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Life Sciences
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October 22, 2024
Pharma Co. Verrica Faces Derivative Suit Over FDA Inspection
Current and former officers and directors of dermatological medication maker Verrica Pharmaceuticals Inc. face a shareholder derivative action alleging the company concealed a "litany of issues" with a manufacturer's facility that ultimately delayed U.S. Food and Drug Administration approval for a skin treatment.
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October 22, 2024
Biotech Cos. Keep Dancing Despite Purple Book Disclosures
Neither biologic nor biosimilar makers have dramatically altered how they engage in exchanging patent information with each other in the three years since a law went into effect making more of that data public, surprising attorneys who expected a certain amount of gamesmanship and withholding.
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October 22, 2024
IQVIA, Veeva Blast Summary Judgment Bids In Secrets Suit
Life sciences data giant IQVIA Inc. and competitor Veeva Systems Inc. slammed each other's summary judgment bids made public Tuesday in a trade secrets lawsuit in New Jersey federal court, with Veeva arguing that IQVIA's purported trade secrets are hardly confidential and IQVIA saying Veeva's assertions are "a last-ditch effort to avoid liability."
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October 22, 2024
Ark. Supreme Court Voids Nov. Effort To Expand Medical Pot
The Arkansas Supreme Court has determined that voters will not get to decide November 5 whether to expand the state's medical marijuana program via a ballot initiative after finding that the title and summary of the proposed constitutional amendment were misleading.
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October 22, 2024
Patent Office Finds Public Engagement Leader
The U.S. Patent and Trademark Office has tapped a former U.S. Small Business Administration program specialist to head the patent office's recently created section meant to bolster its outreach and communication efforts.
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October 22, 2024
Judge Skeptical Amgen Can't Sue Over Colo. Drug Price Caps
A Colorado federal judge on Tuesday seemed to doubt the state could short-circuit drugmaker Amgen's challenge to the state's drug price cap system, pressing the state to explain why limiting what consumers ultimately pay does not affect what companies like Amgen can charge.
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October 22, 2024
LA-Based Wound Group Hits Ch. 11 After Medicare Pay Pause
A Los Angeles-based multistate wound care practice has filed for Chapter 11 protection in a Texas bankruptcy court, saying it can't pay nearly $156 million in charges from its management company after its Medicare payments were suspended last month.
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October 22, 2024
NJ Justices Create Mass Tort Track For Bard Catheter Suits
The New Jersey Supreme Court has established a multicounty litigation track for cases seeking to hold C.R. Bard Inc., Bard Access Systems Inc. and Becton Dickinson and Co. liable for injuries allegedly caused by Bard implanted port catheter products, according to a notice to the bar.
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October 22, 2024
How Law Firms Get And Keep Elite Status
For decades, a handful of New York-based law firms thoroughly dominated the national consciousness when it came to power, profitability and prestige. But in today's legal market, increased movement of partners and clients from one firm to the next has begun to shake things up and create opportunities for go-getters to ascend the ranks.
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October 22, 2024
The 2024 Prestige Leaders
Check out our Prestige Leaders ranking, analysis and interactive graphics to see which firms stand out for their financial performance, attractiveness to attorneys and law students, ability to secure accolades and positive legal news media representation.
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October 22, 2024
In-House Counsel For Veeva, SingleStore Joins Stoel Rives
Stoel Rives LLP has hired the former in-house counsel for technology companies SingleStore and Veeva Systems Inc. in Boise, Idaho, positioning the firm to better serve the increasing demand for sophisticated transactional representations in the area.
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October 21, 2024
Eli Lilly Slams 'Dangerous' Knock-Off Weight Loss Drugs
Eli Lilly & Co. on Monday launched a trio of lawsuits in Indiana, Texas and Washington federal courts accusing three telehealth companies of peddling illicit knockoffs of its weight-loss medications that have not been approved by the U.S. Food and Drug Administration and that pose a danger to patients.
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October 21, 2024
Apple Tells Del. Jury It Wants Smartwatch Infringing To Stop
An Apple attorney told a federal jury in Delaware on Monday that the company is willing to accept only a token damage award from Masimo Corp. for the health tech company's infringement of Apple's smartwatch, but wants the alleged copying barred.
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October 21, 2024
FDA Tells Court Menthol Cigarette Ban Is Still Under Review
The U.S. Food and Drug Administration has said it's still evaluating whether to finalize a proposed ban on menthol cigarettes, urging a California federal court to throw out a lawsuit that's attempting a "judicial end-run" around the ongoing review.
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October 21, 2024
PBMs Keep Door Open To Constitutional Riposte Against FTC
Attorneys for Caremark Rx, Express Scripts and OptumRx kept the door open Monday to challenging the Federal Trade Commission's constitutionality as they face an in-house case accusing the country's three largest pharmacy benefit managers of artificially inflating insulin prices by relying on unfair rebate schemes.
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October 21, 2024
GOP Pols Want Probe Into FDA Laboratory Safety
Three Republican lawmakers on Friday sought information from the U.S. Food and Drug Administration about its oversight of its laboratory safety practices, following a long investigation over an incident about vials of smallpox virus and other hazards found on a National Institutes of Health campus.
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October 21, 2024
Novartis Loses Challenge To Medicare Drug Price Talks
A New Jersey federal judge on Friday tossed Novartis Pharmaceuticals' challenge to a Medicare drug price negotiation program, ruling the company is not required to participate, and that participating in the program does not violate its First Amendment rights.
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October 21, 2024
Goodwin Steers Biotech Firm Septerna's Plans For $175M IPO
Biotechnology firm Septerna Inc. on Monday launched plans for an estimated $175 million initial public offering, joining a hot market for drug developers of late, under guidance from Goodwin Procter LLP and underwriters' counsel Cooley LLP.
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October 21, 2024
McGuireWoods Adds Healthcare Atty From Cooley In NY
McGuireWoods LLP has added a digital health expert from Cooley LLP, aiming to boost its offerings for clients in the space combining healthcare services with information and communications technology, the firm announced Monday.
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October 21, 2024
Catalent CEO Defends Novo Deal, Will Stay On After Buyout
Catalent CEO Alessandro Maselli told the medical company's customers Monday that Catalent will continue to support them following its planned $16.5 billion sale to Novo Holdings, seeking to assure clientele after Sen. Elizabeth Warren and advocacy groups pressured the Federal Trade Commission to scrutinize and potentially block the deal.
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October 18, 2024
Law360 MVP Awards Go To Top Attys From 74 Firms
The attorneys chosen as Law360's 2024 MVPs have distinguished themselves from their peers by securing hard-earned successes in high-stakes litigation, complex global matters and record-breaking deals.
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October 18, 2024
What Attorneys Expect From Harris And Trump On Patents
Patents have scarcely been mentioned during the presidential campaign, but attorneys say that positions taken by the candidates suggest Donald Trump would favor stronger patent rights, while Kamala Harris would focus on steps to make drugs and other patented inventions more widely available.
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October 18, 2024
Chancery Keeps Better Therapeutics SPAC Suit Alive
A Delaware vice chancellor on Friday refused to dismiss a suit challenging the take-public merger of now-defunct Better Therapeutics, saying the investors have sufficiently pleaded direct breach of fiduciary duty claims against the medical technology business' special purpose acquisition company partner and its directors.
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October 18, 2024
Fed. Circ. Won't Question Reviving Vascepa Skinny Label Row
The Federal Circuit has said the full appellate court will not rethink a panel's decision reinstating Vascepa maker Amarin Pharma Inc.'s skinny label patent case against rival U.K. drugmaker Hikma.
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October 18, 2024
Cigna Says Florida Labs Owe $16M After 'Cheating' For Benefits
Three Florida substance abuse laboratories wrongly filed $16 million in claims for medically unnecessary tests and doubled their scheme by failing to seek patient payments, Cigna attorneys told a federal jury on Friday. The labs, however, accused the insurer of breaching policy agreements by failing to pay for services rendered.
Expert Analysis
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Fed. Circ. Skinny Label Ruling Guides On Infringement Claims
The Federal Circuit's recent decision in Amarin v. Hikma shows generic drug manufacturers must pay close attention to the statements in their abbreviated new drug application labels to put themselves in the best position in defending against an induced infringement claim, say Luke Shannon and Roshan Shrestha at Taft Stettinius.
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4 Takeaways From Biotech Patent Invalidity Ruling
The recent Patents Court decision in litigation between Advanced Cell Diagnostics and Molecular Instruments offers noteworthy commentary on issues related to experiments done in the ordinary course of business, joint importation, common general knowledge and mindset, and mosaicking for anticipation, say Nessa Khandaker and Darren Jiron at Finnegan.
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How To Clean Up Your Generative AI-Produced Legal Drafts
As law firms increasingly rely on generative artificial intelligence tools to produce legal text, attorneys should be on guard for the overuse of cohesive devices in initial drafts, and consider a few editing pointers to clean up AI’s repetitive and choppy outputs, says Ivy Grey at WordRake.
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Calif. Ruling Heightens Medical Product Maker Liability
The California Supreme Court's decision in Himes v. Somatics last month articulates a new causation standard for medical product manufacturer liability that may lead to stronger product disclosures nationwide and greater friction between manufacturers and physicians, say attorneys at Cooley.
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Constitutional Protections For Cannabis Companies Are Hazy
Cannabis businesses are subject to federal enforcement and tax, but often without the benefit of constitutional protections — and the entanglement of state and federal law and conflicting judicial opinions are creating confusion in the space, says Amber Lengacher at Purple Circle.
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USPTO Disclaimer Rule Would Complicate Patent Prosecution
The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.
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Series
Boxing Makes Me A Better Lawyer
Boxing has influenced my legal work by enabling me to confidently hone the skills I've learned from the sport, like the ability to remain calm under pressure, evaluate an opponent's weaknesses and recognize when to seize an important opportunity, says Kirsten Soto at Clyde & Co.
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Purdue Ch. 11 Ruling Reinforces Importance Of D&O Coverage
The U.S. Supreme Court's recent decision in Harrington v. Purdue Pharma, holding that a Chapter 11 reorganization cannot discharge claims against a nondebtor without affected claimants' consent, will open new litigation pathways surrounding corporate insolvency and increase the importance of robust directors and officers insurance, says Evan Bolla at Harris St. Laurent.
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Opinion
Industry Self-Regulation Will Shine Post-Chevron
The U.S. Supreme Court's Loper decision will shape the contours of industry self-regulation in the years to come, providing opportunities for this often-misunderstood practice, says Eric Reicin at BBB National Programs.
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3 Ways Agencies Will Keep Making Law After Chevron
The U.S. Supreme Court clearly thinks it has done something big in overturning the Chevron precedent that had given deference to agencies' statutory interpretations, but regulated parties have to consider how agencies retain significant power to shape the law and its meaning, say attorneys at K&L Gates.
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Roundup
After Chevron
Since the U.S. Supreme Court overturned the Chevron deference standard in June, this Expert Analysis series has featured attorneys discussing the potential impact across 36 different rulemaking and litigation areas.
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Series
After Chevron: Expect Few Changes In ITC Rulemaking
The U.S. Supreme Court's opinion overruling the Chevron doctrine will have less impact on the U.S. International Trade Commission than other agencies administering trade statutes, given that the commission exercises its congressionally granted authority in a manner that allows for consistent decision making at both agency and judicial levels, say attorneys at Polsinelli.
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6 PTAB Events To Know From The Last 6 Months
The first half of 2024 brought a flurry of Patent Trial and Appeal Board developments that should be considered in post-grant strategies, including proposed rules on discretionary denial and director review, and the first decisions of the Delegated Rehearing Panel, say attorneys at Fish & Richardson.
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Opinion
Atty Well-Being Efforts Ignore Root Causes Of The Problem
The legal industry is engaged in a critical conversation about lawyers' mental health, but current attorney well-being programs primarily focus on helping lawyers cope with the stress of excessive workloads, instead of examining whether this work culture is even fundamentally compatible with lawyer well-being, says Jonathan Baum at Avenir Guild.
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Parsing Justices' Toss Of Purdue's Controversial Ch. 11 Plan
The U.S. Supreme Court's recent nixing of OxyContin manufacturer Purdue Pharma's Chapter 11 proposal prevents the Sackler family from settling thousands of civil opioid lawsuits without the consent of all of the plaintiffs, and holds profound implications for bankruptcy cases, say attorneys at MoloLamken.