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The boundary of new medicine makers and generic makers
(comparison between Japan, the U.S. and Europe)
Between new medicine makers (Forerunner medical-supply makers) and generic makers (Generic drug makers), barriers on some laws have been established in Japan, the U.S. and Europe, respectively.
Here, the present conditions and the outline of these barriers are introduced as follows.
1. "Data Exclusivity" of Europe and the U.S. in Medicine Approval of New Medicines Production and "The reexamination period after approval of new medicines production" of Japan.
- (1) European "Data Exclusivity"
- Since data, such as clinical and toxicity, is the intellectual property from which the new medicine maker spent a long period of time, a 3rd person cannot use the data during a fixed period without a new medicine maker's permission.
Until now, Denmark, Austria, Finland, etc. prepared "Data Exclusivity for 6 years", and Britain, Germany, France, etc. had prepared "Data Exclusivity for 10 years".
However, the EU pharmaceutical affairs rule was revised in December, 2003, and the European data protection period became "8 years after approval of new drugs" uniformly. (It will be applied from the new medicine of approval in August, 2007 and afterwards)
- (2) U.S. "Data Exclusivity"
- A data protection period is "5 years after approval of new drugs".
(However, an application for generic medicine is possible after 4 years from approval of new drugs)
- (3) "Reexamination period after approval of new medicines production" of Japan
- There is a "Reexamination period after approval of new medicines production" system in Japan instead of a "Data Exclusivity" system.
[Article 14quater of the Japanese Pharmaceutical Affairs Law] (Reexamination period)
You have to apply for a reexamination application within 3 months after the following periods.
(a) "Orphan drugs": a range which exceeds 6 years from approval and does not exceed 10 years.
(b) "Drugs different from approved drug only in terms of efficacy or effect": a range which is shorter than 6 years from approval.
(c) "Drugs other than (a) and (b)": 6 years after approval.
2. Extension of Patent Period Concerning Medicine
In Japan, the U.S. and Europe, the patent period concerning medicine is possible up to a maximum of five years.
3. Possibility of Examining or Studying the Patented Invention before Patent Expiration of a Period for Approval of Generic Medicine
-Existence or nonexistence of infringement of patent rights-
- (1) Europe
- Although it changes somewhat with each country, on the whole, it tends to go in the direction of "no infringement".
- (2) U.S.
- Article 271(e) of U.S. Patent Law
"It is not an infringement of patent right that a generic maker performs an examination which relates to the patented invention for "Abbreviated New Drug Application" (ANDA) during the patent period continuation". (This article was newly established at the time of the "Patent Term Extension Act" enactment.)
- (3) Japan
- The Japanese Supreme Court judgment (1998)
"In order that generic maker may submit an application for approval of a generic drug during patent period continuation, doing an examination or research of the patented invention corresponds to "an examination or research" of Article 69 of Japanese Patent Law. Therefore, it is not an infringement of the patent right"
- (Reference)
- The share of generic medical supplies
Germany, Britain, and the U.S.: 50% or more
Japan: About 12%
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