Correspondence Between the USPTO and the Regulatory Agency

It is the Director’s responsibility to decide whether an applicant has

satisfied the requirements of the statute and whether the patent qualifies for patent term

extension. The regulatory agency possesses expertise and records regarding some of the

statutory requirements and has certain direct responsibilities under

35 U.S.C. 156

for

determining the length of the regulatory review period. Consequently, to facilitate

eligibility decisions and permit the regulatory agency and the Office to carry out their

responsibilities under

35

U.S.C. 156

, both the Food and Drug Administration and the Department

of Agriculture have entered into an “agreement” of cooperation with the Office.

Memorandum of Understanding Between the Patent and Trademark Office and the

Food and Drug Administration,

52 FR 17830 (May 12, 1987);

Memorandum

of Understanding Between the Patent and Trademark Office and the Animal and Plant Health

Inspection Service,

54 FR 26399 (June 23, 1989); 1104 OG 18 (July 11, 1989).

The agreements establish the procedures whereby the regulatory agency assists the Office in

determining a patent’s eligibility for patent term extension under

35 U.S.C. 156

. They

also establish procedures for exchanging information between the regulatory agency and

the Office regarding regulatory review period determinations, due diligence petitions and

informal regulatory agency hearings under the law. The patent term extension applicant

receives a copy of all correspondence between the Office and the regulatory agency.

The Animal and Plant Health Inspection Service of the United States

Department of Agriculture approves veterinary biological products and is responsible for

both (i) assisting the Office in determining the eligibility for term extension of a patent

which claims a veterinary biological product that has been subject to review under the

Virus-Serum-Toxin Act (21 U.S.C. 151-59) and (ii) determining the regulatory review period

of the veterinary biological product

ates

Department of Agriculture approves veterinary biological products and is responsible for

both (i) assisting the Office in determining the eligibility for term extension of a patent

which claims a veterinary biological product that has been subject to review under the

Virus-Serum-Toxin Act (21 U.S.C. 151-59) and (ii) determining the regulatory review period

of the veterinary biological product. The Secretary of Health and Human Services of the

Food and Drug Administration is responsible for assisting the Office in determining the

eligibility of patents for patent term extension which claim any other product for which

regulatory review is required and for determining the regulatory review period for such

products. 21 CFR 60.10.

I.

INFORMATION REGARDING ELIGIBILITY FOR EXTENSION

If the Office has no clear reason to deny eligibility for patent term

extension (even if there are questions concerning eligibility), or if the applicant has

been notified of any informalities and it is anticipated that the informalities will be

corrected or explained, a first letter is sent to the regulatory agency to request

information regarding eligibility. The letter is accompanied by a copy of the patent

term extension application. This letter does

not

request the determination

of the applicable regulatory review period.

The regulatory agency reply is usually in the form of a written

response:

(A) verifying whether the product has undergone a regulatory review

period within the meaning of

35 U.S.C

gency to request

information regarding eligibility. The letter is accompanied by a copy of the patent

term extension application. This letter does

not

request the determination

of the applicable regulatory review period.

The regulatory agency reply is usually in the form of a written

response:

(A) verifying whether the product has undergone a regulatory review

period within the meaning of

35 U.S.C. 156(g)

prior to

commercial marketing or use;

(B) stating whether the marketing permission was for the first

permitted commercial marketing or use of that product, or, in the case of

recombinant DNA technology, whether such commercial marketing or use was the first

permitted under the process claimed in the patent;

(C) informing the Office whether the patent term extension

application was submitted within sixty days after the product was approved for

marketing or use; and

(D) providing the Office with any other information relevant to the

determination of whether a patent related to a product is eligible for patent term

extension.

While the Office has primary responsibility for the eligibility

determination, the regulatory agency often possesses information which is not readily

available to the Office. The assistance of the regulatory agency enables both the Office

and the agency to process applications efficiently and to conserve resources.

II.

PRELIMINARY ELIGIBILITY DECISION

Upon receipt of a reply from the regulatory agency to the first letter

from the Office requesting assistance on determining eligibility, a preliminary

eligibility decision (not the final decision) is made as to whether the patent is

eligible for an extension of its term. As noted above, the reply from the regulatory

agency will usually inform the Office as to whether the permission for commercial

marketing or use of the product on which the application for patent term extension is

based is the

first

such approval for that product

, a preliminary

eligibility decision (not the final decision) is made as to whether the patent is

eligible for an extension of its term. As noted above, the reply from the regulatory

agency will usually inform the Office as to whether the permission for commercial

marketing or use of the product on which the application for patent term extension is

based is the

first

such approval for that product. Furthermore,

the regulatory agency usually provides information regarding the date of product

approval to permit a determination as to whether the application was filed within the

sixty-day statutory period set forth in

35 U.S.C. 156(d)(1)

. The information

provided by the regulatory agency is then compared with the related information from the

application. If no major discrepancies are found and the patent is determined to be

eligible for patent term extension, a second letter requesting a determination of the

length of the regulatory review period of the product is sent to the regulatory agency

not later than sixty (60) days after the Office receipt date of the reply from the

regulatory agency. In the interest of efficiency, if the patent is determined to be

ineligible for patent term extension, the Office will dismiss the application rather

than request a determination of the regulatory review period.

In re Allen &

Hansbury, Ltd.,

227 USPQ 955, 960 n. 9 (Comm’r Pat. & Tm. 1985). The

second letter states that, subject to final review, the patent is considered eligible

for patent term extension and requests a determination of the applicable regulatory

review period.

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