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  • Article

    Doctor Califf Goes To India

    Given its growing role as the "pharmacy to the world," FDA Commissioner Robert Califf, M.D., recently took a trip to India and offered some of his (and FDA's)...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Axinn
    Axinn
  • Article

    One Down, Eight To Go: Texas Judge Dismisses Medicare Drug Price Case – Will Others Follow?

    A domino has fallen, but the question remains whether there are more to come. On February 12, 2024, the U.S. District Court for the Western District of Texas...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Axinn
    Axinn
  • Article

    Reflections On The 12th Annual Summit For Women Leaders In Life Sciences Law

    We closed out July 2025 in Boston alongside several of our Axinn colleagues attending the American Conference Institute's 12th Annual Summit for Women Leaders in Life Sciences Law.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Axinn
    Axinn
  • Article

    The Inflation Reduction Act's First Potential Impact On Biosimilars

    On October 31, 2023, FDA approved Amgen's Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Janssen's Stelara (ustekinumab). Stelara has been selected by the Center...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Axinn
    Axinn
  • Article

    Drug Pricing Debate Surfaces At NIH Nominee's Confirmation Hearing

    The continuing debate as to where to draw the line between encouraging innovation and lowering drug costs was front and center during a Senate HELP Committee confirmation hearing for NIH director...
    United StatesIntellectual Property
    Axinn
    Axinn
  • Article

    Judge Gilstrap: For Implementers Of SEPs, The Penitent Will Pass

    According to Judge Gilstrap in the Eastern District of Texas, obligations to negotiate under fair, reasonable, and non-discriminatory (FRAND)...
    United StatesIntellectual Property
    Axinn
    Axinn
  • Article

    SEP Licensors And Licensees Become Increasingly Fragmented

    In a report by IPlytics, published today, they have confirmed what most in the business already presumed: that ownership of 5G standard essential patents (SEPs)...
    United StatesIntellectual Property
    Axinn
    Axinn
  • Article

    The ITC's Strategic Reset: One Year After Lashify And The Revival Of Fintiv

    The International Trade Commission has undergone a fundamental shift over the past 18 months, with new precedent on domestic industry requirements and dramatic changes in filing patterns. This analysis examines how recent Federal Circuit decisions, USPTO policy reversals, and shifting government priorities are reshaping IP enforcement strategy at the ITC.
    United StatesIntellectual Property
    Axinn
    Axinn
  • Article

    The Sneaky-Powerful Defense That Came Up Short - This Time

    A great thing about patent litigation is the vast array of legal doctrines, arguments, and defenses that can come up in any given case.
    United StatesIntellectual Property
    Axinn
    Axinn
  • Article

    Will The PTO's Proposed Expansion Of Filing Settlement Agreements Help To Reduce Drug Prices?

    In a recent Federal Register notice, the PTO announced a proposed rule requiring that any settlement agreement resolving a PTAB proceeding...
    United StatesIntellectual Property
    Axinn
    Axinn
  • Article

    AI Can't Be An Inventor, But How About A POSA?

    On April 30, 2024, the U.S. Patent and Trademark Office (PTO) issued a Request for Comment on how AI technology could affect the PTO's evaluation of patentability...
    United StatesTechnology
    Axinn
    Axinn
  • Article

    Court Orders Patents Delisted From Orange Book: Is FTC's Newly Aggressive Posture Having An Impact?

    Over the past year, FTC has placed two sets of Orange Book listings in its crosshairs, but, to date, FTC has not actually begun any litigation on its own.
    United StatesIntellectual Property
    Axinn
    Axinn
  • Article

    Axinn Antitrust Insight: "New" HSR Form Remains In Effect For Now – Fifth Circuit Temporarily Freezes District Court Order That Vacated The New HSR Rule

    As we anticipated, the FTC has appealed Judge Kernodle's judgment in Chamber of Commerce v. Federal Trade Commission that vacated the FTC's new HSR Rule and Form.
    United StatesAntitrust/Competition Law
    Axinn
    Axinn
  • Article

    No Voluntary Delistings Or Disputes In FDA's Orange Book Update

    FTC recently placed improper Orange Book patent listings squarely in its crosshairs. In its September 2023 policy statement, FTC announced that it would "scrutinize improper Orange Book listings"...
    United StatesIntellectual Property
    Axinn
    Axinn
  • Podcast

    What's Happening In Germany And Portugal? Catching Up With International Enforcers At The 2025 Spring Meeting (Podcast)

    While on site at the 2025 Spring Meeting of the ABA Antitrust Law Section, managing partner Jeny Maier and partner James Hunsberger conducted one-on-one interviews for the Our Curious Amalgam podcast...
    GlobalAntitrust/Competition Law
    Axinn
    Axinn
  • Article

    A Tale Of Two Experts

    It was a tough day for opposing patent damages experts in Ecolab Inc. v. Dubois Chemicals, Inc., as Judge Andrews of the District of Delaware granted Daubert motions directed to both experts' reasonable royalty opinions.
    United StatesIntellectual Property
    Axinn
    Axinn
  • Article

    More Lessons From Mumbai – Reflections On A Hatch-Waxman And PIV Litigation Panel Discussion

    Reflecting back on our time at the 13th Annual Pharma IPR Conference in Mumbai, there was a lively discussion during the panel that I moderated on Industry Insights...
    United StatesIntellectual Property
    Axinn
    Axinn
  • Article

    Reading Tea Leaves: Oral Arguments In Motorola v. Hytera And The Extraterritorial Reach Of The DTSA

    Last week, the Seventh Circuit heard arguments in Motorola Solutions, Inc. v. Hytera Communications Corp. concerning when, if at all, civil claims under the Defend Trade Secrets Act ("DTSA")...
    United StatesIntellectual Property
    Axinn
    Axinn
  • Article

    The Five Eyes Stare Down Trade Secret Theft (Video)

    On Sunday evening, CBS's 60 Minutes aired a segment featuring "The Five Eyes" and the critical issue of state-sponsored intellectual property ("IP") and trade secret theft.
    GlobalIntellectual Property
    Axinn
    Axinn
  • Article

    Anti-Steering Provisions Remain In Antitrust Limelight As Class Action Lawsuits Proceed Through Court

    Two healthcare providers face class action lawsuits challenging their use of anti-steering and anti-tiering contract provisions that allegedly prevent insurers from designing cost-effective healthcare plans. These follow-on cases emerge after government enforcement actions, with courts finding sufficient evidence of market power and anticompetitive effects to allow the litigation to proceed.
    United StatesAntitrust/Competition Law
    Axinn
    Axinn
  • Showing 61–80 of 322 results

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