IBSA Institut Biochimique v. Teva Pharmaceuticals USA, No. 19-2400 (Fed. Cir. 2020)
Annotate this Case
IBSA's patent, entitled “Pharmaceutical Formulations for Thyroid Hormones,” provides “pharmaceutical formulations based on thyroid hormones enabling a safe and stable oral administration in the framework of the strict therapeutic index prescribed in case of thyroid disorders.” It is listed in the FDA’s “Orange Book” for IBSA’s Tirosint® product, a soft gel capsule formulation containing the active ingredient levothyroxine sodium. Teva sought to market a generic version of Tirosint® and filed an Abbreviated New Drug Application (ANDA) that included a “Paragraph IV certification” that the 390 patent is invalid, unenforceable, or will not be infringed by Teva’s generic product. IBSA filed suit, alleging infringement.
The Federal Circuit affirmed a holding that certain claims are invalid as indefinite under 35 U.S.C. 112. The intrinsic evidence fails to establish the boundaries of the claim term “half-liquid” and there was no clear error in the court’s determination that the extrinsic evidence does not supply “half-liquid” with a definite meaning under section 112.
Some case metadata and case summaries were written with the help of AI, which can produce inaccuracies. You should read the full case before relying on it for legal research purposes.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.