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Life Sciences
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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.
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June 03, 2025
Regeneron Gets $407M After Antitrust Win Over Amgen
Regeneron won a $406.8 million judgment in its antitrust suit against Amgen, following a jury verdict last month saying Amgen illegally undercut the price of Regeneron's anticholesterol drug Praluent through a bundling scheme with two blockbuster Amgen drugs.
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June 03, 2025
6th Circ. Denies PBMs' Privilege Claim In Opioid MDL
A Sixth Circuit panel on Tuesday denied a petition from Cigna's Express Scripts and UnitedHealth's Optum seeking to reverse discovery orders allowing certain personnel files and internal communications into the multidistrict opioid litigation, finding that the two pharmacy benefit managers failed to show extraordinary abuses justifying relief.
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June 03, 2025
Canada Customers Agree To Halt 23andMe Data Breach Suits
23andMe and Canadian customers suing over a data breach agreed on Tuesday to pause lawsuits against non-bankrupt third parties for up to six months amid the DNA testing company's Chapter 11 proceedings in Missouri.
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June 03, 2025
Rosen, Pomerantz To Lead Seattle Biotech Class Action
The Rosen Law Firm PA and Pomerantz LLP will serve as co-lead counsel for shareholders accusing Seattle-based Sana Biotechnology Inc. of misleading investors about its ability to develop certain genetic therapy treatments.
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June 03, 2025
Latham Advises Atai In $390M Merger With Beckley Psytech
U.S.-German biopharmaceutical company atai Life Sciences, advised by Latham & Watkins LLP, said in an announcement Monday that it will acquire Beckley Psytech, led by Mayer Brown LLP and CMS Cameron McKenna Nabarro Olswang LLP, in an all-share transaction that values Beckley at approximately $390 million, creating a combined company focused on fast-acting mental health therapies.
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June 03, 2025
Accord Urges Justices To Reject 'Crush-Resistant' Oxy IP Row
Accord Healthcare Inc. says the U.S. Supreme Court should reject bankrupt OxyContin maker Purdue Pharma LP's attempt to revive its legal effort to use patent laws to block the release of a competing, "crush-resistant" generic painkiller.
Expert Analysis
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Opinion
The BigLaw Settlements Are About Risk, Not Profit
The nine Am Law 100 firms that settled with the Trump administration likely did so because of the personal risk faced by equity partners in today's billion‑dollar national practices, enabled by an ethics rule primed for modernization, says Adam Forest at Scale.
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Neb.'s Cannabis Regulatory Void Poses Operational Risks
With the Nebraska Legislature recently declining to advance any cannabis legislation, leaving the state without a regulatory framework for voter-passed initiatives, the risks of operating without clear rules will likely affect patients, providers and caregivers, says John Cartier at Omnus Law.
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Opinion
Courts Must Revitalize Robust Claim Construction
Two Federal Circuit decisions from earlier this year illustrate the rarity of robust claim construction and the underused reverse doctrine of equivalents — a dual problem that prevents courts from clearly delineating and correctly cabining the scope of rights conferred by patent claims, say attorneys at Klarquist Sparkman.
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What Gene Findings Mean For Asbestos Mesothelioma Claims
Recent advances in genetic research have provided substantial evidence that significant numbers of malignant mesothelioma cases may be caused by inherited mutations rather than asbestos exposure — a finding that could fundamentally change how defendants approach personal injury litigation over mesothelioma, say David Schwartz at Lumanity and Kirk Hartley at LSP Group.
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Series
Brazilian Jiujitsu Makes Me A Better Lawyer
Competing in Brazilian jiujitsu – often against opponents who are much larger and younger than me – has allowed me to develop a handful of useful skills that foster the resilience and adaptability necessary for a successful legal career, says Tina Dorr of Barnes & Thornburg.
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Fed. Circ. In April: Introducing New Evidence During IPR
The Federal Circuit's decision in Sage Products v. Stewart last month upheld the Patent Trial and Appeal Board's decision to allow a petitioner to rely on case-dispositive evidence beyond prior art references, affording petitioners in inter partes review proceedings greater latitude in the timing of evidence presentation, say attorneys at Knobbe Martens.
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FDA Commissioner Speech Suggests New Vision For Agency
In his first public remarks as U.S. Food and Drug Administration commissioner, Marty Makary outlined an ambitious framework for change centered around cultural restoration, scientific integrity, regulatory flexibility and selective modernization, and substantial enforcement shifts for the food and tobacco sectors, say attorneys at Arnall Golden.
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DOJ Export Declination Highlights Self-Reporting Benefits
The U.S. Department of Justice's recent decision not to prosecute a NASA contractor, despite a former employee pleading guilty to facilitating unlicensed exports, underscores the advantages available to companies that self-report sanctions violations, cooperate with investigations and implement timely remediation, say attorneys at Cleary.
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AG Watch: Texas Expands Use Of Consumer Protection Laws
In recent years under Attorney General Ken Paxton, Texas has demonstrated the breadth of its public interest authority by bringing actions in areas not traditionally associated with consumer protection law, including recent actions involving sports and public safety, say attorneys at Kelley Drye.
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Series
Power To The Paralegals: An Untapped Source For Biz Roles
Law firms looking to recruit legal business talent should consider turning to paralegals, who practice several key skills every day that prepare them to thrive in marketing and client development roles, says Vanessa Torres at Lowenstein Sandler.
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A Path Forward For Colo. Pot Products After Failed Safety Test
As cannabis products in Colorado face increasingly rigorous contamination testing, decontamination and remediation can be an alternative to destruction after a failed safety check, in certain circumstances, so understanding the nuances of these procedures is vital, say attorneys at Troutman Pepper.
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Series
Playing Poker Makes Me A Better Lawyer
Poker is a master class in psychology, risk management and strategic thinking, and I’m a better attorney because it has taught me to read my opponents, adapt when I’m dealt the unexpected and stay patient until I'm ready to reveal my hand, says Casey Kingsley at McCreadyLaw.
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What EU 'Killer Acquisition' Study Means For Pharma Deals
The European Commission’s recent study of pharmaceutical companies' acquisitions of emerging competitive threats, the first of its kind globally, has important implications for the industry, and may lead to increased awareness of merger control risks in collaborative agreements, say lawyers at Paul Weiss.
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Legal Risks For Providers Discussing Psychedelic Therapies
The emergence of psychedelic therapies as potential treatments for mental health conditions and other ailments continues to garner significant attention, but the legal landscape surrounding discussions and referrals remains fraught with complexity, creating potential risks for healthcare providers and institutions, says Kimberly Chew at Husch Blackwell.
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Series
Law School's Missed Lessons: Becoming A Firmwide MVP
Though lawyers don't have a neat metric like baseball players for measuring the value they contribute to their organizations, the sooner new attorneys learn skills frequently skipped in law school — like networking, marketing, client development and case evaluation — the more valuable, and less replaceable, they will be, says Alex Barnett at DiCello Levitt.