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Astellas Pharma Inc. et al v. Sandoz Inc. et al

  1. June 02, 2025

    Judge Allows Obviousness Defense At Bladder Drug Retrial

    A Delaware federal judge has released two makers of generic bladder drugs from a stipulation that barred them from arguing patents held by rival Astellas Pharma Inc. are invalid for obviousness, since two other generic-drug makers targeted in the consolidated litigation could make the same argument at a bench trial later this year.

  2. April 15, 2025

    Astellas Bladder Drug Patent Survives Following Bench Trial

    A Delaware federal judge on Tuesday held that generic-drug makers Lupin and Zydus Pharmaceuticals haven't shown "by clear and convincing evidence" that an Astellas Pharma patent covering the bladder medication Myrbetriq is invalid.

  3. June 28, 2023

    Judge Says Pharma Industry Has 'Perverted' Hatch-Waxman

    A Delaware federal judge has refused to further support his finding that a patent on bladder medication Myrbetriq is ineligible for patent protection as owner Astellas Pharma and various generic-drug makers fight over the invalidity finding at the Federal Circuit, but remarked that pharmaceutical companies have "perverted" the bounds of federal patent law.

  4. June 12, 2023

    Bladder Drug Patent Fails To Survive In Del.

    A Delaware federal judge told a Japanese pharmaceutical company that its "zealous defense" of the validity of a patent covering an extended-release version of its brand-name overactive bladder medication ended up conceding the "more fundamental ground" that those new limitations weren't very hard to formulate in the first place.

  5. May 22, 2023

    What IP Attys Should Know About Enablement After Amgen

    The same patent enablement standard that has existed for centuries must be applied to modern antibody patents, the U.S. Supreme Court ruled last week, prompting attorneys to review current patents and applications and look closely at enablement in litigation and prosecution.