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Life Sciences
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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.
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October 28, 2025
Bias Claims From Worker Who Failed Drug Test Can Proceed
A Pennsylvania federal judge narrowed, but didn't throw out, a disability bias suit from a hospital worker who said he was fired after failing a drug test because he took cannabidiol gummies for a spinal condition, saying a reasonable jury might conclude his disability earned him harsher treatment.
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October 28, 2025
Activists Drop Challenge To FDA Inaction On Menthol Cigs
A lawsuit accusing the U.S. Food and Drug Administration of slow-walking the Biden administration's proposed ban of menthol cigarettes was voluntarily dismissed, months after the Trump administration withdrew the ban entirely.
Expert Analysis
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The State Of AI Adoption In The Patent Field
The use of generative artificial intelligence in patent-related practices has lagged behind early predictions, which may be explained by a number of core concerns that organizations must address before seriously considering adoption, say attorney Michael Drapkin and leadership coach Michael Colacchio.
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Purdue Case Could Transform Patent Obviousness Analyses
If accepted for review by the U.S. Supreme Court, Purdue Pharma v. Accord Healthcare — concerning whether Purdue's abuse-deterrent opioid formulation patents were invalid as obvious — could significantly shift how courts weigh secondary considerations in patent obviousness analyses, say attorneys at Lathrop.
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Federal Regs Order May Spell Harsher FDCA Enforcement
A recent executive order aimed at reducing criminal prosecutions of those who unknowingly violate complex federal regulations may actually lead to more aggressive felony indictments under the Federal Food, Drug and Cosmetic Act, but companies and executives can mitigate risks by following several key principals, say attorneys at McGuireWoods.
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Series
Law School's Missed Lessons: Practicing Self-Care
Law schools don’t teach the mental, physical and emotional health maintenance tools necessary to deal with the profession's many demands, but practicing self-care is an important key to success that can help to improve focus, manage stress and reduce burnout, says Rachel Leonard at MG+M.
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ABA Opinion Makes It A Bit Easier To Drop A 'Hot Potato'
The American Bar Association's recent ethics opinion clarifies when attorneys may terminate clients without good cause, though courts may still disqualify a lawyer who drops a client like a hot potato, so sending a closeout letter is always a best practice, say attorneys at Thompson Hine.
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IRhythm IPR Denial Raises Key PTAB Discretion Questions
By giving the passage of time a dispositive role in denying institution of five inter partes review petitions filed by iRhythm Technologies, the U.S. Patent and Trademark Office has upended the strategic considerations for filing and defending against IPRs, disclosing prior art during prosecution, and engaging in licensing negotiations, say attorneys at Dentons.
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Canadian Suit Offers Disclosure Lesson For US Cannabis Cos.
A Canadian class action asserting that Aurora Cannabis failed to warn consumers about the risk of developing cannabinoid hyperemesis syndrome may spawn copycat filings in the U.S., and is a cautionary tale for cannabis and hemp industries to prioritize risk disclosure, says Ian Stewart at Wilson Elser.
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Opinion
IPR Denial In IRhythm Should Not Set A Blanket Rule
Though the Patent Trial and Appeal Board's discretionary denial in iRhythm v. Welch Allyn last month raised concerns that mere knowledge of a patent could bar inter partes review institution, a closer look at the facts and reasoning reveals why this case's holdings should not be reflexively applied to all petitioners, says David McCombs at Haynes Boone.
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What High Court's Tenn. Trans Care Ruling Means Nationally
The U.S. Supreme Court's decision in U.S. v. Skrmetti, upholding a Tennessee ban on gender-affirming medical care for minors, is fairly limited in scope and closely tailored to the specific language of Tennessee's law, but it may have implications for challenges to similar laws in other states, say attorneys at Hall Render.
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How Trump's Trade Policies Are Shaping Foreign Investment
Five months into the Trump administration, investors are beginning to see the concrete effects of the president’s America First Investment Policy as it presents new opportunities for clearing transactions more quickly, while sustaining risk aversion related to Chinese trade and potentially creating different political risks, say attorneys at Covington.
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Series
My Opera And Baseball Careers Make Me A Better Lawyer
Though participating in opera and the world of professional baseball often pulls me away from the office, my avocations improve my legal career by helping me perform under scrutiny, prioritize team success, and maintain joy and perspective at work, says Adam Unger at Herrick Feinstein.
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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.