JAPAN Law and Practice Contributed by: Hirofumi Tada, Ohno & Partners
Typically, a patent owner’s intent to assert a pat - ent with knowledge of details of accused prod - ucts is required to support the necessity of a declaratory judgment. Once standing is found, the plaintiff of the declaratory judgment pro - ceeding may typically seek judgment declaring non-infringement and/or invalidity. Declaratory Judgment in the Life Sciences Field In the life sciences field, the IP High Court recently denied the standing of a declaratory judgment filed by a generic drug company that filed a generic drug marketing application, hold - ing that the application alone does not support the standing of a declaratory judgment, even though a new drug applicant expressed the pos - sibility of patent assertion once the generic drug is approved. Under this decision, it is difficult to judicially resolve the patent issues between a new drug company and a generic drug company before a marketing approval grant. However, the case law in this area is now under development, and the current practice might change. Once a generic drug is approved (and price listed), a generic drug company likely may file a declaratory judgment action to seek declara - tions of non-infringement and invalidity. How - ever, often a generic drug application cannot get approval due to the substance/dosage/ usage patent of a new drug applicant, and the only option for a generic drug company will be invalidity trials before the JPO under such cir - cumstances. 1.10 Doctrine of Equivalents The Doctrine of Equivalents (DoE) in Japan has five requirements:
(1) the difference between a claim and an accused product is not an essential part of a patented invention; (2) the invention can achieve the same purpose and function even with the replacement of the difference; (3) a person ordinarily skilled in the art could easily conceive the replacement at the time of manufacture of the accused product; (4) configuration of the product was neither pub - licly known nor easily conceived at the time of the patent application; and (5) there are no special circumstances such as prosecution estoppel. Requirement (3) is a significant difference from other jurisdictions such as the US. If a patent is granted to the replacement, it might be difficult to assert infringement under the DoE. Requirement (4) corresponds to the Doctrine of Ensnarement or the Formstein Defence. As to requirement (5), Japanese courts tradition - ally have adopted a “complete bar”, meaning that, if a patentee excluded part of a claim during a prosecution history, the DoE does not apply to the excluded part whatever the reason for the exclusion was. However, a recent lower court decision adopts a more flexible approach, so future case law will need to be watched closely. 1.11 Clearing the Way Japan basically does not have patent linkage as to a new drug, and there is no obligation to “clear the way” ahead of a new product launch. As a result, an approved new drug might be sued
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