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Life Sciences
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November 10, 2025
Novartis Argues For High Court To Skip Entresto Patent Case
Novartis Pharmaceuticals Corp. is urging the U.S. Supreme Court to skip MSN Pharmaceuticals Inc.'s request for review of a Federal Circuit decision that barred MSN's generic version of Novartis' blockbuster cardiovascular drug Entresto, asserting there is no conflict in the circuit for the justices to look at.
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November 10, 2025
FDA Lifts Hormone Replacement 'Black Box' Warnings
The U.S. Food and Drug Administration on Monday said it was removing the "black box" warnings from hormone replacement therapy treatments for menopause for the risks of cardiovascular disease, breast cancer and probable dementia.
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November 10, 2025
FTC Risks Help Push Metsera Back To Pfizer
Novo Nordisk AS' aspirations to pry Metsera away from Pfizer Inc. collapsed over the weekend under the pressure of a revised Pfizer offer, twin court challenges and "a call from the U.S. Federal Trade Commission."
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November 10, 2025
Chancery Drops Claims In Murder-Linked Bio Co. Merger Fight
The Delaware Chancery Court dismissed a biotech company's claims against the husband and investment vehicle of convicted fraudster Serhat Gumrukcu, whose murder-for-hire plot allegedly helped conceal past misconduct ahead of a 2018 merger.
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November 10, 2025
Catching Up With Delaware's Chancery Court
Delaware's top court issued a flurry of rulings last week and heard arguments on recently passed legislation that expanded liability shields for some corporate acts while the Court of Chancery passed on another round of arguments over control of Caribbean broadcaster Caribevision.
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November 07, 2025
4th Circ. Opioid Case Brings Public Nuisance Back To The Fore
The Fourth Circuit's ruling that upturned a lower court win for drug distributors in a battle with the West Virginia county at the epicenter of the opioid epidemic was a blast from the past from the fever pitch of courtroom battles over the national crisis just a few years ago.
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November 07, 2025
States Say Macquarie Not Applicable To NH High Court Case
State securities regulators are urging New Hampshire's Supreme Court to uphold a fine against a medical device company whose leader was alleged to have misled investors about his prior legal issues, arguing that the case bears no resemblance to one ruled on by the U.S. Supreme Court last year.
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November 07, 2025
Sleep Apnea Device Co. Investor Says Rollout Was Botched
Medical device company Inspire Medical Systems has been hit with a proposed investor class action alleging its shares dropped by nearly a third of their value after the public learned it concealed low demand and rollout shortcomings associated with its newest sleep apnea device.
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November 07, 2025
Spurned Pfizer Turns To Antitrust Law To Reclaim Biotech
What may be a first-of-its-kind lawsuit is playing out as Pfizer Inc. turns to antitrust law to keep Novo Nordisk from usurping its bid for Metsera.
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November 07, 2025
Canadian Co. Blocked From Using 'Deep Cleansing Oil' Brand
A Pennsylvania federal judge has permanently blocked a Canadian skincare company from infringing a competitor's trademark for "Deep Cleansing Oil," after it failed to respond to the case.
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November 07, 2025
Seattle Pot Shop Slapped With Site Tracking Pixel Privacy Suit
A Seattle cannabis dispensary has been hit with a proposed class action in Washington federal court by a customer who claims the retailer shared his private information about medical marijuana appointments and pot purchases with Google and other third parties by using online browser tracking tools on its website.
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November 07, 2025
USPTO Extends Deadline For PTAB Institution Rules Feedback
The U.S. Patent and Trademark Office has provided a 15-day extension for giving feedback on proposed rules that will likely reduce the institution of certain patent challenges at the Patent Trial and Appeal Board, with Director John Squires saying "now's the time" to finalize rulemaking on discretionary denial issues.
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November 07, 2025
Jury Clears Novo Nordisk Of Medicaid Fraud Over Blood Drug
A Tacoma federal jury cleared Novo Nordisk on Friday of allegations that it defrauded Washington state's Medicaid and Medicare systems by paying kickbacks and promoting off-label use to illegally boost prescriptions of its hemophilia drug NovoSeven.
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November 07, 2025
Fla. Judge Sentences HIV Drug Fraudster To 8 Years In Prison
A Florida federal judge on Friday sentenced a man to more than eight years in prison after he pled guilty to a wire fraud-related charge in connection to a roughly $100 million HIV medication fraud scheme, referencing the harm that called into question the nation's pharmaceutical drug supply.
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November 07, 2025
Merck Wins PTAB Fight Over Blockbuster Drug, Again
Another cancer treatment patent owned by Johns Hopkins University and challenged by a Merck & Co. Inc. subsidiary didn't pass muster with the Patent Trial and Appeal Board, which on Thursday invalidated seven claims in the patent that's at issue in a disagreement between the parties.
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November 07, 2025
Taxation With Representation: Kirkland, Cravath, Paul Weiss
In this week's Taxation With Representation, consumer products giant Kimberly-Clark acquires Tylenol maker Kenvue, shale producers SM Energy and Civitas Resources announce a merger, and power management company Eaton buys Boyd Corp.'s thermal business.
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November 07, 2025
Laborie Buys Postpartum Bleeding Device For Up To $465M
Medical technology company Laborie Medical Technologies, advised by Simpson Thacher & Bartlett LLP and Cooley LLP, unveiled plans Friday to acquire a postpartum uterine bleeding device from New Jersey-based healthcare company Organon for up to $465 million.
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November 06, 2025
Pair Of Health-Focused Startups Net $423M In Combined IPOs
Two startups, spanning the diagnostics and biotechnology sectors, began trading on Thursday after raising a combined $423 million in initial public offerings, guided by three law firms, as more companies continue going public despite a historic government shutdown that has reduced staffing at the U.S. Securities and Exchange Commission.
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November 06, 2025
'Send A Message' To Novo Nordisk Over Kickbacks, Jury Told
Counsel for a whistleblower claiming Novo Nordisk paid illegal kickbacks to boost off-label prescribing of its hemophilia drug NovoSeven urged jurors during closing arguments Thursday to "send a message" to the drugmaker, saying it defrauded Washington state's Medicaid and Medicare systems out of nearly $100 million.
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November 06, 2025
CareFirst Urges Ban On J&J Character Talk At Stelara Trial
Health insurer CareFirst is asking a Virginia federal judge to bar Johnson & Johnson from promoting its "good character" to a jury that will weigh class claims of anticompetitive conduct and patent fraud to extend market protection on the blockbuster autoimmune drug Stelara.
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November 06, 2025
Lilly, Novo Nordisk Enter Obesity Drug Price Deal With Trump
Pharmaceutical giants Eli Lilly and Novo Nordisk cut a deal with the Trump administration to slash the pricing of their popular weight loss drugs in the U.S., becoming the latest to enter "most-favored-nation" pricing agreements, the White House announced Thursday.
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November 06, 2025
Texas AG Wants To Halt Kenvue $400M Shareholder Pay
Texas wants to block Johnson & Johnson consumer health spinoff Kenvue from paying $400 million to shareholders, calling it a "fraudulent transfer" amid the company, which makes Tylenol, facing "tens or hundreds of billions of dollars in liabilities" in the state's suit alleging the company hid the risk that acetaminophen could lead to autism.
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November 06, 2025
Fla. AG Says Planned Parenthood Lied About Abortion Drugs
The Florida Attorney General sued Planned Parenthood on Thursday, alleging the reproductive healthcare nonprofit misrepresented the safety of abortion drugs to women in a mass marketing campaign.
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November 06, 2025
FDA Warns Companies About Illegal Marketing Of Botox
The U.S. Food and Drug Administration has ordered the companies behind 18 websites to stop selling all Botox injectables to consumers that they have marketed as being able to treat chronic migraine, sweaty palms, overactive bladder and blepharospasm, or spasms that force one's eyelids closed.
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November 06, 2025
Squires Rebuffs Another 21 PTAB Petitions Without Comment
U.S. Patent and Trademark Office Director John Squires issued a one-page order Thursday rejecting 21 patent challenges from companies including Microsoft, Apple and Google, continuing his new practice of summarily denying such petitions with no explanation.
Expert Analysis
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Between The Lines Of EPO's Adoption Of Color Drawings
The European Patent Office's decision to accept patent drawings in color starting in October may enhance clarity in technical disclosures and streamline the examination process, and could also enable new patent filing strategies for international applicants, say attorneys at Miller Canfield.
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What Prop 65 Ruling Means For Cosmetics, Personal Care Biz
A California federal court's recent decision on Proposition 65 warnings is good news for companies in the cosmetics and personal care space, as it will relieve businesses of the need to apply such warnings to products containing titanium dioxide and likely stop a wave of pending failure-to-warn litigation, say attorneys at Morgan Lewis.
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Series
Adapting To Private Practice: From Va. AUSA To Mid-Law
Returning to the firm where I began my career after seven years as an assistant U.S. attorney in Virginia has been complex, nuanced and rewarding, and I’ve learned that the pursuit of justice remains the constant, even as the mindset and client change, says Kristin Johnson at Woods Rogers.
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2 Fed. Circ. Rulings Underscore Patent Prosecution Pitfalls
Two recent patent decisions from the Federal Circuit, overturning significant judgments, serve as reminders that claim modifications and cancellations may have substantive effects on the scope of other claims, and that arguments distinguishing prior art and characterizing claims may also limit claim scope, say attorneys at Morgan Lewis.
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Rebutting Price Impact In Securities Class Actions
Defendants litigating securities cases historically faced long odds in defeating class certification, but that paradigm has recently begun to shift, with recent cases ushering in a more searching analysis of price impact and changing the evidence courts can consider at the class certification stage, say attorneys at Katten.
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7 Document Review Concepts New Attorneys Need To Know
For new associates joining firms this fall, stepping into the world of e-discovery can feel like learning a new language, but understanding a handful of fundamentals — from coding layouts to metadata — can help attorneys become fluent in document review, says Ann Motl at Bowman and Brooke.
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Ruling On Labor Peace Law Marks Shift For Cannabis Cos.
Currently on appeal to the Ninth Circuit, an Oregon federal court’s novel decision in Casala v. Kotek, invalidating a state law that requires labor peace agreements as a condition of cannabis business licensure, marks the potential for compliance uncertainty for all cannabis employers in states with labor peace mandates, say attorneys at Sheppard Mullin.
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Fed. Circ. Rulings Refine Patent Claim Construction Standards
Four Federal Circuit patent decisions this year clarify several crucial principles governing patent claim construction, including the importance of prosecution history, and the need for error-free, precise language from claims drafters, say attorneys at Taft.
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How Value-Based Patent Fees May Shape IP Strategies
If the U.S. Patent and Trademark Office implements rumored plans to correlate patent fees with patent value, the financial and strategic consequences would largely depend on the specifics of how, when and how often patent values are assessed, say attorneys at Cleary.
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Agentic AI Puts A New Twist On Attorney Ethics Obligations
As lawyers increasingly use autonomous artificial intelligence agents, disciplinary authorities must decide whether attorney responsibility for an AI-caused legal ethics violation is personal or supervisory, and firms must enact strong policies regarding agentic AI use and supervision, says Grace Wynn at HWG.
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Using Reissue Applications To Strategically Improve Patents
Though reissue applications are an often-overlooked consideration in today's patent environment, they can offer powerful tools for correcting errors, strengthening patent protection, or adapting to evolving business and legal landscapes, says Curtis Powell at Wolf Greenfield.
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FDA Transparency Plans Raise Investor Disclosure Red Flags
The U.S. Food and Drug Administration’s recently announced intent to publish complete response letters for unapproved drugs and devices implicates certain investor disclosure requirements under securities laws, making it necessary for life sciences and biotech companies to adopt robust controls going forward, say attorneys at Arnold & Porter.
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Series
Being A Professional Wrestler Makes Me A Better Lawyer
Pursuing my childhood dream of being a professional wrestler has taught me important legal career lessons about communication, adaptability, oral advocacy and professionalism, says Christopher Freiberg at Midwest Disability.
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Patent Claim Lessons From Fed. Circ.'s Teva Decision
The Federal Circuit's recent decision in Janssen v. Teva is an important precedent for parties drafting patent claims or litigating obviousness where the prior art has potentially overlapping ranges for a claimed element, and may be particularly instructive to patent applicants in the pharmaceutical field, say attorneys at Cooley.
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Series
Law School's Missed Lessons: Adapting To The Age Of AI
Though law school may not have specifically taught us how to use generative artificial intelligence to help with our daily legal tasks, it did provide us the mental building blocks necessary for adapting to this new technology — and the judgment to discern what shouldn’t be automated, says Pamela Dorian at Cozen O'Connor.