Free 3542 - Federal

Department of Health and Human Services Food and Drug Administration

Form Approved: OMB No. 0910-0513 Expiration Date: 7/31/10 See OMB Statement on Page 3. NDA NUMBER NAME OF APPLICANT/NDA HOLDER

PATENT INFORMATION SUBMITTED UPON AND AFTER APPROVAL OF AN NDA OR SUPPLEMENT
For Each Patent That Claims a Drug Substance (Active Ingredient), Drug Product (Formulation or Composition) and/or Method of Use

The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
TRADE NAME

ACTIVE INGREDIENT(S)

STRENGTH(S)

DOSAGE FORM

APPROVAL DATE OF NDA OR SUPPLEMENT

This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) within thirty (30) days after approval of an NDA or supplement or within thirty (30) days of issuance of a patent as required by 21 CFR 314.53(c)(2)(ii) at the address provided in 21 CFR 314.53(d)(4). To expedite review of this patent declaration form, you may submit an additional copy of this declaration form to the Center for Drug Evaluation and Research "Orange Book" staff. For hand-written or typewriter versions of this report: If additional space is required for any narrative answer (i.e., one that does not require a "Yes" or "No" response), please attach an additional page referencing the question number. FDA will not list patent information if you file an incomplete patent declaration or the patent declaration indicates the patent is not eligible for listing. For each patent submitted for the approved NDA or supplement referenced above, you must submit all the information described below. If you are not submitting any patents for this NDA or supplement, complete above section and sections 5 and 6. 1. GENERAL
a. United States Patent Number d. Name of Patent Owner b. Issue Date of Patent Address (of Patent Owner) c. Expiration Date of Patent

City/State ZIP Code Telephone Number e. Name of agent or representative who resides or maintains a place of business within the United States authorized to receive notice of patent certification under section 505(b)(3) and (j)(2)(B) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.52 and 314.95 (if patent owner or NDA applicant/holder does not reside or have a place of business within the United States) FAX Number (if available) E-Mail Address (if available)

Address (of agent or representative named in 1.e.)

City/State ZIP Code Telephone Number FAX Number (if available) E-Mail Address (if available)

f. Is the patent referenced above a patent that has been submitted previously for the approved NDA or supplement referenced above? g. If the patent referenced above has been submitted previously for listing, is the expiration date a new expiration date?

Yes Yes

No No

FORM FDA 3542 (12/08)

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PSC Graphics (301) 443-1090

EF

For the patent referenced above, provide the following information on each patent that claims the drug substance, drug product, or method of use that is the subject of the approved NDA or supplement. FDA will not list patent information if you file an incomplete patent declaration or the patent declaration indicates the patent is not eligible for listing. FDA will consider an incomplete patent declaration to be a declaration that does not include a response to all the questions contained within each section below applicable to the patent referenced above. 2. Drug Substance (Active Ingredient)
2.1 Does the patent claim the drug substance that is the active ingredient in the drug product described in the approved NDA or supplement? 2.2 Does the patent claim a drug substance that is a different polymorph of the active ingredient described in the NDA? 2.3 If the answer to question 2.2 is "Yes," do you certify that, as of the date of this declaration, you have test data demonstrating that a drug product containing the polymorph will perform the same as the drug product described in the NDA? The type of test data required is described at 21 CFR 314.53(b). 2.4 Specify the polymorphic form(s) claimed by the patent for which you have the test results described in 2.3. Yes No

Yes

No

Yes

No

2.5 Does the patent claim only a metabolite of the approved active ingredient? (Complete the information in section 4 below if the patent claims an approved method of using the approved drug product to administer the metabolite.) 2.6 Does the patent claim only an intermediate?

Yes

No

Yes 2.7 If the patent referenced in 2.1 is a product-by-process patent, is the product claimed in the patent novel? (An answer is required only if the patent is a product-by-process patent.) FDA will not list the patent in the Orange Book as claiming the drug substance if: the answers to 2.1 and 2.2 are "No," or, the answer to 2.2 is "Yes" and the answer to 2.3 is "No," or, the answer to 2.3 is "Yes" and there is no response to 2.4, or, the answer to 2.5 or 2.6 is "Yes." the answer to 2.7 is "No."

No

Yes

No

. . . . .

3. Drug Product (Composition/Formulation)
3.1 Does the patent claim the approved drug product as defined in 21 CFR 314.3? Yes 3.2 Does the patent claim only an intermediate? Yes 3.3 If the patent referenced in 3.1 is a product-by-process patent, is the product claimed in the patent novel? (An answer is required only if the patent is a product-by-process patent.) FDA will not list the patent in the Orange Book as claiming the drug product if: the answer to question 3.1 is "No," or, the answer to question 3.2 is "Yes," or, the answer to question 3.3 is "No." No No

Yes

No

. . .

4. Method of Use
Sponsors must submit the information in section 4 for each approved method of using the approved drug product claimed by the patent. For each approved method of use claimed by the patent, provide the following information: 4.1 Does the patent claim one or more approved methods of using the approved drug product? Yes 4.2 Patent Claim Number(s) (as listed in the patent) Does (Do) the patent claim(s) referenced in 4.2 claim an approved method of use of the approved drug product? No

Yes

No

4.2a If the answer to 4.2 is "Yes," identify the use with specific reference to the approved labeling for the drug product.

Use: (Submit indication or method of use information as identified specifically in the approved labeling.)

FORM FDA 3542 (12/08)

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4.2b If the answer to 4.2 is "Yes," also provide the information on the indication or method of use for the Orange Book "Use Code" description.

Use: (Submit the description of the approved indication or method of use that you propose FDA include as the "Use Code" in the Orange Book, using no more than 240 total characters including spaces.)

FDA will not list the patent in the Orange Book as claiming the method of use if: the answer to question 4.1 or 4.2 is "No," or if the answer to 4.2 is "Yes" and the information requested in 4.2a and 4.2b is not provided in full.

. .

5. No Relevant Patents
For this NDA or supplement, there are no relevant patents that claim the approved drug substance (active ingredient) or the approved drug product (formulation or composition) or approved method(s) of use 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. Yes

6. Declaration Certification
6.1 The undersigned declares that this is an accurate and complete submission of patent information for the NDA 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. Warning: A willfully and knowingly false statement is a criminal offense under 18 U.S.C. 1001.
6.2 Authorized Signature of NDA Applicant/Holder or Patent Owner (Attorney, Agent, Representative or other Authorized Official) (Provide Information below) Date Signed

NOTE: Only an NDA applicant/holder may submit this declaration directly to the FDA. A patent owner who is not the NDA applicant/ holder is authorized to sign the declaration but may not submit it directly to FDA. 21 CFR 314.53(c)(4) and (d)(4). Check applicable box and provide information below. NDA Applicant/Holder NDA Applicant's/Holder's Attorney, Agent (Representative) or other Authorized Official Patent Owner's Attorney, Agent (Representative) or Other Authorized Official

Patent Owner Name

Address

City/State

ZIP Code FAX Number (if available)

Telephone Number E-Mail Address (if available)

The public reporting burden for this collection of information has been estimated to average 5 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer (HFA-710) 5600 Fishers Lane Rockville, MD 20857 An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

FORM FDA 3542 (12/08)

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INFORMATION AND INSTRUCTIONS FOR FORM 3542 PATENT INFORMATION SUBMITTED UPON AND AFTER APPROVAL OF AN NDA OR SUPPLEMENT General Information
To submit patent information to the agency the appropriate patent declaration form must be used. Two forms are available for patent submissions. The approval status of your New Drug Application will determine which form you should use. Form 3542a should be used when submitting patent information with original NDA submissions, NDA amendments and NDA supplements prior to approval. Form 3542 should be used after NDA or supplement approval. This form is to be submitted within 30 days after approval of an application. This form should also be used to submit patent information relating to an approved supplement under 21 CFR 314.53(d) to change the formulation, add a new indication or other condition of use, change the strength, or to make any other patented change regarding the drug, drug product, or any method of use. Form 3542 is also to be used for patents issued after drug approval. Patents issued after drug approval are required to be submitted within 30 days of patent issuance for the patent to be considered "timely filed." Only information from form 3542 will be used for Orange Book publication purposes. Forms should be submitted as described in 21 CFR 314.53. Sending an additional copy of form 3542 to the Orange Book Staff will expedite patent publication in the Orange Book. The Orange Book Staff address (as of April 2007) is: Orange Book Staff, Office of Generic Drugs OGD/HFD-610, 7500 Standish Place, Rockville, MD 20855. The receipt date is the date that the patent information is date stamped in the central document room. Patents are considered listed on the date received. Additional copies of these forms may be downloaded from the Internet at: http://www.fda.gov/opacom/morechoices/fdaforms/ fdaforms.html.

. . .

2. Drug Substance (Active Ingredient)
Complete all items in this section if the patent claims the drug substance that is the subject of the approved NDA or supplement. 2.4) Name the polymorphic form of the drug identified by the patent. 2.5) A patent for a metabolite of the approved active ingredient may not be listed. If the patent claims an approved method of using the approved drug product to administer the metabolite, the patent may be listed as a method of use patent depending on the responses to section 4 of this form. 2.7) Answer this question only if the patent is a product-byprocess patent.

3. Drug Product (Composition/Formulation)
Complete all items in this section if the patent claims the drug product that is the subject of the approved NDA or supplement. 3.3) An answer to this question is required only if the referenced patent is a product-by-process patent.

. . . .

4. Method of Use
Complete all items in this section if the patent claims one or more methods of use of the drug product that is the subject of the approved NDA or supplement. 4.2) For each approved use of the drug claimed by the patent, identify by number the claim(s) in the patent that claim the approved use of the drug. An applicant may list together multiple patent claim numbers and information for each approved method of use, if applicable. However, each approved method of use must be separately listed within this section of the form.

4.2a) Specify the part of the approved drug labeling that is claimed by the patent. 4.2b) The answer to this question will be what FDA uses to create a "use-code" for Orange Book publication. The use code designates a method of use patent that claims the approved indication or use of a drug product. Each approved use claimed by the patent should be separately identified in this section and contain adequate information to assist 505(b)(2) and ANDA applicants in determining whether a listed method of use patent claims a use for which the 505(b)(2) or ANDA applicant is not seeking approval. Use a maximum of 240 characters for each "use code."

First Section
Complete all items in this section.

1. General Section
Complete all items in this section with reference to the patent itself. 1c) Include patent expiration date, including any Hatch-Waxman patent extension already include any granted. Do not applicable pediatric exclusivity. The agency will include pediatric exclusivities where applicable upon publication. 1d) Include full address of patent owner. If patent owner resides outside the U.S. indicate the country in the zip code block. 1e) Answer this question if applicable. If patent owner and NDA applicant/holder reside in the United States, leave space blank.

5. No Relevant Patents
Complete this section only if applicable.

6. Declaration Certification
Complete all items in this section. 6.2) Authorized signature. Check one of the four boxes that best describes the authorized signature.

FORM FDA 3542 (12/08)

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