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Life Sciences
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July 29, 2025
Teva, Amneal End Case Over Listing Inhaler IP In Orange Book
A New Jersey federal judge on Tuesday closed litigation between Teva and Amneal, which had led to the Federal Circuit's major decision that patents for Teva's inhalers don't belong in the U.S. Food and Drug Administration's Orange Book.Â
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July 29, 2025
Reported Plan For Value-Based Patent Fees Unnerves Experts
A proposal reportedly under consideration by the Trump administration to charge patent owners a new fee based on the value of their patents has spurred numerous questions and concerns among experts, who say the idea appears nearly unworkable and could hinder innovation.
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July 29, 2025
Ocugen Beats Investor Suit Over Financial Controls
Biopharmaceutical company Ocugen Inc. on Tuesday won permanent dismissal from an investor's class action accusing it of concealing weak financial controls that led to it refiling accounting statements for several periods, with a Pennsylvania federal judge determining that Ocugen's stock price recovered from the announcement it had erred in its reports.
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July 29, 2025
J&J Owes $43M For 30-Year Talc User's Mesothelioma
A Massachusetts state court jury ordered Johnson & Johnson Tuesday to pay more than $42.6 million to a former talc user with mesothelioma and his wife, following a trial in which the man's lawyer told jurors the alleged cancer-causing effects of the company's baby powder were its "dirty little secret."
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July 29, 2025
RFK Jr. Slams Vaccine Injury Program: 3 Things To Know
U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. is taking aim at the national program that compensates people for vaccine injuries, calling it a "heartless" system that he intends to fix.
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July 29, 2025
22 States Sue To Block Defunding Of Planned Parenthood
California and more than 20 other states on Tuesday launched their own legal challenge to budget legislation that halts federal Medicaid funding for Planned Parenthood, alleging the measure illegally targets the organization and violates its First Amendment rights.
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July 29, 2025
Jones Day Hires Former Pharma Co. Counsel In DC
Jones Day has hired a former Morgan Lewis & Bockius LLP partner, who has also worked in-house at two pharmaceutical companies and with the U.S. Drug Enforcement Administration, the firm announced Tuesday.
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July 29, 2025
Seeger Weiss Named Lead Negotiation Counsel In J&J MDL
A New Jersey federal judge overseeing long-running multidistrict federal litigation against Johnson & Johnson over its talcum powder products has appointed Christopher A. Seeger of Seeger Weiss LLP to lead a negotiation team to guide plaintiffs through settlement talks.
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July 29, 2025
Pharma Co. Blasts Adversary For Nudging Judge Assignment
A pharmaceutical solutions group has assailed its opponent's "hurry-up-court" motion nudging the appointment of a new judge after the previous judge overseeing their contract fight retired, saying its adversary "has only itself to blame" for the alleged delays that have put off a final resolution.
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July 29, 2025
NY Judge Faces Recusal Request Over Gilead Stock Holdings
A criminal defendant who admitted to taking part in a black market HIV drug scam has asked the Manhattan federal judge presiding over his case to step away after the judge disclosed brief ownership of nearly 9,000 shares of Gilead Sciences Inc., while the defendant was fighting her $2 million restitution order.
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July 29, 2025
9th Circ. Clarifies Kickback Boundaries For Referral Bonuses
A Ninth Circuit opinion affirming a California man's fraud conviction provides some clarity — and a warning — to the owners of medical testing laboratories wondering what sales tactics are allowed under a 2018 kickbacks law.
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July 29, 2025
Federal Cuts Shake Up Clinical Research Funding Landscape
As the Trump administration makes deep cuts to clinical research funding, healthcare attorneys worry that the delicate balance between federal grants and private investment is at risk. Crowell & Moring LLP partner Linda Malek talks to Law360 Healthcare Authority about the industry's concerns.
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July 28, 2025
Pharma Co. Alleges Clinical Trial Data Was Fabricated
A pharmaceutical research and development company sued New Jersey-based research organization Clinilabs LLC and several Florida clinical research firms Friday claiming they fabricated and covered up important clinical trial data for a new Alzheimer's disease treatment, wasting millions of dollars and setting the drug back at least five years.
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July 28, 2025
PBMs Can't Escape NY State Law Claims In Opioid MDL
Two UnitedHealth subsidiaries cannot escape claims that they exacerbated the opioid crisis by providing data analytics and consulting services to drugmakers, a federal judge overseeing the multidistrict litigation ruled on Monday, saying the New York state municipalities have adequately alleged RICO by claiming they were part of the same criminal conspiracy.
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July 28, 2025
NeoGenomics Wants Jury Trial In Natera DNA Test Patent Fight
NeoGenomics Laboratories Inc. told a North Carolina federal judge that a company suing it for patent infringement over DNA cancer test technology, Natera Inc., had no right to withdraw its demand for a jury trial and move forward with a bench trial.
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July 28, 2025
Splenda-Maker Says Emails Show NC Scientist Ignored Data
The makers of Splenda said new emails and documents unearthed in discovery for its defamation lawsuit against a scientist show that she ignored and manipulated experiment data to suggest that the artificial sweetener is dangerous for humans.
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July 28, 2025
2nd Abbott Baby Formula Bellwether Falls Before Trial
An Illinois federal judge handed Abbott Laboratories summary judgment on Monday in the second bellwether that had been set for trial in multidistrict litigation over allegations its cow's milk-based formula can cause severe gastrointestinal illness in premature babies, while saying she will leave the door open to revive and later try the case.
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July 28, 2025
Eli Lilly Alleges Pharmacy Sells Knockoff Weight-Loss Drugs
Eli Lilly and Company is accusing a Houston pharmacy of selling knockoff versions of two of its Ozempic-like weight-loss drugs.
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July 28, 2025
PREP Act Won't Save COVID Test Manufacturer From IP Suit
The maker of swabs used in COVID-19 tests can't invoke a public health law's immunity protections to avoid patent infringement litigation, a Maine federal judge has ruled.
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July 28, 2025
Cooley-Led Biotech Snags $372.5M For Latest Funding Round
Clinical-stage biopharmaceutical company MapLight Therapeutics, advised by Cooley LLP, on Monday revealed that it clinched its oversubscribed Series D funding round after raising $372.5 million from investors.
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July 28, 2025
J&J Loses Bid To Probe Beasley Allen Talc Litigation Funding
A special master found Monday there is no reason to believe third-party funders are influencing Beasley Allen Law Firm's decisions in a massive talc litigation in New Jersey, defeating a subpoena from Johnson & Johnson digging into alleged third-party litigation funding.
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July 28, 2025
Catching Up With Delaware's Chancery Court
A Delaware vice chancellor last week sent several coordinated derivative suits seeking millions of dollars in damages from AT&T to trial and also chose a boutique firm to lead a potential "blockbuster" suit challenging a take-private deal of a sports and entertainment group after "heated" attacks between competing counsel.
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July 28, 2025
Judge Again Cites Bias In NIH Fund Freeze As Gov't Appeals
A Massachusetts federal judge on Monday reiterated his conclusion that the Trump administration's freeze of $783 million worth of National Institutes of Health grants was based on "palpable" gender and racial discrimination, as he acknowledged a pending request by the government to the U.S. Supreme Court to stay his order that the money be released.
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July 28, 2025
Novo Nordisk Faces Possible Mass Tort Over Ozempic In NJ
Over 20 plaintiffs who have sued Novo Nordisk in New Jersey state court alleging its popular weight loss drugs caused them to lose their vision have filed an application to designate their cases as multicounty litigation, according to a notice to the bar posted on Monday.
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July 28, 2025
Biotech GC Says She Was Ousted Amid 'Systemic' Bias
A former general counsel at Massachusetts life sciences firm Repligen has filed a lawsuit in state court claiming that a pervasive culture of gender bias led to her and other women being treated differently and paid less.
Expert Analysis
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How Patent Attys Can Carefully Integrate LLMs Into Workflows
With artificial intelligence-powered tools now being developed specifically for the intellectual property domain, patent practitioners should monitor evolving considerations to ensure that their capabilities are enhanced — rather than diminished — by these resources, say attorneys at McDonnell Boehnen.
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The Metamorphosis Of The Major Questions Doctrine
The so-called major questions doctrine arose as a counterweight to Chevron deference over the past few decades, but invocations of the doctrine have persisted in the year since Chevron was overturned, suggesting it still has a role to play in reining in agency overreach, say attorneys at Crowell & Moring.
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New PTAB Denial Processes Grow More And More Confusing
Guidance from the U.S. Patent and Trademark Office about the Patent Trial and Appeal Board's new workload management and discretionary denial processes has been murky and inconsistent, and has been further muddled by the acting director's seemingly contradictory decisions, say attorneys at Finnegan.
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Arguing The 8th Amendment For Reduction In FCA Penalties
While False Claims Act decisions lack consistency in how high the judgment-to-damages ratio in such cases can be before it becomes unconstitutional, defense counsel should cite the Eighth Amendment's excessive fines clause in pre-trial settlement negotiations, and seek penalty decreases in post-judgment motions and on appeal, says Scott Grubman at Chilivis Grubman.
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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.