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Life Sciences
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July 09, 2024
HEC Can't Get Damages Over Injunction In Novartis Feud
A Delaware federal court on Tuesday shot down HEC Pharm Co.'s bid for damages stemming from a preliminary injunction against it over the launch of a generic version of Novartis Pharmaceuticals' blockbuster multiple sclerosis treatment Gilenya.
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July 09, 2024
BCBS Unit Fails To Stop Religious Vaccine Objector Suits
A Blue Cross Blue Shield of Michigan subsidiary can't escape claims it treated differently employees who sought accommodations from a COVID-19 vaccine mandate, a Michigan federal judge ruled Tuesday, finding it plausible that religious discrimination "was at least a motivating factor" in the way the workers were dealt with.
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July 09, 2024
3rd Circ. Rips 2nd Circ. In Asset Freeze Ruling For SEC
The Third Circuit is standing by a lower court's decision to freeze a private equity executive's assets as he fights insider trading claims brought by the U.S. Securities and Exchange Commission, criticizing its sister circuit's approach to handling such issues in a precedential ruling Tuesday.
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July 09, 2024
NJ Panel Revokes Coverage For Pharma Co. In Fraud Row
A pharmaceutical company isn't covered for underlying accusations that it was a middleman in a self-dealing scheme orchestrated by its now-deceased board chairman, a New Jersey state appeals court ruled Tuesday, reversing a decision that a capacity exclusion in the company's directors and officers policy didn't apply.
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July 09, 2024
Purdue Plans 'High-Speed' Bid For New Ch. 11 Plan
Purdue Pharma told a New York bankruptcy judge Tuesday that it plans a two-month "high-speed, high-stakes" attempt to replace the Chapter 11 plan shot down by the U.S. Supreme Court last month before unleashing litigation on its former owning family.
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July 09, 2024
NJ Jury Begins Deliberating COVID Test Kit Fraud Case
Jurors began deliberating Tuesday in the retrial of a securities fraud case that ended with a dramatic mistrial after a juror announced in open court last December that he disagreed with the guilty verdict that had just been delivered by the jury forewoman.
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July 09, 2024
Terrorism Victims Push To Keep Pharma Suit In DC Circ.
Terrorism victims warned the D.C. Circuit against sending to a lower court a lawsuit seeking to link pharmaceutical companies to the attacks that injured them, saying a remand could delay the case and frustrate their efforts to collect evidence.
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July 09, 2024
FTC Says Drug Middlemen Inflate Costs, Squeeze Pharmacies
The Federal Trade Commission said Tuesday that its study of pharmacy benefit managers has shown that six large companies now control 95% of all prescriptions filled in the U.S., allowing them to profit at the expense of patients and independent pharmacies.
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July 09, 2024
Gov't Missed Merck Vax Potency Problem, 3rd Circ. Told
Two whistleblowers claiming that Merck & Co. had exaggerated the potency of its mumps vaccine told a Third Circuit panel Tuesday that the U.S. Centers for Disease Control and Prevention's continued purchasing of the vaccine was not proof that the agency knew but didn't care about the alleged deception.
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July 08, 2024
Emergent, J&J Reach $50M Deal In COVID Vax Supply Fight
Johnson & Johnson has agreed to pay Emergent BioSolutions $50 million to resolve claims stemming from a now-terminated COVID-19 vaccine manufacturing deal, according to a disclosure filed with the U.S. Securities and Exchange Commission on Monday.
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July 08, 2024
Biotech Slaps Intellia With IP Suit Over $100M Regeneron Deal
Biotechnology company BlueAllele Corp. sued Intellia Therapeutics Inc. in Delaware federal court Monday, claiming the rival has infringed on three of its patents related to gene editing and using its invented technology to reap over $100 million under a deal with another biotech, Regeneron Pharmaceuticals Inc.
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July 08, 2024
Jurors Told To Decide Who Is Lying In COVID Test Fraud Case
The task for jurors in the retrial of a securities fraud case over a COVID test kit deal that never materialized will be to determine not whether lies were told but who told them, according to closing arguments delivered Monday in New Jersey federal court.
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July 08, 2024
Blank Check Co. Sagaliam Gets Shareholder Suit Trimmed
A Delaware federal judge on Monday trimmed a shareholder suit brought against blank check company Sagaliam Acquisition Corp. over its planned tie-up with biotech company Enzolytics Inc., saying the plaintiffs failed to adequately plead a breach of fiduciary duty claim.
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July 08, 2024
Purdue Creditors Look To Sue Sacklers After Justices' Ruling
The official committee of unsecured creditors in the Chapter 11 case of drugmaker Purdue Pharma asked a New York bankruptcy judge on Monday for standing to bring actions against members of the Sackler family that own the company after the U.S. Supreme Court torpedoed a precarious settlement among the parties.
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July 08, 2024
Biotech Co. Alleges Arbitrator Conflict In Patent Award Fight
Pennsylvania-based biotechnology company Renmatix Inc. is urging the Delaware Court of Chancery to nix an arbitral award favoring Finnish company UPM-Kymmene Corp. in a long-running patent dispute, pointing to an allegedly undisclosed conflict of interest involving the Finnish company's counsel at DLA Piper.
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July 08, 2024
Kirkland, Fenwick Steer Lilly's $3.2B Morphic Acquisition
Eli Lilly and Co. unveiled Monday a $3.2 billion all-cash deal to acquire biopharmaceutical company Morphic Holding Inc., which is developing oral therapies to treat Crohn's disease and other bowel chronic diseases, in a 10-figure transaction guided by Kirkland & Ellis LLP and Fenwick & West LLP.
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July 08, 2024
Ex-Ga. Insurance Chief Wants Lighter Term In Kickback Case
Former Georgia Insurance Commissioner John Oxendine has objected to the government's recommendation that he serve 44 months in prison and pay a $700,000 fine for his role in a multimillion-dollar medical testing kickback scheme, arguing that he is deserving of a lesser sentence.
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July 08, 2024
Rite Aid Says Elixir Buyer In Contempt Over Liability Dispute
Bankrupt pharmacy chain Rite Aid has asked a New Jersey bankruptcy judge to find the purchaser of its prescription benefits subsidiary in contempt, saying the buyer is defying his orders by refusing to assume $200 million of the subsidiary's liabilities.
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July 08, 2024
Catching Up With Delaware's Chancery Court
Prince's heirs were left standing alone in a cold world last week after Delaware's Court of Chancery found their attempts to gain control of the late musician's estate too demanding. Delaware's court of equity also waved a wand for Walt Disney and slashed nearly $10 million from a damages award for Sears stockholders. In case you missed anything, here's a recap of all the latest news from Delaware's Chancery Court.
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July 08, 2024
The Biggest Patent Rulings Of 2024: A Midyear Report
The Federal Circuit issued its first en banc patent decision since 2018, a circuit judge's suspension was solidified and courts shed further light on foreign damages and skinny labels. Here's a look back at these rulings and other top patent decisions from the first half of 2024.
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July 05, 2024
How Reshaped Circuit Courts Are Faring At The High Court
Seminal rulings from the U.S. Supreme Court's latest term will reshape many facets of American society in the coming years. Already, however, the rulings offer glimpses of how the justices view specific circuit courts, which have themselves been reshaped by an abundance of new judges.
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July 05, 2024
Breaking Down The Vote: The High Court Term In Review
The U.S. Supreme Court's lethargic pace of decision-making this term left the justices to issue a slew of highly anticipated and controversial rulings during the term's final week — rulings that put the court's ideological divisions on vivid display. Here, Law360 takes a data dive into the numbers behind this court term.
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July 05, 2024
High Court Flexes Muscle To Limit Administrative State
The U.S. Supreme Court's dismantling of a 40-year-old judicial deference doctrine, coupled with rulings stripping federal agencies of certain enforcement powers and exposing them to additional litigation, has established the October 2023 term as likely the most consequential in administrative law history.
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July 05, 2024
The Sharpest Dissents From The Supreme Court Term
The U.S. Supreme Court's session ended with a series of blockbuster cases that granted the president broad immunity, changed federal gun policy and kneecapped administrative agencies. And many of the biggest decisions fell along partisan lines.
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July 05, 2024
5 Moments That Shaped The Supreme Court's Jan. 6 Decision
When the high court limited the scope of a federal obstruction statute used to charge hundreds of rioters who stormed the Capitol, the justices did not vote along ideological lines. In a year marked by 6-3 splits, what accounts for the departure? Here are some moments from oral arguments that may have swayed the justices.
Expert Analysis
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Series
Being An EMT Makes Me A Better Lawyer
While some of my experiences as an emergency medical technician have been unusually painful and searing, the skills I’ve learned — such as triage, empathy and preparedness — are just as useful in my work as a restructuring lawyer, says Marshall Huebner at Davis Polk.
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Mitigating Incarceration's Impacts On Foreign Nationals
Sentencing arguments that highlighted the disparate impact incarceration would have on a British national recently sentenced for insider training by a New York district court, when compared to similarly situated U.S. citizens, provide an example of the advocacy needed to avoid or mitigate problems unique to noncitizen defendants, say attorneys at Lankler Siffert.
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Contract Disputes Recap: Saying What Needs To Be Said
Edward Arnold and Bret Marfut at Seyfarth Shaw examine three recent decisions that delve into the meaning and effect of contractual releases, and demonstrate the importance of ensuring that releases, as written, do what the parties intend.
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Lessons On Challenging Class Plaintiffs' Expert Testimony
In class actions seeking damages, plaintiffs are increasingly using expert opinions to establish predominance, but several recent rulings from California federal courts shed light on how defendants can respond, say Jennifer Romano and Raija Horstman at Crowell & Moring.
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Exploring An Alternative Model Of Litigation Finance
A new model of litigation finance, most aptly described as insurance-backed litigation funding, differs from traditional funding in two key ways, and the process of securing it involves three primary steps, say Bob Koneck, Christopher Le Neve Foster and Richard Butters at Atlantic Global Risk LLC.
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Del. IP Ruling May Mark Limitation-By-Limitation Analysis Shift
A Delaware federal court's recent ruling in Lindis Biotech v. Amgen, which involved complex technology where the complaint contained neither facts nor a specific allegation directed to a claim limitation, might spark a shift away from requiring a limitation-by-limitation analysis, say Ted Mathias and Ian Swan at Axinn.
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Cell Therapy Cos. Must Beware Limits Of Patent Safe Harbors
Though developers of gene and cell therapy products commonly assume that a legal safe harbor protects them from patent infringement suits, recent case law shows that not all preapproval uses of patented technology are necessarily protected, say Natasha Daughtrey and Joshua Weinger at Goodwin.
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Series
Teaching Yoga Makes Me A Better Lawyer
Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.
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How Clinical Trials Affect Patentability In US And Europe
A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.
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A Vision For Economic Clerkships In The Legal System
As courts handle increasingly complex damages analyses involving vast amounts of data, an economic clerkship program — integrating early-career economists into the judicial system — could improve legal outcomes and provide essential training to clerks, say Mona Birjandi at Data for Decisions and Matt Farber at Secretariat.
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Opinion
State-Regulated Cannabis Can Thrive Without Section 280E
Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Opinion
Feds' Biotech Enforcement Efforts Are Too Heavy-Handed
The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.
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Regulating Resurrected Species Under The ESA
As the prospect of extinct species being resurrected from DNA and reintroduced into the wild grows closer, an analysis of the Endangered Species Act suggests that it could provide a thoughtful, flexible governance framework for such scenarios, say Caroline Meadows and Shelby Bobosky at the SMU Dedman School of Law.