Life Sciences

  • May 09, 2024

    Judge Clarifies Gilead Didn't Directly Infringe HIV Drug IP

    A Delaware federal judge on Thursday rejected Gilead Sciences' request to amend her judgment finding that two medications in its HIV prevention regimen, Truvada and Descovy, directly infringed the government's invalidated patents, but clarified her judgment to say that non-party patients or physicians committed the infringement.

  • May 09, 2024

    First Zantac Trial Plaintiff Says She Can't Live Normal Life

    An Illinois woman suing the former manufacturers of Zantac heartburn medication and claiming her long-term use of the drug caused her colon cancer testified Thursday that she has struggled to control her bowels since her 2015 diagnosis and has experienced multiple accidents in public places that left her humiliated and fearful to leave her home.

  • May 09, 2024

    Judge Halts DEA's Hearing On Proposed Psychedelics Ban

    An administrative law judge with the U.S. Drug Enforcement Administration has ordered the agency to cancel a June 10 hearing on its proposal to ban two psychedelic substances while a researcher's federal lawsuit challenging the agency's actions plays out in court, according to an order made public Thursday.

  • May 09, 2024

    Masimo Makes Offer To End Activist Politan's Proxy Contest

    Medical technology company Masimo Corp. revealed Thursday that it is willing to appoint one of the director nominees put forth by activist investment firm Politan Capital Management LP in exchange for the company dropping its proxy fight, though Politan signaled distaste with the proposed deal.

  • May 09, 2024

    Fed. Circ. Skeptical Allergan Illegally Extended Exclusivity

    A Federal Circuit panel seemed doubtful Thursday that a patent covering Allergan's bowel treatment drug Viberzi should have its life cut short based on the expiration date of related patents, in oral arguments over obviousness-type double patenting.

  • May 09, 2024

    Ex-Dental Device CEO Cops To $10.7M Investor Fraud

    The former CEO of a dental device company pled guilty Thursday to defrauding investors out of $10.7 million with false claims that his company received the U.S. Food and Drug Administration's approval for a device he promised would take the place of X-rays.

  • May 09, 2024

    Ex-Official Says NJ, Ethics Board Are 'Stonewalling' Discovery

    A former New Jersey health official has asked a state judge to order the state and its ethics commission to provide full discovery around his claims that he was fired in 2020 for raising concerns about the governor's chief of staff earmarking COVID-19 tests for relatives, accusing the Garden State of "stonewalling" his requests for documents and communications.

  • May 09, 2024

    Body-Sculpting Device Supplier Hit With Fraud Claims

    A Massachusetts company that sells body-sculpting equipment tricks buyers into believing their operations will be unrealistically lucrative, and harms them with restraints on pricing and coercion against transferring their devices, according to a lawsuit in Connecticut state court.

  • May 09, 2024

    11th Circ. Rejects Monsanto's Roundup Suit Redo Request

    The full Eleventh Circuit has rejected Monsanto's renewed request for review of a panel's ruling that a Georgia doctor can allege the company failed to warn about cancer risks associated with the use of Roundup weedkiller despite federal pesticide labeling requirements.

  • May 09, 2024

    Ex-Pharma Exec Asks 1st Circ. To DQ Judge In Contempt Case

    U.S. District Judge Mark Wolf cannot be impartial and must be disqualified from presiding over a criminal contempt trial against a former pharmaceutical executive accused of using an alias to flout a civil judgment, the defendant told the First Circuit in a Wednesday filing.

  • May 09, 2024

    Apnea Device Maker ProSomnus Gets OK For Ch. 11 Loan

    A Delaware bankruptcy judge Thursday gave sleep apnea device maker ProSomnus interim permission to tap into $13 million in Chapter 11 financing to fund the company through what it says will be the end of its case in August.

  • May 09, 2024

    Deals Rumor Mill: Paramount, Peloton, International Paper

    Sony and Apollo plan to break up Paramount if their $26 billion bid prevails, private equity firms are eyeing a Peloton buyout, and International Paper gets a $15 billion bid from Brazil's Suzano. Here, Law360 breaks down the notable deal rumors from the past week.

  • May 08, 2024

    Quinn Emanuel Atty Says Asset Freeze Hurt Outcome Defense

    The U.S. government's overreach in restraining millions more than it could reasonably trace back to a $1 billion fraud by Outcome Health prevented the company's former CEO from hiring Quinn Emanuel Urquhart & Sullivan LLP attorneys to defend the charges like he originally wanted, an Illinois federal judge heard Wednesday.

  • May 08, 2024

    Opioid Maker Beats Investor Suit Over FDA Warning For Good

    A California federal judge has permanently dismissed a lawsuit from investors of acute pain drug company AcelRx Pharmaceuticals Inc. accusing it of engaging in misbranding violations that put it at greater risk for regulatory scrutiny.

  • May 08, 2024

    Shockwave Medical Investor Challenges $13B Deal With J&J

    A shareholder of cardiovascular treatment company Shockwave Medical Inc. is attempting to halt the company's "unfair" $13 billion proposed transaction with Johnson & Johnson by filing a securities suit, saying the transaction will only benefit company insiders and damage public shareholders.

  • May 08, 2024

    Conn. Justices To Hear McCarter & English Damages Demand

    The Connecticut Supreme Court has accepted a certified question from a federal district court judge in McCarter & English LLP's yearslong fee feud with a former client, agreeing to decide whether the firm can recover punitive damages after years chasing Jarrow Formulas Inc. and winning a jury verdict last year.

  • May 08, 2024

    Kirkland Drives Vance Street To $775M Fund IV Closing

    Los Angeles-based private equity shop Vance Street Capital, advised by Kirkland & Ellis LLP, on Wednesday announced it held the first and final close for its fourth fund with $775 million in tow.

  • May 08, 2024

    Sleep Apnea Co. Hits Ch. 11 Over $41.5M In Debt, Cash Woes

    California-based ProSomnus, which produces devices to prevent sleep apnea, said a balance sheet heavy with more than $41.5 million in debt and difficulty in funding its continued operations forced it to file for Chapter 11 protections in Delaware.

  • May 08, 2024

    Simpson Thacher-Led Silver Lake Lands $20.5B For 7th Fund

    Technology-focused private equity shop Silver Lake, advised by Simpson Thacher & Bartlett LLP, announced Wednesday the closing of its seventh flagship fund after securing $20.5 billion from investors, beating out the amount raised in its predecessor fund by about half a billion dollars.

  • May 07, 2024

    GOP Reps. Want IP Enforcers To Get Tougher On Infringers

    Republican lawmakers complained at a Tuesday congressional hearing about the Biden administration's move to end the controversial Trump-era "China Initiative" aimed at curbing suspected economic espionage and questioned administration officials over how diligently they have pursued intellectual property cases on behalf of U.S. manufacturers, retailers, movie studios and vape companies.

  • May 07, 2024

    Iceberg Image Closes Pacira Drug Patent Infringement Trial

    A generic drugmaker on Tuesday used imagery to argue that the information in a Pacira Biosciences Inc. painkiller patent is just the proverbial tip of the iceberg, positing that regulators would have rejected the application if all the data on the medicine had been revealed.

  • May 07, 2024

    Pharma Co. Falsely Touted Obesity Drug Results, Suit Claims

    Biopharmaceutical company Altimmune Inc. and three of its executives were hit with a proposed class action alleging they overstated the clinical trial results and prospects of its obesity drug and its ability to compete with other weight loss medications like Ozempic.

  • May 07, 2024

    Fed. Circ. Seems Wary Of Broad's CRISPR Inventorship Win

    Federal Circuit Judge Todd Hughes on Tuesday suggested that the Patent Trial and Appeal Board cited the correct standard when reviewing who first invented a particular use of the gene-editing technology CRISPR-Cas9, but then applied an improper standard when ruling in favor of a Massachusetts research team.

  • May 07, 2024

    Colo. Judge Tells Cos. Their Warring Briefs Aren't Helping

    A Colorado federal judge has warned a medical device distributor and a Stryker subsidiary warring over a $2.3 million sanctions request that neither of their briefs appeared to provide "meaningful assistance" to help him determine what to award.

  • May 07, 2024

    Fla. Schools And Hospitals Fight To Save Opioid Claims

    Five public hospital districts and two school districts told a Florida appeals court Tuesday that their claims for damages from the opioid crisis should not be eclipsed by the attorney general's settlements with opioid makers and distributors, arguing that she did not have the authority to bring claims on their behalf.

Expert Analysis

  • Fears About The End Of Chevron Deference Are Overblown

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    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.

  • Negotiating Milestones In Pharma Licenses Requires Care

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    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.

  • Former Minn. Chief Justice Instructs On Writing Better Briefs

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    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.

  • Stay Interviews Are Key To Retaining Legal Talent

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    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.

  • Direct Claims Ruling May Alter Gov't Ties To Software Firms

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    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.

  • Opinion

    Intoxicating Hemp Products: It's High Time For Clarity

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    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.

  • And Now A Word From The Panel: Benefits Of MDL Transfers

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    A recent order from the Judicial Panel on Multidistrict Litigation highlights a critical part of the panel's work — moving cases into an existing MDL — and serves as a reminder that common arguments against such transfers don't outweigh the benefits of coordinating discovery and utilizing lead counsel, says Alan Rothman at Sidley Austin.

  • What Rescheduling Could Mean For Cannabis Bankruptcies

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    Bankruptcy courts have historically been closed for cannabis-related businesses, but recent case law coupled with a possible reclassification of cannabis provides cautious optimism, say attorneys at Duane Morris.

  • Opinion

    Pharmacies Need More Protection Against PBM Fee Practices

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    The Centers for Medicare & Medicaid Services' recent reform regarding direct and indirect remuneration fees will mitigate the detrimental effects that pharmacy benefit manager policies have on struggling pharmacies, but more is needed to prevent PBMs from exploiting loopholes, says Bhavesh Desai at Mazina Law.

  • Contract Disputes Recap: Facts Differ But Same Rules Apply

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    Zachary Jacobson and Sarah Barney at Seyfarth examine two decisions illustrating that reliance on a technicality may not save an otherwise untimely appeal, and that enforcement of commercial terms and conditions under a federal supply schedule contract may be possible.

  • Series

    Spray Painting Makes Me A Better Lawyer

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    My experiences as an abstract spray paint artist have made me a better litigator, demonstrating — in more ways than one — how fluidity and flexibility are necessary parts of a successful legal practice, says Erick Sandlin at Bracewell.

  • Takeaways From The 2023 DOJ Fraud Section Report

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    Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.

  • Judge-Shopping Policy Revisal May Make Issue Worse

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    The Judicial Conference at its March meeting unveiled a revised policy with the stated goal of limiting litigants’ ability to judge-shop in patent cases, but the policy may actually exacerbate the problem by tying the issue to judge-shopping in polarizing political cases, making reform more difficult, say Robert Niemeier and William Milliken at Sterne Kessler.

  • 2nd Circ. Baby Food Ruling Disregards FDA's Expertise

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    The Second Circuit's recent decision in White v. Beech-Nut Nutrition, refusing to defer litigation over heavy metals in baby food until the U.S. Food and Drug Administration weighs in on the issue, provides no indication that courts will resolve the issue with greater efficiency than the FDA, say attorneys at Phillips Lytle.

  • Assessing FDA Pathways For Genome-Edited Plant Foods

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    The U.S. Food and Drug Administration's recent clarification of the regulatory pathways for foods produced from genome-edited plants seeks to strike a balance between public health and innovation, and may hold broader significance for developers of novel human foods subject to voluntary notification programs, say Emily Marden and Diane McEnroe at Sidley Austin.

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