[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.52]

[Page 108-109]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents
 
                         Subpart B--Applications
 
Sec. 314.52  Notice of certification of invalidity or noninfringement of a patent.

    (a) Notice of certification. For each patent which claims the drug 
or drugs on which investigations that are relied upon by the applicant 
for approval of its application were conducted or which claims a use for 
such drug or drugs and which the applicant certifies under 
Sec. 314.50(i)(1)(i)(A)(4) that a patent is invalid, unenforceable, or 
will not be infringed, the applicant shall send notice of such 
certification by registered or certified mail, return receipt requested 
to each of the following persons:
    (1) Each owner of the patent that is the subject of the 
certification or the representative designated by the owner to receive 
the notice. The name and address of the patent owner or its 
representative may be obtained from the United States Patent and 
Trademark Office; and
    (2) The holder of the approved application under section 505(b) of 
the act for each drug product which is claimed

[[Page 109]]

by the patent or a use of which is claimed by the patent and for which 
the applicant is seeking approval, or, if the application holder does 
not reside or maintain a place of business within the United States, the 
application holder's attorney, agent, or other authorized official. The 
name and address of the application holder or its attorney, agent, or 
authorized official may be obtained from the Division of Drug 
Information Resources (HFD-80), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
    (3) This paragraph does not apply to a use patent that claims no 
uses for which the applicant is seeking approval.
    (b) Sending the notice. The applicant shall send the notice required 
by paragraph (a) of this section when it receives from FDA an 
acknowledgment letter stating that its application has been filed. At 
the same time, the applicant shall amend its application to include a 
statement certifying that the notice has been provided to each person 
identified under paragraph (a) of this section and that the notice met 
the content requirement under paragraph (c) of this section.
    (c) Content of a notice. In the notice, the applicant shall cite 
section 505(b)(3)(B) of the act and shall include, but not be limited 
to, the following information:
    (1) A statement that a 505(b)(2) application submitted by the 
applicant has been filed by FDA.
    (2) The application number.
    (3) The established name, if any, as defined in section 502(e)(3) of 
the act, of the proposed drug product.
    (4) The active ingredient, strength, and dosage form of the proposed 
drug product.
    (5) The patent number and expiration date, as submitted to the 
agency or as known to the applicant, of each patent alleged to be 
invalid, unenforceable, or not infringed.
    (6) A detailed statement of the factual and legal basis of the 
applicant's opinion that the patent is not valid, unenforceable, or will 
not be infringed. The applicant shall include in the detailed statement:
    (i) For each claim of a patent alleged not to be infringed, a full 
and detailed explanation of why the claim is not infringed.
    (ii) For each claim of a patent alleged to be invalid or 
unenforceable, a full and detailed explanation of the grounds supporting 
the allegation.
    (7) If the applicant does not reside or have a place of business in 
the United States, the name and address of an agent in the United States 
authorized to accept service of process for the applicant.
    (d) Amendment to an application. If an application is amended to 
include the certification described in Sec. 314.50(i), the applicant 
shall send the notice required by paragraph (a) of this section at the 
same time that the amendment to the application is submitted to FDA.
    (e) Documentation of receipt of notice. The applicant shall amend 
its application to document receipt of the notice required under 
paragraph (a) of this section by each person provided the notice. The 
applicant shall include a copy of the return receipt or other similar 
evidence of the date the notification was received. FDA will accept as 
adequate documentation of the date of receipt a return receipt or a 
letter acknowledging receipt by the person provided the notice. An 
applicant may rely on another form of documentation only if FDA has 
agreed to such documentation in advance. A copy of the notice itself 
need not be submitted to the agency.
    (f) Approval. If the requirements of this section are met, the 
agency will presume the notice to be complete and sufficient, and it 
will count the day following the date of receipt of the notice by the 
patent owner or its representative and by the approved application 
holder as the first day of the 45-day period provided for in section 
505(c)(3)(C) of the act. FDA may, if the applicant amends its 
application with a written statement that a later date should be used, 
count from such later date.

[59 FR 50362, Oct. 3, 1994]