[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.53]

[Page 103-108]
 
                        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.  314.53  Submission of patent information.

    (a) Who must submit patent information. This section applies to any 
applicant who submits to FDA a new drug application or an amendment to 
it under section 505(b) of the act and Sec.  314.50 or a supplement to 
an approved application under Sec.  314.70, except as provided in 
paragraph (d)(2) of this section.
    (b) Patents for which information must be submitted and patents for 
which information must not be submitted--(1) General requirements. An 
applicant described in paragraph (a) of this section shall submit the 
required information on the declaration form set forth in paragraph (c) 
of this section for each patent that claims the drug or a method of 
using the drug that is the subject of the new drug application or 
amendment or supplement to it and with respect to which a claim of 
patent infringement could reasonably be asserted if a person not 
licensed by the owner of the patent engaged in the manufacture, use, or 
sale of the drug product. For purposes of this part, such patents 
consist of drug substance (active ingredient) patents, drug product 
(formulation and composition) patents, and method-of-use patents. For 
patents that claim the

[[Page 104]]

drug substance, the applicant shall submit information only on those 
patents that claim the drug substance that is the subject of the pending 
or approved application or that claim a drug substance that is the same 
as the active ingredient that is the subject of the approved or pending 
application. For patents that claim a polymorph that is the same as the 
active ingredient described in the approved or pending application, the 
applicant shall certify in the declaration forms that the applicant has 
test data, as set forth in paragraph (b)(2) of this section, 
demonstrating that a drug product containing the polymorph will perform 
the same as the drug product described in the new drug application. For 
patents that claim a drug product, the applicant shall submit 
information only on those patents that claim a drug product, as is 
defined in Sec.  314.3, that is described in the pending or approved 
application. For patents that claim a method of use, the applicant shall 
submit information only on those patents that claim indications or other 
conditions of use that are described in the pending or approved 
application. The applicant shall separately identify each pending or 
approved method of use and related patent claim. For approved 
applications, the applicant submitting the method-of-use patent shall 
identify with specificity the section of the approved labeling that 
corresponds to the method of use claimed by the patent submitted. 
Process patents, patents claiming packaging, patents claiming 
metabolites, and patents claiming intermediates are not covered by this 
section, and information on these patents must not be submitted to FDA.
    (2) Test Data for Submission of Patent Information for Patents That 
Claim a Polymorph. The test data, referenced in paragraph (b)(1) of this 
section, must include the following:
    (i) A full description of the polymorphic form of the drug 
substance, including its physical and chemical characteristics and 
stability; the method of synthesis (or isolation) and purification of 
the drug substance; the process controls used during manufacture and 
packaging; and such specifications and analytical methods as are 
necessary to assure the identity, strength, quality, and purity of the 
polymorphic form of the drug substance;
    (ii) The executed batch record for a drug product containing the 
polymorphic form of the drug substance and documentation that the batch 
was manufactured under current good manufacturing practice requirements;
    (iii) Demonstration of bioequivalence between the executed batch of 
the drug product that contains the polymorphic form of the drug 
substance and the drug product as described in the NDA;
    (iv) A list of all components used in the manufacture of the drug 
product containing the polymorphic form and a statement of the 
composition of the drug product; a statement of the specifications and 
analytical methods for each component; a description of the 
manufacturing and packaging procedures and in-process controls for the 
drug product; such specifications and analytical methods as are 
necessary to assure the identity, strength, quality, purity, and 
bioavailability of the drug product, including release and stability 
data complying with the approved product specifications to demonstrate 
pharmaceutical equivalence and comparable product stability; and
    (v) Comparative in vitro dissolution testing on 12 dosage units each 
of the executed test batch and the new drug application product.
    (c) Reporting requirements--(1) General requirements. An applicant 
described in paragraph (a) of this section shall submit the required 
patent information described in paragraph (c)(2) of this section for 
each patent that meets the requirements described in paragraph (b) of 
this section. We will not accept the patent information unless it is 
complete and submitted on the appropriate forms, FDA Forms 3542 or 
3542a. These forms may be obtained on the Internet at http://www.fda.gov 
by searching for ``forms''.
    (2) Drug substance (active ingredient), drug product (formulation or 
composition), and method-of-use patents--(i) Original Declaration. For 
each patent that claims a drug substance (active ingredient), drug 
product (formulation and composition), or method of use, the applicant 
shall submit FDA Form

[[Page 105]]

3542a. The following information and verification is required:
    (A) New drug application number;
    (B) Name of new drug application sponsor;
    (C) Trade name (or proposed trade name) of new drug;
    (D) Active ingredient(s) of new drug;
    (E) Strength(s) of new drug;
    (F) Dosage form of new drug;
    (G) United States patent number, issue date, and expiration date of 
patent submitted;
    (H) The patent owner's name, full address, phone number and, if 
available, fax number and e-mail address;
    (I) The name, full address, phone number and, if available, fax 
number and e-mail address of an agent or representative who resides or 
maintains a place of business within the United States authorized to 
receive notice of patent certification under sections 505(b)(3) and 
505(j)(2)(B) of the act and Sec. Sec.  314.52 and 314.95 (if patent 
owner or new drug application applicant or holder does not reside or 
have a place of business within the United States);
    (J) Information on whether the patent has been submitted previously 
for the new drug application;
    (K) Information on whether the expiration date is a new expiration 
date if the patent had been submitted previously for listing;
    (L) Information on whether the patent is a product-by-process patent 
in which the product claimed is novel;
    (M) Information on the drug substance (active ingredient) patent 
including the following:
    (1) Whether the patent claims the drug substance that is the active 
ingredient in the drug product described in the new drug application or 
supplement;
    (2) Whether the patent claims a polymorph that is the same active 
ingredient that is described in the pending application or supplement;
    (3) Whether the applicant has test data, described in paragraph 
(b)(2) of this section, demonstrating that a drug product containing the 
polymorph will perform the same as the drug product described in the new 
drug application or supplement, and a description of the polymorphic 
form(s) claimed by the patent for which such test data exist;
    (4) Whether the patent claims only a metabolite of the active 
ingredient; and
    (5) Whether the patent claims only an intermediate;
    (N) Information on the drug product (composition/formulation) patent 
including the following:
    (1) Whether the patent claims the drug product for which approval is 
being sought, as defined in Sec.  314.3; and
    (2) Whether the patent claims only an intermediate;
    (O) Information on each method-of-use patent including the 
following:
    (1) Whether the patent claims one or more methods of using the drug 
product for which use approval is being sought and a description of each 
pending method of use or related indication and related patent claim of 
the patent being submitted; and
    (2) Identification of the specific section of the proposed labeling 
for the drug product that corresponds to the method of use claimed by 
the patent submitted;
    (P) Whether there are no relevant patents that claim the drug 
substance (active ingredient), drug product (formulation or composition) 
or method(s) of use, for which the applicant is seeking approval and 
with respect to which a claim of patent infringement could reasonably be 
asserted if a person not licensed by the owner of the patent engaged in 
the manufacture, use, or sale of the drug product;
    (Q) A signed verification which states:

    ``The undersigned declares that this is an accurate and complete 
submission of patent information for the NDA, amendment or supplement 
pending under section 505 of the Federal Food, Drug, and Cosmetic Act. 
This time-sensitive patent information is submitted pursuant to 21 CFR 
314.53. I attest that I am familiar with 21 CFR 314.53 and this 
submission complies with the requirements of the regulation. I verify 
under penalty of perjury that the foregoing is true and correct.''; and

    (R) Information on whether the applicant, patent owner or attorney, 
agent, representative or other authorized official signed the form; the 
name of the person; and the full address, phone number and, if 
available, the fax number and e-mail address.

[[Page 106]]

    (ii) Submission of patent information upon and after approval. 
Within 30 days after the date of approval of its application or 
supplement, the applicant shall submit FDA Form 3542 for each patent 
that claims the drug substance (active ingredient), drug product 
(formulation and composition), or approved method of use. FDA will rely 
only on the information submitted on this form and will not list or 
publish patent information if the patent declaration is incomplete or 
indicates the patent is not eligible for listing. Patent information 
must also be submitted for patents issued after the date of approval of 
the new drug application as required in paragraph (c)(2)(ii) of this 
section. As described in paragraph (d)(4) of this section, patent 
information must be submitted to FDA within 30 days of the date of 
issuance of the patent. If the applicant submits the required patent 
information within the 30 days, but we notify an applicant that a 
declaration form is incomplete or shows that the patent is not eligible 
for listing, the applicant must submit an acceptable declaration form 
within 15 days of FDA notification to be considered timely filed. The 
following information and verification statement is required:
    (A) New drug application number;
    (B) Name of new drug application sponsor;
    (C) Trade name of new drug;
    (D) Active ingredient(s) of new drug;
    (E) Strength(s) of new drug;
    (F) Dosage form of new drug;
    (G) Approval date of new drug application or supplement;
    (H) United States patent number, issue date, and expiration date of 
patent submitted;
    (I) The patent owner's name, full address, phone number and, if 
available, fax number and e-mail address;
    (J) The name, full address, phone number and, if available, fax 
number and e-mail address of an agent or representative who resides or 
maintains a place of business within the United States authorized to 
receive notice of patent certification under sections 505(b)(3) and 
505(j)(2)(B) of the act and Sec. Sec.  314.52 and 314.95 (if patent 
owner or new drug application applicant or holder does not reside or 
have a place of business within the United States);
    (K) Information on whether the patent has been submitted previously 
for the new drug application;
    (L) Information on whether the expiration date is a new expiration 
date if the patent had been submitted previously for listing;
    (M) Information on whether the patent is a product-by-process patent 
in which the product claimed is novel;
    (N) Information on the drug substance (active ingredient) patent 
including the following:
    (1) Whether the patent claims the drug substance that is the active 
ingredient in the drug product described in the approved application;
    (2) Whether the patent claims a polymorph that is the same as the 
active ingredient that is described in the approved application;
    (3) Whether the applicant has test data, described at paragraph 
(b)(2) of this section, demonstrating that a drug product containing the 
polymorph will perform the same as the drug product described in the 
approved application and a description of the polymorphic form(s) 
claimed by the patent for which such test data exist;
    (4) Whether the patent claims only a metabolite of the active 
ingredient; and
    (5) Whether the patent claims only an intermediate;
    (O) Information on the drug product (composition/formulation) patent 
including the following:
    (1) Whether the patent claims the approved drug product as defined 
in Sec.  314.3; and
    (2) Whether the patent claims only an intermediate;
    (P) Information on each method-of-use patent including the 
following:
    (1) Whether the patent claims one or more approved methods of using 
the approved drug product and a description of each approved method of 
use or indication and related patent claim of the patent being 
submitted;
    (2) Identification of the specific section of the approved labeling 
for the drug product that corresponds to the method of use claimed by 
the patent submitted; and

[[Page 107]]

    (3) The description of the patented method of use as required for 
publication;
    (Q) Whether there are no relevant patents that claim the approved 
drug substance (active ingredient), the approved drug product 
(formulation or composition) or approved method(s) of use and with 
respect to which a claim of patent infringement could reasonably be 
asserted if a person not licensed by the owner of the patent engaged in 
the manufacture, use, or sale of the drug product;
    (R) A signed verification which states: ``The undersigned declares 
that this is an accurate and complete submission of patent information 
for the NDA, amendment or supplement approved under section 505 of the 
Federal Food, Drug, and Cosmetic Act. This time-sensitive patent 
information is submitted pursuant to 21 CFR 314.53. I attest that I am 
familiar with 21 CFR 314.53 and this submission complies with the 
requirements of the regulation. I verify under penalty of perjury that 
the foregoing is true and correct.''; and
    (S) Information on whether the applicant, patent owner or attorney, 
agent, representative or other authorized official signed the form; the 
name of the person; and the full address, phone number and, if 
available, the fax number and e-mail address.
    (3) No relevant patents. If the applicant believes that there are no 
relevant patents that claim the drug substance (active ingredient), drug 
product (formulation or composition), or the method(s) of use for which 
the applicant has received approval, and with respect to which a claim 
of patent infringement could reasonably be asserted if a person not 
licensed by the owner of the patent engaged in the manufacture, use, or 
sale of the drug product, the applicant will verify this information in 
the appropriate forms, FDA Forms 3542 or 3542a.
    (4) Authorized signature. The declarations required by this section 
shall be signed by the applicant or patent owner, or the applicant's or 
patent owner's attorney, agent (representative), or other authorized 
official.
    (d) When and where to submit patent information--(1) Original 
application. An applicant shall submit with its original application 
submitted under this part, including an application described in section 
505(b)(2) of the act, the information described in paragraph (c) of this 
section on each drug (ingredient), drug product (formulation and 
composition), and method of use patent issued before the application is 
filed with FDA and for which patent information is required to be 
submitted under this section. If a patent is issued after the 
application is filed with FDA but before the application is approved, 
the applicant shall, within 30 days of the date of issuance of the 
patent, submit the required patent information in an amendment to the 
application under Sec.  314.60.
    (2) Supplements. (i) An applicant shall submit patent information 
required under paragraph (c) of this section for a patent that claims 
the drug, drug product, or method of use for which approval is sought in 
any of the following supplements:
    (A) To change the formulation;
    (B) To add a new indication or other condition of use, including a 
change in route of administration;
    (C) To change the strength;
    (D) To make any other patented change regarding the drug, drug 
product, or any method of use.
    (ii) If the applicant submits a supplement for one of the changes 
listed under paragraph (d)(2)(i) of this section and existing patents 
for which information has already been submitted to FDA claim the 
changed product, the applicant shall submit a certification with the 
supplement identifying the patents that claim the changed product.
    (iii) If the applicant submits a supplement for one of the changes 
listed under paragraph (d)(2)(i) of this section and no patents, 
including previously submitted patents, claim the changed product, it 
shall so certify.
    (iv) The applicant shall comply with the requirements for amendment 
of formulation or composition and method of use patent information under 
paragraphs (c)(2)(ii) and (d)(3) of this section.

[[Page 108]]

    (3) Patent information deadline. If a patent is issued for a drug, 
drug product, or method of use after an application is approved, the 
applicant shall submit to FDA the required patent information within 30 
days of the date of issuance of the patent.
    (4) Copies. The applicant shall submit two copies of each submission 
of patent information, an archival copy and a copy for the chemistry, 
manufacturing, and controls section of the review copy, to the Central 
Document Room, Center for Drug Evaluation and Research, Food and Drug 
Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266. The 
applicant shall submit the patent information by letter separate from, 
but at the same time as, submission of the supplement.
    (5) Submission date. Patent information shall be considered to be 
submitted to FDA as of the date the information is received by the 
Central Document Room.
    (6) Identification. Each submission of patent information, except 
information submitted with an original application, and its mailing 
cover shall bear prominent identification as to its contents, i.e., 
``Patent Information,'' or, if submitted after approval of an 
application, ``Time Sensitive Patent Information.''
    (e) Public disclosure of patent information. FDA will publish in the 
list the patent number and expiration date of each patent that is 
required to be, and is, submitted to FDA by an applicant, and for each 
use patent, the approved indications or other conditions of use covered 
by a patent. FDA will publish such patent information upon approval of 
the application, or, if the patent information is submitted by the 
applicant after approval of an application as provided under paragraph 
(d)(2) of this section, as soon as possible after the submission to the 
agency of the patent information. Patent information submitted by the 
last working day of a month will be published in that month's supplement 
to the list. Patent information received by the agency between monthly 
publication of supplements to the list will be placed on public display 
in FDA's Freedom of Information Staff. A request for copies of the file 
shall be sent in writing to the Freedom of Information Staff (HFI-35), 
Food and Drug Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, 
MD 20857.
    (f) Correction of patent information errors. If any person disputes 
the accuracy or relevance of patent information submitted to the agency 
under this section and published by FDA in the list, or believes that an 
applicant has failed to submit required patent information, that person 
must first notify the agency in writing stating the grounds for 
disagreement. Such notification should be directed to the Drug 
Information Services Branch (HFD-84), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857. The agency will then request of the applicable new drug 
application holder that the correctness of the patent information or 
omission of patent information be confirmed. Unless the application 
holder withdraws or amends its patent information in response to FDA's 
request, the agency will not change the patent information in the list. 
If the new drug application holder does not change the patent 
information submitted to FDA, a 505(b)(2) application or an abbreviated 
new drug application under section 505(j) of the act submitted for a 
drug that is claimed by a patent for which information has been 
submitted must, despite any disagreement as to the correctness of the 
patent information, contain an appropriate certification for each listed 
patent.

[59 FR 50363, Oct. 3, 1994, as amended at 68 FR 36703, June 18, 2003; 69 
FR 13473, Mar. 23, 2004]