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Life Sciences
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February 14, 2025
FTC's Ferguson, PBMs Agree: Nix Leader Removal Safeguards
Federal Trade Commission Chairman Andrew N. Ferguson offered his own support for enabling the president to readily fire independent agency commissioners at the FTC and beyond, a day after pharmacy benefit managers cited the new U.S. Department of Justice policy in their own battle with the FTC.
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February 14, 2025
Digital Health Co. Beats Some Claims In SPAC Investor Suit
A New Jersey federal judge has dismissed, with leave to amend, claims in an investor suit against a blank check company that took digital health equipment venture Butterfly Network Inc. public, finding that some of the shares the plaintiffs purchased are not traceable to the registration statement at issue in the suit.
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February 14, 2025
Fed. Circ. Risks Relying On 'Science Fiction,' Justices Told
The Federal Circuit's presumption that prior art is always enabled can lead it to "sacrifice true innovations based on earlier science fiction," the owner of invalidated food wrapping patents told the U.S. Supreme Court on Thursday.
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February 14, 2025
Trump Admin To Cut Thousands Of Federal Health Employees
The Trump administration has started to cut thousands of federal healthcare employees, following through on its promises to shrink government and enact mass changes to agencies that oversee the health of millions of Americans.
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February 14, 2025
New Delisting Rules Shorten Leash For Distressed Companies
Distressed companies should take heed of new stock exchange rules that are likely to accelerate delistings for stocks that trade below minimum requirements, particularly targeting businesses that rely on reverse stock splits to inflate their share prices, attorneys say.
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February 14, 2025
CVS Wins Arbitration In Medicare Fee Antitrust Suit
An Arizona federal judge ordered four independent pharmacies to arbitrate their claims accusing CVS of exploiting a Medicare loophole to charge them exorbitant fees, saying several unconscionable provisions in an underlying arbitration clause could be severed.
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February 14, 2025
Fed. Circ. Rejects COVID Test Suit In Gilstrap-Authored Ruling
A California federal judge properly found that Spectrum Solutions LLC didn't infringe a COVID-19 test maker's patent directed to preserving biological samples, the Federal Circuit said Friday in an opinion written by a top patent judge visiting the court.
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February 14, 2025
Some Discovery On Hold In Abbott Infant Formula Case
An Illinois federal judge granted in part a request by Abbott Laboratories to pause a shareholder derivative suit over how it managed the 2022 infant formula crisis, allowing written discovery to go on while staying depositions until May.
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February 14, 2025
Fed. Circ. Ruling Shows Even Small Cos. Can Win At ITC
A small biotech company's recent patent win, where the Federal Circuit held that even its limited domestic investments qualified it to sue at the U.S. International Trade Commission, makes clear that the ITC's powerful import bans aren't just available to major businesses, attorneys say.
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February 14, 2025
8 Things Attys Should Know About Conn.'s $55B Budget
Connecticut Gov. Ned Lamont's two-year budget for the years 2026 and 2027 includes drug price limits, an expansion of the state's unfair trade practices act, key changes to hospital ownership laws and slots for 13 new judges.
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February 14, 2025
Judge Upholds Pay-For-Delay Ban Law, But Only In Calif.
A California federal judge has upheld part of a new state law that the Association for Accessible Medicines alleged unlawfully restricted "reverse payment" settlements between makers of brand-name and generic drugs, finding that the law's attempt to regulate deals outside of California runs afoul of the Constitution, but is otherwise valid.
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February 14, 2025
Camston Wrather Files For Ch. 7 With Over $100M In Debt
California-based sustainable resource recovery company Camston Wrather LLC has filed for Chapter 7 bankruptcy listing liabilities between $100 million and $500 million along with up to $50 million in assets, citing insufficient funding to continue operations.
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February 14, 2025
Tariffs On Drugs And Chips May Not Bring Makers Stateside
The White House's planned tariffs on semiconductors, computer chips and pharmaceuticals are likely to raise prices for consumers and businesses, but won't necessarily lead to the president's stated goal of growing domestic manufacturing, attorneys and others told Law360.
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February 14, 2025
2nd Judge Blocks Trump Trans Health Order, Chides DOJ Atty
A Washington federal judge put a second temporary block on President Donald Trump's executive order targeting funding for gender-affirming care for people younger than 19, at a Seattle hearing where the judge said she was extremely frustrated with a federal government attorney's inability to answer questions about the order's discriminatory impact on transgender youth.
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February 13, 2025
Mallinckrodt Fails To Halt Airgas' Generic Nitric Oxide Drug
A Delaware federal judge has rejected Mallinckrodt Pharmaceuticals' attempt to block French industrial gas company Airgas Healthcare from selling a generic version of its inhaled nitric oxide treatment, saying Mallinckrodt didn't show enough evidence that Airgas infringed its patents or that it would suffer irreparable harm.
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February 13, 2025
DC Judge Affirms Approval Of Teva's Generic Sleep Drug
A D.C. federal judge upheld the U.S. Food and Drug Administration's approval of Teva's generic version of Vanda's sleep-walking treatment tasimelteon, ruling Thursday that omitting Braille on the labeling is permissible as it would be "aberrant" to allow safe variations in a drug's substance but not for labeling.
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February 13, 2025
Long-Term Zantac Use Raised Cancer Risks, Jury Hears
Chronic ranitidine ingestion was a factor in the development of prostate cancer in two men who are retrying their claims over the active ingredient in Boehringer Ingelheim's over-the-counter Zantac medication, the University of South Carolina's chief urologist testified in Illinois on Thursday.
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February 13, 2025
Maryland Judge Blocks Trump's Orders On Trans Healthcare
A Maryland federal judge on Thursday temporarily blocked the Trump administration from restricting gender-affirming care for people under the age of 19 and required the administration to keep in place federal funding for healthcare providers that provide transgender care.
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February 13, 2025
Merck Investor Sues Over Gardasil China Market Projections
Pharmaceutical giant Merck & Co. Inc. has been hit with a proposed shareholder class action alleging it overstated global demand for its human papillomavirus vaccine Gardasil, damaging investors when it revealed earlier this month it would not meet its revenue projections for the vaccine and paused shipments to China.
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February 13, 2025
9th Circ. Upholds DEA Denial Of Psilocybin Petition
The Ninth Circuit on Thursday affirmed the U.S. Drug Enforcement Administration's rejection of a Seattle physician's request to treat terminally ill patients with psilocybin.
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February 13, 2025
Musk's $97B OpenAI Bid Dubbed A 'Stunt' Amid Other Rumors
After a Wall Street Journal report on Monday revealed that a consortium of investors led by Elon Musk was offering $97.4 billion to buy the nonprofit that controls OpenAI, rumors began to swirl regarding the true intentions behind the billionaire's bid.
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February 13, 2025
Robert F. Kennedy Jr. Confirmed, Sworn In As HHS Secretary
Robert F. Kennedy Jr. is officially the nation's top healthcare official.
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February 13, 2025
Paul Hastings, Cooley Lead Obesity-Focused Aardvark's IPO
Obesity-focused Aardvark Therapeutics Inc. began trading Thursday after pricing a $94 million initial public offering at the bottom of its range, represented by Paul Hastings LLP and underwriters' counsel Cooley LLP, joining a string of biotechnology firms to go public recently.
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February 13, 2025
Greenberg Traurig Adds Goodwin Life Sciences Pro In Texas
Greenberg Traurig LLP has expanded its life sciences and technology practice with a shareholder in Austin, Texas, who has extensive expertise in handling cross-border deals and came aboard from Goodwin Procter LLP.
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February 12, 2025
Judge Finds No Infringement In Alcon's Eye Drop Patent Suit
Alcon Inc. has failed to persuade a Delaware federal court to block the release of a generic glaucoma treatment that would compete with a brand of eye drops the company sells.
Expert Analysis
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Opinion
3rd. Circ. Got It Right On Cancer Warning Claims Preemption
The Third Circuit's recent, eminently sensible ruling in a failure-to-warn case against Roundup manufacturer Monsanto, holding that the Federal Insecticide, Fungicide and Rodenticide Act preempts state law claims, provides a road map that other courts should adopt, says Lawrence Ebner at the Atlantic Legal Foundation.
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Opinion
To Lower Drug Prices, Harris Must Address Patent Thickets
If Vice President Kamala Harris is serious about her pledge to address high drug prices, she must begin by closing loopholes that allow pharmaceutical companies to develop patent thickets that can deter generic or biosimilar companies from entering the market, says Tahir Amin at the Initiative for Medicines, Access & Knowledge.
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How Methods Are Evolving In Textualist Interpretations
Textualists at the U.S. Supreme Court are increasingly considering new methods such as corpus linguistics and surveys to evaluate what a statute's text communicates to an ordinary reader, while lower courts even mull large language models like ChatGPT as supplements, says Kevin Tobia at Georgetown Law.
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Trending At The PTAB: Obviousness In Director Reviews
Three July decisions from the U.S. Patent and Trademark Office favoring petitioners indicate a willingness by the director to review substantive issues, such as obviousness, particularly in cases where the director believes the Patent Trial and Appeal Board provided incorrect or inadequate rationale to support its decisions, say attorneys at Finnegan.
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Why Attorneys Should Consider Community Leadership Roles
Volunteering and nonprofit board service are complementary to, but distinct from, traditional pro bono work, and taking on these community leadership roles can produce dividends for lawyers, their firms and the nonprofit causes they support, says Katie Beacham at Kilpatrick.
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Opinion
Agencies Should Reward Corporate Cyber Victim Cooperation
The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.
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Firms Must Offer A Trifecta Of Services In Post-Chevron World
After the U.S. Supreme Court’s Loper Bright Enterprises v. Raimondo decision overturning Chevron deference, law firms will need to integrate litigation, lobbying and communications functions to keep up with the ramifications of the ruling and provide adequate counsel quickly, says Neil Hare at Dentons.
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Takeaways From UPC's Amgen Patent Invalidity Analysis
The Unified Patent Court Central Division's decision in Regeneron v. Amgen to revoke a patent for lack of inventive step is particularly clear in its reasoning and highlights the risks to patentees of the new court's central revocation powers, say Jane Evenson and Caitlin Heard at CMS.
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5 Ways Life Sciences Cos. Can Manage Insider Trading Risk
In light of two high-profile insider trading jury decisions against life sciences executives this year, public companies in the sector should revise their policies to account for regulators' new and more expansive theories of liability, says Amy Walsh at Orrick.
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5 Tips To Succeed In A Master Of Laws Program And Beyond
As lawyers and recent law school graduates begin their Master of Laws coursework across the country, they should keep a few pointers in mind to get the most out of their programs and kick-start successful careers in their practice areas, says Kelley Miller at Reed Smith.
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Bayer Antitrust Case Hinged On Evolving Market Definition
Generic flea and tick medication manufacturer Tevra's evolving market definition played a key role in the development and outcome of its five-year antitrust litigation against Bayer Healthcare, highlighting challenges that litigants may face when a proposed definition is assessed at trial, say Amy Vegari and Colleen Anderson at Patterson Belknap.
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IP Hot Topic: The Intersection Of Trademark And Antitrust Law
Antitrust claims – like those in the U.S. Department of Justice’s recent case against Apple – are increasingly influencing trademark disputes and enforcement practices, demonstrating how antitrust law can dilute the power of a trademark, say attorneys at Dentons.
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Series
Being An Opera Singer Made Me A Better Lawyer
My journey from the stage to the courtroom has shown that the skills I honed as an opera singer – punctuality, memorization, creativity and more – have all played a vital role in my success as an attorney, says Gerard D'Emilio at GableGotwals.
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What Drug Cos. Must Know About NY Price Transparency Law
Drug manufacturers must understand the contours of New York's recently implemented law requiring self-reporting of drug price increases, as well as best practices for compliance and challenges against similar laws in other states, say Elizabeth Bierut and Angie Garcia at Friedman Kaplan.
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How Law Firms Can Avoid 'Collaboration Drag'
Law firm decision making can be stifled by “collaboration drag” — characterized by too many pointless meetings, too much peer feedback and too little dissent — but a few strategies can help stakeholders improve decision-making processes and build consensus, says Steve Groom at Miles Mediation.