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Life Sciences
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April 09, 2024
Life Sciences GCs On Tighter Regs, Outside Counsel Advice
General counsel at life sciences venture capital firms are navigating increased regulation in healthcare and looking to outside counsel to act as true advisers and problem-solvers as the healthcare industry becomes more complex.
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April 09, 2024
Jenner & Block Recruits Ex-Sheppard Mullin IP Litigator In SF
Jenner & Block LLP is boosting its intellectual property practice with the addition of a veteran trial lawyer as of counsel in its San Francisco office who was most recently with Sheppard Mullin Richter & Hampton LLP.
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April 09, 2024
Court OKs Decision Clearing Contractor Of Missed IP Deadline
A patent docketing contractor used by major remote law firm FisherBroyles can't be held liable for a "clerical mistake" that led to a missed patent application deadline and then a neurosurgeon's lawsuit potentially seeking nearly $102 million, with a Georgia appeals court affirming a lower court decision that the surgeon never should have relied on those dates in the first place.
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April 08, 2024
Target's Acne Treatments Contain Benzene, Customer Says
A Target customer in Illinois has launched consumer protection claims in federal court targeting acne treatments the retail giant allegedly manufactures and markets without disclosing benzene among their active ingredients.
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April 08, 2024
Walmart Beats Investor Suit Over Opioid Probe Disclosures
Walmart beat back an investor class action on Monday alleging it failed to properly disclose that it was the subject of parallel criminal and civil investigations over its opioid sales, with a Delaware federal judge ruling that the suit's challenged statements were not false or misleading.
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April 08, 2024
SEC 'Shadow Trading' Victory Could Bring DOJ Knocking
Now that the U.S. Securities and Exchange Commission has convinced a jury that a pharmaceutical executive committed insider trading by purchasing a competitor's stock in a practice often referred to as "shadow trading," attorneys say federal prosecutors might be tempted to dip their toe into the waters of the previously untested legal theory.
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April 08, 2024
Roche Again Beats Ex-Service Members' Antimalarial Drug Suit
A California federal judge on Monday tossed a second suit alleging Roche Inc. and its affiliates failed to warn service members that their antimalarial drug could have permanent psychiatric side effects, saying such claims are preempted by federal law.
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April 08, 2024
9th Circ. Urged To Revive J&J, Bausch Talc False Ad Suit
An attorney for a proposed class alleging they were misled by Johnson & Johnson and Bausch Health about their talc products' safety urged a Ninth Circuit panel on Monday to revive the suit, saying a lower court erred in finding his clients needed to point to specific advertisements that misled them.
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April 08, 2024
La. Drug Caps Conflict With Federal Law, AbbVie Says
Drugmaker AbbVie is asking a Louisiana federal judge to grant its summary judgment motion and block new state-level pharmaceutical caps for the federal 340B drug discount program, calling the state's competing summary judgment motion arguments "legally and factually wrong."
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April 08, 2024
PE Firm Calls FTC's Antitrust Claims 'Many Yesterdays' Old
A Texas anesthesiology company and the private equity firm that created it told a Houston federal judge Monday that the Federal Trade Commission has gone back "many yesterdays ago" in making its antitrust case, arguing that there's no imminent threat of a monopoly in an attempt to get the case dismissed.
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April 08, 2024
Catching Up With Delaware's Chancery Court
Last week, a much-watched Chancery Court Match.com decision got reversed, a Philip Morris motion got stubbed out, and a long-frozen Blue Bell Creameries suit started churning again. Delaware's Court of Chancery also saw new suits filed for legal fees, arguments over multibillion-dollar pay packages, and a judge flummoxed over Truth Social.
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April 08, 2024
FDA Finds No Asbestos In Cosmetic Talc Products
The U.S. Food and Drug Administration on Friday said that tests through a third-party contractor last year of cosmetic talc products revealed no traces of asbestos.
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April 08, 2024
Goodwin Adds 5-Atty Tech Team From Cooley In Boston
A team of five partners in technology and life sciences has left Cooley LLP for Goodwin Procter LLP's Boston office.
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April 08, 2024
Kirkland-Led Vista Buying Medtech Co. 'Model N' For $1.25B
Kirkland & Ellis LLP-led Vista Equity Partners has agreed to buy Fenwick & West LLP-advised Model N, a provider of revenue optimization and compliance tools for healthcare tech companies, in a take-private transaction valued at approximately $1.25 billion, the companies said Monday.
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April 05, 2024
Apple Asks Fed. Circ. To Upend ITC Watch Feature Ban
The U.S. International Trade Commission overstepped its authority in banning the import of the Apple Watch after finding it infringes Masimo Corp. patents on technology measuring oxygen in blood, Apple told the Federal Circuit on Friday, saying Masimo rushed its claims before the commission without having a product practicing the asserted patents.
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April 05, 2024
'Take The Win,' Judge Tells Texas In HHS Abortion Pill Suit
Texas' lawsuit challenging the Biden administration's guidance to require pharmacies to dispense abortion medication is moot following revised U.S. Department of Health and Human Services guidance clarifying that access to the drug isn't for abortion purposes, a federal judge ruled Friday, saying the state "should take the win."
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April 05, 2024
Abbott Settles TM Suit Over Gray Market Diabetes Test Strips
Abbott Laboratories told a New York federal judge Friday that the company has settled what remains of its trademark litigation campaign against makers of gray market diabetes test strips that has been going on since 2015.
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April 05, 2024
Judge Lourie's Dissent Revives Debate Over FDA Safe Harbor
U.S. Circuit Judge Alan Lourie has urged the Federal Circuit to reconsider its precedent over a safe harbor that allows infringement when companies are developing products regulated by the U.S. Food and Drug Administration, and many attorneys agreed with him that the appeals court has been improperly expanding the safe harbor for decades.
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April 05, 2024
Fed. Circ. Says Sumitomo's Expired Drug Patent Moots Appeal
The U.S. Patent and Trademark Office received a win on Friday when the Federal Circuit found that since Sumitomo Pharma's patent on a dosage regimen for a schizophrenia drug expired just before the appeals court heard oral arguments, the company's appeal of a decision invalidating all the claims is moot.
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April 05, 2024
Texas Man Gets 7 Years For COVID Testing Fraud
A Texas man was sentenced to seven years in prison and ordered to pay more than $7 million in restitution for colluding with three co-conspirators to conduct a COVID-19 testing scheme, the U.S. Department of Justice announced Thursday.
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April 05, 2024
Ex-Biopharma Officer Seeks Defense Fees Over Fraud Suit
Biopharmaceutical company EpicentRx has been slapped with a lawsuit in Delaware's Court of Chancery by its former corporate secretary and outside counsel seeking advancements of legal fees he has incurred in response to ongoing litigation accusing the company and its officers of fraud.
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April 05, 2024
Mich. Plaintiffs Bar Prepares For Growth After Policy Shifts
After decades of the deck stacked against them, Michigan's plaintiffs attorneys are poised to take advantage of a more hospitable environment for personal injury cases and pharmaceutical class actions, though experts caution the learning curve will be steep.
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April 05, 2024
Publix Wants Ga. High Court Input On Opioid Public Nuisance
Grocery chain Publix has asked the Ohio federal court overseeing the opioid multidistrict litigation to send questions to Georgia's high court about whether that state's law allows public nuisance claims over a healthcare provider's dispensing of prescription narcotics.
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April 05, 2024
Jury Finds Pharma Exec 'Shadow Traded' With Inside Info
A California federal jury found Friday that a former Medivation executive is liable for using inside information from his company when he purchased stock in rival pharmaceutical maker Incyte, in a novel civil "shadow trading" case brought by the U.S. Securities and Exchange Commission.
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April 05, 2024
New Chancery Challenge Launched To Board-Investor Pacts
A biopharmaceutical company stockholder has teed up a new Delaware Chancery Court suit challenging board-investor voting agreements, with the complaint acknowledging wide debate over the pacts and a fast-moving push to amend state corporation law to authorize them.
Expert Analysis
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2024 Trends To Watch As AI And IP Litigation Intersect
Just as generative artificial intelligence tools have proven unpredictable, the resulting legal disputes may also hold a few surprises in store for 2024, as intellectual property litigation related to AI inputs, outputs and the tools themselves takes shape, say Philip Warrick and Chengming Liu at Irell & Manella.
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9th Circ. Scienter Ruling May Strengthen FDA's Leverage
A recent Ninth Circuit decision in U.S. v. Marschall — regarding scienter and violations of the Federal Food Drug and Cosmetic Act — appears to give the U.S. Food and Drug Administration another arrow in its quiver to lob in the direction of any repeat offender, with potentially very broad applications, say Elena Quattrone and Zachary Taylor at Epstein Becker.
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In The World Of Legal Ethics, 10 Trends To Note From 2023
Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.
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What China's New Rare Disease Catalog Means For Drug Cos.
A new list of rare diseases released by the Chinese government may present opportunities for multinational developers of designated orphan drugs to take advantage of preferential policies including exemption from clinical trials, priority review and tax incentives, say attorneys at Zhong Lun Law Firm.
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How Attorneys Can Be More Efficient This Holiday Season
Attorneys should consider a few key tips to speed up their work during the holidays so they can join the festivities — from streamlining the document review process to creating similar folder structures, says Bennett Rawicki at Hilgers Graben.
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3 Defense Takeaways From The Bankman-Fried Trial
FTX founder and former CEO Sam Bankman-Fried’s recent fraud conviction offers several key lessons for future white collar defendants, from the changing nature of cross-examination to the continued risks of taking the stand, say Jonathan Porter and Gregg Sofer at Husch Blackwell.
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Series
Children's Book Writing Makes Me A Better Lawyer
Becoming a children's book author has opened doors to incredible new experiences of which I barely dared to dream, but the process has also changed my life by serving as a reminder that strong writing, networking and public speaking skills are hugely beneficial to a legal career, says Shaunna Bailey at Sheppard Mullin.
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How The PTAB Landscape Shifted In 2023
Attorneys at Finnegan consider the impact of noteworthy Patent Trial and Appeal Board developments in 2023, including rulemaking, litigation, precedential decisions and director reviews that affected PTAB practice, and offer a reference for examining future proceedings and strategies.
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New Pharma Guidelines Bring Pitfalls For Compounders
New guidelines from U.S. Pharmacopeia, which went into effect last month, require some extensive and potentially expensive compliance efforts from hospitals and compounding pharmacies, and smaller compounders could particularly struggle, says Natalia Mazina at Mazina Law.
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Opinion
What Happens If High Court Rejects Releases In Purdue Ch. 11
Reading the tea leaves following the U.S. Supreme Court's recent arguments in Harrington v. Purdue Pharma, it appears likely that the justices will decide that bankruptcy courts lack the power to release third-party claims against nondebtors, which would result in one of three scenarios, says Gregory Germain at Syracuse University.
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FDA's Recent Litigation Records Are Strong, But Imperfect
The U.S. Food and Drug Administration has notched its share of litigation wins in recent years thanks to a number of key advantages, but the FDA has been less successful in certain highly visible arenas, Jonathan Berman and Colleen Heisey at Jones Day.
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Coming To Terms With Means-Plus-Function Patent Claims
Made-up patent claim terms can open arguments that means-plus-function claim interpretation applies under the Patent Act, but a series of practice tips, including the use of structural language immediately after introducing a claim element, can help avoid such perceptions, says Brad Luchsinger at Harness IP.
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5 Steps For Healthcare Companies After Biden's AI Order
Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.
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Opinion
Giving The Gov't Drug Patent March-In Authority Is Bad Policy
The Biden administration's recent proposal to allow government seizure of certain taxpayer-funded drug patents is a terrible idea that would negate the benefits of government-funded research, to the detriment of patients and the wider economy, says Wayne Winegarden at Pacific Research Institute.
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How Clients May Use AI To Monitor Attorneys
Excerpt from Practical Guidance
Artificial intelligence tools will increasingly enable clients to monitor and evaluate their counsel’s activities, so attorneys must clearly define the terms of engagement and likewise take advantage of the efficiencies offered by AI, says Ronald Levine at Herrick Feinstein.