[Ip-health] EFTA-Korea FTA provisions on undisclosed information

[Thiru Balasubramaniam]

http://secretariat.efta.int/Web/ExternalRelations/PartnerCountries/KR/KR_RUAP/view


This is taken from "Annex XIII on Intellectual Property Rights" of the
"EFTA-Republic of Korea - Final Act, Record of Understanding, Annexes
and Joint Declarations".

The link to Annex XII can be found at the url below:

http://secretariat.efta.int/Web/ExternalRelations/PartnerCountries/KR/KR_RUAP/annexes/KR_Annex_XIII_-_IPR.pdf

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Article 3
Undisclosed Information

"The Parties shall protect undisclosed information in accordance with
Article 39
of the TRIPS Agreement. The Parties shall prevent applicants for
marketing approval
for pharmaceuticals and agricultural chemical products from relying on
undisclosed test
or other undisclosed data, the origination of which involves a
considerable effort,
submitted by the first applicant to the competent authority for
marketing approval for
pharmaceuticals and agricultural chemical products, utilising new
chemical entities, for
an adequate number of years [fn2] from the date of approval, except
where approval is
sought for original products. Any Party may instead allow in their
national legislation
applicants to rely on such data if the first applicant is adequately
compensated." [fn3]

fn2   "The number of years shall be determined by the relevant laws and
regulations of the Parties."

fn3  "The Parties note that Korea currently does not have such a
compensation system."