Page:United States Statutes at Large Volume 106 Part 6.djvu/739

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PROCLAMATION 6445- . JUNE 15, 1992 106 STAT. 5297 matter of the patent. In the case of a patented process, the patent confers the right to prevent others not having consent from using that process and from using, selling, or importing at least the product obtained directly by that process. (2) Where the subject matter of a patent is a process for obtaining a product, each Party shall provide that the burden of establishing that an alleged infringing product was not made by the process shall be on the alleged infringer at least in one of the following situations: (A) the product is new, or (B) a substantial likelihood exists that the product was made by the process and the patent owner has been unable through reasonable efforts to determine the process actually used. In gathering and evaluation of evidence to the contrary, the legitimate interests of the defendant in protecting his manufacturing and business secrets shall be taken into account. (3) A patent may only be revoked on grounds that would have justified a refusal to grant the patent. (iii) Exceptions Each Party may provide limited exceptions to the exclusive rights conferred by a patent, such as for acts done for experimental purposes, provided that the exceptions do not significantly prejudice the economic interests of the right-holder. (iv) Term of Protection Each Party shall provide a term of protection of at least 20 years from the date of filing of the patent application or 17 years from the date of grant of the patent. Each Party is encouraged to extend the term of patent protection, in appropriate cases, to compensate for delays caused by regulatory approval processes. (v) Transitional Protection A Party shall provide transitional protection for chemical products, including pharmaceuticals and agricultural chemicals, for which it did not provide product patent protection prior to its implementation of this Agreement, provided the following conditions are satisfied: (1) the subject matter to which the product relates will become patentable after implementation of this Agreement; (2) the product is subject to premarket regulatory review in the territory of the other Party and a patent has been issued for the product by the other Party or an application is pending for the product with the other Party prior to the date on which the subject matter to which the product relates becomes patentable in the territory of the Party providing transitional protection; and (3) the product has not been marketed in the territory of the Party providing such transitional protection. The owner of a patent or of a pending application for a product satisfying the conditions set forth above shall have the right to submit a copy of the patent or provide notification of the existence of a pending application with the other Party, to the Party providing transitional protection. These submissions and notifications shall take place any