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Life Sciences
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October 31, 2024
Purdue Gets More Time For Deal, 'Substantial' Progress Made
Bankrupt OxyContin maker Purdue Pharma LP on Thursday won more time to continue mediating a new settlement with its owners — certain members of the Sackler family — and reported that it is nearing a deal, in a bid to avoid having one of the most complex Chapter 11 cases in U.S. history tumble into a litigation free-for-all.
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October 31, 2024
Flint Water Case Paused For 'Advanced' Settlement Talks
Days after a jury trial meant to decide whether a water firm failed to properly warn of the dangers of the city of Flint's water was delayed a second time, a Michigan federal judge paused two bellwether cases because of "advanced settlement negotiations" between individual plaintiffs and the firm.
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October 31, 2024
Judge Upholds Sanctions Against Ex-Stimwave CEO
A Delaware federal judge has upheld a decision by the bankruptcy judge overseeing the Chapter 11 case of medical device maker Stimwave Technologies to screen the filings of the company's ex-CEO and two of her relatives.
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October 31, 2024
The 2024 Law360 Pulse Leaderboard
Check out the Law360 Pulse Leaderboard to see which firms made the list of leaders in all-around excellence this year.
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October 31, 2024
Firms' Hiring Strategies Are Evolving In Fight For Top Spot
Competition for top talent among elite law firms shows no signs of slowing down, even amid economic uncertainty, with financially strong firms deploying aggressive strategies to attract and retain skilled professionals to solidify their market position.
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October 31, 2024
Teva Fined €463M For Blocking Rival MS Drug Launch
The European Union antitrust enforcer hit pharmaceutical giant Teva with a €463 million ($502 million) fine Thursday for launching a smear campaign against a rival multiple sclerosis drug and misusing the patent system to thwart the competitor's attempt to enter the market.
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October 30, 2024
FDA Didn't Flub Approval In Orphan Drug Case, DC Court Says
The U.S. Food and Drug Administration didn't err in determining that a rival narcolepsy treatment is not the "same drug" as Jazz Pharmaceuticals' exclusive treatment, a D.C. federal judge ruled Wednesday, holding that the FDA's approval of the rival drug didn't run afoul of the Orphan Drug Act.
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October 30, 2024
Alleged Kickback Plotters Can Waive Conflict Over Attorney
A Colorado federal judge on Wednesday concluded that a lab testing company owner charged with participating in a kickback scheme to defraud Medicare and a man who pled guilty to participating in a connected conspiracy could waive any conflicts that might arise from both using the same attorney.
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October 30, 2024
Cigna Wants $16.1M, Florida Labs Seek $5.1M In Benefits Feud
Cigna should pay $5.1 million for harming three Florida laboratories by wrongfully declaring thousands of substance abuse treatment tests medically unnecessary, the labs told a Connecticut jury Wednesday, while Cigna asked to recoup $16.1 million in payouts to the labs for what it called "wasteful" tests.
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October 30, 2024
LA Times Owner Faces Investor Suit Over Drug Co.'s Woes
Officers and directors of biotechnology company ImmunityBio Inc., including L.A. Times owner Patrick Soon-Shiong, face a shareholder's derivative complaint alleging the company concealed issues affecting a path to regulatory approval for one of its key product candidates.
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October 30, 2024
After Exeltis Win, Judge Won't Allow Suits On Dropped Patents
A Delaware federal judge has shot down a request that seven patents Insud Pharma's New Jersey-based division Exeltis USA Inc. dropped in patent litigation against Lupin Pharmaceuticals Inc. be dismissed in a way where they could be refiled later.
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October 30, 2024
Publix Denied Early Win Over Opioid Coverage Defense
A Florida federal court rejected Publix's bid for defense cost coverage for dozens of public nuisance lawsuits related to the opioid crisis, finding that the damages sought are too far removed from particular bodily injuries caused "because of" opioid addiction, as required in Publix's policies.
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October 30, 2024
3rd Circ. Told Medicare Drug Price Talks Not Voluntary
Three pharmaceutical companies told the Third Circuit on Wednesday the Medicare drug price negotiation program is anything but voluntary, arguing the appeals court should revive their challenges to the program because it is unconstitutional.
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October 30, 2024
Biopharma Co. Can't Knock Ex-CFO's Bias Suit Out Of Court
A biopharmaceutical development company can't kick a fired executive's bias suit to arbitration, a California federal judge said, ruling that the harassment she said she faced on the job was gendered enough to invoke a federal law curbing out-of-court-resolutions of sex harassment claims.
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October 30, 2024
Ex-Takeda Exec. Gets Nearly 4 Years For Fake Invoice Scam
A former Takeda Pharmaceuticals executive was sentenced Wednesday to 46 months in prison for stealing millions from the drug company through a fake invoice scam that a Boston federal judge characterized as "utterly unnecessary and pointless" and carried out for no other reason than to fund a luxurious lifestyle.
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October 30, 2024
Yale Researcher's Suit Over Loss Of 'Life's Work' Transferred
A Connecticut state court judge in Fairfield is passing on a researcher's lawsuit accusing Yale School of Medicine of destroying two decades of research worth $28 million, transferring the case to the complex litigation docket in Hartford.
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October 30, 2024
Ohio PBM Case Will Wait For High Court Ruling
The Sixth Circuit agreed to pause a case from Ohio state enforcers accusing Express Scripts and Prime Therapeutics of driving up prescription drug prices while the U.S. Supreme Court decides another case dealing with federal versus state jurisdiction.
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October 30, 2024
DLA Piper's FDA Regulation Vice Chair Joins White & Case
The former vice chair of DLA Piper's FDA regulatory practice has joined White & Case LLP's global life sciences and healthcare group and intellectual property practice.
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October 29, 2024
NY Judge Tosses $14B Decongestant MDL
A New York federal judge threw out a streamlined complaint in a multidistrict litigation accusing companies such as Target and Bayer of making and selling ineffective over-the-counter decongestants, finding Tuesday the state claims are expressly preempted, and the proposed class lacks standing on a federal racketeering claim as indirect purchasers.
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October 29, 2024
Y-mAbs Therapeutics Investors Get Final OK For $19.7M Deal
A New York federal judge has granted final approval to a $19.7 million settlement between Y-mAbs Therapeutics and investors who claim the company misrepresented the likelihood that the U.S. Food and Drug Administration would approve the company's signature pediatric nerve cancer treatment, giving class counsel a $6.5 million cut of the deal.
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October 29, 2024
Retired Fed. Circ. Judge Backs Invisalign In Monopoly Cases
Retired Federal Circuit Judge Paul R. Michel warned the Ninth Circuit on Tuesday that reversing a lower court's decision to toss a pair of class actions accusing Invisalign of monopolizing the clear braces and teeth scanners market by illegally refusing to deal with a rival would increase patent owners' legal uncertainties.
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October 29, 2024
Patent Partner Moves From King & Spalding To Steptoe
A former King & Spalding LLP partner has made the jump to Steptoe LLP, filling out the firm's team of California-based litigators who take on patent cases.
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October 29, 2024
4th Circ. Quizzes Drugmaker Challenging W.Va. Abortion Law
An attorney arguing that West Virginia is preempted by federal law from restricting access to an abortion medication faced skeptical questions Tuesday from two judges who suggested it's entirely normal for states to regulate the practice of medicine.
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October 29, 2024
Biopharma Co. Escapes Investor Suit Over Drug Approval Lies
Biopharmaceutical company Spero Therapeutics Inc. has escaped a proposed investor class action accusing it of concealing warning signs that it would not secure regulatory approval of one of its drugs, with the court ruling that Spero's interactions with the U.S. Food and Drug Administration do not indicate Spero should have known its application would be rejected.
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October 29, 2024
Medical Co. Gets No Coverage For Toxic Tort
An insurer for B. Braun Medical Inc. has no duty to defend or indemnify the company against numerous lawsuits accusing B. Braun of exposing residents near one of its medical device manufacturing plants to a carcinogenic gas, a Pennsylvania federal court ruled, finding a pollution exclusion applicable.
Expert Analysis
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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.
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Allergan Ruling Reinforces Value Of Patent Term Adjustments
The Federal Circuit’s recent ruling in Allergan v. MSN, which held that patent term adjustment awards for first-filed, first-issued patents cannot be stripped away by later-issuing child patents that expire earlier, means practitioners must consider the potential impact of any action that might reduce the adjustment amount, say attorneys at Cooley.
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FTC Focus: How Scrutiny Of PBMs And Insulin May Play Out
Should Express Scripts' recent judicial challenge to the Federal Trade Commission succeed, any new targets could add litigation and choice of forum to their playbooks, and potential FTC court action on insulin could be forced to parallel venues as the issues between the commission and PBMs evolve, say attorneys at Proskauer.
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Opinion
AI May Limit Key Learning Opportunities For Young Attorneys
The thing that’s so powerful about artificial intelligence is also what’s most scary about it — its ability to detect patterns may curtail young attorneys’ chance to practice the lower-level work of managing cases, preventing them from ever honing the pattern recognition skills that undergird creative lawyering, says Sarah Murray at Trialcraft.
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Series
Round-Canopy Parachuting Makes Me A Better Lawyer
Similar to the practice of law, jumping from an in-flight airplane with nothing but training and a few yards of parachute silk is a demanding and stressful endeavor, and the experience has bolstered my legal practice by enhancing my focus, teamwork skills and sense of perspective, says Thomas Salerno at Stinson.
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And Now A Word From The Panel: The MDL Map
An intriguing yet unpredictable facet of multidistrict litigation practice is venue selection for new MDL proceedings, and the Judicial Panel on Multidistrict Litigation considers many factors when it assigns an MDL venue, says Alan Rothman at Sidley Austin.