Rospatent invalidated the patent for tadalafil 1-20 mg

| By | Drug Patents, Rospatent

On July 2, 2018, the Russian Federal Service for Intellectual Property (Rospatent) invalidated the Eurasian patent No. 005416 for the group of inventions “Unified Dosage Form” issued to Eli Lilly. The patent protects tadalafil 1- 20 mg (under the trade name Cialis).

The objection against the patent was filed on January 30, 2018, by Severnaya Zvezda CJSC and, on May 28, 2018, the Board of the Chamber for Patent Disputes upheld the objection.

According to Russian pharma company “Severnaya Zvezda”, the entire group of inventions under the contested patent does not meet such patentability conditions as “novelty” and “inventive step.” The claimant said that the invention in question was part of a known art, as it relates to the master patent for tadalafil.

In turn, the patent holder is confident that the invention protected by the master patent describes a whole class of compounds characterized by a common formula, which can be used for therapeutic and preventive purposes in a wide unified range of doses of 0.5-800 mg and in the range of dosage forms of 0.2-400 mg for capsules and tablets. As for the reduced range of doses of 1-20 mg per day, the master patent has no mention of it. Moreover, it neither has any information on clinical and animal trials with regard to the efficacy of low doses.

The Board of the Chamber for Patent Disputes agreed that there was no novelty in the disputed patent and stated that “it is obvious that the dose of 1-20 mg is part of the dose of 0.2-400 mg as well part of the dose of 0.5-800 mg.”