SPECIAL NOTICE
A -- Molecular Libraries Small Molecule Repository
- Notice Date
- 12/31/2003
- Notice Type
- Special Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, MD, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- Reference-Number-PN-RM-04-000-Statement-of-Facts
- Response Due
- 3/2/2004
- Archive Date
- 3/17/2004
- Point of Contact
- Bruce Anderson, Contracting Officer, Phone 301-443-2234, Fax 301-443-0501,
- E-Mail Address
-
ba9i@nih.gov
- Description
- PN-RM-04-0001 (Statement of Facts) The NIMH is seeking public comments (or alternative plans) regarding potential use of a deviation to the standard patent rights clause (FAR 52.227-11 Patent Rights - Retention by the Contractor (Short Form), in a contract to be awarded under the NIH Roadmap: ?Molecular Libraries Small Molecule Repository?. The proposed clause is included in full text in a separate notice PN-RM-04-0001 (52.227-11 Patent Rights (Deviation)), and also in the solicitation for this contract (RM-04-0001), which can be accessed at: http://www.nimh.nih.gov/grants/indexcon.cfm#RequestforProposal and in the FedBizOpps at: http://vsearch1.eps.gov/servlet/SearchServlet. Due to file size limitations, the Statement of Facts and the proposed deviation to FAR 52.227-11 could not be published together. If a Determination of Exceptional Circumstances (DEC) were implemented, this clause deviation would serve to protect the pre-existing and future patent rights of suppliers of proprietary materials for synthesis or inclusion in the compound collection/repository. The proposed clause deviation only applies to discoveries resulting from routine synthesis activities and repository activities involving the use of proprietary materials (compounds and procedures). Discoveries resulting from research activities pertaining to the development or modification of chemical synthesis procedures, process development, or other unanticipated discoveries developed by the contractor without the use of proprietary materials will be covered by the standard Patent Rights Clause (FAR 52.227-11, Patent Rights - Retention by the Contractor (Short Form) (June 1997). Furthermore, the Contractor will have the right to ask for greater rights, as defined in the clause, if the supplier of the proprietary compound is not interested in the subject invention. Potential offerors and other interested parties are invited to submit comments herein or provide ?alternative plans? when responding to the solicitation for this contract, which would serve to meet the objectives/goals of this Program without the use of this deviation. All plans and comments will be considered and discussed with interested parties. Any comments/plans regarding this clause should be submitted, in writing, by March 2, 2004, to Mr. Bruce Anderson, Contracting Officer, Contract Management Branch, NIMH, NIH, 6001 Executive Blvd., Rm. 8154 (MSC 9661), Bethesda, MD 20892 (for Fed Ex, UPS etc. use Rockville, MD 20852);Voice: (301) 443-2234; Fax: (301) 443-0501; E-Mail: ba9i@nih.gov. See solicitation for instructions on submission of ?alternative plans? with a proposal. The following Statement of Facts provides more detail into the potential use of a deviated patent rights clause: Statement of Facts The primary goal of the Molecular Libraries initiative is to improve public health by stimulating the discovery, development, and commercialization of new research tools and potential therapeutic compounds for the treatment of a variety of disorders and the validation of new targets for drug therapy. We believe the synthesis and repository activities of this contract may constitute an exceptional circumstance where the imposition of a FAR deviation, through a Determination of Exceptional Circumstances (DEC), would further the achievement of the programmatic goals and meet the objectives of 35 U.S.C. 200. Historically, the NIMH has obtained the approval of DECs in similar contract programs where proprietary materials are involved. To meet the goals and objectives of the Molecular Libraries Small Molecule Repository, this contract will need to acquire and maintain a library of hundreds of thousands of diverse small molecules, which will become a major resource to investigators for further evaluation in a wide variety of assays of biological activity. The small molecules collected in this repository will be arrayed and sent to screening centers (i.e. grantees, which are not part of this contract) or investigators, to be evaluated and screened for a large number of possible new activities and applications. Screening will enhance the identification of small molecules that are useful as research tools (e.g., probes to alter the function of novel proteins or molecular imaging probes) or as starting points for the development of novel compounds with therapeutic potential. The contractor shall maintain an appropriate quantity of each compound by either repurchasing additional quantities, or through synthesis efforts. Under this contract, both proprietary and non-proprietary materials will be provided directly by the compound suppliers (or through NIH) to the contractor for inclusion in the compound collection/repository. It is anticipated that some of the most unique and promising compounds with the most interesting biological activities will be proprietary. Therefore, in order for this program to succeed, it will be essential to obtain a sufficient flow of proprietary materials. Our previous experience and discussions with compound suppliers (i.e., investigators at academic institutions, biotechnology companies, and pharmaceutical companies) have shown that they will not submit their proprietary materials without complete assurance that their intellectual property rights will be protected, such as that which could be provided through a DEC. Through discussions with these organizations it was determined that, except for the protection offered by this clause, the NIH would have no other method to gain access to some of these promising compounds; this would result in a less effective and less diverse and unique compound collection. As many of the compounds with the most interesting activity will be proprietary, having an insufficient number of these compounds submitted for inclusion in the repository would inhibit the discovery of promising new leads for further development as potential research tools or therapeutics. This would not appear to appropriately support the objectives of 35 U.S.C. 200, et. seq., or benefit the public health under this program. Pharmaceutical and biotechnology companies are highly unlikely to invest in areas such as the development of research compounds to be used as research tools, imaging probes, or as therapeutics for rare or ?orphan? diseases because of cost-restraints and low potential returns. Therefore, this program will fill a critical need by supporting and stimulating the development of much-needed research tools and potential therapeutics that might not otherwise be developed. It is expected that many investigators who use the compound collection will go on to further develop these compounds into much-needed agents and therapeutics to further research and benefit the public health. We recognize the scientific expertise of the contractors and the importance of the Bayh-Dole Act in protecting the intellectual property rights of contractors. While Bayh-Dole provides incentives for the commercialization of Government supported research and development by allowing contractors to retain rights to inventions, the Act also permits an exception to this provision under exceptional circumstances. In this instance, we believe that restriction or elimination of the contractor?s right to retain title to subject inventions, in a narrow field, may be needed to further the programmatic goals of research and development in order to benefit public health. If adopted, use of the proposed restricted Patent Rights clause has been narrowly tailored to apply only to subject inventions using proprietary materials obtained and evaluated under these contracts, and not to subject inventions outside the scope of the deviated patent rights clause. The Contractor will have the right to ask for greater rights, as defined in the clause, if the supplier of the proprietary materials is not interested in licensing or pursuing the invention. Furthermore, even if a DEC were implemented, rights to subject inventions made without the use of proprietary materials would remain with the contractor, and will be subject to the standard clause at FAR 52.227-11, Patent Rights-Retention by the Contractor (Short Form) (June 1997). Based on previous experience with similar programs, we have discussed and considered approaches other than the use of a DEC for acquiring and evaluating proprietary materials, but we are not currently aware of any viable alternatives that would adequately address the concerns noted above. [End of Statement of Facts]
- Record
- SN00497311-W 20040102/031231211704 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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