Life Sciences

  • June 13, 2024

    Full Fed. Circ. Rejects Rehearing Bids In Xifaxan Case

    The Federal Circuit has shot down bids for rehearing filed by both sides in a case involving an April decision that prevents an Alvogen unit from releasing a generic version of Bausch Health's diarrhea and brain disorder drug Xifaxan until 2029.

  • June 13, 2024

    Feds' Forfeiture Error Won't Tank Outcome Execs' Conviction

    Outcome Health executives can't wipe out their $1 billion fraud convictions or receive a new trial despite arguing that improperly frozen assets prevented them from hiring their chosen lawyers, an Illinois federal judge said Wednesday, ruling that they waived their challenge to the forfeiture by waiting too long.

  • June 13, 2024

    Cannabis Cos. Make Deal Ahead Of Expected DEA Downgrade

    An attorney and cannabis entrepreneur is betting that the federal government will reschedule marijuana before winter, announcing his equipment manufacturing firm will ally with a Native American-owned cannabis oil processing company to build out a pharmaceutical cannabis extraction facility.

  • June 13, 2024

    North Carolina Lawmakers Mull Outlawing 'Gas Station Heroin'

    A bill to make the drug tianeptine a scheduled substance in the Tar Heel state that passed in the North Carolina House of Representatives this week has been kicked over to the state Senate for consideration.

  • June 13, 2024

    Teva Wins Pause Of Order Ousting Patents From Orange Book

    A New Jersey federal judge ordered on Thursday a 30-day stay of his Monday ruling that a handful of patents covering Teva-brand asthma inhalers were improperly listed in the federal Orange Book, saying he wanted the matter to reach the Federal Circuit in the most orderly way possible.

  • June 13, 2024

    CVS Dodges Discovery Audit In Generic Drug Collusion Suit

    A federal judge declined to make CVS hire a forensic auditor to evaluate its compliance with information demands in a lawsuit alleging it colluded with drugmakers to keep Medicare beneficiaries from accessing certain generic drugs, despite a whistleblower bemoaning "woefully deficient" discovery on the pharmacy chain's part.

  • June 13, 2024

    GOP Lawmakers Want China Patent Data Amid Tech Pact Talks

    Republican lawmakers are urging the U.S. Commerce Department to provide a full accounting of whether the U.S. government has funded research that resulted in Chinese patents, arguing they need the data to assess potential national security risks as the Biden administration negotiates a new science and technology agreement with China.

  • June 13, 2024

    Vero Biotech Tried To 'String Along' Safety Monitor, Suit Says

    Georgia-based medical device maker Vero Biotech LLC reneged on a payment plan with a consulting firm hired to monitor its products, according to a lawsuit filed in Massachusetts state court on Wednesday.

  • June 13, 2024

    EU Makes First Ever Formal Pharma Price-Fixing Complaint

    European Union antitrust authorities issued their first ever price-fixing complaint in the pharmaceutical industry Thursday, going after the only company that did not agree to a €13.4 million ($14.4 million) settlement in October.

  • June 13, 2024

    JP Morgan Closes Debut Life Sciences Fund At Over $500M

    J.P. Morgan Private Capital on Thursday announced that it clinched its inaugural life sciences private capital offering with more than $500 million in tow.

  • June 13, 2024

    Abortion Medication Case Ends 'With A Whimper' At High Court

    A case that threatened to cut off access to a widely used abortion medication while disrupting the U.S. Food and Drug Administration's authority over drugs and medical devices ended Thursday at the U.S. Supreme Court with a decision concerned solely with challengers' right to sue.

  • June 12, 2024

    Tillis Told Drug Patents Are Too Complex For Easy Answers

    When and how generic drugs enter the marketplace varies widely among different drugs and isn't necessarily related to how many patents are covering those drugs, the U.S. Patent and Trademark Office said Wednesday in a report requested by a top member of the U.S. Senate's Intellectual Property Subcommittee.

  • June 12, 2024

    Lies At Heart Of Fraud Case Over COVID Test Kits, Jurors Told

    The retrial of a securities fraud case over a COVID test kit deal that never materialized will center on lies, according to opening statements delivered in New Jersey federal court Wednesday.

  • June 12, 2024

    2nd Circ. Backs Brokerage In Suit Over Biotech's Failed IPO

    The Second Circuit on Wednesday declined to reinstate a Texas company's suit against an investment brokerage that advised biotech Inpellis on an initial public offering that failed and sent the company to file Chapter 7, ruling a lower court rightly found a global settlement eclipsed the need for a jury trial.

  • June 12, 2024

    Lipitor Buyers Get Final OK For $93M Deal In Antitrust Fight

    A New Jersey federal judge gave final approval Wednesday to a $93 million settlement between a class of buyers of Lipitor and Pfizer, resolving their claims in sprawling antitrust litigation that Pfizer conspired with a drug manufacturer to delay the release of a cheaper generic version of Lipitor and monopolize the market.

  • June 12, 2024

    SPAC Dealmakers Expect Modest Pickup After Market Bottom

    Market professionals expect a slow pickup in deals involving special-purpose acquisition companies starting in the second half of 2024, predicting on Wednesday that a leaner market will emerge following the recent crash and imposition of tighter regulations.

  • June 12, 2024

    Directors Of Defunct Med Tech SPAC Seek Toss Of Del. Suit

    Directors of a special purpose acquisition company that merged with now-defunct medical technology company Better Therapeutics Inc. urged Delaware's Court of Chancery on Wednesday to toss a shareholder's suit about the $15 million de-SPAC merger, saying it wasn't like other problematic SPAC deals.

  • June 12, 2024

    Forte Biosciences Reaches $2M Deal To End Chancery Suit

    Clinical-stage biopharmaceutical company Forte Biosciences has reached a multipart, $2 million concession-plus-cash settlement in Delaware's Court of Chancery with a private investment fund that ran a board proxy contest after its calls to liquidate the business were met with poison pill pushback.

  • June 12, 2024

    'Natural' Toothpaste Brand Loaded With PFAS, Moms Say

    Natural toothpaste company RiseWell LLC falsely advertised its kids toothpaste as "natural" and "safe to swallow," two mothers alleged Tuesday in a proposed class action, saying a U.S. Department of Defense-certified laboratory test found 750 times more "forever chemicals" in the toothpaste than researchers found in heavily tainted kale.

  • June 12, 2024

    32 AGs Urge Justices Take Up Okla. PBM Law Fight

    Thirty-two attorneys general urged the U.S. Supreme Court to take up Oklahoma's petition for review of a Tenth Circuit decision holding that federal law preempted portions of a state law regulating pharmacy benefit managers, arguing the justices needed to intervene to resolve a circuit split.

  • June 11, 2024

    Martin Shkreli Told To Hand Over Wu-Tang Album

    A New York federal judge ordered Martin Shkreli on Tuesday to hand over any copies he might have of the Wu-Tang Clan's album he once bought before it was sold off by the federal government to settle a $7.3 million tab from Shkreli's criminal judgment on securities fraud.

  • June 11, 2024

    Pharmacy Co. Optio Gets Interim OK For $10M DIP Package

    Illinois-based specialty pharmacy chain Optio received interim approval at a first-day hearing Tuesday in Delaware bankruptcy court to access a $10 million in new money debtor-in-possession financing to fund its Chapter 11.

  • June 11, 2024

    Fed. Circ. Reinstates Parts Of Blood Analyzer Secrets Verdict

    The Federal Circuit decided Tuesday that a Rhode Island jury was right to find that an Italian company's blood analyzer computer code was stolen by a U.S. rival, but another jury will have to determine any damages.

  • June 11, 2024

    9th Circ. Judge On Theranos Appeal: 'Good Story' For Holmes

    Two Ninth Circuit judges on a three-judge panel expressed concerns Tuesday that the district judge presiding over convicted former Theranos CEO Elizabeth Holmes' criminal trial erred by allowing a layperson witness to offer expert testimony at trial, with one judge saying, "There's a pretty good story here for Ms. Holmes."

  • June 11, 2024

    AI No Scarier Than Nail Guns Or Microscopes, Kappos Says

    Former U.S. Patent and Trademark Office Director David Kappos cautioned attorneys Tuesday to "keep ourselves grounded" about the use of artificial intelligence in intellectual property, saying it's just a tool like a microscope or nail gun, rather than something justifying "panic."

Expert Analysis

  • What 100 Federal Cases Suggest About Changes To Chevron

    Author Photo

    With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.

  • Why High Court May Have Rejected IP Obviousness Appeal

    Author Photo

    Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.

  • Microplastics At The Crossroads Of Regulation And Litigation

    Author Photo

    Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.

  • The Fed. Circ. In April: Hurdles Remain For Generics

    Author Photo

    The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.

  • Tylenol MDL Highlights Expert Admissibility Headaches

    Author Photo

    A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.

  • Don't Use The Same Template For Every Client Alert

    Author Photo

    As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.

  • Don't Fall On That Hill: Keys To Testifying Before Congress

    Author Photo

    Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.

  • Online Portal Helps Fortify Feds' Unfair Health Practices Fight

    Author Photo

    The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.

  • Series

    Walking With My Dog Makes Me A Better Lawyer

    Author Photo

    Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.

  • Think Like A Lawyer: Follow The Iron Rule Of Trial Logic

    Author Photo

    Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.

  • The Art Of Asking: Leveraging Your Contacts For Referrals

    Author Photo

    Though attorneys may hesitate to ask for referral recommendations to generate new business, research shows that people want to help others they know, like and trust, so consider who in your network you should approach and how to make the ask, says Rebecca Hnatowski at Edwards Advisory.

  • Trending At The PTAB: Permissible New Reply Arguments

    Author Photo

    In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.

  • Wave Of Final Rules Reflects Race Against CRA Deadline

    Author Photo

    The flurry of final rules now leaping off the Federal Register press — some of which will affect entire industries and millions of Americans — shows President Joe Biden's determination to protect his regulatory legacy from reversal by the next Congress, given the impending statutory look-back period under the Congressional Review Act, say attorneys at Jenner & Block.

  • 'Beauty From Within' Trend Poses Regulatory Risks For Cos.

    Author Photo

    Companies capitalizing on the current trend in oral supplements touting cosmetic benefits must note that a product claim that would be acceptable for an externally applied cosmetic may draw much stronger scrutiny from the U.S. Food and Drug Administration when applied to a supplement, say Natalie Rainer and Katherine Staba at K&L Gates.

  • McKesson May Change How AKS-Based FCA Claims Are Pled

    Author Photo

    The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.

Want to publish in Law360?


Submit an idea

Have a news tip?


Contact us here
Can't find the article you're looking for? Click here to search the Life Sciences archive.
Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!