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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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10 Lessons From A Deep Dive Into IP Damages
Decisions on challenging an intellectual property expert's opinion can benefit from the in-depth study of court rulings on admissibility grounds, where the findings include the fact that patent cases see the most challenges of any IP area, say Deepa Sundararaman and Cleve Tyler at Berkeley Research.
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What Shareholder Approval Rule Changes Mean For Cos.
The U.S. Securities and Exchange Commission recently approved proposed rule changes to shareholder requirements by the New York Stock Exchange, an approval that will benefit listed companies in many ways, including by making it easier to raise capital from passive investors, say attorneys at Baker Botts.
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Reimagining Law Firm Culture To Break The Cycle Of Burnout
While attorney burnout remains a perennial issue in the legal profession, shifting post-pandemic expectations mean that law firms must adapt their office cultures to retain talent, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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Expediting Psychedelics Approvals In The EU, UK, Australia
Accelerated pathways for regulatory approvals for psychedelic drugs in the European Union, U.K. and Australia is indispensable to facilitate a seamless advancement of treatments from the research environment to the consumer, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.
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Series
ESG Around The World: Brazil
Environmental, social and governance issues have increasingly translated into new legislation in Brazil since 2020, and in the wake of these recently enacted regulations, we are likely to see a growing number of legal disputes in the largest South American country related to ESG issues such as greenwashing if companies are not prepared to adequately adapt and comply, say attorneys at Mattos Filho.
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Opinion
Gilead Ruling Signals That Innovating Can Lead To Liability
A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.
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Opinion
Vidal Should Amend USPTO Precedent In Automaker Review
U.S. Patent and Trademark Office Director Kathi Vidal's recent decision to review Ford and Honda patent challenges that were rejected by the Patent Trial and Appeal Board provides an opportunity to revisit precedents that have unfairly denied companies a fair review process and align them with commonsense principles of legal equity, says former Sen. Patrick Leahy.
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Grant Compliance Takeaways From Ga. Tech's FCA Settlement
Georgia Tech’s recent False Claims Act settlement over its failure to detect compliance shortcomings in a grant program was unique in that it involved a voluntary repayment of funds prior to the resolution, offering a few key lessons for universities receiving research funding from the government, says Jonathan Porter at Husch Blackwell.
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Series
Competing In Dressage Makes Me A Better Lawyer
My lifelong participation in the sport of dressage — often called ballet on horses — has proven that several skills developed through training and competition are transferable to legal work, especially the ability to harness focus, persistence and versatility when negotiating a deal, says Stephanie Coco at V&E.
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How Poor Governance, Weak Contracts Harm Cannabis Cos.
Decades into cannabis decriminalization and legalization, many companies in the industry still operate on a handshake basis or fail to keep even minimally required records, which can have devastating effects and lead to costly, business-killing litigation, says Griffen Thorne at Harris Bricken.
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Del. Ruling Adds Momentum For Caremark Plaintiffs
The Delaware Supreme Court's recent opinion in Lebanon County Employees' Retirement Fund v. Collis could be viewed as expanding plaintiffs' ability to viably plead a Caremark claim against directors, so Delaware companies should be on heightened alert and focus on creating a record of board oversight, say attorneys at V&E.
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How Biotech Cos. Can Utilize Synthetic Royalty Financing
Synthetic royalty transactions have been on the rise as a funding structure for biotechnology companies, but questions have arisen surrounding how such transactions work, and structuring them correctly requires a nuanced understanding, say Todd Trattner and Ryan Murr at Gibson Dunn.
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The Legal Industry Needs A Cybersecurity Paradigm Shift
As law firms face ever-increasing risks of cyberattacks and ransomware incidents, the legal industry must implement robust cybersecurity measures and privacy-centric practices to preserve attorney-client privilege, safeguard client trust and uphold the profession’s integrity, says Ryan Paterson at Unplugged.
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Fed. Circ. In Jan.: One Word Can Affect Claim Construction
The Federal Circuit's recent Pacific Biosciences v. Personal Genomics decision highlights how even construction of a simple term can be dispositive, and thus disputed, in view of the specific context provided by the surrounding claim language, say Jeremiah Helm and Sean Murray at Knobbe.
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5 Reasons Associates Shouldn't Take A Job Just For Money
As a number of BigLaw firms increase salary scales for early-career attorneys, law students and lateral associates considering new job offers should weigh several key factors that may matter more than financial compensation, say Albert Tawil at Lateral Hub and Ruvin Levavi at Power Forward.