[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
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

[[Page 319]]

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 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]