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Life Sciences
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January 22, 2025
Wyden Urges National Standard For Hemp Regulation
Sen. Ron Wyden, D-Ore., rallied on Wednesday for his bill that would beef up regulation of products with hemp-derived cannabinoids in order to protect consumers, particularly children.
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January 22, 2025
Cooley-Led Insulin Device Maker Preps $113M IPO
Insulin delivery system maker Beta Bionics on Wednesday announced the terms for its initial public offering, planning to raise $113 million.
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January 22, 2025
Nixed Invitae Asset Buyer Asks Ch. 11 Court To Stop Litigation
Genetic testing company Natera has launched an adversary lawsuit against Invitae, a competitor that sought insolvency protection last year, asking a New Jersey bankruptcy judge to stop Invitae's Chapter 11 plan administrator from collecting payments owed under a rejected contract.
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January 21, 2025
Key Justices Stay Quiet As High Court Weighs FCC Deference
Several U.S. Supreme Court justices on Tuesday appeared open to giving district courts more leeway to review the Federal Communciations Commission's tome of regulations under the Telephone Consumer Protection Act, although the two justices expected to cast pivotal votes refrained from posing questions.
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January 21, 2025
Intuitive Seeks Midtrial End To Robo-Surgery Antitrust Suit
Before calling its first defense witness Tuesday, Intuitive Surgical urged a federal judge to find in its favor in a trial over claims that it abused its market dominance by blocking third parties from refurbishing a component of its da Vinci surgery robot, saying there's no evidence of an unlawful tying arrangement.
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January 21, 2025
The Legal And Practical Questions Around Trump's WHO Exit
President Donald Trump’s first-day order setting in motion the United States’ withdrawal from the World Health Organization could leave the nation less prepared for global health threats and trigger legal clashes over the president’s authority to act unilaterally.
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January 21, 2025
Last Sackler Family Members Join Purdue Draft Deal
The final holdouts among two branches of Sackler family members are ready to join a settlement in the bankruptcy of OxyContin maker Purdue Pharma LP, a business owned by the family, according to a report from the co-mediators handling negotiations.
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January 21, 2025
Bacon Giant Smithfields Leads 3 IPOs Primed To Exceed $1B
Bacon maker Smithfields Foods Inc. led a trio of companies unveiling price ranges for initial public offerings Tuesday that could raise $1.3 billion combined over the next week, with 10 law firms guiding the IPOs in various capacities.
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January 21, 2025
Trump Taps Pot Legalization Opponent As Acting DEA Head
A stalled effort to loosen federal restrictions on marijuana will be overseen, at least temporarily, by a former U.S. Drug Enforcement Administration agent who has previously spoken out against marijuana reform and specifically criticized the former administration's bid to recategorize the drug.
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January 21, 2025
Justices Doubt Retailers Are 'Bystanders' In FDA Challenge
Several U.S. Supreme Court justices appeared to agree Tuesday that Texas and Mississippi retailers could join a North Carolina e-cigarette manufacturer in challenging the U.S. Food and Drug Administration's denial of its marketing application, and Justice Clarence Thomas questioned the agency's motivation to argue otherwise.
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January 21, 2025
Firm Slams Beasley Allen's Bid To Nix Suit Over Talc Team-Up
Smith Law Firm PLLC is urging a Mississippi federal court to reject Beasley Allen Law Firm's bid to dismiss or transfer a defamation and breach of contract lawsuit over their joint venture agreement for talc litigation against Johnson & Johnson, saying the case shouldn't be thrown out in favor of Beasley Allen's Alabama suit.
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January 21, 2025
What IP Attorneys Need To Know From Trump's First Days
Since the Trump administration took over on Monday, a new acting director for the U.S. Patent and Trademark Office has been sworn in, federal workers have been mandated to return to working in person and the Biden administration's artificial intelligence executive order has been rescinded. Here's what IP attorneys should know.
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January 17, 2025
Law360 Names Practice Groups Of The Year
Law360 would like to congratulate the winners of its Practice Groups of the Year awards for 2024, which honor the attorney teams behind litigation wins and significant transaction work that resonated throughout the legal industry this past year.
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January 17, 2025
Law360 Names Firms Of The Year
Eight law firms have earned spots as Law360's Firms of the Year, with 54 Practice Group of the Year awards among them, steering some of the largest deals of 2024 and securing high-profile litigation wins, including at the U.S. Supreme Court.
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January 20, 2025
Trump, Musk Sued By Nonprofits Over DOGE Transparency
Public Citizen and other nonprofits hit the Trump administration with multiple lawsuits seeking to shut down the new Department of Government Efficiency in D.C. federal court Monday, alleging the Elon Musk-led advisory committee targeting government waste lacks requisite transparency guardrails to prevent DOGE from solely advancing private interests.
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January 17, 2025
Walgreens Knowingly Filled Invalid Prescriptions, Feds Say
The U.S. Department of Justice has accused Walgreens of knowingly filling millions of prescriptions for opioids and other controlled substances that did not have a legitimate medical purpose or were not valid, intervening in cases brought by four whistleblowers in Illinois federal court.
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January 17, 2025
MSN Wants Generic Entresto Launch After Patent Expired
MSN Pharmaceuticals asked the Federal Circuit Friday to let it launch its generic version of Novartis' blockbuster heart drug Entresto while the drugmakers continue their litigation over a newly expired patent, by lifting a temporary injunction barring that launch.
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January 17, 2025
Bayer, J&J Minimized Drug Reaction Data, 3rd Circ. Told
A doctor urged the Third Circuit on Friday to revive his whistleblower suit against Bayer Corp. and Johnson & Johnson, arguing that the drugmakers' regulatory approval applications played down the side effects of the antibiotics Cipro and Levaquin.
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January 17, 2025
Up Next At High Court: Forum Shopping & TCPA Definitions
The U.S. Supreme Court will return to the bench Tuesday for a short argument session, during which the justices will consider the U.S. Food and Drug Administration's bid to limit forum shopping by manufacturers challenging agency decisions and how much deference district courts must give to Federal Communications Commission orders.
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January 17, 2025
NC Biotech Co. Can't Restrain Co-Founder's Rival Biz Yet
A biotechnology company can't stop its co-founder from conducting research and soliciting customers at his new company using what it believes is stolen confidential information, a North Carolina state court judge said Friday, pointing to a lack of urgency and glaring holes in the record.
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January 17, 2025
3rd Circ. Vexed By Remedies For Defunct Vax Mandate
The Third Circuit wrestled Friday with how it could remedy injuries claimed to be suffered by nurses who lost their jobs for not complying with New Jersey Gov. Phil Murphy's vaccine mandate for healthcare workers, asking what order it could give about something that is no longer in effect and about jobs they no longer have.
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January 17, 2025
Duke U. Strikes Deal In Female Scientist's Pay Bias Suit
Duke University and a female scientist have brokered an agreement to end her suit claiming she was paid less than her male counterparts and was threatened with demotions after complaining about it, according to a Friday filing in North Carolina federal court.
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January 17, 2025
Crown Labs Tops Rival Bid In Quest To Buy Biotech Revance
Skincare product company Crown Laboratories Inc. has offered to raise its all-cash bid to buy healthcare biotech company Revance Therapeutics Inc. from $3.10 per share to $3.65 per share as it seeks to beat out a surprise bid from a Revance shareholder, according to a securities filing on Friday.
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January 17, 2025
1st Circ. Revives Biotech Worker's COVID-19 Vax Challenge
The First Circuit on Thursday resuscitated religious discrimination claims brought by a former pharmaceutical company employee who alleged her employer's COVID-19 vaccination mandate during the pandemic was in conflict with her sincerely held religious beliefs.
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January 17, 2025
Taxation With Representation: Simpson Thacher, Covington
In this week's Taxation With Representation, Eli Lilly and Co. buys a precision breast cancer program, Applied Digital Corp. enters a financing agreement for its high-performance computing business, Clearwater Analytics buys Enfusion, and Lantheus Holdings Inc. buys Life Molecular Imaging Ltd.
Expert Analysis
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Opinion
This Election, We Need To Talk About Court Process
In recent decades, the U.S. Supreme Court has markedly transformed judicial processes — from summary judgment standards to notice pleadings — which has, in turn, affected individuals’ substantive rights, and we need to consider how the upcoming presidential election may continue this pattern, says Reuben Guttman at Guttman Buschner.
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A Look At The PTAB's Assessment Of Prior Art Exceptions
The Patent Trial and Appeal Board's approach over the last 10 years to assessing Section 102(b) prior art exceptions reveals a few trends, including that evidence of common ownership may have a higher likelihood of successfully disqualifying prior art under Section 102(b)(2)(C) at the institution stage, say Louis Panzica and David Holman at Sterne Kessler.
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Series
Playing Diplomacy Makes Us Better Lawyers
Similar to the practice of law, the rules of Diplomacy — a strategic board game set in pre-World War I Europe — are neither concise nor without ambiguity, and weekly gameplay with our colleagues has revealed the game's practical applications to our work as attorneys, say Jason Osborn and Ben Bevilacqua at Winston & Strawn.
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How Patent Litigation Is Changing Amid Decline In Filings
Marked by a notable decline in case filings and preferred venue shifts, patent litigation has undergone significant changes over the last decade and litigation hot spots have shifted, encouraging a more strategic approach to patent disputes, says Saishruti Mutneja at Winston & Strawn.
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Mental Health First Aid: A Brief Primer For Attorneys
Amid a growing body of research finding that attorneys face higher rates of mental illness than the general population, firms should consider setting up mental health first aid training programs to help lawyers assess mental health challenges in their colleagues and intervene with compassion, say psychologists Shawn Healy and Tracey Meyers.
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Opinion
FTC's Report Criticizing Drug Middlemen Is Flawed
The Federal Trade Commission's July report, which claims that pharmacy benefit managers are inflating drug costs, does not offer a credible analysis of PBMs, and its methodology lacks rigor, says Jay Ezrielev at Elevecon.
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Series
Collecting Art Makes Me A Better Lawyer
The therapeutic aspects of appreciating and collecting art improve my legal practice by enhancing my observation skills, empathy, creativity and cultural awareness, says attorney Michael McCready.
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Del. Dispatch: Cautionary Tales Of 2 Earnout Effort Breaches
The Delaware Court of Chancery's tendency to interpret earnout provisions precisely as written, highlighted in two September rulings that found buyers breached their shareholder obligations when they failed to make reasonable efforts to hit certain product development milestones, demonstrates the paramount importance of precisely wording these agreements, say attorneys at Fried Frank.
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Takeaways From Novo Nordisk's Fight For Market Exclusivity
Generic competitors’ challenge to Novo Nordisk’s patents in hopes of capturing a portion of the rapidly expanding Type 2 diabetes and obesity treatment market highlights the role of abbreviated new drug application litigation, inter partes review and multidistrict litigation in patent defense, says Pedram Sameni at Patexia.
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Using Primacy And Recency Effects In Opening Statements
By understanding and strategically employing the primacy and recency effects in opening statements, attorneys can significantly enhance their persuasive impact, ensuring that their narrative is both compelling and memorable from the outset, says Bill Kanasky at Courtroom Sciences.
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Secret Service Failures Offer Lessons For Private Sector GCs
The Secret Service’s problematic response to two assassination attempts against former President Donald Trump this summer provides a crash course for general counsel on how not to handle crisis communications, says Keith Nahigian at Nahigian Strategies.
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Opinion
Bill Is Key To Protecting US Economy From Patent Piracy
It is critical that Congress pass a recently introduced bill that would protect U.S. investors from intellectual property theft by restoring court-ordered injunctions as the default remedy in patent infringement cases to ensure inventors get the justice they deserve, says Andrei Iancu at Sullivan & Cromwell.
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Defending AI, Machine Learning Patents In Life Sciences
Ten years after the U.S. Supreme Court's decision in Alice v. CLS Bank, artificial intelligence and machine learning technology remain at risk for Alice challenges, but reviewing recent cases can help life sciences companies avoid common pitfalls and successfully defend their patents, say attorneys at Mintz.
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Litigation Inspiration: Honoring Your Learned Profession
About 30,000 people who took the bar exam in July will learn they passed this fall, marking a fitting time for all attorneys to remember that they are members in a specialty club of learned professionals — and the more they can keep this in mind, the more benefits they will see, says Bennett Rawicki at Hilgers Graben.
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From Concept To Capital: 5 Stages Of Evolving IP Needs
Companies must understand the shifting intellectual property needs throughout an organization’s life cycle in order to protect innovation, which can be done by fortifying the IP portfolio, expanding and leveraging IP assets, and more, says Keegan Caldwell at Caldwell Law.