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Life Sciences
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March 21, 2024
Home Health Cos. Stiffed Workers On OT Pay, Suit Claims
The operators of several Ohio-based home care staffing agencies have been failing to pay their employees for all the overtime hours they worked, according to a recent proposed class and collective action.
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March 21, 2024
Teleflex Catheter Patent Makes It Through Fed. Circ.
The Federal Circuit on Thursday opted to leave untouched an administrative patent board ruling that rejected a legal effort to invalidate a patent covering a type of catheter that's sold by Teleflex.
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March 21, 2024
Woman Lost Independence Due To Strattice Mesh, Jurors Told
A Kentucky woman told New Jersey state jurors on Thursday that LifeCell skipped important safety steps while designing its Strattice surgical mesh, and that those skipped steps caused a hernia to reoccur and ultimately resulted in the loss of her independence.
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March 21, 2024
3rd Circ. Agrees Investors Have No Case Against Vax Maker
The Third Circuit on Thursday upheld a Pennsylvania federal judge's ruling that a putative class of investors alleging biopharmaceutical company Ocugen Inc. made misleading statements about its ability to quickly produce a COVID-19 vaccine failed to state a claim against the company.
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March 21, 2024
6th Circ. Doubtful Of Hospital Workers' Vax Exemption Claim
A Sixth Circuit panel appeared skeptical Thursday of an argument from a class of former employees of Ohio Children's Hospital that their First Amendment rights to freedom of religion were violated under the hospital's COVID-19 employee vaccination policy.
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March 21, 2024
Fed. Circ. Upholds Edwards' PTAB Win On Heart Valve Patent
The Federal Circuit has affirmed a Patent Trial and Appeal Board finding that various parts of medical technology maker Cardiovalve's patent on an artificial heart valve implant were invalid as obvious.
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March 21, 2024
6th Circ. Zeroes In On CBA In Vax Bias Preemption Battle
A Sixth Circuit panel pressed on Thursday a cargo airline and pilots who say they were unlawfully fired for refusing COVID-19 vaccinations about the pilots' union contract, with one judge asking whether the open questions about their collective bargaining agreement meant the discrimination case was preempted.
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March 21, 2024
Chancery Denies Icahn Midcase Appeal In Illumina Board Suit
Carl Icahn can't interrupt his Chancery Court lawsuit against biotech Illumina Inc.'s board to appeal a decision about redactions to the Delaware Supreme Court, a vice chancellor ruled Wednesday, saying there are no "exceptional circumstances" that call for a midcase review.
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March 21, 2024
Greenberg Traurig Adds Jackson Walker FDA Pro In Houston
Greenberg Traurig LLP's most recent Houston addition is a shareholder who came aboard from Jackson Walker LLP, where he established and led its U.S. Food and Drug Administration practice.
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March 20, 2024
4th Circ. Backs Rockefeller Group in Guatemalans' Syphilis Suit
A group of Guatemalans who sued The Rockefeller Foundation over venereal disease experiments conducted on prisoners and psychiatric patients in the 1940s did not show an American doctor involved in the gruesome activities acted on behalf of the organization, a Fourth Circuit panel ruled Wednesday.
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March 20, 2024
Endo Plan To Trim $5B In Debt Confirmed By NY Judge
Drugmaker Endo International got a New York bankruptcy judge's approval for its Chapter 11 plan that aims to cut more than $5 billion in debt and hand over ownership to its lenders, roughly a month after it finalized a $465 million deal to resolve criminal and civil opioid claims.
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March 20, 2024
PTAB To Analyze Moderna COVID Vaccine Patents
The Patent Trial and Appeal Board has agreed to review two Moderna COVID-19 vaccine patents challenged by rivals Pfizer and BioNTech as having "unimaginably broad claims directed to a basic idea that was known long before."
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March 20, 2024
Jenner & Block-Led Lonza To Buy Roche's $1.2B US Facility
Swiss healthcare company Lonza said on Wednesday that it has agreed to acquire one of the largest medicine manufacturing facilities in the world from biotech giant Roche for $1.2 billion to increase its manufacturing capacity.
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March 20, 2024
Digital Comms Filings Bolster Record EPO Applications
Companies and inventors filed the highest number of European patent applications to date in 2023, buoyed by marked increases in filings for digital communications and energy technologies.
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March 20, 2024
Int'l Olympic Committee Rips Russia For Politicizing Sports
The International Olympic Committee has slammed Russia's newly created "Friendship Games" as a cynical ploy to politicize sports, saying that the Russian government's plan to host its own summer and winter games runs contrary to resolutions by the United Nations General Assembly.
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March 20, 2024
Top Attorney For Bristol-Myers Squibb Earned $5.9M In '23
The longtime general counsel for biopharma giant Bristol-Myers Squibb earned more than $5.9 million in compensation for last year, a figure that was down slightly from $6.1 million in 2022 but still buoyed by her work on its recent CEO transition and other matters.
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March 20, 2024
Boehringer Wins Diabetes Treatment Patent On Appeal In EU
Boehringer Ingelheim saved its diabetes drug patent from the chopping block after a European appellate board ruled that the treatment for patients with moderately damaged kidneys was new and innovative despite eight oppositions.
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March 20, 2024
How The Supreme Court Could Narrow Chevron
After hours of oral argument in a closely watched administrative law case, it appeared that some U.S. Supreme Court justices could be open to limiting the opportunities for lower courts to defer to federal agencies' legal interpretations in disputes over rulemaking — and legal experts said there are a number of ways they could do it.
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March 20, 2024
2 Biotechs Unveil Separate Fundings Totaling $325M
Life sciences companies Clasp Therapeutics and Cooley-advised Capstan Therapeutics, which develop treatments for a range of health conditions including cancer and autoimmune diseases, separately announced funding rounds Wednesday that together total $325 million.
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March 20, 2024
Law360 Announces The Members Of Its 2024 Editorial Boards
Law360 is pleased to announce the formation of its 2024 Editorial Advisory Boards.
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March 20, 2024
US Chamber's Litigation Funding Concerns Spur 2 State Laws
Amid concerns from the U.S. Chamber of Commerce about third-party litigation funding, including from potentially hostile foreign entities, state legislatures in Indiana and West Virginia have recently passed bills imposing restrictions on the practice.
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March 19, 2024
Healthcare Policy Roundup: HHS Budget, Telehealth, PBMs
Amid a government funding battle, work of interest to healthcare lawyers and agency watchers was getting done on federal legislation and policy in recent days.
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March 19, 2024
Schumer Scolds McConnell For Judge-Shopping Policy Rebuff
Senate Majority Leader Chuck Schumer on Tuesday lauded the Judicial Conference's updated policy on random case assignments to prevent litigants from judge-shopping, saying that Senate Minority Leader Mitch McConnell is pushing back against the policy since it'd make it tough for hard-right partisans "to hijack our courts for their purposes."
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March 19, 2024
Acorda Says Tribunal Ignored Patent Law In MS Drug Feud
Acorda Pharmaceuticals is pressing the Federal Circuit to award it nearly $66 million more than the $16.5 million it won in arbitration against Irish biopharmaceutical company Alkermes in a licensing fight over a multiple sclerosis drug, arguing that the tribunal disregarded clear patent law.
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March 19, 2024
Law Firm Hit With Suit Over Abandoned Patent Application
A Louisiana-based medical software company has sued a law firm that was hired to help it with an application for a patent for its platform, saying the firm's alleged negligence led to the application being abandoned.
Expert Analysis
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Cross-Market Implications In FTC's Anesthesia Complaint
The Federal Trade Commission's recent complaint against a private equity firm's acquisition of anesthesiology practices highlights the controversial issue of cross-market harm in health care provider mergers, and could provide important insights into how a court may view such theories of harm, say Christopher Lau and Dina Older Aguilar at Cornerstone Research.
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FTC Orange Book Move Signals New Pharma Patent Scrutiny
The Federal Trade Commission's recent dispute against improper listing of drug patents in the U.S. Food and Drug Administration's Orange Book indicates heightened surveillance of the pharmaceutical industry, particularly where competition-related consequences of patent or regulatory processes are concerned, say attorneys at Fenwick.
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AI Can Help Lawyers Overcome The Programming Barrier
Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.
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How Legal Teams Can Prep For Life Sciences' Tech Revolution
The life sciences and health care industries are uniquely positioned to take advantage of new efficiencies created by cloud computing and generative artificial intelligence, but the sensitivity of their data also demands careful navigation of an expanding legislative and regulatory landscape, say Kristi Gedid, Zack Laplante and Lisa LaMotta at Ernst & Young.
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Preparing Law Students For A New, AI-Assisted Legal World
As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.
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Series
ESG Around The World: South Korea
Numerous ESG trends have materialized in South Korea in the past three years, with impacts ranging from greenwashing prevention and carbon neutrality measures to workplace harassment and board diversity initiatives, say Chang Wook Min and Hyun Chan Jung at Jipyong.
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General Counsel Need Data Literacy To Keep Up With AI
With the rise of accessible and powerful generative artificial intelligence solutions, it is imperative for general counsel to understand the use and application of data for myriad important activities, from evaluating the e-discovery process to monitoring compliance analytics and more, says Colin Levy at Malbek.
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Trending At The PTAB: Administrative Procedure
A pair of recent Federal Circuit rulings on Patent Trial and Appeal Board inter partes review shed light on applications of the Administrative Procedure Act, adding to an ever-growing body of case law showing the board's final written decision must be based on arguments clearly put forth by the parties, say Robert High and Benjamin Saidman at Finnegan.
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Rite Aid's Reasons For Ch. 11 Go Beyond Opioid Suits
Despite opioid-related lawsuits being the perceived reason that pushed Rite Aid into bankruptcy, the company's recent Chapter 11 filing reveals its tenuous position in the pharmaceutical retail market, and only time will tell whether bankruptcy will right-size the company, says Daniel Gielchinsky at DGIM Law.
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Navigating Discovery Of Generative AI Information
As generative artificial intelligence tools become increasingly ubiquitous, companies must make sure to preserve generative AI data when there is reasonable expectation of litigation, and to include transcripts in litigation hold notices, as they may be relevant to discovery requests, say Nick Peterson and Corey Hauser at Wiley.
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FDA's Lab-Developed Test Rule May Bring Historic Challenges
If finalized, the U.S. Food and Drug Administration's proposed rule for regulating laboratory-developed tests will provoke some of the most interesting legal challenges that the agency has faced in decades, with outcomes that will likely reverberate across the agency's product centers, says Stacy Amin at MoFo.
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Finding Focus: Strategies For Attorneys With ADHD
Given the prevalence of ADHD among attorneys, it is imperative that the legal community gain a better understanding of how ADHD affects well-being, and that resources and strategies exist for attorneys with this disability to manage their symptoms and achieve success, say Casey Dixon at Dixon Life Coaching and Krista Larson at Stinson.
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A Look At DOJ's New Nationwide Investment Fraud Approach
Investment fraud charges are increasingly being brought in unlikely venues across the country, and the rationale behind the U.S. Department of Justice's approach could well be the heightened legal standards in connection with prosecuting investment fraud, says Jonathan Porter at Husch Blackwell.
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Earnout Contract Considerations After NC Good Faith Ruling
The North Carolina Supreme Court's recent Value Health Solutions v. Pharmaceutical Research decision, holding the implied covenant of good faith and fair dealing did not apply in an earnout dispute related to an asset sale, demonstrates the need for practitioners to pay careful attention to milestone concepts in M&A transactions, says Benjamin Hicks at Wagner Hicks.
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FDA's Off-Label Comms Guidance Is A Reluctant Step Forward
The U.S. Food and Drug Administration's latest draft guidance expands its safe harbor for health care providers that communicate information about their products' off-label uses, but does not fully resolve the First Amendment disconnect between federal courts and the agency's regulatory goals, say Jeffrey Shapiro and Lisa Dwyer at King & Spalding.