[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
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 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

[[Page 319]]

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 Dockets Management Branch (HFA-305), rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857.

[57 FR 56261, Nov. 27, 1992]