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Life Sciences
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October 30, 2025
Fed. Circ. Explains Rule While Upholding Merck PTAB Loss
The Federal Circuit sided with generics makers Thursday and upheld the Patent Trial and Appeal Board's invalidation of claims in two Merck KGaA patents on the blockbuster multiple sclerosis drug Mavenclad, while clarifying how to treat invalidity arguments that involve overlapping inventors.
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October 30, 2025
2nd Ex-Magellan Exec Avoids Jail Over Faulty Lead Tests
A second former Magellan Diagnostics executive ducked prison time Thursday for his role in an alleged scheme to hide a defect in the company's lead-testing devices ahead of its sale in 2016.
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October 30, 2025
Lawmakers Slam Value-Based Patent Fee Proposal
Six members of the U.S. House of Representatives wrote to U.S. Secretary of Commerce Howard Lutnick on Thursday expressing concern over the proposal to charge patent holders fees based on their patent's value, saying that will harm innovation and economic growth.
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October 30, 2025
J&J's Janssen Says 3rd Circ. Should Reverse $1.6B FCA Win
Johnson & Johnson's Janssen Products LP urged the Third Circuit to overturn a $1.6 billion False Claims Act judgment over two of its HIV drugs, arguing the district court allowed whistleblowers to prove fraud based solely on "off-label" marketing rather than any false claim actually submitted to the government.
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October 30, 2025
Generic-Drug Firms Want To Fast-Track Conn. Price Cap Fight
An industry group for generic and biosimilar pharmaceutical companies has asked a Connecticut federal judge to fast-track its lawsuit seeking to block the state's new drug price cap, claiming it will suffer "imminent harm" if the case is delayed.
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October 30, 2025
McCarter & English Used Doctrine As 'Whipsaw,' Panel Hears
A biotech company on Thursday urged a New Jersey appellate panel to revive its legal malpractice suit against McCarter & English LLP, arguing that the claims were distinct from the firm's own suit seeking unpaid fees.
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October 30, 2025
Mich. Top Court Upholds Gilead Immunity In COVID Drug Case
The Michigan Supreme Court on Wednesday said it won't consider an appeal from a man who was injected with a COVID-19 treatment made by Gilead Sciences Inc. that was later recalled for containing glass shards, a few months after a lower appellate court found the company immune because of a federal health emergency law.
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October 30, 2025
Judge Unpauses 'Important' Suit Over Vax Guidelines
A Massachusetts federal judge agreed Thursday to lift a government shutdown-related stay of litigation challenging new COVID-19 vaccine recommendations for children and pregnant women, calling the case a "matter of national importance" that warrants keeping the case moving over the U.S. Department of Justice's objection.
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October 30, 2025
Novo Nordisk Bids $9B For Metsera, Jeopardizing Pfizer Deal
Metsera Inc. said Thursday that Novo Nordisk has put forth a $9 billion buyout proposal that is "superior" to its existing agreement to sell itself to Pfizer, prompting a response from Pfizer stating that it is prepared to "pursue all legal avenues" to keep its agreement intact.
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October 29, 2025
DOJ Subpoena Called 'Pressure' To Ax Gender-Affirming Care
The U.S. Department of Justice issued a subpoena to intimidate a telehealth organization into ending gender-affirming medical care, a Seattle federal judge said in a ruling that found the agency is using the guise of an investigation to further the Trump administration's stated goal of eliminating transgender and gender-diverse patients' access to healthcare.
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October 29, 2025
DexCom Misled Investors About Its Diabetes Tech, Suit Says
Medical device maker DexCom is facing a proposed investor class action in Manhattan federal court alleging the company hurt shareholders by failing to disclose changes to a glucose monitoring device affecting the reliability of the device's readings.
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October 29, 2025
Conn. Med Spa Says Ex-Workers Poaching Clients, Employees
Two former employees of a Connecticut medical spa violated their employment contract when they lured a co-worker to join them at a nearby competitor and began soliciting the spa's clients, a state court lawsuit alleges.
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October 29, 2025
Where PTAB Institution Reviews Stand As Squires Takes Lead
U.S. Patent and Trademark Office Director John Squires will be maintaining the agency leader's new role of gatekeeper at the Patent Trial and Appeal Board. Here's what to know about his plans and the pushback on them.
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October 29, 2025
Taro Pharma Beats Investor Suit Over $43-Per-Share Buyout
A New York federal judge tossed a proposed class action brought by minority shareholders of Taro Pharmaceutical Industries Ltd. that alleged the company and its majority shareholder misled them during the approval process for a $43-per-share buyout, finding the minority shareholders have failed to plead any actionable misstatements or omissions.
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October 29, 2025
Ga. Panel Backs Sanctions For 'Delaying Tactic' In Pot Dispute
The Georgia Court of Appeals on Wednesday backed sanctions rulings against two companies that filed litigation after they were denied cannabis licenses by Georgia, only to draw out the proceedings for years before dropping their claims at "quite literally the last minute."
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October 29, 2025
FDA Unveils Plan To Speed Biosimilar Drugs To Market
The Trump administration on Wednesday said it plans to slash the cost of biologics by shortening the time required to bring a biosimilar drug to market and making it easier for patients to switch to the cheaper products.
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October 29, 2025
3 Pharmaceutical Firms Will Pay $4M To Tribes In Opioid MDL
Indivior, Sun Pharmaceuticals and Zydus Pharmaceuticals have inked deals to compensate tribes for their role in the opioid crisis, according to stipulated dismissals entered on Wednesday in Ohio federal court.
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October 29, 2025
Brothers Found Guilty Of $100M HIV Drug Fraud
A Florida federal jury on Wednesday convicted two Maryland brothers accused of conspiring to distribute about $100 million worth of misbranded HIV drugs, finding them guilty of fraud charges related to selling the medication with fake tracing documents.
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October 29, 2025
PE-Backed Medical Supplies Giant Medline Files For IPO
Private equity-backed medical supplies giant Medline has filed for its long-awaited initial public offering, eyeing a return to public markets four years after being taken private through a large buyout.
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October 29, 2025
'Smart Drugs' Amphetamine Suit Moves Forward Minus Execs
A Washington federal judge declined to trim claims from a former army nurse's suit alleging that Thesis "smart drugs" contained amphetamines without warning consumers, while dismissing her claims against two executives for the company.
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October 29, 2025
3 Firms Guide Thermo Fisher On $8.9B Clario Deal
Thermo Fisher Scientific Inc. said on Wednesday it will acquire Clario Holdings Inc., a provider of endpoint data solutions for clinical trials, from a shareholder group led by Astorg, Nordic Capital, Novo Holdings and Cinven for $8.875 billion in cash.
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October 28, 2025
Off-Label Prescribing Was Common, Novo Nordisk Tells Jury
A whistleblower suing drugmaker Novo Nordisk for allegedly defrauding Washington state's Medicaid system acknowledged from the witness stand Tuesday that she previously prescribed hemophilia drugs for off-label use in her own practice — despite concerns she raised in her lawsuit about other doctors' off-label prescription of Novo Nordisk's drug NovoSeven.
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October 28, 2025
Apple Spared From Some Masimo Patent Claims Before Trial
A California federal judge issued a mixed ruling in Masimo's case claiming Apple infringed its patents covering pulse oximetry technology for smartwatches, dismissing certain infringement theories but preserving other parts of the case for next week's trial.
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October 28, 2025
Perceptive Asks Chancery To Block Kindbody Ex-CEO's NY Suit
Attorneys for senior lenders to nationwide fertility clinic chain Kindbody Inc. told a Delaware vice chancellor Tuesday that amendments to a former CEO's suit against the company's controlling lenders and directors in New York triggered a right to pull the dispute into Delaware's Court of Chancery.
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October 28, 2025
Trump Admin Ordered To Halt Some Shutdown-Linked Layoffs
A California federal judge on Tuesday granted a preliminary injunction to eight unions for federal workers who lost their jobs during the government shutdown, saying they were likely to succeed on their claims that the Trump administration's actions were "political retribution" and unlawful.
Expert Analysis
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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.
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Series
Performing As A Clown Makes Me A Better Lawyer
To say that being a clown in the Macy’s Thanksgiving Day Parade has changed my legal career would truly be an understatement — by creating an opening to converse on a unique topic, it has allowed me to connect with clients, counsel and even judges on a deeper level, says Charles Tatelbaum at Tripp Scott.
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A Midyear Tuneup For Your Trade Secret Portfolio
Halfway through 2025, now is a good time for companies to thoroughly evaluate their trade secret portfolios and follow eight steps to reassess protection processes for confidential information, says Robert Jensen at Wolf Greenfield.
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Focusing On Fluoride: From FDA To Class Action
A class action filed two days after the U.S. Food and Drug Administration announced plans to remove ingestible fluoride prescription drug products for children from the market may be the tip of the iceberg in terms of the connection between government pronouncements on safety and their immediate use as evidence in lawsuits, says Rachel Turow at Skadden.