August, 2015｜News Letter

1. How should Specific Use of Pharmaceutical Composition be Recognized?

Suntory Holdings Limited v. Commissioner of JPO, Case No. 2014 (Gyo-Ke) 10182 (Decision rendered on August 20, 2015)

The Applicant, Suntory, filed a patent application relating to a composition for ameliorating a reduced amount of diurnal activity and/or depressive symptoms in 2005, but the application was finally rejected on the grounds of lacking inventive step by the Appeal Board of the JPO in 2014. Against the JPO's decision, Suntory filed a cancellation action with the IPHC in 2014.

Claim 4 of the Suntory’s patent application at issue claims as follows:
A composition for ameliorating depressive symptoms, the composition comprising a triglyceride in which part or all of a constituent fatty acid is arachidonic acid.

One of the main issues in this case lied in how the specific use of a pharmaceutical composition should be recognized. The IPHC answered to the issue as follows.

In the JPO’s decision, the JPO first recognized that the use of a formulation disclosed in prior art reference (p.a.r.) 1 was for “treating any psychiatric, neurological or other central or peripheral nervous system disease, in particular schizophrenia, depression, bipolar disorder” on the basis of the description in prior art reference (p.a.r.) 1 that “[t]he formulations of the present invention may be used for the treatment of a wide range of diseases and disorders including: any psychiatric, neurological or other central or peripheral nervous system disease, in particular schizophrenia, depression, bipolar disorder and …”. On the basis of the above recognition, the JPO concluded that the use in the claimed invention of the patent application at issue was easily conceivable for those skilled in the art, and denied inventive step of the claimed invention.

However, having reviewed p.a.r. 1 and other prior art references showing the common technical knowledge in detail, the IPHC found (i) that working examples of p.a.r 1 demonstrated using the formulation for schizophrenia only, and did not demonstrate using it for depression, (ii) that schizophrenia and depression were generally recognized as different diseases in which the causes of the diseases and the methods for treatment thereof were different from each other although they were psychiatric diseases in common, and (iii) that no specific evidence showing that there was any common technical knowledge that a pharmaceutical composition which had been confirmed to be effective for the treatment of schizophrenia could be directly used for the treatment of depression was found.
On the basis of the above findings, the IPHC decided (i) that the use of the formulation disclosed in p.a.r. 1 should have been limitedly recognized as the use for treating schizophrenia, and thus (ii) that the difference between the use of the claimed invention of the patent application at issue and that of the invention disclosed in p.a.r. 1 was substantial, and those skilled in the art could have not easily conceived the claimed invention having the difference.

Conclusively, the IPHC upheld the Suntory’s appeal, and cancelled the JPO's decision.

An appeal to the Supreme Court was NOT filed against this decision, and thus the decision is final and binding.

K&P's CommentsThe above decision teaches that even though a prior art reference generally states that a compound or a pharmaceutical composition can be used for the treatment of various diseases with their names listed, the pharmaceutical use disclosed in the prior art reference should be restrictively recognized as that specifically demonstrated in the working examples, unless there is any common technical knowledge that a compound or a pharmaceutical composition which has been confirmed to be effective for the treatment of a particular disease can be directly used for the treatment of a different disease.

In August 2015, the IPHC handed down 12 decisions including the above case on patent and utility model, and overturned previous decisions in 5 cases.

In August 2015, the IPHC handed down 3 decisions on trademark, and overturned all of the previous decisions.