Approval of Patent Term Extension, even when the Same Active Ingredient of the Drug was Previously Accepted (Japanese Supreme Court Decision of April 2011)
In our previous issue, we introduced provisions for patent term extension. Extension can be used for recovery when the granted patent of a pharmaceutical invention is inoperable due to disposition requirements for the sale and manufacture of the drug. The Ministry of Health, Labor, and Welfare must have ordered a disposition for the sale and manufacture of a drug if extension of the patent term is to be requested with the JPO. The reason is because there is no necessity to extend the patent term if the invention does not require a disposition, and thus is operable.
Last month, the Japanese Supreme Court made a noteworthy decision regarding the matter above as a result of the court case Takeda Pharmaceutical Company (Takeda) vs. the Japan Patent Office (JPO).
The problem was that a third party had previously received approval from the Ministry of Health, Labor, and Welfare for the sale and manufacture of active ingredient A. Afterwards, a disposition was ordered for a drug produced by Takeda which fused the same active ingredient A with a specialized capsule. After approval, Takeda applied for extension of this patent right term. The intended purpose for both the drug of the third party and Takeda's drug was the same, as pain relief for cancer patients.
According to the JPO, because active ingredient A was already approved for the third party, although the preparation methods of the two drugs differed, it was deemed that there was no ban on use of Takeda’s invention, and patent term extension was rejected.
The Supreme Court overruled, stating that it is not appropriate to reject extension of Takeda’s patent term on the grounds that a drug with the same active ingredients or effects/advantages was approved in the past, under the condition that the previously accepted drug is not included in the technical scope of Takeda's patent. It is true that even if a previous approval was received, if the invention is inoperable, the term of that patent right should be extendable. Thus the recent decision was valid. Again, it has also been made clear that the patent term is extendable for drugs approved by the Ministry of Health, Labor, and Welfare with the same active ingredient or effect but a different formula, and creating an advantage for patent right holders.