Page:United States Statutes at Large Volume 102 Part 4.djvu/1018

 102 STAT. 3988

35 USC 156.

PUBLIC LAW 100-670—NOV. 16, 1988 initially 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 (I)(B) 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)(l) 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 5050*) 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,

�