[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR60.10]
[Page 318-319]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 60 PATENT TERM RESTORATION--Table of Contents
Subpart B Eligibility Assistance
Sec. 60.10 FDA assistance on eligibility.
(a) Upon written request from the U.S. Patent and Trademark Office,
FDA will assist the U.S. Patent and Trademark Office in determining
whether a patent related to a product is eligible for patent term
restoration as follows:
(1) Verifying whether the product was subject to a regulatory review
period before its commercial marketing or use;
(2) For human drug products, food additives, color additives, and
medical devices, determining whether the permission for commercial
marketing or use of the product after the regulatory review period is
the first permitted commercial marketing or use of the product either:
(i) Under the provision of law under which the regulatory review
period occurred; or
(ii) Under the process claimed in the patent when the patent claims
a method of manufacturing the product that primarily uses recombinant
deoxyribonucleic acid (DNA) technology in the manufacture of the
product;
(3) For animal drug products, determining whether the permission for
commercial marketing or use of the product after the regulatory review
period:
(i) Is the first permitted commercial marketing or use of the
product; or
(ii) Is the first permitted commercial marketing or use of the
product for administration to a food-producing animal, whichever is
applicable, under the
[[Page 319]]
provision of law under which the regulatory review period occurred;
(4) Informing the U.S. Patent and Trademark Office whether the
patent term restoration application was submitted within 60 days after
the product was approved for marketing or use, or, if the product is an
animal drug approved for use in a food-producing animal, verifying
whether the application was filed within 60 days of the first approval
for marketing or use in a food-producing animal; and
(5) Providing the U.S. Patent and Trademark Office with any other
information relevant to the U.S. Patent and Trademark Office's
determination of whether a patent related to a product is eligible for
patent term restoration.
(b) FDA will notify the U.S. Patent and Trademark Office of its
findings in writing, send a copy of this notification to the applicant,
and file a copy of the notification in the docket established for the
application in FDA's Division of Dockets Management (HFA-305), 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
[57 FR 56261, Nov. 27, 1992]
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