JAPAN Law and Practice Contributed by: Hirofumi Tada, Ohno & Partners
Requirement (d) corresponds to the Doctrine of Ensnarement or the Formstein Defence. As to requirement (e), Japanese courts traditionally have adopted a “complete bar”, meaning that, if a pat ‑ entee 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 for patent infringe ‑ ment after launch and can be excluded from the mar ‑ ket later on. 1.12 Experts Expert declarations often help parties persuade judg ‑ es on technical issues both on infringement and valid ‑ ity. There are no specific requirements or procedures for evidence from experts, but the parties file written declarations instead of oral testimonies as Japanese procedures are highly focused on written evidence. Sometimes, a party retains multiple experts, but too much focus on technical issues is usually not effec ‑ tive nor persuasive to the judges as most of them do not have technical backgrounds. However, it is highly important to choose a good expert trustworthy to Japanese judges. The Japanese court separately appoints an expert who supports the judge’s understanding of technical aspects of the case from a very early stage in the proceedings. 1.13 Use of Experiments Japan does not have specific mechanisms or proce ‑ dures to submit experimental results. Any forms of experimental result report are admissible as long as the person who prepared the report signs and/or seals it. As most Japanese judges do not have technical backgrounds, too complicated or lengthy a report is
not preferable, and it is helpful to attach an expert declaration explaining the meaning of the results. 1.14 Discovery/Disclosure Japan does not have discovery even in the post-action stages. There are document production order and inspection procedures, but their availability is limited, as explained in 1.7 Pre-Action Discovery/Disclosure . 1.15 Defences and Exceptions to Patent Infringement In Japan, invalidity is the most frequently asserted defence in infringement actions. Also, the consent/ licence, prior use, exhaustion, and experimental use defences are available. In the life science field, it is often asserted that an injunction is vastly against the public good, but it is highly unlikely that the court will refrain from granting an injunction based on this ground. Japan has a com ‑ pulsory licence system, but it has never been granted. 1.16 Stays and Relevance of Parallel Proceedings Japan does not have any official framework to stay litigation due to parallel proceedings. Some court judges tend to wait for the outcome of an invalidity proceeding before the JPO if it will be granted in a few months, but others do not. It is important to know your judge. Japanese courts generally do not wait for foreign proceedings. 1.17 Patent Amendment Even during infringement litigation, a patent owner may file an amendment demand before the JPO. A patent owner is required to file an amendment demand to raise an amendment re-defence against an invalid ‑ ity defence in the infringement litigation, so it is highly important to timely file an amendment demand before the JPO. (In some circumstances, such as when a patent owner cannot file an amendment demand due to the timing limitation imposed by the Patent Act, an amendment demand is not required to raise the re- defence.) The amendment re-defence is often used and effective in infringement actions.
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