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Life Sciences
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July 18, 2025
MSN Urges Fed. Circ. To Allow Launch Of Generic Entresto
MSN Pharmaceuticals asked the Federal Circuit on Friday to lift a temporary injunction and allow the company to launch a generic version of the blockbuster heart drug Entresto, a move MSN says would benefit the public by reducing costs for Medicare and Medicaid.
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July 18, 2025
Fed. Circ. Frees Medtronic From $125M Patent Judgment
The Federal Circuit on Friday overturned a more than $125 million judgment against Medtronic's CoreValve unit for infringing a Colibri Heart Valve LLC patent, saying changes made to the patent during examination mean that Medtronic should not have been found to infringe.
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July 18, 2025
Off The Bench: Latest NASCAR Win, Trans Athlete Fights Ban
In this week's Off The Bench, Michael Jordan's racing team fails to bounce back right away from a tough defeat in its battle with NASCAR, a transgender woman fights a last-minute expulsion from a college women's track and field event, and a football player sees his window to playing an extra college season slammed shut by the NCAA and the Seventh Circuit.
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July 18, 2025
Trump Flexes Air Law Power To Delay Compliance Deadlines
President Donald Trump has postponed deadlines to comply with air pollution standards for companies in the coal power, chemical manufacturing, medical sterilization and iron ore industries, relying on special presidential power contained in the Clean Air Act.
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July 18, 2025
Supply Co. Looks To Spur New Judge Amid NC Staff Shortage
A medical supply procurement company on Friday sought to hasten the assignment of a new judge to its contract suit against a pharmaceutical middleman after the previous judge retired, acknowledging there are staffing issues in the Western District of North Carolina but saying the "serious case" needs attention to stay on track.
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July 18, 2025
Taxation With Representation: Wachtell, Slaughter And May
In this week's Taxation With Representation, Blackstone pours billions into data centers and related infrastructure, Waters Corp. and Becton Dickinson look to form a new life sciences powerhouse, Reckitt sells 70% of its Essential Home business to private equity firm Advent, and Chevron completes its acquisition of Hess following a favorable arbitral award.
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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.
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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.
Expert Analysis
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Opinion
Subject Matter Eligibility Test Should Return To Preemption
Subject matter eligibility has posed challenges for patentees due to courts' arbitrary and confusing reasoning, but adopting a two-part preemption test could align the applicant, the U.S. Patent and Trademark Office and the courts, says Manav Das at McDonnell Boehnen.
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8 Ways Lawyers Can Protect The Rule Of Law In Their Work
Whether they are concerned with judicial independence, regulatory predictability or client confidence, lawyers can take specific meaningful actions on their own when traditional structures are too slow or too compromised to respond, says Angeli Patel at the Berkeley Center of Law and Business.
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Is SEC Moving Away From Parallel Insider Trading Cases?
The U.S. Securities and Exchange Commission's apparent lack of follow-up in four recent criminal cases of insider trading brought by the Justice Department suggests the SEC may be reconsidering the expense and effort of bringing parallel civil charges for insider trading, say attorneys at Dentons.
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Rising Enforcement Stakes For Pharma Telehealth Platforms
Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.
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Series
Law School's Missed Lessons: Communicating With Clients
Law school curricula often overlook client communication procedures, and those who actively teach this crucial facet of the practice can create exceptional client satisfaction and success, says Patrick Hanson at Wiggam Law.
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3 Judicial Approaches To Applying Loper Bright, 1 Year Later
In the year since the U.S. Supreme Court overturned Chevron deference in its Loper Bright Enterprises v. Raimondo decision, a few patterns have emerged in lower courts’ application of the precedent to determine whether agency actions are lawful, say attorneys at Husch Blackwell.
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Prepping For SEC's Changing Life Sciences Enforcement
By proactively addressing several risk areas, companies in the life sciences sector can position themselves to minimize potential exposure under the U.S. Securities and Exchange Commission's return to back-to-basics enforcement focused on insider trading and fraud, say attorneys at Morgan Lewis.
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Series
Adapting To Private Practice: From US Rep. To Boutique Firm
My transition from serving as a member of Congress to becoming a partner at a boutique firm has been remarkably smooth, in part because I never stopped exercising my legal muscles, maintained relationships with my former colleagues and set the right tone at the outset, says Mondaire Jones at Friedman Kaplan.
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How Providers Can Brace For Drug Pricing Policy Changes
Though it's uncertain which provisions of the Trump administration's executive order aimed at addressing prescription drug costs will eventually be implemented, stakeholders can reduce potential negative outcomes by understanding pathways that could be used to effectuate the order's directives, say attorneys at McDermott.
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Discretionary Denial Rulings May Spur Calls For PTAB Reform
The U.S. Patent and Trademark Office's recent decision in iRhythm Technologies v. Welch Allyn, denying inter partes review based on the patent owner's settled expectations that the patent would not be challenged, could motivate patent holders to seek Patent Trial and Appeal Board reform to preserve patent quality without burdening owners, say attorneys at Dechert.
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Comparing New Neural Data Privacy Laws In 4 States
Although no federal law yet addresses neural privacy comprehensively, the combined effect of recent state laws in Colorado, California, Montana and Connecticut is already shaping the regulatory future, but a multistate compliance strategy has quickly become a gating item for those experimenting with neuro-enabled workplace tools, says Kristen Mathews at Cooley.
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Spinoff Transaction Considerations For Biotech M&A
Amid current market challenges, boards and management teams of biotech companies can consider several strategies for maximizing value should a spinoff opportunity arise, but not without significant advance planning and careful implementation, particularly in cases that might qualify as tax-free, say attorneys at Paul Hastings.
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Opinion
Senate's 41% Litigation Finance Tax Would Hurt Legal System
The Senate’s latest version of the Big Beautiful Bill Act would impose a 41% tax on the litigation finance industry, but the tax is totally disconnected from the concerns it purports to address, and it would set the country back to a time when small plaintiffs had little recourse against big defendants, says Anthony Sebok at Cardozo School of Law.
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Psychedelic Treatment Regs May Be At A Tipping Point
Recent scientific and public attention suggest that development of psychedelics as treatment for some conditions may be at a tipping point, which could bring on more rapid change and opportunities for stakeholders who may in the future benefit from greater access to safe and effective psychedelic medicines, say attorneys at King & Spalding.
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Tips For Litigating Apex Doctrine Disputes Amid Controversy
Litigants once took for granted that deposition requests of high-ranking corporate officers required a greater showing of need than for lower-level witnesses, but the apex doctrine has proven controversial in recent years, and fights over such depositions will be won by creative lawyers adapting their arguments to this particular moment, say attorneys at Hangley Aronchick.