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Life Sciences
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March 05, 2025
Pfizer Beats Claims Of Copay Aid Scheme For Good
Litigation firms accusing Pfizer of a scheme to inflate drug prices for Medicare and Medicaid plans saw their suit dismissed permanently, with a Washington, D.C., federal judge ruling they had been given "enough chances" to remedy pleading deficiencies in their claims.
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March 05, 2025
Nationwide Block Of Trump Trans Healthcare Orders Extended
A Maryland federal judge has extended a nationwide injunction that was set to expire this week prohibiting the Trump administration from enforcing executive orders banning federal funding for gender-affirming care for people under the age of 19, finding the harm inflicted by the orders is "non-speculative, concrete, and potentially catastrophic."
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March 05, 2025
Biotech Co. Maravai Hit With Investor's Internal Controls Suit
Health research tools company Maravai LifeSciences Holdings Inc. has been hit with a proposed shareholder class action alleging it failed to report that it had issues with its internal reporting controls ahead of its announcement that an inaccurate report led to the misallocation of $3.9 million.
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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.
Expert Analysis
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The Shifting Role Of Patent Attorneys In The Age Of AI
The integration of artificial intelligence into patent drafting represents a significant change in how legal work is performed, and patent attorneys must shift from manual drafting to a strategy-oriented approach, says Ian Schick at Draft Builders.
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8 Childhood Lessons That Can Help You Be A Better Attorney
A new school year is underway, marking a fitting time for attorneys to reflect on some fundamental life lessons from early childhood that offer a framework for problems that no legal textbook can solve, say Chris Gismondi and Chris Campbell at DLA Piper.
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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.