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Life Sciences
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July 17, 2025
FDA Signs Off On Juul E-Cig Products After 5-Year Review
The U.S. Food and Drug Administration on Thursday gave Juul the green light to market five e-cigarette products, although the FDA noted that the long-awaited authorization "does not mean these tobacco products are safe, nor are they FDA-approved."
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July 17, 2025
FDA Warns Firms Over Illegal Kratom Product Marketing
The U.S. Food and Drug Administration has warned seven companies — including a California company facing a proposed class action — that they are illegally marketing products containing a potent kratom-derived compound, in letters that indicate intensified federal scrutiny of the opioid-like supplement.
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July 17, 2025
SEC Fraud Suit Against Ex-Online Pharmacy Execs Advances
A New York federal judge has declined to dismiss a majority of the U.S. Securities and Exchange Commission's claims against former executives of a now-defunct online pharmacy called Medly, finding the agency adequately pleaded that the executives made false statements or acted recklessly, among other misconduct.
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July 17, 2025
11th Circ. Says Ex-Quest Diagnostics Worker's FCA Suit Fails
The Eleventh Circuit declined to revive a former Quest Diagnostics Inc. compliance officer's False Claims Act suit against the lab testing company, ruling she had failed to allege a specific claim of medical billing fraud after some 15 years of litigation.
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July 17, 2025
Stanford Trims Roche IP Suit, But Others Face Most Claims
Stanford University was let out of all but one claim brought by subsidiaries of F. Hoffmann-La Roche AG over alleged trade secret theft, but a California federal judge allowed most claims to move forward against several Stanford professors and a startup they founded.
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July 17, 2025
Senators Float 'Patent Thicket' Bill To Limit Generic Litigation
A bill floated in the U.S. Senate would limit the use of so-called patent thickets that are asserted by major pharmaceutical companies in litigation to restrict generic competition.
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July 17, 2025
6 Cases For Patent Attys To Watch In The Second Half Of 2025
The Federal Circuit is considering major questions about when delays in prosecuting patents become bad faith and whether the acting U.S. Patent and Trademark Office director is legally allowed to apply new rules retroactively. Here's what you need to know about these cases and others that attorneys are keeping an eye on for the rest of the year.
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July 17, 2025
Ex-CEO Agrees To $27.5M Judgment In Medicare Fraud Case
A day before his trial was set to begin, the former CEO and owner of the now-defunct laboratory Premier Medical Inc. agreed to a $27.5 million consent judgment, acknowledging he was likely to be found liable in the suit brought against him by the federal government and three states.
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July 17, 2025
Fla. AG, Sandoz Clash With Other Enforcers Over 'Done' Deal
Sandoz and Florida's attorney general pressed a Connecticut federal judge Wednesday to let them settle out of sweeping price-fixing litigation against generic-drug makers, contending that federal civil procedure rules give no room for objections from other state enforcers worried the Sunshine State deal interferes with their own ability to negotiate settlements. Â
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July 17, 2025
PE Firm Is Denied FDA Docs For Defense In Deal Challenge
An Illinois federal court on Wednesday denied a request from private equity firm GTCR BC Holdings LLC to force the U.S. Food and Drug Administration to produce more than a decade's worth of medical device approval applications as the firm fights a merger challenge from enforcers.
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July 17, 2025
J&J Loses Bid To DQ Beasley Allen From Talc MDL Committee
A New Jersey federal judge on Thursday denied Johnson & Johnson's bid to remove the Beasley Allen Law Firm from the plaintiffs steering committee in the multidistrict talc litigation but said that changes would be made to the committee's structure.
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July 17, 2025
Iowa Church Says DEA Can't 'Pocket Veto' Drug Exemption
An Iowa church is asking the D.C. Circuit to force the Drug Enforcement Administration to rule on an application it filed more than six years ago for a religious exemption to use a psychedelic in its services, saying the DEA shouldn't be allowed to "pocket veto" the application and leave the church hanging.
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July 16, 2025
Pharmacy Benefit Managers Say Ohio Can't Recast Suit
The state of Ohio can't "recast its complaint on appeal" in order to convince the Sixth Circuit that its enforcement suit accusing two pharmacy benefit managers of working to raise the cost of prescription drugs belongs in state court, those managers have told the appellate court.
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July 16, 2025
Gilgo Beach Killer Case Puts New DNA Science To The Test
The only physical evidence linking the Gilgo Beach serial killings to the defendant, Rex Heuermann, are five hairs that could only be analyzed via a newer technique known as whole genome sequencing, but as the court decides whether the science is jury ready, experts are divided.
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July 16, 2025
Hims & Hers Brass Face Suit Over 'Knockoff' Wegovy Sales
Executives and directors of telehealth company Hims & Hers Health Inc. have been hit with a shareholder derivative suit in California federal court accusing them of allowing the company to exploit its now-terminated partnership with Novo Nordisk to sell "knockoff" versions of Novo's weight loss drug Wegovy,.
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July 16, 2025
Glucose Monitoring Co. LifeScan Hits Ch. 11 With $1.7B Debt
LifeScan Global Corp., a company that makes blood glucose monitoring devices, has filed for Chapter 11 protection in Texas bankruptcy court with $1.7 billion of debt and a plan supported by its private equity backer to trim more than 75% of debt by handing the business to existing lenders.
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July 16, 2025
Novartis Denied Bid To Block Generic Entresto In TM Feud
A New Jersey federal judge has rethought her initial decision blocking a Novartis competitor from potentially selling a generic version of a heart failure treatment drug, saying she got it wrong when she earlier analyzed a trade dress claim.
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July 16, 2025
CooperSurgical Wants Conn. Embryo Loss Claims Tossed
CooperSurgical Inc. should not have to face a Connecticut federal lawsuit over embryos lost to its recalled culture medium for in vitro fertilization, the company said in motions to dismiss or pause the litigation based in part on "significant briefing and discovery" in a first-filed case in California.
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July 15, 2025
GTCR Seeks Rival's Sales Data To Counter FTC Challenge
The private equity firm looking to buy medical device coating company Surmodics is seeking Salesforce data from another competitor in the space, saying the information is crucial to showing that the industry will still be competitive if its acquisition is cleared.
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July 15, 2025
Biohaven's Drug Prospects Were Overhyped, Suit Says
Biopharmaceutical company Biohaven Ltd. was hit with an investor suit claiming it overstated the odds that two of its product candidates would receive regulatory approval, hurting investors as it announced disappointing results.
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July 15, 2025
Trump Admin Seeks Win In Harvard $2B Funding Freeze Case
The Trump administration urged a Massachusetts federal judge Monday to grant it summary judgment in Harvard University's lawsuit challenging the government's effort to freeze $2.2 billion in funding, arguing the dispute is a contract fight that belongs in the Federal Claims Court and the allegations fail on the merits.
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July 15, 2025
Patent Fight Over Xtandi Erupts Anew Before RFK Jr.
A new dispute is playing out over the price of a prostate cancer drug that was developed at University of California, Los Angeles, and is being sold by Pfizer, with the federal government being pushed on the issue of using its authority to allow early entry of generics.
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July 15, 2025
Court Blocks Generic Selenium Products Amid Patent Suit
A New Jersey federal judge has temporarily blocked a group of generic-drug companies from selling versions of a selenium injection treatment covered by patents owned by American Regent Inc., which accused the group of patent infringement.
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July 15, 2025
The Biggest IP Agency Developments Of 2025: Midyear Report
The U.S. Patent and Trademark Office and the U.S. Copyright Office have not been spared from the Trump administration's shake-ups and changes across the federal government in the first half of the year.
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July 15, 2025
Split 4th Circ. Rejects GenBioPro Abortion Ban Challenge
A split Fourth Circuit panel on Tuesday rejected GenBioPro's challenge to a West Virginia law banning medication abortion with narrow exceptions, with the majority finding the ban does not conflict with federal regulators' statutory authority to impose safety requirements on drug manufacturers.
Expert Analysis
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How Courts Weigh Section 1782 Discovery For UPC Cases
A look at cases from six different federal district courts reveals a number of discretionary factors that influence how courts consider Section 1782 discovery applications in connection with Unified Patent Court proceedings, say attorneys at Finnegan.
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Opinion
In Vape Case, Justices Must Focus On Agencies' Results
With the U.S. Supreme Court's ruling in U.S. Food and Drug Administration v. Wages and White Lion Investments having put off the question of whether agency decisions arrived at erroneously are always invalid, the court should give the results of agency actions more weight than the reasoning behind them when it revisits this case, says Jonathan Sheffield at Loyola University Chicago School of Law.
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Series
Volunteer Firefighting Makes Me A Better Lawyer
While practicing corporate law and firefighting may appear incongruous, the latter benefits my legal career by reminding me of the importance of humility, perspective and education, says Nicholas Passaro at Ford.
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E-Discovery Quarterly: The Perils Of Digital Data Protocols
Though stipulated protocols governing the treatment of electronically stored information in litigation are meant to streamline discovery, recent disputes demonstrate that certain missteps in the process can lead to significant inefficiencies, say attorneys at Sidley.
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Defense Strategies After Justices' Personal Injury RICO Ruling
In Medical Marijuana v. Horn, the U.S. Supreme Court recently held that the Racketeer Influenced and Corrupt Organizations Act can be invoked by some plaintiffs with claims arising from personal injuries — but defense counsel can use the limitations on civil RICO claims to seek early dismissal in such cases, say attorneys at Debevoise.
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Series
Law School's Missed Lessons: Preparing For Corporate Work
Law school often doesn't cover the business strategy, financial fluency and negotiation skills needed for a successful corporate or transactional law practice, but there are practical ways to gain relevant experience and achieve the mindset shifts critical to a thriving career in this space, says Dakota Forsyth at Olshan Frome.
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3 Red Flags To Watch For When Valuing Patent Portfolios
As forward-looking intellectual property valuations become increasingly popular, recognizing potential concerns during the due diligence process can help develop a more accurate understanding of a portfolio's true value and potential risk, says Keegan Caldwell at Caldwell Law.
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How Cos. Can Mitigate Increasing Microplastics Liability Risk
Amid rising scrutiny in the U.S. and Europe of microplastics' impact on health and the growing threat of litigation against consumer product and food and beverage manufacturers, companies can limit liability through compliance with labeling laws, careful contract management and other practices, say attorneys at Rogers Joseph.
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A Cold War-Era History Lesson On Due Process
The landmark Harry Bridges case from the mid-20th century Red Scare offers important insights on why lawyers must be free of government reprisal, no matter who their client is, says Peter Afrasiabi at One LLP.
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Series
Improv Makes Me A Better Lawyer
Improv keeps me grounded and connected to what matters most, including in my legal career where it has helped me to maintain a balance between being analytical, precise and professional, and creative, authentic and open-minded, says Justine Gottshall at InfoLawGroup.
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How BigLaw Executive Orders May Affect Smaller Firms
Because of the types of cases they take on, solo practitioners, small law firms and public interest attorneys may find themselves more dramatically affected by the collective impact of recent government action involving the legal industry than even the BigLaw firms named in the executive orders, says Reuben Guttman at Guttman Buschner.
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Opinion
Lawsuits Shouldn't Be Shadow Assets For Foreign Capital
Third-party litigation financing amplifies inefficiencies from litigation and facilitates national exposure to foreign influence in the U.S. justice system, so full disclosure of financing arrangements should be required as a matter of institutional integrity, says Roland Eisenhuth at the American Property Casualty Insurance Association.
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How To Accelerate Your Post-Attorney Career Transition
Professionals seeking to transition to nonattorney careers may encounter skepticism as nontraditional candidates, but there are opportunities for thought leadership and to leverage speaking and writing to accelerate a post-attorney career transition, say Janet Falk at Falk Communications and Evgeny Efremkin at Toronto Metropolitan University.
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5 Key Licensing Considerations For AI Innovations
As businesses increasingly integrate artificial intelligence technology into their operations, they must prepare to address complex intellectual property challenges and questions surrounding licensing AI-based innovations, which require careful consideration of ownership, usage rights and regulatory compliance, says Lestin Kenton at Sterne Kessler.
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A Higher Bar For Expert Witnesses In Drug Patent Litigation
With recent decisions emphasizing courts' growing insistence on robust methodologies in pharmaceutical patent disputes, litigators must be strategic in how they utilize expert testimony and adapt to venue-specific expectations, says Jeremy Scholem at WIT Legal.