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Life Sciences
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March 05, 2025
Senators Press Trump's NIH Nominee On Grant Cuts, Vaccines
Dr. Jay Bhattacharya vowed to support research into chronic diseases but repeatedly refused Wednesday to express an opinion on cost-cutting efforts at the National Institutes of Health, sidestepping bipartisan questions during a hearing on his nomination to run the biomedical research agency.
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March 05, 2025
Pfizer, BioNTech Get PTAB To Invalidate Moderna Vaccine IP
The Patent Trial and Appeal Board handed a massive victory to Pfizer and BioNTech on Wednesday, as it invalidated two Moderna patents covering its Spikevax COVID-19 vaccine, which the challengers stand accused of infringing.
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March 05, 2025
Trump's NIH Cost-Cutting Measure Blocked By Judge
A Massachusetts federal judge ruled Wednesday that the Trump administration cannot cap indirect costs for research grants at the National Institutes of Health, rejecting the move as a rushed cost-saving measure that violates federal law governing the expenses.
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March 05, 2025
3 Firms Build Jazz Pharmaceuticals' $935M Chimerix Buy
Jazz Pharmaceuticals on Wednesday revealed plans to acquire biopharmaceutical company Chimerix in a $935 million deal built by three law firms that will further diversify Jazz's oncology portfolio.
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March 05, 2025
Skin Care Tech Co. Files Ch. 11 With $400M Prepackaged Plan
Skin care and beauty technology company Cutera Inc. filed for Chapter 11 protection in a Texas bankruptcy court Wednesday with over $429 million in debt and a prepackaged debt-swap plan to cut that number by nearly $400 million.
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March 04, 2025
Meijer Says 1st Circ. Must Resolve Takeda Arbitration Order
Grocery store chain Meijer on Tuesday urged a Massachusetts federal judge to allow it to immediately appeal his ruling granting Takeda Pharmaceutical's bid to arbitrate the grocer's antitrust claims over a constipation drug, arguing that the case presents several issues that the First Circuit needs to address.
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March 04, 2025
Gov't Says 2 Lab Owners Billed $40M In COVID Test Scheme
Federal prosecutors opened their case Tuesday against two laboratory owners, telling jurors in Florida that they ran a more than $40 million scheme to submit medically unnecessary COVID-19 testing claims to healthcare benefit programs.
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March 04, 2025
Apple Seeks Ban Against Masimo's Original Smartwatch
Apple has urged a Delaware federal judge to issue an injunction against a healthcare technology company found last year to have infringed two of the tech giant's design patents with its W1 smartwatch and charger, calling the defense's refusal to agree to the injunction "telling."
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March 04, 2025
Fed. Circ. Affirms PTAB Decision Backing Stem Cell Patent
A biotech research outfit failed Tuesday to persuade Federal Circuit judges to rethink an administrative board ruling that rejected a challenge mounted against a stem cell patent.
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March 04, 2025
Moderna Faces MRNA Vax Patent Suits In Canada And Beyond
Pennsylvania drug developer Arbutus Biopharma and Genevant Sciences have taken their COVID-19 vaccine litigation against Moderna worldwide, suing the pharmaceutical company in courts in Canada, Japan and Switzerland, along with the Unified Patent Court, alleging infringement.
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March 04, 2025
Alcon, Lens.com Settle 7-Year Trademark Fight In NY
Alcon and Lens.com informed a New York federal judge Tuesday that they've agreed to resolve their long-running trademark dispute over claims that Lens.com was reselling some of Alcon's products without authorization.
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March 04, 2025
PBMs Ask 8th Circ. To Pause FTC's Insulin Pricing Case
Caremark Rx, Express Scripts and OptumRx have asked the Eighth Circuit to pause the Federal Trade Commission's in-house case accusing the pharmacy benefit managers of artificially inflating insulin prices as they push their constitutional claims against the agency.
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March 04, 2025
After 'Historic Low' In 2023, Number Of ITC Cases Soar In 2024
The U.S. International Trade Commission saw a significant uptick in disputes last year, according to a Tuesday report by a firm that represents expert witnesses used in litigation.
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March 04, 2025
In Rare Move, Texas Judge Shuns Out-Of-State BigLaw Attys
Two out-of-state BakerHostetler attorneys' "frequent" work in the Lone Star State has sunk their bids to be admitted pro hac vice in a lawsuit accusing the U.S. Food and Drug Administration of catering to Big Pharma by nixing cheaper versions of the miracle weight loss drug Ozempic.
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March 04, 2025
Freezer Co. Drops Supplier Suit Over $15M Embryo Loss
Freezer maker Chart Inc. has dropped its lawsuit alleging one of its suppliers should pay part of a $15 million verdict stemming from an implosion of Chart's cryopreservation tanks in 2018, which destroyed human eggs and embryos, according to an order Monday.
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March 04, 2025
Colo. Biotech, Founders Owe SEC $14.3M Over Fraud Claims
A Colorado federal judge has ordered a biotech startup and two of its founders to pay the U.S. Securities and Exchange Commission roughly $14.3 million and barred them from serving as officers and directors of public companies after finding that they fraudulently raised over $10 million by overstating their own investments in the company.
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March 04, 2025
IRS Asks To Toss Abbott Labs' FOIA Action For Tax Records
Discovery limitations in a U.S. Tax Court case apply to documents related to an Internal Revenue Service investigation of Abbott Laboratories' transfer policies and thus mean that Abbott can't access them with a Freedom of Information Act request, the IRS told a D.C. federal court.
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March 04, 2025
Lead Testing Operations Chief To Admit Misbranding Charge
The former chief operating officer of Magellan Diagnostics will admit to defrauding the public by hiding flaws in the company's lead testing devices for years, according to a filing in Massachusetts federal court.
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March 04, 2025
Feds Seek 40 Mos. For Husband Of Ex-Takeda Exec
The husband of a former Takeda Pharmaceuticals vice president should spend more than three years in custody for his role in a fraudulent invoice scheme that netted the couple $2.3 million, prosecutors have told a federal judge in Massachusetts.
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March 03, 2025
Ultragenyx Loses Bid To Toss Suit Over Henrietta Lacks' Cells
A Maryland federal judge on Monday refused to toss a lawsuit lodged by the family of the late Henrietta Lacks against biotechnology company Ultragenyx for allegedly profiting off her stolen "immortal" cells, saying proof Ultragenyx engaged in intrastate business in Maryland would thwart its contention the lawsuit was filed too late.
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March 03, 2025
Full Fed. Circ. Won't Take On Teva's Orange Book Appeal
The Federal Circuit on Monday rejected a request for an en banc rehearing from Teva Pharmaceuticals challenging a panel decision finding that the company improperly listed its asthma inhaler patents on a key U.S. Food and Drug Administration database that lists patents for drugs.
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March 03, 2025
Sandoz Settles Florida's Generic Drug Price-Fixing Claims
Sandoz AG reached a settlement with Florida that ends federal antitrust claims the Sunshine State lodged against the drugmaker within wider litigation claiming numerous pharmaceutical companies and individuals participated in a conspiracy to fix generic drug prices, according to a Friday court filing.
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March 03, 2025
Teva Should Face Key Copaxone Antitrust Claims, Court Told
Mylan and pharmaceutical wholesalers should be allowed to proceed with some, but not all, parallel claims accusing Teva of using regulatory deception, false advertising, improper rebates and more to delay generic competition to its Copaxone multiple sclerosis treatment, a special master has recommended in New Jersey federal court.
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March 03, 2025
Sanofi Grilled By Judge Over $1.2M In Amgen Patent Saga
A federal judge in Delaware has told lawyers for Sanofi to rethink some of a $1.2 million costs bid, pointing to issues he had with the "bells and whistles" in litigation costs the French pharmaceutical giant had proposed after its successful defense of a decade-long patent fight by Amgen over cholesterol medication.
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March 03, 2025
Calif. Farm Sues Tenn. Sheriff Over $3.9M In Destroyed Hemp
A California hemp farm is suing a Tennessee sheriff's department, alleging that a deputy wrongly arrested a driver who was carrying $3.9 million in legal hemp and had it destroyed.
Expert Analysis
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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.
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Consultants Should Be Aware Of DOJ's Potential New Reach
The U.S. Department of Justice's recent first-of-its-kind settlement with McKinsey & Co. indicates not only the DOJ's more aggressive stance toward businesses' potential criminal wrongdoings, but also the benefits of self-disclosure and cooperation when wrongdoing becomes apparent, says Dom Caamano at Kibler Fowler.
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Lessons Learned From 2024's Top FMLA Decisions
Last year's major litigation related to the Family and Medical Leave Act underscores why it is critical for employers to understand the basics of when leave and accommodations are required, say attorneys at Dechert.
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Product Safety Issues In 2024 Highlight Need For Vigilance
A look at some of the medications and foods that led to significant class actions last year demonstrates the need for robust regulatory systems and proactive measures to protect consumers from defective and harmful products, says Jennifer Taylor at the Law Offices of James Scott Farrin.
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Series
Playing Esports Makes Me A Better Lawyer
Competing in a global esports tournament at Wimbledon last year not only fulfilled my childhood dream, but also sharpened skills that are essential to my day job, including strategic thinking, confidence and networking, says AJ Schuyler at Jackson Lewis.
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Health Tech Regulatory Trends To Watch In 2025
With an upcoming change in administration and the release of some long-awaited rules, the healthcare industry should prepare for shifting trends, including a growing focus on health data and interest in technology-enabled delivery of healthcare, say attorneys at Orrick.