Life Sciences

  • May 16, 2024

    Gilead, Teva Want 17 HIV Drug Antitrust Appeals Consolidated

    Gilead Sciences Inc. and Teva Pharmaceuticals are asking the Ninth Circuit to consolidate 17 appeals contesting their win in a case alleging they delayed generic versions of HIV medications, saying the three groups of buyers are raising largely the same issues but refuse to commit to combining their briefs.

  • May 16, 2024

    Pa. Pot Co. Says No Deal To Breach In Growth IP Suit

    A Pennsylvania cannabis cultivator is asking a federal court to dismiss a suit claiming it broke an oral agreement with a consulting firm and continued to use the firm's trade secrets, saying no oral contract existed, nor was the firm's information trade secrets.

  • May 16, 2024

    $5.5M Apotex Generic Drug Price-Fixing Deal Gets Initial OK

    A Pennsylvania federal judge gave preliminary approval to yet another settlement in the sweeping generic drug price-fixing multidistrict litigation, this time signing off on pharmaceutical company Apotex's $5.5 million settlement with clinics, hospitals and independent pharmacies.

  • May 16, 2024

    HUD Calls Pa. Medical Marijuana Housing Suit Premature

    A Pennsylvania housing authority and two would-be residents acted hastily in suing the U.S. Department of Housing and Urban Development, since HUD hadn't formally threatened to pull the authority's funding over a state court order to offer assistance to medical marijuana users, a HUD lawyer told a federal judge Thursday.

  • May 16, 2024

    Biden Admin Proposes To Loosen Restrictions On Marijuana

    President Joe Biden on Thursday announced that his administration has formally recommended relaxing restrictions on marijuana, marking the most significant federal policy shift on cannabis since the drug was criminalized more than 50 years ago.

  • May 15, 2024

    'Excellent' Altria MDL Deal Earns Attys Fees Above Benchmark

    A California federal judge on Wednesday awarded $13.65 million in plaintiffs' attorney fees as part of tobacco giant Altria's $45.5 million deal resolving consumer claims in multidistrict litigation alleging the company helped fuel a youth vaping crisis created by e-cigarette maker Juul, saying the "excellent result" merited fees above the normal 25% benchmark.

  • May 15, 2024

    Lilly Lands Default ITC Order Against Weight Loss Copycats

    The U.S. International Trade Commission voted on Wednesday to give Eli Lilly a default win against the remaining companies in the drugmaker's trademark case surrounding its highly popular, billion-dollar weight loss drugs.

  • May 15, 2024

    Feds, Pesticide Cos. Seek More Time To Find Mediator

    The Federal Trade Commission and agricultural chemical companies Syngenta and Corteva are seeking extra time to select a mediator as they litigate claims that the manufacturers leverage loyalty programs to suppress competition from cheaper generic pesticides.

  • May 15, 2024

    Anthem Blue Cross Owes $3.8M For COVID Tests, Lab Says

    Anthem Blue Cross Blue Shield of Connecticut should be forced to pay nearly $3.8 million for medical laboratory work, including COVID-19 tests, that the insurer either denied, underpaid or failed to acknowledge, according to a federal lawsuit by a New Jersey-based company with facilities in Pennsylvania.

  • May 15, 2024

    AstraZeneca Sales Reps Win Early Cert. In Gender Bias Suit

    An Illinois federal judge on Tuesday granted a bid by workers to conditionally certify a collective in a lawsuit alleging AstraZeneca paid women less than men, giving the green light for notices to be sent out to female sales representatives who have worked at the pharmaceutical giant since late 2018.

  • May 15, 2024

    Monsanto's $23M False Ad Deal Challenged At 9th Circ.

    Counsel representing a certified class of Missouri consumers urged the Ninth Circuit on Wednesday to reverse Monsanto's nationwide $23 million settlement resolving consumer false ad claims over risks associated with its Roundup weedkiller, arguing that Monsanto hid the settlement from the Missouri plaintiffs and that the class is effectively "getting absolutely nothing."

  • May 15, 2024

    Former Sandoz Executive Avoids Prison In Price-Fixing Case

    A Pennsylvania federal judge on Wednesday approved a request from prosecutors and ex-Sandoz Pharmaceuticals executive Hector Armando Kellum for a one-year probation sentence in the generic drug price-fixing case against him, citing his cooperation with the government's investigation into a larger conspiracy. 

  • May 14, 2024

    Biotech Co. Sued In Del. For Faulty Election, Share Hike Vote

    A Cardiff Oncology Inc. stockholder has launched a direct and derivative suit in Delaware Chancery Court accusing the clinical stage biotech company of failing to count "against" votes in decisions that added 2 million shares to the company's limit in 2022 and reelected board members in 2022 and 2023.

  • May 14, 2024

    The PREP Immunity Question Won't Be Decided Yet

    The Federal Circuit opted Tuesday not to say whether a 2005 public health law provides any legal immunity in a patent dispute between rival manufacturers of COVID-19 test swabs, leaving the thorny question unanswered.

  • May 14, 2024

    Norwich, Bausch Ask Fed. Circ. To Rethink Xifaxan IP Ruling

    Alvogen's Norwich Pharmaceuticals unit and Bausch Health have launched bids for the Federal Circuit to rehear a case in which it affirmed a Delaware federal court's decision preventing the release of a generic version of Bausch's blockbuster diarrhea and brain disease drug, Xifaxan, until 2029.

  • May 14, 2024

    Calif. City Sues Dow, Shell Over TCP-Tainted Water

    Dow Chemical and Shell USA are facing a negligence suit in California federal court by the city of Pomona, alleging the companies are responsible for manufacturing commercial products containing the toxic 1,2,3-trichloropropane that has migrated into the city's water supply and seeking to recoup costs over response efforts.

  • May 14, 2024

    Vein Tech Maker Faces Investor Suit Over DOJ Kickback Probe

    Vein disease device maker Inari Medical Inc. and three of its current and former executives face a proposed investor class action over claims that the company's share price fell after it disclosed an investigation into its compliance with federal anti-kickback laws.

  • May 14, 2024

    Jury's $2M Medical Device Infringement Verdict Upended

    A Delaware federal judge ruled Tuesday that Kurin Inc. did not infringe claims of a Magnolia Medical Technologies Inc. patent tied to sepsis testing, reversing a 2022 jury verdict that Kurin had infringed the patent and should pay $2 million.

  • May 14, 2024

    States Accuse EEOC Of 'Smuggling' Abortion Into PWFA Rule

    Louisiana and Mississippi have sued the U.S. Equal Employment Opportunity Commission seeking to invalidate regulations implementing the Pregnant Workers Fairness Act, claiming the agency's stance that employers must provide workers accommodations if they get an abortion flouts U.S. Supreme Court precedent and the PWFA itself.

  • May 14, 2024

    Biotech Co. Hits Bankruptcy With Creditor Deal In Hand

    Biotech company Gamida Cell Inc. filed for Chapter 11 protection in Delaware bankruptcy court after reaching a take-private deal with its largest creditor to extend up to $45 million in new capital and forgive more than $4 million in secured debt.

  • May 14, 2024

    Congressional IP Attorneys Keeping Close Watch On AI

    Top intellectual property attorneys from the U.S. Senate and U.S. House of Representatives told a room full of Federal Circuit practitioners on Tuesday that artificial intelligence is the biggest thing to watch within IP law over the next few years.

  • May 14, 2024

    Mich. AG Says Eli Lilly 'Cherry-Picking' Enforcement Data

    Michigan's attorney general has hit back against Eli Lilly's arguments that recent consumer protection law recoveries show her office is not being hampered in its investigations, as she seeks subpoenas in a probe of the pharmaceutical giant's pricing for an insulin drug.

  • May 14, 2024

    Shire Settles Claims Over Alleged ADHD Generic Delay

    Purchasers of the medication Intuniv have settled a years-old class action against drugmaker Shire PLC and manufacturer Actavis over allegations that the companies struck an anti-competitive deal to delay the production of a generic version of the attention-deficit/hyperactivity disorder drug.

  • May 14, 2024

    Chinese Drug Co. Sanctioned After 'Tortuous' 3-Year Info Fight

    Chinese drug firm Zhejiang Huahai Pharmaceutical Co. Ltd. has been hit with sanctions after its chief executive officer failed to sit for a court-ordered deposition in sprawling multidistrict litigation taking place in New Jersey over generic drugs that U.S. authorities say were contaminated with carcinogens.

  • May 13, 2024

    USPTO Eyes Change To Patent Applicants' Disclaimer Practice

    The U.S. Patent and Trademark Office is looking to add a requirement for patent applicants filing so-called terminal disclaimers in order to overcome rejections by patent examiners over obviousness-type double patenting, a move that lawyers and a former USPTO official say could change the agency's approach considerably, especially for patents covering brand-name drugs.

Expert Analysis

  • What CRA Deadline Means For Biden Admin. Rulemaking

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    With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.

  • 5 Takeaways From FDA's Biosimilars Promotion Guidance

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    New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.

  • Dual-Track IPO-M&A Exit Strategies For Life Science Cos.

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    A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.

  • Does Expert Testimony Aid Preliminary IPR Responses?

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    Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.

  • Are Concessions In FDA's Lab-Developed Tests Rule Enough?

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    Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

  • Rebuttal

    Double-Patenting Ruling Shows Terminal Disclaimers' Value

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    While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.

  • Series

    Swimming Makes Me A Better Lawyer

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    Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.

  • Mid-2024 FCA Enforcement And Litigation Trends To Watch

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    Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.

  • What 100 Federal Cases Suggest About Changes To Chevron

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    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

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    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

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    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

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    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

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    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

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    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

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    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.

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