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Article 20.27 - Sui generis protection for pharmaceuticals (CETA)
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Domain: World
Definition
1. For the purposes of this Article:
basic patent means a patent which protects a product as such, a process to obtain a product or an application of a product, and which has been designated by the holder of a patent that may serve as a basic patent, as the basic patent for the purpose of the granting of sui generis protection; and
product means the active ingredient or combination of active ingredients of a pharmaceutical product.
2. Each Party shall provide a period of sui generis protection in respect of a product that is protected by a basic patent in force at the request of the holder of the patent or his successor in title, provided the following conditions have been met:
(a) an authorisation has been granted to place the product on the market of that Party as a pharmaceutical product (referred to as “marketing authorisation” in this Article);
(b) the product has not already been the subject of a period of sui generis protection; and
(c) the marketing authorisation referred to in sub-paragraph (a) is the first authorisation to place the product on the market of that Party as a pharmaceutical product.
3. Each Party may:
(a) provide a period of sui generis protection only if the first application for the marketing authorisation is submitted within a reasonable time limit prescribed by that Party; and
(b) prescribe a time limit of no less than 60 days from the date on which the first marketing authorisation was granted for the submission of the request for the period of sui generis protection. However, where the first marketing authorisation is granted before the patent is granted, each Party will provide a period of at least 60 days from the grant of the patent during which the request for a period of protection under this Article may be submitted.
4. In the case where a product is protected by one basic patent, the period of sui generis protection shall take effect at the end of the lawful term of that patent. In the case where a product is protected by more than one patent that may serve as a basic patent, a Party may provide for only a single period of sui generis protection, which takes effect at the end of the lawful term of the basic patent,
(a) in the case where all the patents that may serve as a basic patent are held by the same person, selected by the person requesting the period of sui generis protection; and
(b) in the case where the patents that may serve as a basic patent are not held by the same person and this gives rise to conflicting requests for the sui generis protection, selected by agreement between the patent holders.
5. Each Party shall provide that the period of sui generis protection be for a period equal to the period which elapsed between the date on which the application for the basic patent was filed and the date of the first marketing authorisation, reduced by a period of five years.
6. Notwithstanding paragraph 5 and without prejudice to a possible extension of the period of sui generis protection by a Party as an incentive or a reward for research in certain target populations, such as children, the duration of the sui generis protection may not exceed a period of two to five years, to be established by each Party.
7. Each Party may provide that the period of sui generis protection shall lapse:
(a) if the sui generis protection is surrendered by the beneficiary; or
(b) if any prescribed administrative fees are not paid.
Each Party may reduce the period of sui generis protection commensurate with any unjustified delays resulting from the inactions of the applicant after applying for the market authorisation, when the holder of the basic patent is the applicant for market authorisation or an entity related to it.
8. Within the limits of the protection conferred by the basic patent, the sui generis protection shall extend only to the pharmaceutical product covered by the marketing authorisation and for any use of that product as a pharmaceutical product that has been authorised before the expiry of the sui generis protection. Subject to the preceding sentence, the sui generis protection shall confer the same rights as conferred by the patent and shall be subject to the same limitations and obligations.
9. Notwithstanding paragraphs 1 through 8, each Party may also limit the scope of the protection by providing exceptions for the making, using, offering for sale, selling or importing of products for the purpose of export during the period of protection.
10. Each Party may revoke the sui generis protection on grounds relating to invalidity of the basic patent, including if that patent has lapsed before its lawful term expires or is revoked or limited to the extent that the product for which the protection was granted would no longer be protected by the claims of the basic patent, or on grounds relating to the withdrawal of the marketing authorisation or authorisations for the respective market, or if the protection was granted contrary to the provisions of paragraph 2.
basic patent means a patent which protects a product as such, a process to obtain a product or an application of a product, and which has been designated by the holder of a patent that may serve as a basic patent, as the basic patent for the purpose of the granting of sui generis protection; and
product means the active ingredient or combination of active ingredients of a pharmaceutical product.
2. Each Party shall provide a period of sui generis protection in respect of a product that is protected by a basic patent in force at the request of the holder of the patent or his successor in title, provided the following conditions have been met:
(a) an authorisation has been granted to place the product on the market of that Party as a pharmaceutical product (referred to as “marketing authorisation” in this Article);
(b) the product has not already been the subject of a period of sui generis protection; and
(c) the marketing authorisation referred to in sub-paragraph (a) is the first authorisation to place the product on the market of that Party as a pharmaceutical product.
3. Each Party may:
(a) provide a period of sui generis protection only if the first application for the marketing authorisation is submitted within a reasonable time limit prescribed by that Party; and
(b) prescribe a time limit of no less than 60 days from the date on which the first marketing authorisation was granted for the submission of the request for the period of sui generis protection. However, where the first marketing authorisation is granted before the patent is granted, each Party will provide a period of at least 60 days from the grant of the patent during which the request for a period of protection under this Article may be submitted.
4. In the case where a product is protected by one basic patent, the period of sui generis protection shall take effect at the end of the lawful term of that patent. In the case where a product is protected by more than one patent that may serve as a basic patent, a Party may provide for only a single period of sui generis protection, which takes effect at the end of the lawful term of the basic patent,
(a) in the case where all the patents that may serve as a basic patent are held by the same person, selected by the person requesting the period of sui generis protection; and
(b) in the case where the patents that may serve as a basic patent are not held by the same person and this gives rise to conflicting requests for the sui generis protection, selected by agreement between the patent holders.
5. Each Party shall provide that the period of sui generis protection be for a period equal to the period which elapsed between the date on which the application for the basic patent was filed and the date of the first marketing authorisation, reduced by a period of five years.
6. Notwithstanding paragraph 5 and without prejudice to a possible extension of the period of sui generis protection by a Party as an incentive or a reward for research in certain target populations, such as children, the duration of the sui generis protection may not exceed a period of two to five years, to be established by each Party.
7. Each Party may provide that the period of sui generis protection shall lapse:
(a) if the sui generis protection is surrendered by the beneficiary; or
(b) if any prescribed administrative fees are not paid.
Each Party may reduce the period of sui generis protection commensurate with any unjustified delays resulting from the inactions of the applicant after applying for the market authorisation, when the holder of the basic patent is the applicant for market authorisation or an entity related to it.
8. Within the limits of the protection conferred by the basic patent, the sui generis protection shall extend only to the pharmaceutical product covered by the marketing authorisation and for any use of that product as a pharmaceutical product that has been authorised before the expiry of the sui generis protection. Subject to the preceding sentence, the sui generis protection shall confer the same rights as conferred by the patent and shall be subject to the same limitations and obligations.
9. Notwithstanding paragraphs 1 through 8, each Party may also limit the scope of the protection by providing exceptions for the making, using, offering for sale, selling or importing of products for the purpose of export during the period of protection.
10. Each Party may revoke the sui generis protection on grounds relating to invalidity of the basic patent, including if that patent has lapsed before its lawful term expires or is revoked or limited to the extent that the product for which the protection was granted would no longer be protected by the claims of the basic patent, or on grounds relating to the withdrawal of the marketing authorisation or authorisations for the respective market, or if the protection was granted contrary to the provisions of paragraph 2.