NEWS

National provisions for the extension of the patent period.

Release time:

2022-12-26 10:35

 

ApplicationPatentedByCountriesReview by the competent authorityApproval(AUTHORIZATION) ANNOUNCEMENTThe patent applicant.Beginningget the patent right. on the other hand,Most countries have requirements for the registration of pharmaceutical products on the market, which must undergo clinical trials and complete the registration.AfterabilityGet a drug certificate and applylisting,In this waylead"During this period"Within, the patentee, even if it owns the patent, isThe inability to exercise the patent right damages the rights of the patentee. As a result, most national patent laws have established systems to extend the duration of patent rights to compensate for"this period of time" the loss of the patentee.

It is worth noting that,StatesThe identification of "this period" varies and can be roughly divided into the clinical trial period (period A) and the administrative operation period for applying for a license (period B). Japan,South Korea finds that the period may be extended.(Period X),Yesfor periodA plus period B, I .e. X = A B, and the upper limit cannot exceed 5 years at most. Japan further limits the period X to be greater than 2 years. In the United States, the period A that can be extended is at most half of the clinical trial time, I .e. X = A/2 B. European regulations are more different, with the recognition of period X being deducted for a further five years from the date of application to the date of obtaining the permit. In addition, the United States, China and Europe also limit the actual period of time that pharmaceuticals can be marketed (period Y) to a maximum of 14 years in the United States and China and 15 years in Europe.

It is generally believed that pharmaceuticalspatent rightCan be extended automatically5 years, although the practice varies from country to country and the actual period of extension varies from case to case.The following is a list of the provisions of the five major patent offices on the extension of patent rights. :

ChinaSince 2021.6, X≤ 5 and Y≤ 14

United States: X=A/2 B，且X≤ 5, and y≤ 14

Europe: X = C-5 X≤ 5, and y≤ 15

Japan: X=A B，且2≤ X≤ 5

South Korea: X=A B，且X≤ 5