U.S.-Singapore Free Trade Agreement

ARTICLE 16.8: MEASURES RELATED TO CERTAIN REGULATED PRODUCTS

1. If a Party requires the submission of information concerning the safety and efficacy of a pharmaceutical or agricultural chemical product prior to permitting the marketing of such product, such Party shall not permit third parties not having the consent of the party providing the information to market the same or a similar product on the basis of the approval granted to the party submitting such information for a period of at least five years from the date of approval for a pharmaceutical product and ten years from the date of approval for an agricultural chemical product.¹³

2. If a Party provides a means of granting approval to market products specified in paragraph 1 on the basis of the grant of an approval for marketing of the same or similar product in another country, the Party shall defer the date of any such approval to third parties not having the consent of the party providing the information in the other country for a period of at least five years from the date of approval for a pharmaceutical product and ten years from the date of approval for an agricultural chemical product in the Party or in the other country, whichever is later.

3. Where a product is subject to a system of marketing approval pursuant to paragraph 1 or 2 and is also subject to a patent in the Party, the Party shall not alter the term of protection specified in paragraphs 1 or 2 in the event that the patent expires on a date earlier than the end of the term of such protection.

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FOOTNOTE:

¹³ Where a Party, on the date of its implementation of the TRIPS Agreement, had in place a system for protecting pharmaceutical or agricultural chemical products not involving new chemical entities from unfair commercial use which conferred a different form or period of protection shorter than that specified in Article 16.8.1, that Party may retain such system notwithstanding the obligations of said paragraph.