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Life Sciences
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April 29, 2024
Boehringer Accused Of Monopolizing Inhaler Product Market
Boehringer Ingelheim Pharmaceuticals has manipulated the U.S. patent and drug approval system to unlawfully block makers of generic inhaler medications, health and welfare funds claimed in a lawsuit filed Monday in Connecticut federal court, arguing that the "availability of generics has tangible cost and life-saving effects."
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April 29, 2024
Pharma Co. Hit With Investor Suit Over Liver Drug Trials
Biopharmaceutical company Akero Therapeutics and three of its executives were hit with a proposed class action in California federal court alleging they made misleading statements about the patient population in a clinical trial for its liver disease treatment.
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April 29, 2024
HHS Delays Menthol Cigarette Ban Indefinitely
U.S. Secretary of the Department of Health and Human Services Xavier Becerra said Friday that a proposed ban on menthol cigarettes has been put on hold for now, citing the need to process considerable feedback from civil rights groups and the criminal justice movement.
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April 29, 2024
Amid Backlash, FDA Extends Control For Lab-Developed Tests
The U.S. Food and Drug Administration inked a final rule Monday that gives the agency broad authority over lab-developed tests by classifying them as medical devices, a move that has drawn ire from congressional leadership and those in the healthcare and life sciences industries.
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April 29, 2024
Catching Up With Delaware's Chancery Court
A multibillion-dollar Tesla trust proposal, a Truth Social bond, power plays over Prince's estate, and three in the ring for World Wrestling Entertainment. All of this and much more came up in Delaware Chancery Court dockets last week.
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April 29, 2024
AI Pharma Co. Sued By Investor Over Handling Of Fired CEO
Artificial intelligence-driven pharmaceutical company Exscientia PLC has been hit with a proposed class action alleging its former CEO engaged in inappropriate personal relationships with employees, and that the company's chairman knew but concealed it.
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April 29, 2024
Alcon Owes $34M In Glaucoma Patent Row, Jury Finds
A Delaware federal jury has found that Alcon and various related entities are on the hook for a $34 million judgment in a patent suit about medical devices to treat glaucoma launched by Sight Sciences.
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April 29, 2024
4th Circ. OKs Sanctions Against Law Firm In Bestwall Ch. 11
A split Fourth Circuit panel on Monday refused to overturn more than $402,000 in sanctions against a law firm and its clients as part of bankruptcy proceedings for a Georgia-Pacific unit, saying the contempt and sanctions orders can't be appealed because they aren't final judgments.
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April 29, 2024
PTAB Rejects Masimo's Concurrent Bid To Review Apple Patent
A board of administrative patent judges has declined one of the petitions challenging claims in an Apple patent involved in some of its disputes with medical technology startups Masimo and AliveCor, citing the board's skeptical view of "multiple, staggered petitions."
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April 29, 2024
Judge Rejects Class Certification Of Seizure Drug Customers
An Illinois federal judge has rejected a class certification bid in a suit against drugmaker Mallinckrodt and prescription delivery platform Express Scripts, ruling that the plaintiffs were unable to meet their predominance burden as a class.
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April 29, 2024
Connecticut Firm Seeks $500K Fee In Magnesium Class Action
A Connecticut law firm has asked a New Jersey federal judge to approve its request for $500,000 in attorney fees and expenses for its representation in a class action over a company's allegedly deceptive advertising of a magnesium supplement.
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April 29, 2024
Deciphera Stock Soars On $2.4B Deal With Japan's Ono
Deciphera Pharmaceuticals Inc. said Monday it has agreed to be purchased by Japan's Ono Pharmaceutical Co. Ltd. for $2.4 billion, which sent the Waltham, Massachusetts-based cancer drugmaker's stock soaring more than 72%.
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April 29, 2024
Justices To Weigh RICO Injury Scope In CBD Case
The U.S. Supreme Court on Monday agreed to hear a case brought by a trio of CBD companies asking the justices to establish whether a plaintiff can bring a personal injury claim under the Racketeer Influenced and Corrupt Organizations Act.
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April 29, 2024
Philips Inks $1.1B Deal To Resolve CPAP Injury Claims
The plaintiffs' attorneys leading a multidistrict litigation against Koninklijke Philips NV and some of its American subsidiaries announced Monday that they had reached a $1.1 billion settlement agreement for plaintiffs claiming that degraded foam in their breathing machines caused them personal injuries or will require long-term medical monitoring.
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April 26, 2024
Law360 Reveals Titans Of The Plaintiffs Bar
In the past year, plaintiffs have won settlements and judgments for millions and billions of dollars from companies such as Wells Fargo, Goldman Sachs, Facebook and Fox News, with many high-profile cases finally wrapping up after years of fighting. Such cases — involving over-the-top compensation packages, chemical contamination, gender discrimination and data mining — were led by attorneys whose accomplishments earned them recognition as Law360's Titans of the Plaintiffs Bar for 2024.
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April 26, 2024
Ex-McKinsey Partner Says Firm Made Him Opioids 'Scapegoat'
A former McKinsey & Co. partner lobbed defamation claims at the consulting firm, claiming Friday that it lied to the government and the public about his purported role in deleting evidence amid government investigations into the firm's work with opioid manufacturers, an alleged scheme designed to make him the "scapegoat."
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April 26, 2024
New FDA Official Talks Food Safety After Formula Outbreak
James "Jim" Jones, the first U.S. Food and Drug Administration deputy commissioner for human food, was named to the role last year in the wake of an infant formula contamination outbreak. He sat down this week with Law360 to discuss what he's learned from his first months in the position.
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April 26, 2024
Ex-USPTO Solicitor Heads To Carmichael IP
A veteran intellectual property attorney who once served as the chief legal officer at the U.S. Patent and Trademark Office has made the move to Carmichael IP PLLC.
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April 26, 2024
Latham, Akin Beat NJ Suit Over Alleged IP Theft Scheme
A New Jersey federal court on Friday tossed a lawsuit claiming attorneys from Latham & Watkins LLP and Akin Gump Strauss Hauer & Feld LLP manipulated patent litigation to steal a former Cornell University graduate student's DNA sequencing intellectual property, calling that graduate student's claims "conspiracy theories."
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April 26, 2024
Ga. Residents Want In On $300M Monkey Farm Fight
Four Georgia residents have asked a federal judge to let them intervene in a dispute over the construction of a sprawling primate-rearing farm in Bainbridge, alleging the local development authority that approved a $300 million bond deal for the project is colluding with the farm's backers to advance the project.
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April 25, 2024
QuidelOrtho Execs Lied About COVID Test Revenue, Suit Says
A QuidelOrtho Corp. investor on Thursday filed a derivative shareholder suit in New York federal court against board members and executives of the diagnostic healthcare company, alleging they made misleading statements about the company's ability to maintain a high margin revenue after sales of its COVID-19 detection tests plunged.
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April 25, 2024
Astellas Can't Block Generic Myrbetriq Amid Patent Suit
A Delaware federal judge has shot down Astellas Pharma's request to issue an injunction blocking rival pharmaceutical companies from selling generic copies of the overactive bladder medication Myrbetriq as they hash out a patent infringement suit, agreeing with a magistrate judge that Astellas isn't likely to win its case.
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April 25, 2024
CureVac, Acuitas Reach Deal In COVID Vax Patent Dispute
CureVac SE told a Virginia federal judge Thursday that it has reached a settlement to resolve Acuitas Therapeutics Inc.'s lawsuit inventorship credit on patents related to lipid nanoparticle technology used to develop the blockbuster Pfizer and BioNTech COVID-19 vaccine.
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April 25, 2024
GSK Hits Pfizer And BioNTech With COVID Vaccine Patent Suit
GlaxoSmithKline alleged in a suit filed Thursday in Delaware federal court that the COVID-19 vaccines made by Pfizer and BioNTech infringe five of its patents on mRNA technology, the latest in a series of lawsuits over the vaccines that have generated tens of billions of dollars in revenue.
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April 25, 2024
Stryker Says Sanctions Bid Goes 'Galaxies Beyond' Law
Medical device maker Stryker urged a Colorado federal judge to reject an ex-distributor's latest request for sanctions, arguing in a brief that the distributor's $2.2 million bid goes "galaxies beyond" what it asked for at trial and what the Tenth Circuit said the court could entertain.
Expert Analysis
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Opinion
Requiring Leave To File Amicus Briefs Is A Bad Idea
A proposal to amend the Federal Rules of Appellate Procedure that would require parties to get court permission before filing federal amicus briefs would eliminate the long-standing practice of consent filing and thereby make the process less open and democratic, says Lawrence Ebner at the Atlantic Legal Foundation and DRI Center.
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2 Recent Suits Show Resiliency Of Medicare Drug Price Law
Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.
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4 Ways To Motivate Junior Attorneys To Bring Their Best
As Gen Z and younger millennial attorneys increasingly express dissatisfaction with their work and head for the exits, the lawyers who manage them must understand and attend to their needs and priorities to boost engagement and increase retention, says Stacey Schwartz at Katten.
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Defense Attys Must Prep For Imminent AI Crime Enforcement
Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.
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Planning For Healthcare-Private Equity Antitrust Enforcement
U.S. antitrust agency developments could mean potential enforcement actions on healthcare-related acquisitions by private equity funds are on the way, and entities operating in this space should follow a series of practice tips, including early assessment of antitrust risks on both the state and federal level, say Ryan Quillian and John Kendrick at Covington.
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Opinion
Why USPTO Should Issue Inherency Guidance Memo
The U.S. Patent and Trademark Office should issue a new guidance memo in regard to the standard for inherency during the examination process, as the standard is frequently misapplied during prosecution, and consistency of the standard in the USPTO should match that in the federal courts, says Irving Feit at Lucas & Mercanti.
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How Purdue Pharma High Court Case May Change Bankruptcy
The U.S. Supreme Court’s upcoming ruling in Purdue Pharma may be the death of most third-party releases in Chapter 11 cases, and depending on the decision’s breadth, could have much more far-reaching effects on the entire bankruptcy system, say Brian Shaw and David Doyle at Cozen O'Connor.
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3 Health Insurance Paths For Psychedelic-Assisted Therapy
Ahead of potential U.S. Food and Drug Administration approvals for psychedelics as insured treatments, attorneys at Husch Blackwell review pathways for these drugs to achieve coverage as treatments for complex mental health conditions.
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Series
Serving As A Sheriff's Deputy Made Me A Better Lawyer
Skills developed during my work as a reserve deputy — where there was a need to always be prepared, decisive and articulate — transferred to my practice as an intellectual property litigator, and my experience taught me that clients often appreciate and relate to the desire to participate in extracurricular activities, says Michael Friedland at Friedland Cianfrani.
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Fears About The End Of Chevron Deference Are Overblown
While some are concerned about repercussions if the U.S. Supreme Court brings an end to Chevron deference in the Loper and Relentless cases this term, agencies and attorneys would survive just fine under the doctrines that have already begun to replace it, say Daniel Wolff and Henry Leung at Crowell & Moring.
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Negotiating Milestones In Pharma Licenses Requires Care
For life sciences companies, understanding the unique issues that arise in licensing agreements' milestone payment provisions can increase the likelihood and amount of payments received by the licensor and ensure payments are carefully and closely tied to events that truly drive value for the licensee, say Edward Angelini at Amneal Pharmaceutical and Lori Waldron at Sills Cummis.
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Former Minn. Chief Justice Instructs On Writing Better Briefs
Former Minnesota Supreme Court Chief Justice Lorie Gildea, now at Greenberg Traurig, offers strategies on writing more effective appellate briefs from her time on the bench.
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Stay Interviews Are Key To Retaining Legal Talent
Even as the economy shifts and layoffs continue, law firms still want to retain their top attorneys, and so-called stay interviews — informal conversations with employees to identify potential issues before they lead to turnover — can be a crucial tool for improving retention and morale, say Tina Cohen Nicol and Kate Reder Sheikh at Major Lindsey.
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Direct Claims Ruling May Alter Gov't Ties To Software Firms
A recent Federal Circuit decision allowing a software developer to pursue legal action under the Contract Disputes Act could change the government's relationship with commercial software providers by permitting direct claims, even in third-party purchase situations, say Dan Ramish and Zach Prince at Haynes Boone.
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Opinion
Intoxicating Hemp Products: It's High Time For Clarity
Thanks to ambiguity in the 2018 Farm Bill, intoxicating hemp cannabinoid products are largely unregulated and are widely available without restrictions on who can buy the products, and although there are several possible solutions, voluntary industry action by good actors is the best option, say Andrew Kline and Tommy Tobin at Perkins Coie.