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Life Sciences
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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.
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June 03, 2025
Calif. Suffers Setback In Tariff Suit, But Gets Shot At 9th Circ.
A California federal judge said Monday that the U.S. Court of International Trade has exclusive jurisdiction over California's lawsuit challenging President Donald Trump's recent tariffs, but declined the federal government's request to transfer the case to the CIT and instead dismissed the suit so that California can appeal her decision to the Ninth Circuit.
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June 03, 2025
Fortrea Faces Investor Suit Over Post-Labcorp Financial Woes
Clinical research company Fortrea Holdings Inc. was hit with a proposed shareholder class action alleging that it overstated the strength of its business model after being spun off from Labcorp Holdings Inc., causing investors harm as the truth about Fortrea's financial struggles emerged.
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June 03, 2025
Pharma Group Can Pursue Challenge To Insulin Pricing Law
A Minnesota federal judge refused Tuesday to throw out a lawsuit over a state law requiring drugmakers to provide insulin to low-income diabetic patients, finding the drug industry's top lobbying group has plausibly alleged that a new registration fee imposed by the law could be unconstitutional.
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June 03, 2025
Patent Deals Accelerate Access To Generics, Drug Group Says
Deals between the makers of brand name drugs and the companies behind their generic versions have led to billions of dollars in healthcare cost savings and faster access to cheaper medicines, according to a new report.
Expert Analysis
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Reproductive Health Under Trump So Far, And What's Next
Based on priorities stated so far, the Trump administration will likely continue to weaken Biden-era policies that protect reproductive health, with abortion, in vitro fertilization and contraception all being issues to watch closely amid a post-Dobbs shift, say attorneys at McDermott.
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Series
Playing Football Made Me A Better Lawyer
While my football career ended over 15 years ago, the lessons the sport taught me about grit, accountability and resilience have stayed with me and will continue to help me succeed as an attorney, says Bert McBride at Trenam.
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10 Arbitrations And A 5th Circ. Ruling Flag Arb. Clause Risks
The ongoing arbitral saga of Sullivan v. Feldman, which has engendered proceedings before 10 different arbitrators in Texas and Louisiana along with last month's Fifth Circuit opinion, showcases both the risks and limitations of arbitration clauses in retainer agreements for resolving attorney-client disputes, says Christopher Blazejewski at Sherin and Lodgen.
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Keys To Handling Digital Investigations In Pharma IP Litigation
In the high-stakes realm of pharmaceutical intellectual property litigation, efficient e-discovery and digital investigation workflows are essential to supporting strategic arguments, building defensible cases and proving that the requirements for market entry have been adequately met, says Jerry Lay at FTI Consulting.
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Series
Power To The Paralegals: The Value Of Unified State Licensing
Texas' proposal to become the latest state to license paraprofessional providers of limited legal services could help firms expand their reach and improve access to justice, but consumers, attorneys and allied legal professionals would benefit even more if similar programs across the country become more uniform, says Michael Houlberg at the University of Denver.
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What's Next For Lab Test Regulation Without FDA Authority
A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.
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10 Soft Skills Every GC Should Master
As businesses face shifting regulatory and technological uncertainty, general counsel will need to strengthen certain soft skills to succeed, from admitting when they make a mistake to maintaining a healthy dose of dispassion, says Douglas Brown at Manatt.
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6 Criteria Can Help Assess Executive Branch Actions
With new executive policy changes announced seemingly every day, several questions can help courts, policymakers and businesses determine whether such actions are proper, effective and in keeping with our democratic norms, say Marc Levin and Khalil Cumberbatch at the Council on Criminal Justice.
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An Unrestrained, Bright-Eyed View Of Legal AI's Future
Todd Itami at Covington offers a bright-eyed, laughing-all-the-way, skydive look at what the legal industry could look like after an artificial intelligence revolution, which he believes may happen much sooner and more dramatically than we expect.
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Tracking The Evolution In Litigation Finance
Despite continued innovation, litigation finance remains an immature market with borrowers recieving significantly different terms as lenders learn to value cases, which firms need a strong handle on to ensure lending terms do not overwhelm collateral value, says Robert Wilkins at Lightfoot Franklin.
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Keys To Regulatory Diligence In Life Sciences Transactions
Conducting effective regulatory due diligence for life sciences deals requires careful review of a target company's activities, and separate sets of considerations for commercial and pipeline products, says Anna Zhao at GunnerCooke.
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How Courts Weigh Section 1782 Discovery For UPC Cases
A look at cases from six different federal district courts reveals a number of discretionary factors that influence how courts consider Section 1782 discovery applications in connection with Unified Patent Court proceedings, say attorneys at Finnegan.
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Opinion
In Vape Case, Justices Must Focus On Agencies' Results
With the U.S. Supreme Court's ruling in U.S. Food and Drug Administration v. Wages and White Lion Investments having put off the question of whether agency decisions arrived at erroneously are always invalid, the court should give the results of agency actions more weight than the reasoning behind them when it revisits this case, says Jonathan Sheffield at Loyola University Chicago School of Law.
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Series
Volunteer Firefighting Makes Me A Better Lawyer
While practicing corporate law and firefighting may appear incongruous, the latter benefits my legal career by reminding me of the importance of humility, perspective and education, says Nicholas Passaro at Ford.
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E-Discovery Quarterly: The Perils Of Digital Data Protocols
Though stipulated protocols governing the treatment of electronically stored information in litigation are meant to streamline discovery, recent disputes demonstrate that certain missteps in the process can lead to significant inefficiencies, say attorneys at Sidley.