Sec. 7. Proper disclosure of government support
640 words·~3 min read·
/bill/116/s/2387/is/section-7·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
In this section— the term contractor — has the meaning given the term in section 201 of title 35, United States Code; and includes an assignee of a contractor to the extent that the assignee is the entity that files an application described in section 202(c)(6); the term covered contractor means a contractor that— is a party to a funding agreement that contains an appropriate provision to effectuate the requirement under section 202(c)(6); and files a United States patent application with respect to a subject invention that the contractor conceived or first actually reduced to practice in the performance of work under the funding agreement described in subparagraph (A); the term covered patentee means the patentee with respect to a patent issuing from an application described in paragraph (2)(B); the term drug has the meaning given that term in section 201 of the Federal Food, Drug, and Cosmetic Act; the terms funding agreement and subject invention have the meanings given the terms in section 201 of title 35, United States Code; the term patentee has the meaning given the term in section 100 of title 35, United States Code; and the term section 202(c)(6) means section 202(c)(6) of title 35, United States Code.
A person (including a government entity) may bring a civil action in an appropriate district court of the United States against a covered patentee— on the ground that the application for the patent with respect to which the covered patentee holds title failed to comply with the requirement under section 202(c)(6); and if the person is injured by the failure to comply described in clause (i). In an action brought under subparagraph (A), if the court finds by a preponderance of the evidence that the application described in that subparagraph failed to comply with the requirement under section 202(c)(6), the court shall cancel as unpatentable any claim of the patent issuing from that application.
Section 311 of title 35, United States Code, is amended by striking subsection
(b)and inserting the following: A petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent— on a ground that could be raised under section 102 or 103; and on the basis of prior art consisting of patents or printed publications; or on the ground that the application with respect to the patent was subject to the requirement in section 202(c)(6) and failed to comply with that requirement. . Section 111(a)(2) of title 35, United States Code, is amended— in subparagraph (B), by striking and at the end; in subparagraph (C), by striking the period and inserting ; and ; and by adding at the end the following: with respect to a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) covered by a qualifying patent on the drug, on a method of using such drug, or on a method or machine used to manufacture or administer such drug, a disclosure of any Federal grant received in the 10-year period prior to submitting the application, in which the applicant is listed as the principal investigator or co-investigator with respect to the grant. . Not later than 5 years after the date of enactment of this Act, and once every 5 years thereafter, the Comptroller General of the United States shall— conduct a study that reviews— the compliance by covered contractors with the requirement under section 202(c)(6); and the effectiveness of the National Institutes of Health in conducting oversight of the extent to which covered contractors are complying with the requirement under section 202(c)(6); and submit to Congress the results of each study conducted under paragraph (1), which shall include, in each case, recommendations for additional practices and policies to improve the effectiveness of the requirement under section 202(c)(6), including any mechanism to better enforce that requirement.