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Life Sciences
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May 14, 2025
Integra Brass Face Investor Suit Over FDA Compliance Lapses
Executives and directors of medical device company Integra Lifesciences Inc. were hit with a derivative suit alleging they misled investors about the company's compliance with regulatory standards for over five years, causing share declines when information regarding Integra's violations emerged.
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May 14, 2025
Regeneron-Amgen Trial Goes To Jury With An Extra Day
Federal jurors started deliberating on a Regeneron Pharmaceuticals Inc. antitrust suit late Wednesday accusing Amgen Inc. of tripping up Regeneron's anti-cholesterol drug insurance eligibility by illegally bundling Amgen's competing version with rebates for two unrelated drugs, with potential triple damages in the balance.
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May 14, 2025
Sage Therapeutics Brass Sued Over Drug Candidate Claims
The top brass of Sage Therapeutics Inc. have been hit with a shareholder derivative suit in New York federal court alleging they misled investors about the safety, efficacy, durability and commercial prospects of three of the company's drug candidates and overstated their likelihood to be approved by the U.S. Food and Drug Administration.
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May 14, 2025
2nd Circ. Has Tough Questions On Nixing Medical Imaging Award
The Second Circuit appeared divided on Wednesday on whether parties to a medical imaging joint venture could agree to designate New York courts to decide whether to vacate an arbitral award issued in Switzerland under their contract without violating an underlying treaty.
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May 14, 2025
10th Circ. Chilly To Biotech's SEC Asset Freeze Challenge
A panel of Tenth Circuit judges seemed skeptical Wednesday that a lower court had abused its discretion in granting a freeze of a biotech firm's assets in a suit brought by the U.S. Securities and Exchange Commission accusing the company and its founders of misappropriating roughly $9 million.
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May 14, 2025
Harvard Researcher Charged With Smuggling Amid ICE Case
Federal prosecutors on Wednesday unsealed criminal smuggling charges against a Russian national and Harvard Medical School researcher who has been challenging her monthslong detention by U.S. Immigration and Customs Enforcement after she returned to the U.S. from Europe carrying frog embryos.
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May 14, 2025
Alnylam Halts Patent Row Over Pfizer, BioNTech COVID-19 Vax
Alnylam Pharmaceuticals has decided to end a district court patent case over the COVID-19 vaccine made by Pfizer and BioNTech, asking a Delaware federal judge Tuesday to rule that the companies do not infringe its mRNA patents, while potentially setting the stage for an appeal.
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May 14, 2025
Novo Nordisk, Septerna Ink Up To $2.2B Obesity Drug Deal
Denmark's Novo Nordisk said Wednesday it has signed a drug development deal worth up to $2.2 billion with U.S.-based Septerna, part of its continued push to expand treatments for obesity, Type 2 diabetes and related diseases.
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May 14, 2025
D'Oh! Kimberly-Clark Can't Keep Wage Suit In Federal Court
A Pennsylvania federal judge invoked "The Simpsons" as he granted a Kimberly-Clark employee's request to ship his unpaid overtime proposed class action back to state court, saying the paper goods company is trying to "embiggen" the amount in controversy beyond what's feasible.
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May 14, 2025
Eckert Seamans Enters NYC With 11 Hawkins Parnell Attys
Eckert Seamans Cherin & Mellott LLC said Wednesday that it has launched an office in New York City with the addition of an 11-attorney team from Hawkins Parnell & Young LLP, while scaling back its New Jersey presence.
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May 14, 2025
Biotech Firm Verax Tells Court Eviction Could End Company
Biotech company Verax Biomedical Inc. has said it faces the prospect of going out of business unless a Massachusetts judge agrees to block its landlord from proceeding with an eviction, at least through the end of its current lease.
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May 14, 2025
RFK Jr. Defends HHS Cuts, Pledges To 'Spend Smarter'
In his first appearance on Capitol Hill since his confirmation, U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday characterized a massive reorganization and reductions in workforce as practical moves to optimize the sprawling agency.
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May 14, 2025
Biogen Sues Ex-Collaborator Over Rights To Drug Tech
Biogen said its partner on a since-shelved Alzheimer's drug is trying to claim rights to an unrelated novel therapeutic that the Massachusetts company recently shared with the Swiss partner under a confidentiality agreement, according to a lawsuit filed Tuesday.
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May 13, 2025
Asterisk Doesn't Save CVS In Sanitizer Row, 9th Circ. Told
An attorney for a man suing CVS Pharmacy urged the Ninth Circuit on Tuesday to revive his claims alleging the company misled consumers with a promise its hand sanitizer kills 99.99% of germs, arguing the asterisk on the front label does not clear the company of wrongdoing despite a recent ruling from the circuit that gives significance to that type of asterisk.
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May 13, 2025
PTAB Ramps Up Fintiv Denials After Withdrawal Of Memo
Weeks after the U.S. Patent and Trademark Office withdrew a memo that limited when patent challenges could be rejected based on parallel litigation, the Patent Trial and Appeal Board has denied dozens of petitions by citing upcoming trials, mostly in the Eastern District of Texas.
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May 13, 2025
Magistrate Judge Cuts Defendants In J&J Talc Unit Fraud Suit
A New Jersey magistrate judge on Tuesday dropped a collection of defendants from a class action brought by cancer patients alleging that Johnson & Johnson's maneuvers to settle thousands of tort claims through Chapter 11 involved fraud.
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May 13, 2025
Becton Dickinson Sues Baxter Over Infusion Pump Patents
Becton Dickinson has accused Baxter International of willfully infringing six of its patents for infusion pump technologies used to deliver medications to patients, telling a Delaware federal court that marketing materials for a Baxter infusion pump platform touted several Becton inventions.
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May 13, 2025
Regeneron-Amgen Drug Bundling Trial Heads Toward Jury
An economics expert called by Amgen Inc. told a Delaware federal jury Tuesday that none of the company's deals to bundle other discounted major medications with its cholesterol-reducing drug Repatha foreclosed market competition, a day before jurors begin deliberating on an antitrust suit targeting the practice.
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May 13, 2025
10x Genomics, Bruker Strike Deal After $31M Patent Verdict
Gene sequencing technology firm 10x Genomics and scientific instrument maker Bruker Corp. have reached a settlement in a patent infringement lawsuit that previously led biotechnology company NanoString to file for Chapter 11 bankruptcy relief.
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May 13, 2025
NIH Letters Ending Grants Lack Factual Support, Judge Says
A Massachusetts federal judge said Tuesday that a "blast" of hundreds of virtually identical letters in March canceling National Institutes of Health-funded research projects appeared to offer no factual basis, only unsupported assertions that the projects were unscientific or discriminatory.
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May 13, 2025
PBMs Get Bipartisan Bashing At Hearing On Drug Costs
Senators across party lines slammed pharmacy benefit managers on Tuesday, sometimes in coarse language, as they wrestled with how to reduce drug prices for patients while also preventing the closure of rural pharmacies.
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May 13, 2025
Cancer Centers Want Fed. Circ. To Rehear Antibody IP Fight
The Dana-Farber Cancer Institute and Memorial Sloan-Kettering Cancer Center say the full Federal Circuit should review a decision rejecting Xencor's application for an antibody patent, arguing that the decision wrongly created a new precedent that could be harmful to other patents.
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May 13, 2025
Former J&J, Moderna Exec Joins Goodwin Procter In Boston
Goodwin Procter is continuing to grow its resources in the life sciences practice with the recent addition to the Boston office of an attorney who has gone back to private practice after more than seven years as an in-house counsel for Johnson & Johnson and Moderna.
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May 13, 2025
Express Scripts, FTC Say Defamation Suit 'Should Proceed'
The Federal Trade Commission's new Republican leadership is ready to defend against an Express Scripts defamation lawsuit targeting an agency report excoriating it and other pharmacy benefit managers for allegedly inflating drug costs, the agency and the PBM told a Missouri federal judge Monday.
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May 12, 2025
W.Va. High Court Declines 4th Circ. Request For Opioid Input
The West Virginia Supreme Court of Appeals on Monday declined the Fourth Circuit's request to answer whether the state's public nuisance law applies to the distribution of opioids, saying disputed facts in litigation between local governments and drug distribution companies must first be resolved.
Expert Analysis
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Patent Policy Changes To Track Under New Gov't Leadership
The new federal government will likely bring pivotal shifts in U.S. patent policy through legislation and initiatives that reflect a renewed focus on strengthening intellectual property rights, fostering innovation and enhancing the nation's competitive edge, says PK Chakrabarti at Butzel Long.
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Liability Risk For AI In Medical Devices Demands Greater Care
As regulators push for legal reform surrounding artificial intelligence and cases implicating product liability for AI in medical technology continue to rise, manufacturers must adapt and implement new strategies to accommodate evolving risks, say attorneys at Crowell & Moring.
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5 E-Discovery Predictions For 2025 And Beyond
In the year to come, e-discovery will be shaped by new and emerging trends, from the adoption of artificial intelligence provisions in protective orders, to the proliferation of emojis as a source of evidence in contemporary litigation, say attorneys at Littler.
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4 Trade Secret Developments To Follow This Year
Significant developments in trade secret law are likely in 2025, and areas to watch include protection of AI-related innovations, the fate of the Federal Trade Commission's noncompete ban, and questions of the federal Defend Trade Secrets Act's extraterritorial reach, say attorneys at Faegre Drinker.
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Republican Trifecta Amplifies Risks For Cos. In 3 Key Areas
Expected coordination between a Republican Congress and presidential administration may expose companies to simultaneous criminal, civil and congressional investigations, particularly with regard to supply chain risks in certain industries, government contracting and cross-border investment, say attorneys at Morgan Lewis.
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7 Ways 2nd Trump Administration May Affect Partner Hiring
President-elect Donald Trump's return to the White House will likely have a number of downstream effects on partner hiring in the legal industry, from accelerated hiring timelines to increased vetting of prospective employees, say recruiters at Macrae.
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How Trump 2.0 May Change Business In Latin America
Companies in Latin America should expect to face more trade restrictions, tighter economic sanctions and enhanced corruption risks, as the incoming administration shifts focus to certain non-U.S. actors, most notably China, says Matteson Ellis at Miller & Chevalier.
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Opinion
Courts Must Curb The Drug Price Negotiation Program
The Inflation Reduction Act's drug price negotiation program upends incentive structures that drive medical innovation, and courts must act appropriately to avoid devastating consequences for American healthcare and the pharmaceutical industry, says Jeff Stier at the Consumer Choice Center.
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E-Discovery Quarterly: Rulings On Custodian Selection
Several recent rulings make clear that the proportionality of additional proposed custodians will depend on whether the custodians have unique relevant documents, and producing parties should consider whether information already in the record will show that they have relevant documents that otherwise might not be produced, say attorneys at Sidley.
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Series
Exercising On My Peloton Bike Makes Me A Better Lawyer
While I originally came to the Peloton bike for exercise, one cycling instructor’s teachings have come to serve as a road map for practicing law thoughtfully and mindfully, which has opened opportunities for growth and change in my career, says Andrea Kirshenbaum at Littler.
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5 Drug And Device Developments That Shaped 2024
The last year saw significant legal developments affecting drug and device manufacturers, with landmark decisions and regulatory changes that require vigilance and agility from the industry, say attorneys at Faegre Drinker.
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How To Manage During A Trade Dispute With USMCA Partners
Companies can try to minimize the potential impacts of future tariffs on Mexican and Canadian goods, and uncertainty about future trade relations, by evaluating supply chains, considering how they may be modified, and engaging with the new administration over exemptions and the upcoming review of the U.S.-Mexico-Canada Agreement, say attorneys at Holland & Knight.
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Rejoinder Strategy After Allergan Double-Patenting Case
A closer look at last year's Allergan v. MSN case at the Federal Circuit highlights the importance of rejoinder during patent prosecution in view of the risks associated with obviousness-type double patenting based on later-filed applications in the same patent family, say attorneys at BCLP.
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Takeaways From 2024's Emerging IP Licensing Trends
Themes in intellectual property licensing from the past year – including artificial intelligence; risk management; and name, image and likeness rights – highlight key considerations for navigating an evolving landscape, say attorneys at Ballard Spahr.
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Exploring Venue Strategy For Trump-Era Regulatory Litigation
Litigation will likely play a prominent role in shaping policy outcomes during the second Trump administration, and stakeholders have several tools at their disposal to steer regulatory litigation toward more favorable venues, say attorneys at Covington.