Page:United States Statutes at Large Volume 98 Part 2.djvu/438

 98 STAT. 1598

PUBLIC LAW 98-417—SEPT. 24, 1984 TITLE II—PATENT EXTENSION

SEC. 201. (a) Title 35 of the United States Code is amended by adding the following new section immediately after section 155A: 35 USC 156. Claims.

Marketing.

Claims.

"§ 156. Extension of patent term "(a) 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 this section from the original expiration date of the patent if— "(1) the term of the patent has not expired before an application is submitted under subsection (d) for its extension; "(2) the term of the patent has never been extended; "(3) an application for extension is submitted by the owner of record of the patent or its agent and in accordance with the requirements of subsection (d); "(4) the product has been subject to a regulatory review period before its commercial marketing or use; "(5)(A) except as provided in subparagraph (B), the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred; or "(B) in the case of a patent which claims a method of manufacturing the product which primarily uses recombinant DNA technology in the manufacture of the product, the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of a product manufactured under the process claimed in the patent. The product referred to in paragraphs (4) and (5) is hereinafter in this section referred to as the 'approved product*. "(b) The rights derived from any patent the term of which is extended under this section shall during the period during which the patent is extended— "(1) in the case of a patent which claims a product, be limited to any use approved for the approved product before the expiration of the term of the patent under the provision of law under which the applicable regulatory review occurred; "(2) in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent and approved for the approved product before the expiration of the term of the patent under the provision of law under which the applicable regulatory review occurred; and "(3) in the case of a patent which claims a method of manufacturing a product, be limited to the method of manufacturing as used to make the approved product. "(c) The term of a patent eligible for extension under subsection (a) shall be extended by the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued, except that— "(1) each period of the regulatory review period shall be reduced by any period determined under subsection (d)(2)(B) during which the applicant for the patent extension did not act with due diligence during such period of the regulatory review period;

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