The Japanese Government’s IP Strategic Headquarters announced plans to revise the patent examination standards for medical inventions of known drug compounds. The new standard will grant patent protection for new and inventive dosage regimens and modes of administration as a “product-related invention” provided the claimed medicament has remarkable effects beyond that which is expected by a person skilled in the art. The new examination standard will go into effect as early as the end of this year.
Since 2005, Japan has allowed new medicinal use claims of a known pharmaceutical ingredient to be a patentable subject matter. However, this will be the first time novelty is conferred on optimization of known medicines. Talks are also underway for methods for medical treatment claims (claims pertaining to surgery and other therapeutic treatment of the human body) to be patentable. Those in the pharmaceutical industry should see this change as a very positive step towards other changes to come relating to patents for medical inventions.
The Japan IP Strategic Headquarter’s report entitled “The Current State of Patent Protection in Advanced Medicine” is here. (via Keisen Associates)