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Life Sciences
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August 04, 2025
MOVEit Data Breach MDL Advances With Slimmed Frame
A Massachusetts federal judge has pared down but declined to toss sprawling multidistrict litigation over a data breach tied to Progress Software's MOVEIt file transfer tool, with negligence and several other claims allowed to proceed against the software vendor and four bellwether groups of companies that used the tool.
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August 04, 2025
GTCR Says Buyer In Place For Potential FTC Divestiture Deal
Private equity firm GTCR BC Holdings told an Illinois federal court it has a signed agreement with a buyer for a deal that should fix the concerns raised by the Federal Trade Commission over its planned $627 million purchase of a medical device coatings company.
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August 04, 2025
Feds Get 2nd Crack At Regeneron FCA Case After Key Ruling
The government may pursue an alternate theory of its False Claims Act kickback case against Regeneron Pharmaceuticals Inc. and try again for a pretrial win after a First Circuit ruling created a "critical shift" in the law, a Massachusetts federal judge said Monday.
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August 04, 2025
Chemical Group Says Fluoride Judge Got It Wrong
The American Chemistry Council told the Ninth Circuit that a California federal judge who ruled that current limits on fluoride in drinking water aren't protective enough misinterpreted the Toxic Substances Control Act and urged reversal of his decision.
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August 04, 2025
Investors Say Novo Nordisk Misled Them Over Drug Demand
Novo Nordisk was hit with a proposed securities class action in New Jersey federal court alleging the company misled investors over its revenue outlook for 2025 by allegedly overstating the likelihood patients would switch to its branded diabetes and weight loss drugs.
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August 04, 2025
Moderna Seeks To Be Cleared In $5B COVID Vax Patent Case
Moderna has urged a Delaware federal judge to clear it in a rival mRNA vaccine developer's $5 billion patent suit over the company's COVID-19 vaccines, saying it is shielded because it made them for the federal government.
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August 04, 2025
Rising Star: Keker's Bailey Heaps
Bailey Heaps of Keker Van Nest & Peters LLP helped two chemistry professors defeat a lawsuit centering on the commercialization of a scientific breakthrough and won an $80 million verdict in a dispute over a milestone payment, earning him a spot among the life sciences law practitioners under age 40 honored by Law360 as Rising Stars.
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August 04, 2025
Barnes & Thornburg Adds Leader Of FDA Practices At 2 Firms
Barnes & Thornburg LLP has hired the former leader of both Husch Blackwell LLP and Michael Best & Friedrich LLP's U.S. Food and Drug Administration-focused practices who brings a perspective to its Washington, D.C., office that includes working at the agency for more than a decade.
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August 04, 2025
Healthcare Investor Clinches $1.86B For 5th Credit Fund
Healthcare investment firm OrbiMed, advised by Gunderson Dettmer Stough Villeneuve Franklin & Hachigian LLP, on Monday announced that it wrapped its latest fund after securing $1.86 billion of investment commitments, which will be used to partner with healthcare companies across various sectors.
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August 04, 2025
Ex-FDA Chief Of Staff Joins Hogan Lovells' Pharma Team
The former chief of staff at the U.S. Food and Drug Administration, who most recently was a senior policy adviser there in the commissioner's office, has joined Hogan Lovells' Washington, D.C., team as a partner, the firm announced Monday.
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August 01, 2025
Meta Illegally Recorded Flo Users' Data, Calif. Jury Finds
A California federal jury Friday found Meta Platforms Inc. liable for violating the state's wiretap law by using a data analytics tool to retrieve sensitive health data from users of the popular menstrual tracking app Flo, in what plaintiffs' counsel called "one of the first times" a major tech company has been held accountable for such practices.Â
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August 01, 2025
Wheeling & Appealing: Midyear Highlights For Every Circuit
In this special edition of Wheeling & Appealing, we're spotlighting key decisions and developments in every circuit court during the first half of 2025, while also previewing August's most intriguing oral arguments, including a remarkably "fierce" showdown between Edible Arrangements and 1-800-Flowers with millions of dollars in attorney fees on the line.
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August 01, 2025
IP Owners Largely Win In Stewart's Newest Discretion Orders
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart dismissed most of the 50 petitions for inter partes review addressed in her latest decisions over discretionary denials at the Patent Trial and Appeal Board.
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August 01, 2025
USPTO Tightens Rules On Patent Challengers' Arguments
Patent challengers at the Patent Trial and Appeal Board will no longer be able to skirt a requirement that they must identify where all the elements of the patent are found in prior art patents or printed publications, according to a notice from the U.S. Patent and Trademark Office.
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August 01, 2025
AGs Sue Trump Over 'Onslaught Of Pressure' On Trans Care
The Trump administration has improperly "weaponized" federal laws against drug misbranding, false claims and female genital mutilation as part of a pressure campaign to undermine state protections for gender-affirming care, a coalition of state attorneys general argued in a new suit Friday.
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August 01, 2025
En Banc 9th Circ. Backs LA Schools In Vax Mandate Fight
A majority en banc Ninth Circuit has affirmed a lower court's decision upholding Los Angeles Unified School District's COVID-19 vaccine mandate for employees, while two partially dissenting judges disagreed with the majority's conclusion that the policy passes constitutional muster.
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August 01, 2025
States Urge High Court To Keep NIH Grant Funds Flowing
A coalition of 16 states pressed the U.S. Supreme Court on Friday to reject the Trump administration's push to resume the mass termination of scientific research grants, saying a district judge had authority to pause the cuts.
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August 01, 2025
Monthly Merger Review Snapshot
The U.S. Department of Justice abandoned its challenge of a corporate travel management deal, while lawmakers are calling for scrutiny of the agency's recent decision to settle a different case, and the Federal Trade Commission agreed to nix the requirements placed on a pair of oil and gas deals.
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August 01, 2025
OptumRx Moves To DQ Motley Rice In Utah Opioid Case
Pharmacy benefit manager OptumRx has moved to disqualify Motley Rice LLC from representing the state of Utah in an opioid crisis lawsuit, claiming the firm clearly violated ethical rules by investigating OptumRx on behalf of government entities, then suing OptumRx in a private capacity.
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August 01, 2025
J&J Unit's Catheter Rival Scores Injunction After $442M Win
A California federal judge will block Johnson & Johnson's Biosense Webster from refusing clinical support for its Carto cardio mapping systems from hospitals that use competitors' cardiac catheters, requiring the company to institute nondiscriminatory pricing for its services at hospitals regardless of which products they use.
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July 31, 2025
Hospitals Want To Duck Pharmacy Career Match Program Suit
A professional pharmacy organization and a group of teaching hospitals teed up motions to dismiss Wednesday against proposed class action allegations that they conspired to restrict wages and benefits by funneling new pharmacists through a job-matching program, telling a Maryland federal judge that there's no sign of an agreement.
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July 31, 2025
Biotech Co. Beats Investor Suit Over Antifungal Drug Recall
Biotechnology company Scynexis Inc. has won dismissal, for now, of a proposed investor class action alleging that it triggered a 34% share decline by knowingly misleading investors about manufacturing compliance issues that led to a drug recall, with the court finding the allegations the company should have known and disclosed issues only show "fraud by hindsight."
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July 31, 2025
Robotic Surgery Co.'s Antitrust Appeal Backed At 9th Circ.
Surgical Instrument Service Co. Inc. has received backing at the Ninth Circuit from a trade association and others groups as it looks to revive its case accusing Intuitive Surgical Inc. of blocking third parties from refurbishing components for its popular da Vinci surgery robot.
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July 31, 2025
18 GOP Sens. Urge Trump To Fill IP Negotiator Post
Eighteen Republican U.S. senators urged President Donald Trump to appoint someone to the vacant role of chief innovation and intellectual property negotiator of the U.S. Trade Representative in order to work to remove what they called "market-distorting price controls" in the pharmaceutical industry.
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July 31, 2025
HHS Plans To Test Rebates In 340B Drug Pricing Program
The Trump administration on Thursday announced plans for a pilot project that would allow certain drugmakers to abandon upfront discounts in the 340B program and instead require hospitals to apply for rebates, testing an idea that would fundamentally reshape the long-running program.
Expert Analysis
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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.
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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.