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Life Sciences
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June 06, 2025
Genentech Wants $18M Novartis Award Over Licenses OK'd
California-based biotech firm Genentech Inc. has asked a D.C. federal court to recognize a $17.8 million arbitral award against Novartis Pharma AG stemming from a dispute over a licensing agreement for an eye medication.
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June 06, 2025
Fed. Circ. Weighs Purview Over Acorda's $17M Arbitral Award
A Federal Circuit panel on Friday wrestled with its authority to consider arbitration appeals dealing with patent law, with at least one judge appearing skeptical that it could consider Acorda Therapeutics Inc.'s bid to increase a $16.6 million award in a fight with Alkermes PLC over a multiple sclerosis drug.
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June 06, 2025
CVS Health Can't Dodge Blame In Omnicare False Claims Suit
A New York federal judge rebuffed an attempt from CVS Health Corp. to evade responsibility in a False Claims Act case, after a jury found that its subsidiary Omnicare bilked the federal government out of over $135 million in fraudulent drug claims.
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June 06, 2025
Stewart Says PTAB Should 'Never' Cancel IP As A Sanction
The acting director of the U.S. Patent and Trademark Office revived Longhorn Vaccines & Diagnostics LLC patent claims on Thursday that her predecessor had invalidated to punish Longhorn for misconduct.
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June 06, 2025
Exelixis Escapes Cancer Drug Invalidity Bid At PTAB
Exelixis has beaten back a challenge to one of its patents covering the blockbuster drug Cabometyx after the Patent Trial and Appeal Board denied Azurity Pharmaceuticals' request to review the patent.
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June 06, 2025
Honeywell Says 'Patent Troll' Trying To Extort Settlement
Honeywell is taking aim at a Canadian company that has allegedly pursued nearly 200 infringement lawsuits against various businesses based on the same five patents, saying in a federal complaint that the company is trying to scheme its way into a settlement.
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June 06, 2025
Greenberg Traurig Adds Perkins Coie Tech Transactions Pro
Greenberg Traurig LLP is expanding its technology team, bringing in a Perkins Coie LLP transactions whiz as a shareholder in its San Diego office.
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June 06, 2025
Mayer Brown Adds Partner To NY Corporate, Securities Team
Aideen Brennan, a former mergers and acquisitions and private equity senior managing associate at Sidley Austin, has joined Mayer Brown's global corporate and securities practice as a partner in New York.
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June 05, 2025
Red States Double Down On Bid To Stymie Trans Health Rule
More than a dozen Republican attorneys general challenging a Biden-era rule that protected gender-affirming care under the Affordable Care Act said the U.S. Department of Health and Human Services can't keep the rule on the books just because the new administration is unlikely to enforce it.
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June 05, 2025
Latham-Led Virtual Health Startup Omada Prices $150M IPO
Venture-backed virtual care provider Omada Health Inc. on Thursday priced a $150 million initial public offering within its marketed range, represented by Latham & Watkins LLP and underwriters counsel Davis Polk & Wardwell LLP.
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June 05, 2025
Elon Musk Seeks $5B For AI Startup, Amid Other Reports
Elon Musk is planning a $5 billion debt sale for his AI startup, Ontario’s pension seeks final bids for an Indian hospital system, and Merck eyes a Swiss biotech with a potential $3 billion price tag. Here's a rundown of these and other notable deal rumors from the last week.
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June 05, 2025
Sens. Float Automatic Biosimilar Interchangeable Label
A bipartisan group of U.S. senators has reintroduced legislation that would reduce what the lawmakers called barriers to accessing lower-cost versions of biologic drugs, making an adjustment to how biosimilars are deemed interchangeable with their name-brand equivalents.
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June 05, 2025
4 AGs Urge FDA To Lift Abortion Pill Restrictions
Attorneys general from California, Massachusetts, New York and New Jersey on Thursday urged the U.S. Food and Drug Administration to lift restrictions on the abortion drug mifepristone, saying they aren't necessary under statutory requirements for an FDA drug safety program.
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June 05, 2025
3rd Circ. Says Amgen Can Proceed With Subpoena In IP Suit
The Third Circuit on Thursday sided with biotechnology company Amgen Inc. in its efforts to subpoena a competitor that it accused of patent infringement, reasoning that the panel lacked jurisdiction to hear the case because the lower court's decision regarding discovery was not ripe for appeal.
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June 05, 2025
Ex-Bush Admin Atty To Lead HHS Civil Rights Office
The U.S. Department of Health and Human Services has appointed an attorney to lead its civil rights office who brings more than 30 years of experience across the public sector and private practice, including as counsel for HHS during the George W. Bush administration.
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June 05, 2025
High Court Drops Class Cert. Clarification Bid
The U.S. Supreme Court declined Thursday to weigh in on whether federal courts can certify classes that include uninjured members, holding it improperly agreed to hear a disability discrimination case against diagnostics company Labcorp that raised the important question.
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June 04, 2025
Calif. Won't Get Insulin Pricing Case Sent Back To State Court
The New Jersey federal judge overseeing multidistrict litigation accusing Express Scripts, CVS Caremark and other pharmacy benefit managers of conspiring to fix the prices of insulin on Wednesday refused to ship a case brought by the state of California back to state court.
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June 04, 2025
23andMe, Bidders Agree To Post-Ch. 11 Auction Offer Process
The winner of 23andMe's Chapter 11 auction and a nonprofit started by its co-founder can improve their offers to acquire the DNA testing company under procedures agreed to Wednesday in Missouri bankruptcy court, despite disruptions from a tornado warning and an attorney letting slip nonpublic details of an offer.
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June 04, 2025
USPTO Says Study Disproves Pharma Patent Thicket Claims
A U.S. Patent and Trademark Office unit has found that pharmaceutical patent thickets are rare after investigating arguments about their effect on drug pricing, the division's leader said Wednesday as part of a discussion on large patent families.
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June 04, 2025
SEC Gets $1.1M Win Against Alleged Ga. Crypto Scammer
A Georgia man is on the hook for over $1.1 million in penalties after failing to defend himself from U.S. Securities and Exchange Commission allegations he ran an $800,000 affinity fraud scheme involving a purported cryptocurrency he said was backed by gold and stem cell technology.
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June 04, 2025
Novo Nordisk Wants Hospital Sanctioned For Insulin Pen Suit
Novo Nordisk Inc. has asked a Connecticut federal judge to sanction Griffin Health Services Corp. for suing the pharmaceutical company after settling a separate insulin pen contamination lawsuit, saying the hospital's complaint left out five important facts that could point blame back toward its own staff.
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June 04, 2025
House Committee Puts Intoxicating-Hemp Ban In Spending Bill
A U.S. House of Representatives committee on Wednesday released a spending bill that includes a major change to the statutory definition of hemp and hemp products in its agriculture appropriations that would effectively rewrite national hemp policy if it becomes law.
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June 04, 2025
Fed. Circ. Upholds Moderna's IP Win Over COVID Vax
A Delaware federal judge rightly interpreted claims of two Alnylam Pharmaceuticals Inc. patents, which means Moderna Inc.'s COVID-19 vaccine doesn't infringe them, the Federal Circuit said Wednesday.
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June 04, 2025
ITC Issues Import Ban In Dermatology Needle Patent Case
The U.S. International Trade Commission has blocked certain imports of skin treatment devices that infringe a series of patents owned by the U.S. subsidiary of a South Korean dermatologist's needle business.
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June 04, 2025
Vape Cos. Urge 5th Circ. To Toss FDA Vape Marketing Rule
A group of small e-cigarette companies is asking the Fifth Circuit to revive their suit challenging the U.S. Food and Drug Administration's rule for premarket authorization of new tobacco products, saying the FDA failed to account for how the rule would affect small businesses.
Expert Analysis
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What Trump Actions Mean For Federal Research Funding
New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.
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How Courts Can Filter Nonmeritorious Claims In Mass Torts
Nonmeritorious claims have been a key obstacle to settlement in many recent high-profile mass torts, but courts may be able to use tools they already have to solve this problem, says Samir Parikh at Wake Forest University.
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Series
Racing Corvettes Makes Me A Better Lawyer
The skills I use when racing Corvettes have enhanced my legal practice in several ways, because driving, like practicing law, requires precision, awareness and a good set of brakes — complete with the wisdom to know how and when to use them, says Kat Mateo at Olshan Frome.
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Opinion
Attorneys Must Act Now To Protect Judicial Independence
Given the Trump administration's recent moves threatening the independence of the judiciary, including efforts to impeach judges who ruled against executive actions, lawyers must protect the rule of law and resist attempts to dilute the judicial branch’s authority, says attorney Bhavleen Sabharwal.
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Rethinking 'No Comment' For Clients Facing Public Crises
“No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.
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As Failure-To-Warn Preemption Wanes, Justices May Weigh In
Federal preemption of state failure-to-warn claims has long been a powerful defense in strict liability tort cases, but is now under attack in litigation over the weedkiller Roundup and other products — so the scope and application of preemption may require clarification by the U.S. Supreme Court, says Michael Sena at Segal McCambridge.
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How Design Thinking Can Help Lawyers Find Purpose In Work
Lawyers everywhere are feeling overwhelmed amid mass government layoffs, increasing political instability and a justice system stretched to its limits — but a design-thinking framework can help attorneys navigate this uncertainty and find meaning in their work, say law professors at the University of Michigan.
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The Fate Of Biden-Era Clinical Study Guidance Under Trump
Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.
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Trending At The PTAB: Insights From 2024 Fed. Circ. Statistics
Looking at stats from the Federal Circuit's decisions in 219 Patent Trial and Appeal Board appeals last year sheds light on potential trends and strategy considerations that could improve appeals' chances of success, say attorneys at Finnegan.
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Opinion
Weight Drug Suits Highlight Need For Legal Work On Safety
The rapid ascent of glucagon-like peptide-1 receptor agonists like Ozempic has revolutionized diabetes management and weight loss — but legal wrangling over issues including off-label prescriptions, side effects and compounded versions underscores lawyers' roles in protecting patient safety, says attorney Gregg Goldfarb.
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10 Issues To Watch In Aerospace And Defense Contracting
This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.
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Del. Justices' D&O Ruling Clarifies 'Related' Claim Analysis
In its recent decision in the Alexion Pharmaceuticals coverage case, the Delaware Supreme Court adopted a "meaningful linkage" standard for relatedness analysis, providing further guidance to Delaware policyholders on how to navigate those directors and officers insurance disputes, say attorneys at Hunton.
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Compliance Pointers For DOJ's Sweeping Data Security Rule
A new Justice Department rule broadly restricts many common data transactions with the goal of preventing access by countries of concern, and with an effective date of April 8, U.S. companies must quickly assess practices related to employee, customer and vendor data, says Sam Castic at Hintze Law.
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Series
Competitive Weightlifting Makes Me A Better Lawyer
The parallels between the core principles required for competitive weightlifting and practicing law have helped me to excel in both endeavors, with each holding important lessons about discipline, dedication, drive and failure, says Damien Bielli at VF Law.
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The Case For Compliance During The Trump Administration
Given the Trump administration’s shifting white collar enforcement priorities, C-suite executives may have the natural instinct to pare back compliance initiatives, but there are several good reasons for companies to at least stay the course on their compliance programs, if not enhance them, say attorneys at Riley Safer.