Page:United States Statutes at Large Volume 102 Part 4.djvu/1015

 PUBLIC LAW 100-670—NOV. 16, 1988

102 STAT. 3985

the permission for the commercial marketing or use of the drug or product after the r ^ u l a to r y review period for use in foodproducing animals is the first permitted commercial marketing or use of the drug or product for administration to a foodproducing animal.". (b) SECTION 156(b).—Section 156(b) is amended to read as follows: 35 USC 156. "(b) The rights derived from any patent the term of which is extended under this section shall during the period during which the term of the patent is extended— "(1) in the case of a patent which claims a product, be limited to any use approved for the product— "(A) before the expiration of the term of the patent— "(i) under the provision of law under which the applicable regulatory review occurred, or (ii) under the provision of law under which any regulatory review described in paragraph (1), (4), or (5) of subsection (g) occurred, and "(B) on or after the expiration of the regulatory review period upon which the extension of the patent was based; "(2) in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent and approved for the product— "(A) before the expiration of the term of the patent— "(i) under any provision of law under which an applicable regulatory review occurred, and "(ii) under the provision of law under which any regulatory review described in paragraph (1), (4), or (5) of subsection (g) occurred, and "(B) on or after the expiration of the regulatory review period upon which the extension of the patent was based; and "(3) in the case of a patent which claims a method of manufacturing a product, be limited to the method of manufacturing as used to make— "(A) the approved product, or "(B) the product if it has been subject to a regulatory review period described in paragraphs (1), (4), or (5) of subsection (g). As used in this subsection, the term 'product' includes an approved product.". (c) SECTION 156(c)(2).—Section 156(c)(2) is amended by striking out "and (3KBXi)" and inserting in lieu thereof "(3)(B)(i), (4)(B)(i), and (5)(B)(i)". (d) SECTION 156(d)(l)(C).—Section 156(d)(l)(C) is amended by inserting "or the Secretary of Agriculture" after "Services". (e) SECTION 156(d)(2)(A).—Section 156(d)(2)(A) is amended to read as follows: "(2)(A) Within 60 days of the submittal of an application for extension of the term of a patent under paragraph (1), the 0)mmissioner shall notify— "(i) the Secretary of Agriculture if the patent claims a drug product or a method of using or manufacturing a drug product and the drug product is subject to the Virus-Serum-Toxin Act, and "(ii) the Secretary of Health and Human Services if the patent claims any other drug product, a medical device, or a food additive or color additive or a method of using or manufac-

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