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APPENDIX 9. STANDARD PATENTS RIGHTS CLAUSE (PHS GPS 9505)


The following contains the text of the standard patents rights clause contained in 37 CFR 401.14 which is applicable to Nonprofit Organizations and Small Business Firms.

(a) Definitions.

(1) "Invention" means any invention or discovery which is or may be patentable or otherwise protectable under Title 35 of the United States Code, or any novel variety of plant which is or may be protected under the Plant Variety Protection Act (7 U.S.C. 2321 et seq.).

(2) "Subject invention" means any invention of the grantee institution conceived or first actually reduced to practice in the performance of work under this grant, provided that in the case of a variety of plant, the date of determination (as defined in section 41 (d) of the Plant Variety Protection Act, 7 U.S.C. 2401 (d)) must also occur during the period of grant performance.

(3) "Practical Application" means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by law or government regulations, available to the public on reasonable terms.

(4) "Made" when used in relation to any invention means the conception or first actual reduction to practice of such invention.

(5) "Small Business Firm" means a small business concern as defined at section 2 of Pub. L. 85-536 (15 U.S.C. 632) and implementing regulations of the Administrator of the Small Business Administration. For the purpose of this clause, the size standards for small business concerns involved in government procurement and subcontracting at 13 CFR 121.3-8 and 13 CFR 121.3-12, respectively, will be used.

(6) "Nonprofit Organization" means a university or other institution of higher education or an organization of the type described in section 501 (c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. 501 (c) and exempt from taxation under section 501 (a) of the Internal Revenue Code (25 U.S.C. 501 (a)) or any nonprofit scientific or educational organization qualified under a state nonprofit organization statute.

(b) Allocation of Principal Rights.

The grantee institution may retain the entire right, title, and interest throughout the world to each subject invention subject to the provisions of this clause and 35 U.S.C. 203. With respect to any subject invention in which the grantee institution retains title, the Federal government shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the subject invention throughout the world.

(c) Invention disclosure, Election of Title and Filing of Patent Application by Grantee Institution.

(1) The grantee institution will disclose each subject invention to the Federal Agency within two months after the inventor discloses it in writing to grantee institution personnel responsible for patent matters. The disclosure to the agency shall be in the form of a written report and shall identify the grant under which the invention was made and the inventor(s). It shall be sufficiently complete in technical detail to convey a clear understanding to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological or electrical characteristics of the invention. The disclosure shall also identify any publication, on sale or public use of the invention and whether a manuscript describing the invention has been submitted for publication and, if so, whether it has been accepted for publication at the time of disclosure. In addition, after disclosure to the agency, the grantee institution will promptly notify the agency of the acceptance of any manuscript describing the invention for publication or of any on sale or public use planned by the grantee institution.

(2) The grantee institution will elect in writing whether or not to retain title to any such invention by notifying the Federal agency within two years of disclosure to the Federal agency. However, in any case where publication, on sale or public use has initiated the one year statutory period wherein valid patent protection can still be obtained in the United States, the period for election of title may be shortened by the agency to a date that is no more than 60 days prior to the end of the statutory period.

(3) The grantee institution will file its initial patent application on a subject invention to which it elects to retain title within one year after election of title or, if earlier, prior to the end of any statutory period wherein valid patent protection can be obtained in the United States after a publication, on sale, or public use. The grantee institution will file patent applications in additional countries or international patent offices within either ten months of the corresponding initial patent application or six months from the date permission is granted by the Commissioner of Patents and Trademarks to file foreign patent applications where such filing has been prohibited by a Secrecy Order.

(4) Requests for extension of the time for disclosure, election, and filing under subparagraphs (1), (2), and (3) may, at the discretion of the agency, be granted.

(d) Conditions When the Government May Obtain Title.

The grantee institution will convey to the Federal agency, upon written request, title to any subject invention-

(1) If the grantee institution fails to disclose or elect title to the subject invention within the times specified in (c), above, or elects not to retain title; provided that the agency may only request title within 60 days after learning of the failure of the grantee institution to disclose or elect within the specified times.

(2) In those countries in which the grantee institution fails to file patent applications within the times specified in (c) above; provided, however, that if the grantee institution has filed a patent application in a country after the times specified in (c) above, but prior to its receipt of the written request of the Federal agency, the grantee institution shall continue to retain title in that country.

(3) In any country in which the grantee institution decides not to continue the prosecution of any application for, to pay the maintenance fees on, or defend in reexamination or opposition proceeding on, a patent on a subject invention.

(e) Minimum Rights to Grantee Institution and Protection of the Grantee Institution Right to File.

(1) The grantee institution will retain a nonexclusive royalty-free license throughout the world in each subject invention to which the government obtains title, except if the grantee institution fails to disclose the invention within the times specified in (c), above. The grantee institution's license extends to its domestic subsidiary and affiliates, if any, within the corporate structure of which the grantee institution is a party and includes the right to grant sublicenses of the same scope to the extent the grantee institution was legally obligated to do so at the time the grant was awarded. The license is transferable only with the approval of the Federal agency except when transferred to the successor of that party of the grantee institution's business to which the invention pertains.

(2) The grantee institution's domestic license may be revoked or modified by the funding federal agency to the extent necessary to achieve expeditious practical application of the subject invention pursuant to an application for an exclusive license submitted in accordance with applicable provisions at 37 CFR Part 404 and agency licensing regulations (if any). This license will not be revoked in that field of use or the geographical areas in which the grantee institution has achieved practical application and continues to make the benefits of the invention reasonably accessible to the public. The license in any foreign country may be revoked or modified at the discretion of the funding federal agency to the extent the grantee institution, its licensees, or the domestic subsidiaries or affiliates have failed to achieve practical application in that foreign country.

(3) Before revocation or modification of the license, the funding federal agency will furnish the grantee institution a written notice of its intention to revoke or modify the license, and the grantee institution will be allowed thirty days (or such other time as may be authorized by the funding federal agency for good cause shown by the grantee institution) after the notice to show cause why the license should not be revoked or modified. The grantee institution has the right to appeal, in accordance with applicable regulations in 37 CFR Part 404 and agency regulations (if any) concerning the licensing of government-owned inventions, any decision concerning the revocation or modification of the license.

(f) Grantee Institution Action to Protect the Government's Interest.

(1) The grantee institution agrees to execute or to have executed and promptly deliver to the Federal agency all instruments necessary to (i) establish or confirm the rights the government has throughout the world in those subject inventions to which the grantee institution elects to retain title, and (ii) convey title to the Federal agency when requested under paragraph (d) above and to enable the government to obtain patent protection throughout the world in that subject invention.

(2) The grantee institution agrees to require, by written agreement, its employees, other than clerical and nontechnical employees, to disclose promptly in writing to personnel identified as responsible for the administration of patent matters and in a format suggested by the grantee institution each subject invention made under grant in order that the grantee institution can comply with the disclosure provisions of paragraph (c), above, and to execute all papers necessary to file patent applications on subject inventions and to establish the government's rights in the subject inventions. This disclosure format should require, as a minimum, the information required by (c)(1), above. The grantee institution shall instruct such employees through employee agreements or other suitable educational programs on the importance of reporting inventions in sufficient time to permit the filing of patent applications prior to U.S. or foreign statutory bars.

(3) The grantee institution will notify the Federal agency of any decisions not to continue the prosecution of a patent application, pay maintenance fees, or defend in a reexamination or opposition proceeding on a patent, in any country, not less than thirty days before the expiration of the response period required by the relevant patent office.

(4) The grantee institution agrees to include, within the specification of any United States patent applications and any patent issuing thereon covering a subject invention, the following statement, "This invention was made with government support under (identify the grant) awarded by (identify the federal agency). The government has certain rights in the invention."

(5) The grantee institution agrees to provide a final invention statement and certification prior to the close-out of a grant listing all subject inventions or stating that there were none.

(6) The grantee institution will provide the patent application filing date, serial number and title; copy of the page of the patent application with the statement identified in (4) above (and upon request, a copy of the patent application); and patent number and issue date for any subject invention in any country in which the grantee institution has applied for patent.

(g) Subcontracts.

(1) The grantee institution will include this clause, suitably modified to identify the parties, in all subcontracts, regardless of tier, for experimental, developmental or research work to be performed by a small business firm or domestic nonprofit organization. The subcontractor will retain all rights provided for the grantee institution in this clause, and the grantee institution will not, as part of the consideration for awarding the subcontract, obtain rights in the subcontractor's subject inventions.

(2) In the case of subcontracts, at any tier, when the prime award with the federal agency was a contract (but not a grant or a cooperative agreement), the agency, subcontractor, and contractor agree that the mutual obligations of the parties created by this clause constitutes a contract between the subcontractor and the Federal agency with respect to matters covered by the clause; provided, however, that nothing in this paragraph is intended to confer any jurisdiction under the Contract Disputes Act in connection with proceedings under paragraph (j) of this clause.

(h) Reporting on Utilization of Subject Inventions.

The grantee institution agrees to submit on request periodic reports no more frequently than annually on the utilization of a subject invention or on efforts at obtaining such utilization that are being made by the grantee institution or its licensees or assignees. Such reports shall include information regarding the status of development, date of first commercial sale or use, gross royalties received by the grantee institution, and such other data and information as the agency may reasonably specify. The grantee institution also agrees to provide additional reports as may be requested by the agency in connection with any march-in proceeding undertaken by the agency in accordance with paragraph (j) of this clause. As required by 35 U.S.C. 202(c)(5), the agency agrees it will not disclose such information to persons outside the government without permission of the grantee institution.

(i) Preference for United States Industry.

Notwithstanding any other provision of this clause, the grantee institution agrees that neither it nor any assignee will grant to any person the exclusive right to use or sell any subject inventions in the United States unless such person agrees that any products embodying the subject invention or produced through the use of the subject invention will be manufactured substantially in the United States. However, in individual cases, the requirement for such an agreement may be waived by the federal agency upon a showing by the grantee institution or its assignee that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible.

(j) March-in Rights.

The grantee institution agrees that with respect to any subject invention in which it has acquired title, the Federal agency has the right in accordance with the procedures in 37 CFR 401.6 and any supplemental regulations of the agency to require the grantee institution, an assignee or exclusive licensee of a subject invention to grant a nonexclusive, partially exclusive, or exclusive license in any field of use to a responsible applicant or applicants, upon terms that are reasonable under the circumstances, and if the grantee institution, assignee, or exclusive licensee refuses such a request the federal agency has the right to grant such a license itself if the federal agency determines that:

(1) Such action is necessary because the grantee institution or assignee has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in such field of use.

(2) Such action is necessary to alleviate health or safety needs which are not reasonably satisfied by the grantee institution, assignee or their licensees;

(3) Such action is necessary to meet requirements for federal regulations and such requirements are not reasonably satisfied by the grantee institution, assignee or licensees; or

(4) Such action is necessary because the agreement required by paragraph (i) of this clause has not been obtained or waived or because a licensee of the exclusive right to use or sell any subject invention in the United States is in breach of such agreement.

(k) Special Provisions for grants with Non-profit organizations.

If the grantee institution is a nonprofit organization, it agrees that:

(1) Rights to a subject invention in the United States may not be assigned without the approval of the federal agency, except where such assignment is made to an organization which has as one of its primary functions the management of inventions, provided that such assignee will be subject to the same provisions as the grantee institution;

(2) The grantee institution will share royalties collected on a subject invention with the inventor, including federal employee co-inventors (when the agency deems it appropriate) when the subject invention is assigned in accordance with 35 U.S.C. 202(e) and 37 CFR 401.10,

(3) The balance of any royalties or income earned by the grantee institution with respect to subject inventions, after payment of expenses (including payments to inventors) incidental to the administration of subject inventions, will be utilized for the support of scientific research or education; and

(4) It will make efforts that are reasonable under the circumstances to attract licensees of subject invention that are small business firms and that it will give a preference to a small business firm when licensing a subject invention if the grantee institution determines that the small business firm has a plan or proposal for marketing the invention which, if executed, is equally as likely to bring the invention to practical application as any plans or proposals from applicants that are not small business firms; provided, that the grantee institution is also satisfied that the small business firm has the capability and resources to carry out its plan or proposal. The decision whether to give a preference in any specific case will be at the discretion of the grantee institution. However, the grantee institution agrees that the Secretary may review the grantee institution's licensing program and decisions regarding small business applicants, and the grantee institution will negotiate changes to its licensing policies, procedures, or practices with the Secretary when the Secretary's review discloses that the grantee institution could take reasonable steps to implement more effectively the requirements of this paragraph (k)(4).

(l) Communication.

All disclosures, elections, confirmatory licenses to the government, face page of the patent applications, waivers and other routine communications should be sent to the following:

For grants awarded by NIH:

National Institutes of Health
Director, Extramural Invention Reports Office
Building 31, Room 5B41
31 CENTER DRIVE MSC 2184,
Bethesda, MD 20892-2184

For grants awarded by CDC:

Centers For Disease Control
Director, Procurement and Grants
255 Paces Ferry Road, Room 506
Atlanta, GA 30305

For all other PHS awarding components, invention information and communications should be sent to the Grants Management Officer.



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