XIX. Suggestions to the DVA on how to improve and expedite TT

The suggestions to the Department of Veterans Affairs (DVA) which are enumerated below have been prepared based upon seven years of direct experience in attempting to interest private companies in manufacturing and marketing the devices and techniques developed at the RR&D Center of the VA Medical Center in Palo Alto, CA:

1. Copy TT officer (if any) on ALL correspondence between Field Station and Central Office (CO) or GC involving patents, patent disclosures, TT agreements, new laws and regulations affecting TT, and other TT related topics. There is currently no mechanism for the TT officer to receive any response from a letter that he/she may initiate, not to mention legislative or regulatory changes affecting TT. This makes for ineffective or erroneous communication with industry and indefinite delays, where such delays are costly.

2. Initiate logging in and out of all official TT correspondence by all parties through whom the correspondence must pass. Also require that the Directors Office of each facility notify the initiator when the correspondence actually leaves the Field Station.This will minimize time spent on one desk, and will give the sender essential information on when the correspondence actually went out. It is sometimes weeks before important TT correspondence leaves the Station. Companies cannot afford such delays. Perhaps initiate rewards for VA offices that can document expeditious handling of transactions.

3. Stop the practice of routinely granting patent rights to the employee-inventor on patent disclosures which may have commercial potential. This practice prevents our granting licenses under Section 207 of Title 35 USC . It also effectively prevents the Field Stations from making use of any arrangement with a professional firm for patent management of government-owned inventions. (Two such arrangements are now in place at the Palo Alto VAMC.) Finally, it often makes it less likely that such products will ever become available to veterans who need them, since individual inventors (1) can seldom afford the cost of TT in both time and dollars, (2) may have no desire to spend their time and money on such an endeavor, and (3) cannot continue to work on the project for the government without a conflict of interest.

4. Grant to the Field Stations the authority to license background patents to collaborating parties under Cooperative R&D Agreements so that they are protected in their investments both in the new patents and in existing patents and know-how. The know-how protection would simply require a ruling by GC that FOIA does not apply to results of research and development. (DOD has already made such a ruling for their Department.)

5. Either provide government patent and licensing services or else provide the funds and authority to have patents and licenses handled by the Field Stations through outside professional services. At present we have neither. We have therefore resorted to royalty agreements with professional TT organizations, but they are generally searching for the big commercial winners, not usually found in rehabilitation.

6. Suggest that the Congress introduce legislation to establish an Orphan Product Act (like the Orphan Drug legislation) to subsidize the commercialization (not just clinical testing) of rehab products that have a real need but do not represent a market size that would justify the investment of a commercial firm to set up the necessary manufacturing and marketing resources. The Traction Backboard developed at Palo Alto is a good example, as is the Finger-Spelling Hand.

7. Consider the possibility of converting VA Rehab R&D Centers from government owned government operated (GOGO) into government owned contractor operated (GOCO; i.e., National) Laboratories, thereby allowing each Center to take over patent rights and copyrights and to administer patents and patent licensing in a less restrictive atmosphere (like DOE). This would in turn mean more effective and efficient technology transfer. In the case of Palo Alto, if the contractor were Stanford University, it would immediately make available the extensive experience, expertise, and resources of Stanfords Office of Technology Licensing for facilitating technology transfer. Note that the new CRADA between Stanford and Palo Alto VA [Appendix M], now accomplishes this purpose, except for VA employees who are not also paid by Stanford.

8. Since Technology Transfer (TT) depends so heavily on personal contacts, as opposed to publications, the rules for travel funds should be loosened for personnel assigned to Technology Transfer. That is, any funds which are specifically allotted internally for TT purposes should be usable for travel required for TT, provided this is legal. Written justifications to the Service Chief could be required, specifying why it is important to TT. For example, a direct visit to a company can often save significant time, effort, and money in selecting a collaborative partner for commercialization of a product.

9. According to the Stevenson-Wydler Act of 1980 (Appendix D) as amended by PL 99-502, section 10(b)(1) each laboratory having 200 or more FTE scientific, engineering, and related technical positions shall provide one or more FTE positions and staff for its Office of Research and Technology Applications (ORTA). Many of the VA Medical Centers across the country would seem to fall into this category, particularly if physicians are included in this description. Yet there seem to be no such TT officers within the VA. This question should be addressed, since a recent survey conducted by Rancho Engineering Center showed that the most successful TT was carried out by laboratories having at least one such full-time position.