TABLE 2
FROM:
Data protection: The new IP Frontier — An overview of existing laws and regulations
Dolores Cullen
BACK TO ARTICLETable 2. Summary of the relevant provisions
| NAFTA |  Exclusivity is granted for pharmaceutical products that utilise new chemical entities (NCE) for not less than five years from the date the Party granted approval. Protection is granted to undisclosed test or other data that is required to determine safety and efficacy. |
| US–Vietnam | Exclusivity is granted for pharmaceutical products for not less than five years from the date the Party granted approval. Protection is granted to undisclosed test or other data. |
| US–Jordan FTA | Exclusivity is granted for pharmaceutical products that utilise new chemical entities. New chemical entities include the protection for new uses for old chemical entities for a period of three years. When reliance on evidence of approval in another country, information shall be protected for the same period of time the other country is protecting such information against unfair commercial use. Protection is granted to undisclosed test or data, or evidence of approval in another country. |
| US–Singapore FTA | Exclusivity is granted for pharmaceutical products for not less than five years from the date the Party granted approval. When reliance on approval in another country period of protection is of at least five years from the approval of the product in the Party of reference or in the Party whatever is later. Protection is granted to information that is submitted as a requirement to determine safety and efficacy; Word 'undisclosed' was dropped. Does not allow regulatory authorities to grant marketing approval for 'same or similar' product. Shorter periods may be available if on the date of the implementation of its TRIPS Agreement, the Party had a system for protecting pharmaceutical products not involving NCE that was shorter. |
| US–Chile FTA | Exclusivity is granted for pharmaceutical products that utilise new chemical entities for at least five years from the date the Party granted approval. Protection is granted to undisclosed information that is required to determine safety and efficacy. Shorter time periods may be available if on the date of its implementation of the TRIPS Agreement, a Party had a system for protecting pharmaceutical products not involving new chemical entities from unfair commercial use that was shorter. |
| US–CAFTA DR FTA | Exclusivity is granted to new pharmaceutical products (those that do not contain a chemical entity that has been previously approved in the territory of the Party) for at least five years from the date the Party granted approval. When reliance on approval in another country the period of protection is of at least five years from the approval of the product in the Party to the person who received approval in the other territory. A country may require that such person seek approval within five years after obtaining marketing approval in the other territory. Protection is granted to undisclosed data that is required to determine safety and efficacy. Shorter time periods may be available if on the date of its implementation of the TRIPS Agreement, there was a system for protecting pharmaceutical products not involving new chemical entities from unfair commercial use, which conferred a shorter period of protection. |
| US–Australia | Exclusivity is granted to new pharmaceutical products (those that do not contain a chemical entity that has been previously approved in the Party) for at least five years from the date the Party granted approval. When reliance on approval or information concerning safety or efficacy submitted to obtain marketing approval in another country the period of protection is of at least five years from the date of marketing approval by the Party or the other country, whichever is later. Protection is granted to undisclosed test or other data that is required to determine safety and efficacy; Additional protection of at least three years from the date of approval in the Party for (a) new clinical information (other than the information related to bioequivalency) or (b) evidence of prior approval of a product in another territory that requires such information, which is essential to the approval of a pharmaceutical product. Does not allow regulatory authorities to grant marketing approval for 'same or similar' product. A Party shall not alter the period of exclusivity if the patent term terminates on a date earlier so exclusivity may go beyond the term of a patent. |
| US–Morocco FTA | Exclusivity is granted to new pharmaceutical products (those that do not contain a chemical entity that has been previously approved in the Party) for at least five years from the date the Party granted approval. Protection is granted to safety and efficacy data or evidence of prior approval of the product in another territory that requires such information. Additional protection of at least three years from the date of approval in the Party for (a) new clinical information that is essential to the approval of a pharmaceutical product (other than the information related to bioequivalency) or (b) evidence of prior approval of a product in another territory that requires such information. A Party shall not alter the period of exclusivity if the patent term terminates on a date earlier so exclusivity may go beyond the term of a patent. |
| US–Bahrain FTA | Exclusivity is granted to new pharmaceutical products (those that do not contain a chemical entity that has been previously approved in the Party for use in a pharmaceutical product) for at least five years from the date the Party granted approval. When reliance on approval in another country the period of protection is of at least five years from the approval of the product in the Party. Protection is granted to information concerning safety and efficacy the submission of which is required or permitted. Term 'undisclosed' was dropped. Additional protection of at least three years for new clinical information (other than information related to bioequivalency). When reliance on approval for the new clinical information in another country the period of protection is of at least three years from the approval of the product in the Party (ie not in the first country). Does not allow regulatory authorities to grant marketing approval for 'same or similar' product. A Party shall not alter the period of exclusivity if the patent term terminates on a date earlier so exclusivity may go beyond the term of a patent. |
| US–Oman FTA | Exclusivity is granted to new pharmaceutical products (those that do not contain a chemical entity that has been previously approved in the Party for use in a pharmaceutical product) for at least five years from the date the Party granted approval. When reliance on approval in another country the period of protection is of at least five years from the approval of the product in the Party. Protection is granted to information concerning safety and efficacy the submission of which is required or permitted. Term 'undisclosed' was dropped. Additional protection of at least three years for new clinical information (other than information related to bioequivalency). When reliance on approval for the new clinical information in another country the period of protection is of at least three years from the approval of the product in the Party (ie not in the first country). Does not allow regulatory authorities to grant marketing approval for 'same or similar' product. A Party shall not alter the period of exclusivity if the patent term terminates on a date earlier so exclusivity may go beyond the term of a patent. |
| US–Peru FTA | Exclusivity is granted to pharmaceutical products that utilise a new chemical entity for a reasonable period of time which shall normally mean five years from the date on which the Party granted approval to the person that produced the data for approval to market its product, taking account of the nature of the data and person's efforts and expenditures in producing them. Protection is granted to undisclosed test or other data necessary to determine safety and effectiveness. Where there is reliance on approval granted by the other Party, and the Party grants approval within six months of the filing for marketing approval, the reasonable period of exclusive use of the data shall begin with the date of the first marketing approval relied on. The protection may not be enforced to protect public health according to the Doha Declaration on the TRIPS Agreement and Public Health, TRIPS waivers or amendments. A Party shall not after the period of exclusivity if the patent term terminates on a date earlier so exclusivity may go beyond the term of a patent. |
| US–Colombia FTA | Exclusivity is granted to pharmaceutical products that utilise a new chemical entity for a reasonable period of time which shall normally mean five years from the date on which the Party granted approval to the person that produced the data for approval to market its product, taking account of the nature of the data and person's efforts and expenditures in producing them. Protection is granted to undisclosed test or other data necessary to determine safety and effectiveness. Where there is reliance on approval granted by the other Party, and the Party grants approval within six months of the filing for marketing approval, the reasonable period of exclusive use of the data shall begin with the date of the first marketing approval relied on. The protection may not be enforced to protect public health according to the Doha Declaration on the TRIPS Agreement and Public Health, TRIPS waivers or amendments. A Party shall not after the period of exclusivity if the patent term terminates on a date earlier so exclusivity may go beyond the term of a patent. |
| US–Panama FTA | Exclusivity is granted to pharmaceutical products that utilise a new chemical entity for a reasonable period of time which shall normally mean five years from the date on which the Party granted approval to the person that produced the data for approval to market its product, taking account of the nature of the data and person's efforts and expenditures in producing them. Protection is granted to undisclosed test or other data necessary to determine safety and effectiveness. Where there is reliance on approval granted by the other Party, and the Party grants approval within six months of the filing for marketing approval, the reasonable period of exclusive use of the data shall begin with the date of the first marketing approval relied on. The protection may not be enforced to protect public health according to the Doha Declaration on the TRIPS Agreement and Public Health, TRIPS waivers or amendments. A Party shall not after the period of exclusivity if the patent term terminates on a date earlier so exclusivity may go beyond the term of a patent. |
| US–South Korea FTA | Exclusivity is granted to new pharmaceutical products (those that do not contain a chemical entity that has been previously approved in the Party for use in a pharmaceutical product) for at least five years from the date of marketing approval in the Party. When reliance on approval in another country the period of protection is of at least five years from the approval of the product in the Party. Protection is granted to information concerning safety and efficacy the submission of which is required or permitted. Term 'undisclosed' was dropped. Additional protection of at least three years for new clinical information that is essential to the approval of the pharmaceutical product containing the previously approved chemical entity (other than information related to bioequivalency). When reliance on approval for the new clinical information in another country the period of protection is of at least three years from the approval of the product in the Party (ie not in the first country). Does not allow regulatory authorities to grant marketing approval for 'same or similar' products. A Party may not alter the period of exclusivity if the patent term terminates on a date earlier. |
