Record facts for a patent term extension application

Key facts

Human involvement

Yellow · Close supervision

How AI is used

Record the patent number, the product, the permission date the file states, and the claim numbers the lawyer identifies. Leave the sixty-day date and any extension length blank. Write no application and do not decide eligibility.

What the lawyer must review

You decide eligibility and you write any application. Section 156(a) says the term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with that section from the original expiration date, which includes any patent term adjustment granted under section 154(b), if the conditions in subsection (a) are met. You read the whole of subsection (a), including the first-permitted-commercial-marketing condition, before you treat a patent as eligible. Section 154(b) was not opened. Subsection (c) extends an eligible patent by the regulatory review period for the approved product which occurs after the patent is issued. Each period of that regulatory review period is reduced by any period determined under subsection (d)(2)(B) during which the applicant did not act with due diligence. After that reduction, the period of extension includes only one-half of the time remaining in the periods described in paragraphs (1)(B)(i), (2)(B)(i), (3)(B)(i), (4)(B)(i), and (5)(B)(i) of subsection (g). If the period remaining in the term after the date of approval, added to the regulatory review period as revised under paragraphs (c)(1) and (c)(2), exceeds fourteen years, the extension is reduced so that the total of both periods does not exceed fourteen years. In no event shall more than one patent be extended under subsection (e)(1) for the same regulatory review period for any product. Except as paragraph (d)(5) provides, the owner of record or its agent may submit an application only within the sixty-day period beginning on the date the product received permission for commercial marketing or use, or, for a drug product described in subsection (i), within the sixty-day period beginning on the covered date defined in subsection (i). You read paragraph (d)(5) and subsection (i) before you use another window. The application contains the identity of the approved product and the federal statute under which regulatory review occurred, and the identity of the patent and of each claim which claims the approved product or a method of using or manufacturing it. Subsection (f) defines product to include a drug product. A drug product means the active ingredient of a new drug, antibiotic drug, or human biological product, as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, or of a new animal drug or veterinary biological product, as those terms are used in that Act and the Virus-Serum-Toxin Act, which is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques, including any salt or ester of the active ingredient. You read subsection (g) before you compute a regulatory review period. Section 41(b) maintenance fees are a different payment. The tool calculates no date and no length.

Written for / version

United States versionUS