FAQ

Is PMS (Post Marketing Surveillance) available for diagnostic drugs?

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PMS (Post Marketing Surveillance) is NOT available for in vitro diagnostic drugs. However, PMS (Post Marketing Surveillance) is generally available for in vivo diagnostic drugs.


Does Japan have “data exclusivity” system? What is PMS (Post marketing Surveillance) period?

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Generic Entry in the Second Largest Market The timing of generic entry (often synonymously, LOE or loss of exclusivity) is critically important for both innovative companies and generic companies since it is the timing for an innovative company to lose its market share of its blockbuster drugs built on exclusivity and for a generic company to embark for a promising market. It is widely known that […]


Is US type “Orange Book” available in Japan to determine or estimate Loss of Exclusivity (LOE)?

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Japan does not have US type Orange Book Listing, as motivated by Hatch Waxman Act in the US. Therefore, relevant patents need to be carefully identified and reviewed from scratch for accurate determination of the timing of generic entry, in addition to the careful analysis on PMS (Post Market Surveillance) period and NHI (National Health Insurance) price listing. Obtaining the reasonably accurate […]


Is it worth filing patent term extension in Japan when expected patent term extension is only a few weeks or even a few days?

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Yes, in Japan there is a “de facto” exclusivity that in effect extends your exclusivity even after the patent expiration. Japan has unique Price Listing System to control price of drugs. Patients can receive benefit from National Health Insurance (NHI) only for drugs that are listed in so called NHI price listing. Therefore, in most cases, generic companies cannot practically (not legally) market […]


How long does it take for generic companies to obtain MA from the filing of an application for MA?

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Generic companies generally need MA (Marketing Approval) to sell its generics in Japan.  Further, generic companies also need NHI (National Health Insurance) price listing to sell its generics at competitive price. For generics, an opportunity for NHI price listing is only twice a year, currently, June and December. For June NHI Price Listing, only Marketing Approval given by a reference date (whi […]


How long is PMS (Post Marketing Surveillance) period in Japan?

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In Japan, we have Post Marketing Surveillance (PMS) system, which serves somewhat like data exclusivity in the US and Europe. The standard period for Post Marketing Surveillance (PMS) is currently as follows.  However, they are not “per se ” rule.  Therefore, how you characterize your product in the negotiatio with MHLW is sometimes becomes important to maximize or adjust PMS period to […]


Can we file a patent application in Japan with specification, claims, drawings, and abstract prepared in English?

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Yes. Although the application per se has to be prepared in Japanese, the application can be filed with specification, claims, drawings, and abstract attached thereto prepared in English (JPL 36-2(1)). In this case, a Japanese translation thereof must be filed within 1 year and 2 months from the earliest priority date (JPL 36-2(2), JPL 17-3). The benefit of filing an application with English specif […]


What is the difference between an Invalidation Trial and an Opposition in Japan?

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An Invalidation Trial adopts “Inter Partes” procedure. An Opposition adopts “Ex Parte” procedure.  Therefore, the involvement of an Opposition Filer is limited mainly to the fling of an Opposition thus triggering the review by the JPO. Because of this difference, survival through an Opposition does not necessarily mean that the patent was exposed to the keen dispute between conflicting parties. Th […]


Is it possible to file an Invalidation Trial or an Opposition by a straw person in Japan?

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An Opposition can be filed by a straw man.  Therefore, practically, patent attorneys can file an Opposition by himself/herself for their clients so that the clients’ name can be kept unidentified. However, due to the recent revision of our patent law, an Invalidation Trial must be filed by an “interested person” (JPL123(2)). JPL123(2) Any person may file a request for a trial for […]


How long does it take after the filing of an Invalidation Trial for such fact to be available to the public?

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According to the Japanese Patent Law, the fact of filing of an invalidation trial will be registered in the patent register.  It should take about three weeks after the filing.  After another month or so, such fact will become available on the JapanPlatPat website which is a database provided by the JPO (more precisely, JPO related organization). The patent register is a public information.  Howev […]


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