Page:United States Statutes at Large Volume 98 Part 2.djvu/434

This page needs to be proofread.
PUBLIC LAW 98-000—MMMM. DD, 1984

98 STAT. 1594

Claims.

Marketing.

Ante, p. 1592. Effective dates.

Claims.

PUBLIC LAW 98-417—SEPT. 24, 1984

approval under this subsection and for which information is required to be filed under paragraph (1) or subsection (c)— "(i) that such patent information has not been filed, "(ii) that such patent has expired, "(iii) of the date on which such patent will expire, or "(iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted; and "(B) if with respect to the drug for which investigations described in paragraph (1)(A) were conducted information was filed under paragraph (1) or subsection (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use. "(3)(A) An applicant who makes a certification described in paragraph (2)(A)(iv) shall include in the application a statement that the applicant will give the notice required by subparagraph (B) to— "(i) each owner of the patent which is the subject of the certification or the representative of such owner designated to receive such notice, and "(ii) the holder of the approved application under subsection (b) for the drug which is claimed by the patent or a use of which is claimed by the patent or the representative of such holder designated to receive such notice. "(B) The notice referred to in subparagraph (A) shall state that an application has been submitted under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of the drug before the expiration of the patent referred to in the certification. Such notice shall include a detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid or will not be infringed. "(C) If an application is amended to include a certification described in paragraph (2)(A)(iv), the notice required by subparagraph (B) shall be given when the amended application is submitted.", (b) Section 505(c) of such Act (as amended by section 102(a)(2)) is amended by adding at the end the following: "(3) The approval of an application filed under subsection 0>) which contains a certification required by paragraph (2) of such subsection shall be made effective on the last applicable date determined under the following: "(A) If the applicant only made a certification described in clause (i) or (ii) of subsection (b)(2)(A) or in both such clauses, the approval may be made effective immediately. (B) If the applicant made a certification described in clause (iii) of subsection (b)(2)(A), the approval may be made effective on the date certified under clause (iii). "(C) If the applicant made a certification described in clause (iv) of subsection (b)(2)(A), the approval shall be made effective immediately unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice provided under paragraph (3)(B) is received. If such an action is brought before the expiration of such days, the approval may be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under paragraph (3)(B) or such shorter or longer period as the court may order because