Fighting to Implement Bayh-Dole However, this did not mean that the fledgling Bayh-Dole Act was out of the woods by any means. Just because a law is enacted does not necessarily mean it will be implemented as Congress intended. Creating the necessary regulations instructing the federal agencies how to apply the various provisions of Bayh-Dole were critical to its uniform application. If undermined by the bureaucracy, the regulations could provide sufficient loopholes to undo its intent.
With Senator Bayh defeated in the 1980 election, the Senate going from Democratic to Republican control, the defeat of an incumbent President and the incoming President’s team not firmly in place, there was plenty of opportunity for mischief. What next ensued was a two year battle over the initial regulations and with continuous bureaucratic skirmishing over the next five years.
That the original intent of the law was preserved in the regulations was only because there was a strong oversight entity insuring that the intent of Congress was met. This operation was headed by Norman Latker, former patent attorney for the National Institutes of Health. Mr. Latker was intimately familiar with the problems in the old government patent policies having seen first hand at NIH that unless universities were allowed to manage their inventions, taxpayers were not likely to see research turn into products improving public health and well being.
The impetus of the Bayh-Dole Act was the administrative program Latker established allowing universities to retain patient ownership of NIH funded inventions. Not only did the Carter Administration overturn this policy, it also sought to fire Latker. Mr. Latker only remained a federal employee due to the strong intervention of Senators Bayh and Dole. Subseqently, Latker moved to the Office of Federal Procurement Policy (OFPP). Because of his presence there, Bayh and Dole placed the regulatory authority for the new law at OFPP. That this confidence was well placed was soon borne out.
Because he understood both the language and intent of Bayh-Dole and the ins and outs of bureaucratic infighting, Latker was able to go toe to toe with DOE over the implementing regulations. Without this strong policy oversight, Bayh-Dole would have been smothered at birth under the very red-tape it was designed to remove.
One significant fight was over DOE’s attempted to use the “exceptional circumstances” provisions of the law (exempting title to universities in extraordinary circumstances) to exclude any technologies listed under export control regulations from the law. Since the list of such technologies is very large, this would have seriously eroded the impact of Bayh-Dole creating a dangerous precedent for other agencies to follow. Norm Latker was able to fight off DOE with assistance from Senator Dole’s office which closely followed the implementation fight.
In addition to fighting the regulations, DOE made it clear that it had no intention of using the discretion under the law to allow its university operated federal laboratories to manage their inventions. Thus, the discretionary nature of the original statute was an insufficient carrot for change. Policy makers reached for the stick.
In the first term of President Reagan, it became apparent that something significant was occurring under the Bayh-Dole Act helping the U.S. to restore its competitiveness. In 1983, the President asked David Packard to report how to get similar results from the federal laboratories. The report said:
The ultimate purpose of federal support for R&D is to develop
the science and technology base needed for a strong national defense,
for the health and well-being of U.S. citizens, and for a healthy U.S.
committed to its highest service, and totally dependent on it for support. They
perceive industry as an awkward partner with a different value system. Although
the degree of interaction with universities and industry varied among the laboratories visited, the Panel feels that this interaction could be increased at all
President Reagan accepted the Panel’s recommendation and issued a patent policy memorandum to all federal agencies instructing that “to the extent permitted by law” policies regarding the ownership of all federally funded research should be treated under the principles of the Bayh-Dole Act. It was felt that such language would spur DOE to overhaul its centralized management practices.
This was not the case.