Life Sciences

  • April 09, 2024

    Philips, Feds Enter Consent Decree Over Sleep Apnea Devices

    Philips Respironics can't make sleep apnea breathing machines until it hires an independent monitor, undergoes inspections and meets its obligations under a plan to remediate patients affected by a 2021 recall of such devices, the U.S. Department of Justice and U.S. Food and Drug Administration announced Tuesday.

  • April 09, 2024

    Pfizer Cancer Drug Way Too Expensive, Biden Told

    The U.S. government is being asked yet again to use patent laws to lower the price of a prostate cancer drug that was developed at UCLA and is being sold by Pfizer for $136 a pill in the U.S.

  • April 09, 2024

    HK Arbitrator Halts Commercialization Of Leukemia Treatment

    A Cayman Islands pharmaceutical company has announced that an emergency arbitrator in Hong Kong has ordered a Chinese biopharma firm to stop commercializing a treatment for leukemia as the two companies arbitrate a dispute over a terminated license agreement.

  • April 09, 2024

    Former Pharma Exec Can't Oust Judge In Contempt Case

    A federal judge in Massachusetts on Tuesday denied what he called a "frivolous" motion to recuse himself from a criminal contempt proceeding against a former pharmaceutical executive who has acknowledged using an alias to flout an injunction banning him from working in the securities field.

  • April 09, 2024

    Endo Sues FDA Over Generic Adrenalin Approvals

    Endo has filed a lawsuit against federal health regulatory authorities, alleging that they are wrongfully giving the go-ahead for a generic version of the Adrenalin epinephrine injection, asking for a stay of the decision.

  • April 09, 2024

    Biotech Co. Insiders Sued In Del. Over $200M PIPE Deal Gain

    Investors of clinical-stage pharmaceutical company Taysha Gene Therapies Inc. sued the company's directors and officers in Delaware Chancery Court to recover more than $200 million in damages on behalf of the company after its insiders allegedly wrongfully profited from a public equity sale.

  • April 09, 2024

    Tech M&A Reigns Supreme In Q1 After Rare Hiccup In Q4

    The technology sector logged the greatest total value of global mergers and acquisitions in the first quarter of 2024, following a rare quarter that saw the industry fall out of the top spot and into third place, data from Dealogic shows.

  • 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.

  • 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.

  • 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.

  • 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. 

  • 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.

  • 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.

  • 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.

  • 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.

  • 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."

  • 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.

  • 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.

  • 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.

  • 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.

  • 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. 

  • 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.

  • 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."

  • 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.

  • 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.

Expert Analysis

  • Global Cartel Enforcement Looks Set To Intensify In 2024

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    The cartel enforcement winds may strengthen this year, with the U.S. Department of Justice, as well as regulators in other countries, placing a renewed focus on pursuing international cartels and more traditional, hard-core cartel conduct, say attorneys at Simpson Thacher.

  • Series

    Baking Bread Makes Me A Better Lawyer

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    After many years practicing law, and a few years baking bread, I have learned that there are a few keys to success in both endeavors, including the assembly of a nourishing and resilient culture, and the ability to learn from failure and exercise patience, says Rick Robinson at Reed Smith.

  • Supreme Court Amgen Ruling's Major Effect On Enablement

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    The U.S. Supreme Court's Amgen v. Sanofi invalidity holding continues to significantly affect technologies and all aspects of the patent system by providing confidence in the Federal Circuit's approach and a clearer understanding on enforceability and the disclosure needed for compliance, say Irena Royzman and Daniel Williams at Kramer Levin.

  • Federal Courts And AI Standing Orders: Safety Or Overkill?

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    Several district court judges have issued standing orders regulating the use of artificial intelligence in their courts, but courts should consider following ordinary notice and comment procedures before implementing sweeping mandates that could be unnecessarily burdensome and counterproductive, say attorneys at Curtis.

  • 7 E-Discovery Predictions For 2024 And Beyond

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    The legal and technical issues of e-discovery now affect virtually every lawsuit, and in the year to come, practitioners can expect practices and policies to evolve in a number of ways, from the expanded use of relevancy redactions to mandated information security provisions in protective orders, say attorneys at Littler.

  • Top Considerations For Retailers Using AI To Combat Theft

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    The Federal Trade Commission's recent enforcement action against Rite Aid indicates a significant evolution in the landscape surrounding biometric information and artificial intelligence data collection by retailers, meaning retailers should take reasonable measures to prevent harm to customers, say attorneys at Dentons.

  • 2 FCPA Settlements Illuminate Self-Disclosure, Disgorgement

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    Two of last year’s Foreign Corrupt Practices Act settlements — with biomedical company Lifecore and mining company Corsa Coal — suggest that the government will be much more flexible in negotiating disgorgement amounts if an entity voluntarily self-discloses misconduct, say Michael Gilbert and Lucas Amodio at Sheppard Mullin.

  • Opinion

    Anti-Kickback Statute Does Not Require But-For Causation

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    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.

  • 5 Litigation Funding Trends To Note In 2024

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    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.

  • Medtronic's Cautionary Tale Of Fed. Circ. Word Limits

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    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.

  • Key Legal Trends For Healthcare And Life Sciences In 2024

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    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.

  • Series

    ESG Around The World: South Africa

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    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.

  • FOIA Exemption Questions On Redacted HHS Cannabis Letter

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    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.

  • Fed. Circ. Ruling Seemingly Offers PTAB Deadline Immunity

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    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.

  • Evaluating Retroactivity Of Mich. Drugmaker Immunity Repeal

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    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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