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Life Sciences
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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.
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April 25, 2024
3rd Circ. Lets Mallinckrodt Off Sanofi's Royalty Hook
A Third Circuit panel said Thursday that Mallinckrodt PLC's Chapter 11 bankruptcy could sever its obligation to pay Sanofi-Aventis US LLC royalties on sales of an autoimmune disease drug, finding that Sanofi's contract to sell Mallinckrodt the rights to the drug created a claim ripe to be extinguished.
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April 25, 2024
Becton BIPA Suit Gets Cut Short Under Health Exception
An Illinois federal judge permanently tossed a Chicago health worker's biometric privacy claims targeting Becton Dickinson and Co.'s drug dispensing cabinets, saying his arguments for putting distance between his case and foreclosing precedent "border on the frivolous."
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April 25, 2024
Philips Gets $506M Economic Loss Deal OK'd In CPAP MDL
A Pennsylvania federal judge on Thursday gave final approval to a $506.3 million settlement to end economic loss claims in multidistrict litigation over Philips' recalled CPAP breathing machines, including $94.4 million for the plaintiffs' attorneys.
Expert Analysis
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Opinion
Anti-Kickback Statute Does Not Require But-For Causation
A proper interpretation of the Anti-Kickback Statute clearly indicates that but-for causation is not required for False Claims Act Liability, and courts that hold otherwise will make it significantly easier for fraudsters to avoid accountability, says Kenneth Capesius at Baron & Budd.
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5 Litigation Funding Trends To Note In 2024
Over the next year and beyond, litigation funding will continue to evolve in ways that affect attorneys and the larger litigation landscape, from the growth of a secondary market for funded claims, to rising interest rates restricting the availability of capital, says Jeffery Lula at GLS Capital.
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Medtronic's Cautionary Tale Of Fed. Circ. Word Limits
The Federal Circuit's ruling in Medtronic v. Teleflex that Medtronic waived an argument that it had sought to incorporate by reference illustrates the pitfalls facing parties in complex patent cases involving numerous issues that cannot all be addressed within the strict word limits for appellate briefs, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Key Legal Trends For Healthcare And Life Sciences In 2024
Due to the impact of contentious legal battles over drug pricing negotiations, the growing integration of artificial intelligence into drug development and manufacturing, and the publication of industry segment-specific guidance, the year ahead promises to be a dynamic period of changes and challenges, say Xin Tao and Lois Liu at Baker McKenzie.
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Series
ESG Around The World: South Africa
While South Africa has yet to mandate the reporting of nonfinancial and environmental, social, and corporate governance issues, policy documents and recent legislative developments are likely to have a material impact in the country's transition to a low-carbon economy and in meeting its international obligations, say Glynn Kent at Eversheds Sutherland.
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FOIA Exemption Questions On Redacted HHS Cannabis Letter
The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.
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Fed. Circ. Ruling Seemingly Offers PTAB Deadline Immunity
The Federal Circuit's recent Purdue Pharma v. Collegium Pharmaceutical Inc. decision that the Patent Trial and Appeal Board had authority to issue a final written decision in a post grant review after the prescribed statutory deadline underscores how courts should consider the overall objective of the statutory scheme when balancing the classic conflict between bright-line rules and flexible standards, says Matthew Dowd at Dowd Sheffel.
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Evaluating Retroactivity Of Mich. Drugmaker Immunity Repeal
In assessing whether a new Michigan law lifting drugmakers' blanket immunity from product liability suits will apply retroactively, there are four key factors that Michigan courts will likely consider, say Sherry Knutson and Brenda Sweet at Tucker Ellis.
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4 Legal Ethics Considerations For The New Year
As attorneys and clients reset for a new year, now is a good time to take a step back and review some core ethical issues that attorneys should keep front of mind in 2024, including approaching generative artificial intelligence with caution and care, and avoiding pitfalls in outside counsel guidelines, say attorneys at HWG.
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FTC Rite Aid Order Holds Biometrics And AI Compliance Tips
The Federal Trade Commission's recent enforcement action against Rite Aid over its use of facial biometric technology on customers provides lessons that can be leveraged to reduce and manage the risk of regulatory scrutiny of biometrics and artificial intelligence, says David Oberly at Baker Donelson.
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Bribery Settlement Gives Insight On DOJ Policies
Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.
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SEC Case May Expand Scope Of Insider Trading Liability
The U.S. Securities and Exchange Commission's first-of-its-kind enforcement action against an individual in a case involving "shadow trading" demarcates an expansion of insider trading liability to circumstances in which there is a market connection between the source of information and the issuer of the securities traded, say attorneys at Steptoe.
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Opinion
Waiving COVID-19 IP Protections Would Harm US Industry
President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.
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Fed. Circ. Patent Decisions In 2023: An Empirical Review
The Federal Circuit decided 306 patent cases last year, which is still well down from the pre-pandemic norm of around 440, and on the whole the court's decisions were markedly less patentee-friendly in 2023 than in 2022, says Dan Bagatell at Perkins Coie.
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What The Law Firm Of The Future Will Look Like
As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.