Three ways Bayh-Dole advocates abuse their audiences

Folks who advocate for Bayh-Dole generally abuse their audiences three ways.

First, they recite fake history. 

Bayh-Dole did not make any great change in ownership of inventions made in projects receiving federal support, especially for universities.

Prior to Bayh-Dole, contractors could own such inventions.  The Kennedy and Nixon executive branch patent policies expressly permitted contractor ownership. If a contractor had an established non-governmental commercial position, for instance. Or if a contractor otherwise petitioned for ownership and a federal agency determined that such ownership might advance a public purpose. The Department of Defense notably routinely permitted contractors (many of which had established non-governmental commercial positions) to own inventions made in projects receiving federal support.

For nonprofits, the NIH and NSF Institutional Patent Agreement programs permitted nonprofits to own inventions made in projects with federal support. The requirements for ownership were in many ways even more favorable than those of Bayh-Dole, with less fussy paperwork. The one place then that we should *not* expect to see much change in university invention practice based on Bayh-Dole is with NIH and NSF funding–the sources of the majority of most universities’ federal funding.

The government was not doing so bad a job managing inventions.

Advocates claim there were 28,000 patented inventions owned by the federal government and only 5% were “commercialized.” That’s about the historic average for all patented inventions. Further, most of those patents were defense-related, where the federal contractors had declined to take ownership of the inventions. Of those that were biomedical inventions, the federal government commercialization rate was 23%, which was comparable to the overall claimed university rate of 25% to 30% (which is a sketchy claim, anyway) and is way better than the universities’ performance in the NIH IPA program of about 5% (4 products from 96 inventions). At the time of Bayh-Dole, university patent licensing performance was 5x worse than the federal government’s performance. The IPA program was shut down as ineffective and prone to exclusive licenses and the university exclusive licenses appeared to be sweetheart deals with pharma. Bayh-Dole was introduced the next year, modeled on the IPA program by the same NIH attorney that had revived the IPA program. Why would anyone expect Bayh-Dole to do anything better than the IPA program?

Bayh-Dole did not launch university technology transfer nor expand it. 

University technology transfer dates from as early as 1912, with the creation of Research Corporation by University of California professor Frederick Cattrell, and the formation of the Wisconsin Alumni Research Foundation in 1925. Many universities created similar research foundations. In the 1960s and 70s, only a handful of universities operated in-house patent licensing offices–University of California, MIT, Stanford among them. Research Corporation had contracts with many universities to manage inventions made by faculty and it was Research Corporation that advocated for the creation of “technology transfer” offices at universities–to expedite the transfer of inventions from the university to Research Corporation. Nothing in Bayh-Dole required or encouraged a change in university technology transfer. Whatever happened was not caused by Bayh-Dole.

Federally supported inventions in biomedicine did result in new drugs reaching the market prior to Bayh-Dole. 

Vaccines, better penicillin, treatments for leukemia. Advocates have backed down on this claim recently, substituting a claim that sounds about as good but is so narrow as to be vacuous. They assert instead that no biomedical invention taken from a nonprofit by the federal government has ever been commercialized as a new drug. But given that the NIH permitted nonprofits to own these inventions under the IPA program–at least from 1968 to 1978–how many biomedical inventions could there possibly be that were “taken away” by the federal government? Yeah. An empty claim. Abusing their audience.

The Salk vaccine, for instance, did become commercially available, even though the work leading to it was funded by a nonprofit and the federal government and Salk did not patent his work. It is just this outcome that university patent administrators want to prevent from ever happening again. Thus, the fake history.

Second, the advocates for Bayh-Dole misrepresent the law. 

The advocates for Bayh-Dole have created a faux version of the law, and have repeated it so many times many of them believe their faux version is the true version.  Sincerity, though, without a regard for the truth, is just more bullshit. It may well be that faux Bayh-Dole has had a significant effect on university licensing–but that is as much as saying that university licensing officials decided on what to do, made up a rationale for it, and attributed that rationale to Bayh-Dole. That’s bogus.

They say Bayh-Dole applies to universities and even to inventors. It doesn’t.

Bayh-Dole applies to federal agencies. Bayh-Dole requires federal agencies to use a standard patent rights clause unless they can justify a different clause, and Bayh-Dole specifies what must be in that clause. There are actually four distinct patent rights clauses in the implementing regulations. Three of them are now combined in what is referred to as the standard patent rights clause at 37 CFR 401.14. The fourth–specific to inventors–is in 37 CFR 401.9. It is the standard patent rights clause that universities agree to comply with, and the standard patent rights clause contains provisions that aren’t in Bayh-Dole at all. The standard patent rights clause requires universities (and others receiving federal funds) to require their employee-inventors to agree to become parties to the federal funding agreements.

They say Bayh-Dole gives universities special rights to acquire inventions made with federal support. It doesn’t.

The Supreme Court was clear on this point. Bayh-Dole, a part of federal patent law, does not give any university or other “contractor” any special right to obtain title to an invention made with federal support. But university officials persist in making this claim–inventors must assign their inventions to the university to comply with federal law. It’s a false claim. University patent policies also have made such a claim–some not revised even after the Supreme Court ruled that Bayh-Dole gave no special benefit to universities receiving federal funding for research.

They say Bayh-Dole applies to inventions made with federal support. It does, but not in the way claimed.

According to the Supreme Court, Bayh-Dole applies to inventions only after a party to a federal funding agreement has acquired ownership. If a party to a federal funding agreement does not own an invention, Bayh-Dole does not apply. (Of course, Bayh-Dole clearly applies to federally owned inventions–but these are not called “subject” inventions and aren’t a matter of a federal funding agreement; furthermore Bayh-Dole does stipulate a general public covenant for all inventions arising in federally supported research or development without regard for the ownership of those inventions–but that’s way beyond what advocates of Bayh-Dole would ever comprehend).

Bayh-Dole did not repeal prior law or federal agency policies regarding federally funded research inventions–instead, it preempted those laws and policies when a party to a federal funding agreement came to own an invention made in work supported by the federal government. Bayh-Dole applies only after a contractor has obtained ownership, and offers no help to contractors to obtain ownership.

They say Bayh-Dole requires commercialization. It doesn’t.

The standard in Bayh-Dole is utilization of inventions. An invention may be used, with benefits available to the public on reasonable terms, without any commercialization whatsoever. For instance, methods can become standards. Or an invention may be made available under a royalty-free, non-exclusive license for any professional to practice, as would be the case with disease assays, if university officials did not put their thumb in every opportunity and attempt to profit from a patent monopoly. Throughout Bayh-Dole wherever there are references to commercialization, they are accompanied by “availability.” We might say non-exclusive licensing of inventions

And third, advocates for Bayh-Dole make outrageous, unsupported claims about the law.

They claim Bayh-Dole is a great success. In fact, Bayh-Dole is a dismal failure. 

Before Bayh-Dole and outside the NIH and NSF IPA programs, if the federal government acquired an invention, it released it for all to use. Thus, only the handful of inventions that universities claimed ownership of (96, between 1968 and 1978) were placed behind a patent paywall. The rest were freely available for all to use and develop. After Bayh-Dole, universities began withholding most inventions behind a patent paywall. Bayh-Dole doesn’t require such a thing–university administrators decided to do this on their own. But now nearly all significant university technology-directed research findings–those that are patentable–are unavailable to the public for two decades. Most go unlicensed, and most of the few that do get licensed (almost always exclusively) never become products. Universities now hold over 120,000 US patents, of which over 50,000 cite federal support. That’s a huge bureaucratic dam of practical research findings, withheld from the public so that bureaucrats can attempt to profit from monopoly patent positions–which mostly they bungle.

They substitute proxy metrics for Bayh-Dole metrics.

Bayh-Dole is so unimportant that they don’t bother collecting the actual metrics that Bayh-Dole suggests are important–such as utilization with public benefits on reasonable terms and date of first commercial sale or use. Instead, they substitute the number of patents they have obtained, and the number of licenses, and the number of startups, and the like. None of these metrics are relevant to Bayh-Dole’s objectives.

Worse, universities don’t bother to distinguish Bayh-Dole inventions from other inventions–they conflate federally supported inventions with all other inventions, and conflate patentable inventions with whatever administrators choose to call an “invention.” Thus, they count inventions that aren’t patentable and even inventions that aren’t inventions. They create large-sounding numbers and attribute these to Bayh-Dole, when 60% of their patent activity does not involve federal funding at all.

They substitute “university technology transfer” successes for Bayh-Dole successes.

Even in lists of inventions that somehow have become commercial properties as the result of Bayh-Dole, ,many of the inventions were made before Bayh-Dole or without federal support or where there was federal support Bayh-Dole practices were not material to the invention’s success. Cohen-Boyer gene splicing inventions, for instance, are pre-Bayh-Dole, were made available non-exclusively, and the pharma industry did not boycott them. That’s a university technology transfer “success”–it’s just not a Bayh-Dole “success.” Furthermore, as the licensing officer involved later made clear, the patents had nothing to do with the use of gene-splicing techniques–companies were going to use those techniques anyway.

Despite the fake history, the misrepresentation, and the undocumented claims of success, some people apparently believe that the faux Bayh-Dole version is a really, really great idea–authorize university bureaucrats to confiscate with impunity faculty research inventions, force those inventors to put the inventions behind university paywalls, and then seek out favorite companies and investors that demand monopoly positions in order to speculate on the future value of the monopolies on those inventions. Exclude their work from public accountability. Allow them to make up whatever silliness they want to justify their practice. No worries. What could possibly go wrong?

 

This entry was posted in Bayh-Dole and tagged , , , . Bookmark the permalink.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.