EXTENSION OF PATENT TERM.

SEC. 201. EXTENSION OF PATENT TERM. (a) Section 156(a)(5).—Section 156(a)(5) is amended— (1) by inserting “or (C)” after “subparagraph (B)” in subparagraph (A), (2) by striking out “or” at the end of subparagraph (A), and (3) by striking out the period at the end of subparagraph (B) and inserting “; or” and the following: “(C) for purposes of subparagraph (A), in the case of a patent which— “(i) claims a new animal drug or a veterinary biological product which (I) is not covered by the claims in any other patent which has been extended, and (II) has received permission for the commercial marketing or use in non-food-producing animals and in food-producing animals, and “(ii) was not extended on the basis of the regulatory review period for use in non-food-producing animals, 102 STAT. 3985the permission for the commercial marketing or use of the drug or product after the regulatory review period for use in food-producing animals is the first permitted commercial marketing or use of the drug or product for administration to a food-producing animal.”. (b) Section 156(b).—Section 156(b) is amended to read as follows; “(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 (3)(B)(i)” and inserting in lieu thereof “(3)(B)(i), (4)(B)(i), and (S)(B)(i)”. (d) Section 156(d)(1)(C).—Section 156(d)(1)(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 Commissioner 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-102 STAT. 3986taring such a product, device, or additive and if the product, device, and additive are subject to the Federal Food, Drug, and Cosmetic Act, of the extension application and shall submit to the Secretary who is so notified a copy of the application. Not later than 30 days after the receipt of an application from the Commissioner, the Secretary receiving the application shall review the dates contained in the application pursuant to paragraph (1)(C) and determine the applicable regulatory review period, shall notify the Commissioner of the determination, and shall publish in the Federal Register a notice of such determination.”. (f) Section 156(d)(2)(B).—Section 156(d)(2)(B) is amended to read as follows: “(B)(i) If a petition is submitted to the Secretary making the determination under subparagraph (A), not later than 180 days after the publication of the determination under subparagraph (A), upon which it may reasonably be determined that the applicant did not act with due diligence during the applicable regulatory review period, the Secretary making the determination shall, in accordance with regulations promulgated by such Secretary, determine if the applicant acted with due diligence during the applicable regulatory review period. The Secretary making the determination shall make such determination not later than 90 days after the receipt of such a petition. For a drug product, device, or additive subject to the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, the Secretary may not delegate the authority to make the determination prescribed by this clause to an office below the Office of the Commissioner of Food and Drugs. For a product subject to the Virus-Serum-Toxin Act, the Secretary of Agriculture may not delegate the authority to make the determination prescribed by this clause to an office below the office of the Assistant Secretary for Marketing and Inspection Services. “(ii) The Secretary making a determination under clause (i) shall notify the Commissioner of the determination and shall publish in the Federal Register a notice of such determination together with the factual and legal basis for such determination. Any interested person may request, within the 60-day period beginning on the publication of a determination, the Secretary making the determination to hold an informal hearing on the determination. If such a request is made within such period, such Secretary shall hold such hearing not later than 30 days after the date of the request, or at the request of the person making the request, not later than 60 days after such date. The Secretary who is holding the hearing shall provide notice of the hearing to the owner of the patent involved and to any interested person and provide the owner and any interested person an opportunity to participate in the hearing. Within 30 days after the completion of the hearing, such Secretary shall affirm or revise the determination which was the subject of the hearing and shall notify the Commissioner of any revision of the determination and shall publish any such revision in the Federal Register.”. (g) Section 156(f).—Section 156(f) is amended— (1) by striking out “human” in paragraph (1)(A) and by amending paragraph (2) to read as follows: “(2) The term ‘drug product’ means the active ingredient of— 102 STAT. 3987 “(A) a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act), or “(B) a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Virus-Serum-Toxin Act) which is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques, including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.”, (2) by amending subparagraphs (B) and (C) of paragraph (4) to read as follows: “(B) Any reference to section 503, 505, 507, 512, or 515 is a reference to section 503, 505, 507, 512, or 515 of the Federal Food, Drug, and Cosmetic Act. “(C) Any reference to the Virus-Serum-Toxin Act is a reference to the Act of March 4, 1913 (21 U.S.C. 151–158).”, and (3) by adding at the end the following: “(7) The term ‘date of enactment as used in this section means September 24, 1984, for a human drug product, a medical device, food additive, or color additive. “(8) The term ‘date of enactment’ as used in this section means the date of enactment of the Generic Animal Drug and Patent Term Restoration Act for an animal drug or a veterinary biological product.”. (h) Section 156(g).— (1) Paragraph (1) of section 156(g) is amended— (A) in subparagraph (A), by striking out “human drug product” and inserting in lieu thereof “new drug, antibiotic drug, or human biological product”, (B) in subparagraph (B)— (i) by striking out “human drug product” in the matter before clause (i) and inserting in lieu thereof “new drug, antibiotic drug, or human biological product”, and (ii) by striking out “human drug product” in clauses (i) and (ii) and inserting in lieu thereof “product”. (2) Paragraph (1)(A) of section 156(g) is amended by striking out “paragraph (4)” and inserting in lieu thereof “paragraph (6)”. (3) Paragraphs (2)(A) and (3)(A) are each amended by striking out “paragraph (4)” and inserting in lieu thereof “paragraph (4)” and inserting in lieu thereof “paragraph (6)”. (4) Section 156(g) is amended by redesignating paragraph (4) as paragraph (6) and by inserting after paragraph (3) the following: “(4)(A) In the case of a product which is a new animal drug, the term means the period described in subparagraph (B) to which the limitation described in paragraph (6) applies. “(B) The regulatory review period for a new animal drug product is the sum of— “(i) the period beginning on the earlier of the date a major health or environmental effects test on the drug was initiated or the date an exemption under subsection (j) of section 512 became effective for the approved new animal drug product and ending on the date an application was 102 STAT. 3988initially submitted for such animal drug product under section 512, and “(ii) the period beginning on the date the application was initially submitted for the approved animal drug product under subsection (b) of section 512 and ending on the date such application was approved under such section. “(5)(A) In the case of a product which is a veterinary biological product, the term means the period described in subparagraph (B) to which the limitation described in paragraph (6) applies. “(B) The regulatory period for a veterinary biological product is the sum of— “(i) the period beginning on the date the authority to prepare an experimental biological product under the Virus-Serum-Toxin Act became effective and ending on the date an application for a license was submitted under the Virus-Serum-Toxin Act, and “(ii) the period beginning on the date an application for a license was initially submitted for approval under the Virus-Serum-Toxin Act and ending on the date such license was issued.”. (5) Paragraph (6) (as so redesignated) of section 156(g) is amended— (A) by striking out “paragraph (1MB) was submitted” in subparagraph (B)(i) and inserting in lieu thereof “paragraph (1)(B) or (4)(B) was submitted and no request for the authority described in paragraph (5)(B) was submitted”, (B) by striking out “paragraph (2)” in subparagraph (B)(ii) and inserting in lieu thereof “paragraph (2)(B) or (4)(B)”, and (C) in subparagraph (C), by inserting before the period the following: “or in the case of an approved product which is a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act or the Virus-Serum-Toxin Act), three years”. (i) Section 271(e).— (1) Section 271(e)(1) is amended— (A) by inserting before the last close parenthesis the following: “which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques”, and (B) by inserting before the period the following: “or veterinary biological products”. (2) Section 271(e)(2) is amended to read as follows: “(2) It shall be an act of infringement to submit— “(A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent, or “(B) an application under section 512 of such Act or under the Act of March 4, 1913 (21 U.S.C. 151–158) for a drug or veterinary biological product which is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques and which is claimed in a patent or the use of which is claimed in a patent, 102 STAT. 3989 if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug or veterinary biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.”. (3) Section 271(e)(4) is amended by inserting “or veterinary biological product” after “drug” each place it occurs.