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Life Sciences
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October 31, 2025
Amgen Again Challenges Colo. Price Cap For Arthritis Drug
Amgen has once again sued Colorado over its price cap for the arthritis drug Enbrel, claiming that the Centennial State's drug price-control statute violates the U.S. Constitution, conflicts with federal patent law and threatens patients' access to lifesaving medications.
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October 31, 2025
Ga. Panel Says McClain Standard Applies In Sterigenics Case
The Georgia Court of Appeals on Friday vacated a trial court's decision in eight toxic tort bellwether suits claiming harmful emissions from a Sterigenics sterilization plant caused cancer and birth defects, saying the trial court used the wrong legal standard regarding expert testimony in toxic tort cases.
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October 31, 2025
Wheeling & Appealing: The Latest Must-Know Appellate Action
In this installment of Wheeling & Appealing, November's appellate calendar features a Trump lawsuit against Hillary Clinton, New York City housing disputes, drug pricing battles, immigrant rights cases, and challenges to so-called patent troll laws.
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October 31, 2025
Monthly Merger Review Snapshot
The Justice Department battled with state attorneys general trying to peek behind its controversial settlement clearing Hewlett Packard Enterprise's Juniper purchase, United Kingdom officials deepened their probe into Getty's proposed acquisition of Shutterstock and Pfizer cried foul when Novo Nordisk tried to swoop in over its Metsera purchase.
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October 31, 2025
Hawaii Judge Declares FDA's Mifepristone Regs Unlawful
The U.S. Food and Drug Administration failed to sufficiently justify restrictions on the abortion drug mifepristone, a Hawaii federal judge ruled in an order declaring the restrictions unlawful under the Administrative Procedure Act.
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October 31, 2025
Gov't Owes $330K In Fees For NSF Funding Fight, Court Told
A higher education association seeks more than $330,000 in attorney fees and costs from the government after winning a ruling blocking the Trump administration from cutting certain National Science Foundation funding, according to a memorandum filed in Massachusetts federal court.
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October 31, 2025
FDA Warns Against Fluoride Use In Young Children
The U.S. Food and Drug Administration on Friday said it is stopping sales of unapproved fluoride products labeled for use by children under the age of three as part of the Trump administration's Make America Healthy Again movement.
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October 31, 2025
Bayer Investors Get Final OK For $38M Settlement, Atty Fees
A California federal judge has finalized a $38 million settlement between Germany-based Bayer AG and a class of investors who claim the company deceived them about the litigation risks of acquiring Roundup producer Monsanto, with the lead plaintiffs' attorney saying the deal reaffirmed investors' ability to hold foreign companies responsible for violating U.S. securities laws.
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October 31, 2025
Squires Vows To Open USPTO Doors To AI Technologies
New U.S. Patent and Trademark Office Director John Squires said Friday his agency will embrace artificial intelligence technologies during his tenure, telling attorneys at the American Intellectual Property Law Association's annual gathering in Washington, D.C., that AI is "the most transcendent and transformative technology of our time — perhaps of any time."
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October 31, 2025
Obesity Drugmaker Escapes Clinical Trial Securities Suit
Biopharmaceutical company BioAge Labs Inc. has, for now, escaped a suit alleging investors were hurt by plummeting share prices after the company unexpectedly halted a clinical trial for a weight loss drug, saying that the investors failed to plausibly show the company did not properly disclose risks to the trial.
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October 31, 2025
3 Argument Sessions Benefits Attys Should Watch In Nov.
The Third Circuit will hear a union's appeal in a withdrawal liability battle, a union health plan defends its partial win in a coverage fight at the Ninth Circuit, and pharmacy benefit managers will take a challenge to the Federal Trade Commission's authority to the full Eighth Circuit. Here are three arguments to keep an eye on in November.
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October 31, 2025
Industry Groups Seek More Time To Comment On PTAB Rules
A coalition of organizations representing the technology, automotive and pharmaceutical sectors has urged U.S. Patent and Trademark Office Director John Squires to allow 30 additional days of public comments regarding new proposed rules that would curtail the number of Patent Trial and Appeal Board reviews.
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October 31, 2025
3rd Circ. Preview: BMW, MiLB And Sandoz Top Nov. Lineup
The Third Circuit in November will hear a pair of disputes over awards handed out in New Jersey federal court, including a nearly $4 million attorney fee for class counsel representing BMW drivers and a $70 million win for Sandoz Inc. in a contract battle over blood pressure medicine.
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October 30, 2025
Philly Accuses PBMs Of Knowingly Enabling Opioid Crisis
Philadelphia on Thursday sued CVS Caremark, Express Scripts and Optum, accusing the pharmacy benefit managers of contributing to the city's opioid epidemic via deceptive marketing and conspiring with drugmakers to increase the sale of OxyContin and other prescription opioids.
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October 30, 2025
Med Robot Co. Tells 9th Circ. Not To Revive 'Disfavored' Suit
Intuitive Surgical urged the Ninth Circuit not to revive a surgical repair company's claims alleging it blocked third parties from refurbishing components for its popular da Vinci surgery robot, defending the district court's findings that cases alleging anticompetitive harm to a single brand aftermarket are "rare and disfavored."
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October 30, 2025
Fiber Optics Co. Agrees To Reforms To End Derivative Suit
Fiber optic equipment company Luna Innovations Inc. has reached a deal with its investors to settle their derivative claims alleging the company was damaged by its failure to properly recognize revenue in its filings with the U.S. Securities and Exchange Commission.
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October 30, 2025
Avantor Minimized Competition On Lab Biz, Investor Says
Biotech company Avantor Inc. was hit with a proposed securities class action in Pennsylvania federal court Thursday alleging it misled investors when it minimized the effects of increased competition on its business and operations while touting strong competitive positioning, causing stock prices to plunge when the truth came out.
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October 30, 2025
Fed. Circ. Explains Rule While Upholding Merck PTAB Loss
The Federal Circuit sided with generics makers Thursday and upheld the Patent Trial and Appeal Board's invalidation of claims in two Merck KGaA patents on the blockbuster multiple sclerosis drug Mavenclad, while clarifying how to treat invalidity arguments that involve overlapping inventors.
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October 30, 2025
2nd Ex-Magellan Exec Avoids Jail Over Faulty Lead Tests
A second former Magellan Diagnostics executive ducked prison time Thursday for his role in an alleged scheme to hide a defect in the company's lead-testing devices ahead of its sale in 2016.
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October 30, 2025
Lawmakers Slam Value-Based Patent Fee Proposal
Six members of the U.S. House of Representatives wrote to U.S. Secretary of Commerce Howard Lutnick on Thursday expressing concern over the proposal to charge patent holders fees based on their patent's value, saying that will harm innovation and economic growth.
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October 30, 2025
J&J's Janssen Says 3rd Circ. Should Reverse $1.6B FCA Win
Johnson & Johnson's Janssen Products LP urged the Third Circuit to overturn a $1.6 billion False Claims Act judgment over two of its HIV drugs, arguing the district court allowed whistleblowers to prove fraud based solely on "off-label" marketing rather than any false claim actually submitted to the government.
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October 30, 2025
Generic-Drug Firms Want To Fast-Track Conn. Price Cap Fight
An industry group for generic and biosimilar pharmaceutical companies has asked a Connecticut federal judge to fast-track its lawsuit seeking to block the state's new drug price cap, claiming it will suffer "imminent harm" if the case is delayed.
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October 30, 2025
McCarter & English Used Doctrine As 'Whipsaw,' Panel Hears
A biotech company on Thursday urged a New Jersey appellate panel to revive its legal malpractice suit against McCarter & English LLP, arguing that the claims were distinct from the firm's own suit seeking unpaid fees.
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October 30, 2025
Mich. Top Court Upholds Gilead Immunity In COVID Drug Case
The Michigan Supreme Court on Wednesday said it won't consider an appeal from a man who was injected with a COVID-19 treatment made by Gilead Sciences Inc. that was later recalled for containing glass shards, a few months after a lower appellate court found the company immune because of a federal health emergency law.
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October 30, 2025
Judge Unpauses 'Important' Suit Over Vax Guidelines
A Massachusetts federal judge agreed Thursday to lift a government shutdown-related stay of litigation challenging new COVID-19 vaccine recommendations for children and pregnant women, calling the case a "matter of national importance" that warrants keeping the case moving over the U.S. Department of Justice's objection.
Expert Analysis
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9th Circ. Decisions Help Clarify Scope Of Legal Lab Marketing
Two Ninth Circuit decisions last week provide a welcome development in clarifying the line between laboratories' legal marketing efforts and undue influence that violates the Eliminating Kickbacks in Recovery Act, and offer useful guidance for labs seeking to mitigate enforcement risk, says Joshua Robbins at Buchalter.
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$95M Caremark Verdict Should Put PBMs On Notice
A Pennsylvania federal judge’s recent ruling that pharmacy benefits manager CVS Caremark owes the government $95 million for overbilling Medicare Part D-sponsored drugs highlights the effectiveness of the False Claims Act, as scrutiny of PBMs’ outsized role in setting drug prices continues to increase, say attorneys at Duane Morris.
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Biotech Collaborations Can Ease Uncertainty Amid FDA Shift
As concerns persist that the U.S. Food and Drug Administration's reduced headcount will impede developments at already-strapped biotech companies, licensing and partnership transactions can provide the necessary funding and pathways to advance innovative products, say attorneys at Troutman.
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Series
Playing Mah-Jongg Makes Me A Better Mediator
Mah-jongg rewards patience, pattern recognition, adaptability and keen observation, all skills that are invaluable to my role as a mediator, and to all mediating parties, says Marina Corodemus.
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Does Research Tool Safe Harbor Cover AI Drug Development?
As artificial intelligence increasingly takes root in drug development, many questions may emerge regarding current gaps in courts' application of the research tool exception to the safe harbor defense against patent infringement, and whether that defense applies to AI-based tools, say attorneys at Arnold & Porter.
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Series
Law School's Missed Lessons: Navigating Client Trauma
Law schools don't train students to handle repeated exposure to clients' traumatic experiences, but for litigators practicing in areas like civil rights and personal injury, success depends on the ability to view cases clinically and to recognize when you may need to seek help, says Katie Bennett at Robins Kaplan.
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Opinion
4 Former Justices Would Likely Frown On Litigation Funding
As courts increasingly confront cases involving hidden litigation finance contracts, the jurisprudence of four former U.S. Supreme Court justices establishes a constitutional framework that risks erosion by undisclosed financial interests, says Roland Eisenhuth at the American Property Casualty Insurance Association.
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How Attys Can Use AI To Surface Narratives In E-Discovery
E-discovery has reached a turning point where document review is no longer just about procedural tasks like identifying relevance and redacting privilege — rather, generative artificial intelligence tools now allow attorneys to draw connections, extract meaning and tell a coherent story, says Rose Jones at Hilgers Graben.
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Leveraging Diligence Findings For Better Life Sciences Deals
Life sciences parties should utilize due diligence strategically to review and draft deal documents, address issues identified during the diligence, and craft solutions to achieve the party's transactional goals, says Anna Zhao at Gunner Cooke.
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IP Due Diligence Tips For AI Assets In M&A Transactions
Artificial intelligence systems' integration into business operations creates new considerations for intellectual property due diligence in mergers and acquisitions and financing transactions, and implementing a practical approach to identifying AI assets can help avoid litigation and losses, say Armin Ghiam and Senna Hahn at Hunton.
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How McKesson Ruling Will Inform Interpretations Of The TCPA
Amid the U.S. Supreme Court's ruling in McLaughlin Chiropractic Associates v. McKesson, we can expect to see both plaintiffs and defendants utilizing the decision to revisit the Federal Communications Commission's past Telephone Consumer Protection Act interpretations and decisions they did not like, says Jason McElroy at Saul Ewing.
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AbbVie Frees Taxpayers From M&A Capital Loss Limitations
The U.S. Tax Court’s June 17 opinion in AbbVie v. Commissioner, finding that a $1.6 billion break fee was an ordinary and necessary business expense, marks a pivotal rejection of the Internal Revenue Service’s position on the tax treatment of termination fees related to failed mergers or acquisitions, say attorneys at Holland & Knight.
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Opinion
New USPTO Leadership Must Address Low-Quality Patents
With John Squires in line to become the new director of the U.S. Patent and Trademark Office, the agency has an opportunity to refocus its mission on prioritizing quality in patent examination and taking a harsher stance against low-quality patents and patent trolls, says Jill Crosby at Engine Advocacy & Foundation.
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Opinion
High Court Must Overrule Outdated Patent Eligibility Doctrine
A certiorari petition should directly ask the U.S. Supreme Court to correct its 1972 patent decision in Gottschalk v. Benson, the critical point where patent eligibility law veered from the statutory text toward judicial policymaking, says Robert Greenspoon at Dunlap Bennett.
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Series
Playing The Violin Makes Me A Better Lawyer
Playing violin in a string quartet reminds me that flexibility, ambition, strong listening skills, thoughtful leadership and intentional collaboration are all keys to a successful legal practice, says Julie Park at MoFo.