in a Federal Register notice set to be published Wednesday.

  • December 03, 2024

    Vidal Aimed To Put USPTO Rulemaking In The Spotlight

    Kathi Vidal's tenure as director of the U.S. Patent and Trademark Office has been marked by dedication to making the agency's decisions and processes more transparent, attorneys said ahead of her mid-December departure.

  • December 03, 2024

    FDA Issues Guidance On Potential Infant Formula Shortages

    The U.S. Food and Drug Administration has put forth draft guidance on how the country's infant food manufacturers should tell the agency about permanent or temporary stoppages in the making of infant formula, several years after an outbreak and a national shortage.

  • December 03, 2024

    4 Mass. State Court Rulings You May Have Missed In Nov.

    An age discrimination case was undone by the fine print of an employment agreement, while an "utterly inadequate" document search led to a five-figure sanctions order, among other notable recent decisions in Massachusetts state court.

Expert Analysis

  • Failed W.Va. Patent Challenge Reveals Secret Prior Art's Risks

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    A West Virginia federal court's recent ruling — that references used by a patent challenger to establish an ordinarily skilled artisan's existing knowledge must be published before a patent's filing — may discourage claim construction challenges based on secret prior art and steer drafters away from externally defined terms, says Brianna Potter at Baker Botts.

  • Navigating Decentralized Clinical Trials With FDA's Guidance

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    The U.S. Food and Drug Administration's recently finalized guidance on conducting decentralized clinical trials, while not legally binding, can serve as a road map for sponsors, investigators and others to ensure trial integrity and participant safety, say attorneys at Phillips Lytle.

  • The Bar Needs More Clarity On The Discovery Objection Rule

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    Almost 10 years after Federal Rule of Civil Procedure 34 was amended, attorneys still seem confused about what they should include in objections to discovery requests, and until the rules committee provides additional clarity, practitioners must beware the steep costs of noncompliance, says Tristan Ellis at Shanies Law Office.

  • How Patent Landscape Analysis Drives Business Growth

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    Keegan Caldwell at Caldwell Law explores how patent landscape analysis serves as a key driver of sustainable growth — examining how its components, strategic advantages and implementation best practices are reshaping innovation leadership.

  • In Terror Case, DC Circ. Must Weigh Justices' Twitter Ruling

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    When the D.C. Circuit hears oral argument in AstraZeneca UK v. Atchley, how the court interprets the U.S. Supreme Court's 2023 ruling in Twitter v. Taamneh will have a significant impact on future claims brought under the Anti-Terrorism Act and Justice Against Sponsors of Terrorism Act, say attorneys at Lewis Baach.

  • Marching In On Orange Book Drugs May Have Limited Effect

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    Statistical analysis shows that marching in on Orange Book drug patent holders to require additional licensees would have a relatively minimal impact on drug prices, and should be weighed against the harms it could have on pharmaceutical innovation, say researchers at Competition Dynamics.

  • Series

    Being A Navy Reservist Makes Me A Better Lawyer

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    Serving this country in uniform has not only been one of the greatest honors of my life, but it has also provided me with opportunities to broaden my legal acumen and interpersonal skills in ways that have indelibly contributed to my civilian practice, says Phillip Smith at Weinberg Wheeler.

  • Incoming Admin May Shake Up Life Sciences Regulation

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    Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.

  • Next Steps In The $2.8B Blue Cross Payout To Providers

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    Healthcare providers deciding whether to participate in Blue Cross Blue Shield network's recent $2.8 billion antitrust class action settlement must weigh key recovery factors, including provider type and litigation cost, say attorneys at Hall Render.

  • So You Want To Move Your Law Practice To Canada, Eh?

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    Google searches for how to move to Canada have surged in the wake of the U.S. presidential election, and if you’re an attorney considering a move to the Great White North, you’ll need to understand how the practice of law differs across the border, says David Postel at Henein Hutchison.

  • What To Expect Next From Federal Health Tech Regulation

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    Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.

  • Trump Rollback Of Biden Enviro Policies: What To Expect

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    Donald Trump's upcoming second presidential term will usher significant shifts in U.S. environmental and natural resource law and policy — and while the Biden administration is racing to secure its legacy, the incoming Trump administration is making plans to dramatically roll back most, if not all, of Biden's environmental initiatives, say attorneys at Beveridge & Diamond.

  • Takeaways From State Votes On Abortion In The 2024 Election

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    Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.

  • Key Territory-Split Licensing Lessons For Life Sciences Cos.

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    Territory-split deals can allow life sciences companies to maximize products' potential across a range of geographic areas, but these deals also present unique challenges requiring highly bespoke structures that can make or break the value of an asset, say attorneys at Covington.

  • Legislation Most Likely To Pass In Lame Duck Session

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    As Congress begins its five-week post-election lame duck session, attorneys at Greenberg Traurig break down the legislative priorities and which proposals can be expected to pass.

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