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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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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.
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Ch. 11 Ruling Voiding $2M Litigation Funding Sends A Warning
A recent Texas bankruptcy court decision that a postconfirmation litigation trust has no obligations to repay a completely drawn down $2 million litigation funding agreement serves as a warning for estate administrators and funders to properly disclose the intended financing, say attorneys at Kleinberg Kaplan.
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DOJ's Novel Cybersecurity FCA Case Is A Warning To Medtech
The U.S. Department of Justice's recent False Claims Act settlement with Illumina over alleged cybersecurity deficiencies suggests that enforcement agencies and whistleblowers are focusing attention toward cybersecurity in life sciences and medical tech, but also reveals key unanswered questions about the legal viability of such allegations, say attorneys at Morgan Lewis.
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Future-Proof Patent Law By Starting Talent Pipelines Early
Law firms struggling with a narrow talent pipeline in the intellectual property space should consider beginning their recruitment strategies for potential candidates as early as high school, and raise awareness for career opportunities that do not require a law degree, says Christine Hollis at Marshall Gerstein.
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Demystifying The Civil Procedure Rules Amendment Process
Every year, an advisory committee receives dozens of proposals to amend the Federal Rules of Civil Procedure, most of which are never adopted — but a few pointers can help maximize the likelihood that an amendment will be adopted, says Josh Gardner at DLA Piper.
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How USPTO Examiner Memo Informs Software Patent Drafting
A memorandum recently released by the U.S. Patent and Trademark Office provides useful clues as to how the USPTO and examining corps will evaluate claims in software-implemented inventions for subject matter eligibility going forward, says Michael Lew at Squire Patton.
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How 2nd Circ. Cannabis Ruling Upends NY Licensing
A recent Second Circuit decision in Variscite NY Four v. New York, holding that New York's extra-priority cannabis licensing preference for applicants with in-state marijuana convictions violates the dormant commerce clause, underscores that state-legal cannabis markets remain subject to the same constitutional constraints as other economic markets, say attorneys at Harris Beach.
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Parenting Skills That Can Help Lawyers Thrive Professionally
As kids head back to school, the time is ripe for lawyers who are parents to consider how they can incorporate their parenting skills to build a deep, meaningful and sustainable legal practice, say attorneys at Alston & Bird.
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Enablement Standard Insights From Fed. Circ. Agilent Ruling
The Federal Circuit's recent enablement standard decision in Agilent v. Synthego underscores three critical takeaways for patent practitioners, including reaffirmation that the enablement inquiry under Section 102 of the Patent Act is distinct from the inquiry under Section 112, say attorneys at MoFo.