Patent Term Extendable Based on Approval for Different Usage of Pharmaceutical Product Supreme Court Dismisses JPO’s Final Appeal

On November 17, 2015, the Supreme Court of Japan negated the JPO’s conventional practice regarding rejection reasons for an application to register a patent term extension and gave new ruling that a patent term extension should be granted to a pharmaceutical product based on a manufacturing and marketing approval for a different usage of the single pharmaceutical product.

Patent Term Extension System in Japan (Article 67 (2) of Patent Act)

In the field of pharmaceutical products, it sometimes takes a long time until a manufacturing and marketing approval is granted that is imposed by laws intended to ensure safety. This poses a problem for a patent holder that in spite of the presence of his/her patent right he/she is unable to benefit from the exclusive right until the approval is obtained. Therefore, when there is a period during which a patented invention cannot be implemented before an approval required by laws, the patent term may be extended, upon request, by a period not exceeding five years.

Summary of Supreme Court Decision

・Main text: The final appeal by the Japan Patent Office is dismissed.
・Reason:
In regard to manufacturing and marketing of patented pharmaceutical products, if there exists a preceding first approval and a subsequent second approval, which is the basis for an application to register a patent term extension, the first and second approvals are compared regarding examination matters directly related to the substantial identicalness as a pharmaceutical product, in view of a type and a target of the patent invention concerning the application for patent term extension. When it is found that the manufacturing and marketing of the pharmaceutical product permitted by the first approval include those permitted by the second approval, then it is regarded unnecessary to obtain the second approval for implementing the patent invention concerning the application for patent term extension, and thus it is adequate to interpret that the extension of the patent term should not be accepted.
When applying this rule to the present case, the patent invention of the present patent right relates to a composition for the treatment of cancer, comprising a therapeutically effective amount of a VEGF antagonist, which is an invention of a product targeted at ingredients of the pharmaceutical product. When the preceding first approval regarding the present pharmaceutical product and the second approval which is the basis for the application for patent term extension of the present case are compared, although the manufacturing and marketing of the present pharmaceutical product for XELOX – Bevacizumab combination therapy were not permitted by the first approval, these were permitted only after the second approval.
Judging from the above, in the present case, it is not deemed that the manufacturing and marketing of the pharmaceutical product with respect to the first approval include those with respect to the second approval. Therefore, by unanimous decision of the justices, the decision is made in the form of the main text.

Our Comments

The Supreme Court upheld the Intellectual Property High Court’s decision that the JPO Appeal Board decision rejecting the application for patent term extension should be revoked and dismissed the final appeal of the JPO.
The current JPO’s Examination Guidelines set forth a reason for rejecting an application for patent term extension on a single pharmaceutical product based on the second and after manufacturing and marketing approval (see, 3.1.1(2)(ii) of the JPO’s Examination Guidelines). However, since the JPO’s conventional practice of the Guidelines was negated, the Guidelines will be revised in response to the Supreme Court’s decision.
Therefore, from now on, the pharmaceutical-related patent rights will be more widely protected in Japan, which will promote the IP activities including filing Japanese patent applications on inventions relating to the pharmaceutical products, etc.

If you have any questions about the Japanese patent practice, please let us know.