PUBLIC LAW 100-670—NOV. 16, 1988

102 STAT. 3981

sentence, the Secretary may not require that the assay meth-
odology used to determine the withdrawal period of the new
animal drug be more rigorous than the methodology used to
determine the withdrawal period for the approved new animal
drug referred to in the application. If such studies are required
and if the approved new animal drug, referred to in the applica-
tion for the new animal drug for which such studies are re-
quired, is approved for use in more than one animal species,
such studies shall be conducted for one species, or if the Sec-
retary deems appropriate based on scientific principles, shall be
conducted for more than one species.".

SEC. 102. PATENT INFORMATION.

(a) SECTION 512(b).—Section 512(bXl) of such Act is amended by 21 use 360b.
adding at the end the following: "The applicant shall file with the
application the patent number and the expiration date of any patent

which claims the new animal drug for which the applicant filed the
application or which claims a method of using such drug and with
respect to which a claim of patent infringement could reasonably be
asserted if a person not licensed by the owner engaged in the
manufacture, use, or sale of the drug. If an application is filed under
this subsection for a drug and a patent which claims such drug or a
method of using such drug is issued after the filing date but before
approval of the application, the applicant shall amend the applica-
tion to include the information required by the preceding sentence.
Upon approval of the application,- the Secretary shall publish
information submitted under the two preceding sentences.".

(b) OTHER SECTIONS.—-

(1) Section 512(c) is amended by adding at the end the
following:

"(3) If the patent information described in subsection (bXD could
not be filed with the submission of an application under subsection
(bXl) because the application was filed before the patent information
was required under subsection (bXD or a patent was issued after the
application was approved under such subsection, the holder of an
approved application shall file with the Secretary the patent
number and the expiration date of any patent which claims the new
animal drug for which the application was filed or which claims a
method of using such drug and with respect to which a claim of
patent infringement could reasonably be asserted if a person not
licensed by the owner engaged in the manufacture, use, or sale of
the drug. If the holder of an approved application could not file
patent information under subsection (bXl) because it was not re-
quired at the time the application was approved, the holder shall file
such information under this subsection not later than 30 days after
the date of the enactment of this sentence, and if the holder of an
approved application could not file patent information under subsec-
tion (bXD because no patent had been issued when an application
was filed or approved, the holder shall file such information under
this subsection not later than 30 days after the date the patent
involved is issued. Upon the submission of patent information under
this subsection, the Secretary shall publish it.".

(2) The first sentence of section 512(dXD is amended by re-
designating subparagraphs (G) and (H) as subparagraphs (H)
and (I), respectively and by inserting after subparagraph (F) the
following:

Public
information.

21 USC 360b.

i

Public
information.

21 USC 360b.