102 STAT. 3988 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 bio-
logical product, the term means the period described in subpara-
graph (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/'.

35 USC 156. (5) Paragraph (6) (as so redesignated) of section 156(g) is

amended—

(A) by striking out "paragraph (1)(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 author-
ity 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 recom-
binant DNA, recombinant RNA, hybridoma technology, or
other processes involving site specific genetic manipulation
techniques", and

(B) by inserting before the period the following: "or vet-
erinary 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,