JAPAN Law and Practice Contributed by: Hirofumi Tada, Ohno & Partners
1.6 Requirements to Bring Infringement Action A patent must be granted and registered before fil ‑ ing an infringement lawsuit. There are no additional requirements such as validation or translation. The types of patents do not matter to the requirements for bringing an action. 1.7 Pre-Action Discovery/Disclosure Japan does not have discovery at all. There are pre- action evidence preservation procedures, but avail ‑ ability is significantly limited due to the strict standard. Japanese courts generally accept materials legally obtained in other jurisdictions without limitation. In fact, US discovery under 28 USC Section 1782 is sometimes used to collect evidence for Japanese infringement actions. 1.8 Search and Seizure Orders Search and seizure orders are not available for patent cases. A court grants a document production order under certain circumstances, but the availability and scope are substantially limited. Recently, Japan newly established an inspection procedure which allows a court-appointed expert to inspect the manufacturing plant of an accused infring ‑ er. However, a patent owner first must show a certain level of probability of infringement to use this proce ‑ dure, and the availability is limited. Japanese courts generally accept materials legally obtained in other jurisdictions such as US discovery without limitation. 1.9 Declaratory Relief Declaratory Judgment of Patent Dispute Typically, a patent owner’s intent to assert a pat ‑ ent with knowledge of details of accused products is required to support the standing of a declaratory judgment. Once standing is found, the plaintiff of the declaratory judgment proceeding 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 denied the standing of a declaratory judgment filed by a generic drug company that filed a generic drug marketing
application, holding 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 judi ‑ cially resolve the patent issues between a new drug company and a generic drug company before a mar ‑ keting approval grant. While a generic drug company may still request an invalidation trial before the Pat‑ ent Office, it is usually difficult to invalidate a patent through this path. Once a generic drug is approved (and price listed), a generic drug company likely may file a declaratory judgment action to seek declarations of non-infringe ‑ ment and invalidity. However, 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 invalid ‑ ity trials before the JPO under such circumstances. 1.10 Doctrine of Equivalents The Doctrine of Equivalents (DoE) in Japan has five requirements: (a) the difference between a claim and an accused product is not an essential part of a patented inven ‑ tion; (b) the invention can achieve the same purpose and function even with the replacement of the difference; (c) a person ordinarily skilled in the art could easily conceive the replacement at the time of manufacture of the accused product; (d) configuration of the product was neither publicly known nor easily conceived at the time of the patent application; and (e) there are no special circumstances such as pros ‑ ecution estoppel. Requirement (c) 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 infringe ‑ ment under the DoE.
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