- Article contributed to Bimonthly Journal of “AIPPI JAPAN” Vol. 42 No. 2  2017 –

Product-by-Process Claims: Changes in the Japanese Practice further to the Supreme Court Decisions on the Pravastatin Sodium Case, and a Comparison with Other Jurisdictions

Abstract
A product-by-process claim may be interpreted according to one of the two following theories: a “product identity theory” by which the claim is construed as being directed to the product irrespective of the recited manufacturing process; and the “process limitation theory” by which a claim is construed as being directed to the product and limited by the recited manufacturing process. In Japan, the Supreme Court clearly ruled in two decisions on June 5, 2015 that a product-by-process claim is to be construed according to the “product identity theory”, and introduced a new requirement for clarity of claims, which has caused some confusion in the current practice. Although, the confusion has somewhat settled through the guidance given by the Japan Patent Office and the decisions of the Intellectual Property High Court rendered subsequent to the Supreme Court decisions, it remains that different approaches are adopted in Japan and other jurisdictions. The present article discusses the current practice in assessing product-by-process claims in various jurisdictions with a focus on changes in the Japanese practice further to the Supreme Court decisions.

1. Introduction
2. In Japan
2.1 Outline of the Supreme Court Decisions in the Pravastatin Sodium Case
2.1 Handling by the Japan Patent Office
2.2.1 During Examinations
2.2.2 Handling in Trials and Oppositions
2.3 Handling by the Courts
3. Current State of Handling of Product-by-Process Claims in Other Countries
3.1 In the United States
3.2 In Europe
3.3 In China
3.4 In Korea
3.5 In Germany, the United Kingdom, Taiwan, and India
4. Conclusion

(*A PDF copy is available here by courtesy of AIPPI JAPAN)