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Life Sciences
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July 18, 2025
Investor Sues Biotech Capricor After Product's FDA Denial
Biotechnology company Capricor Therapeutics Inc. faces a proposed investor class action alleging it misrepresented its lead product candidate's approval prospects before the U.S. Food and Drug Administration.
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July 18, 2025
Judge Advised Against State AG Intervention In Sandoz Deal
A special master on Friday advised a Pennsylvania federal court to deny a bid by California and other state attorneys general to intervene in a $275 million settlement resolving generic-drug price-fixing claims against Sandoz, finding they lacked standing to represent the interests of consumers.
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July 18, 2025
Stewart Issues Discretion Decisions For 56 More Petitions
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart issued 25 more orders on requests for discretionary denial, deciding a total of 56 cases, while the results of earlier proceedings she let move forward have started to roll out.
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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.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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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 to 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.