Recently, the Bayh-Dole Act has come under attack as inhibiting the spread of technological innovation. One thing the writers seem to have in common is the absence of any ability to recall what the situation was pre-Bayh-Dole when private companies tried to license inventions from “universities” that were made with Government funding. Title to such inventions rested with the U.S. Government agency that had financed the research, and Government agencies in the 70’s and early 80’s did not have anything like the modern technology transfer offices that many universities and other non-profit institutions have today. When I arrived in Minneapolis in 1984, my employer, Merchant & Gould represented both the University of Minnesota and the Mayo Clinic, and had filed fewer than 20 patent applications for each of them—although Merchant & Gould had been in business for more than 80 years.
Archive for the ‘Tech Transfer’ Category
On Saturday, March 2, at the AUTM Annual Meeting in San Antonio, I will be part of a role-playing panel involving Eric Guttag, Kevin Noonan of PatentDocs and Christopher McKinney of Georgia Health Sciences University. Come see them do their best to help a fairly clueless professor-inventor (me), navigate the shallows and whirlpools of today’s increasingly complex patents and licensing landscape. We promise more intrigue, trap doors and secret stairs than an episode of “What the Butler Saw.” (I guess to avoid totally dating us, I should have said “Downton Abbey.”
With major litigation looming over invention ownership rights affected by the Bayh Dole Act (see my post of November 3rd on Stanford v. Roche), the link below is to a site created by AUTM and a number of other organizations concerned with university tech transfer. The site provides some good background on the history and the impact of the Act. A House resolution honoring the Act has been introduced and a celebration is planned in DC for December 1st.
Since 1980, thousands of companies (not all still with us) have been created in the U.S. due to patenting and licensing activities mandated by the Bayh-Dole Act, and hundreds of millions of dollars in licensing revenue have flowed into universities from patenting and out-licensing technology to established corporations (like big pharma) as well as to start-ups that go the distance (often to take-over by a larger med tech company). I emphasize life sciences commercialization because more than 80% of university/institutional patenting is in this area. Not bad for an “unfunded mandate.” A recent study that was published in Nature Reviews-Drug Discovery, looked at FDA approvals between 1997 and 2008 and found that 24% of approved drugs originated from university research. All had been licensed to pharma or biotech companies. (Find story here.)
On a more personal note, the first two IP talks I ever did were for the Chemistry and the Law Division of the American Chemical Society at National Meetings in 1987 and 1988. The first was entitled, “Selected Aspects of Patent Law Affecting the University Inventor,” and the second was “”Technology Transfer: From Non-Profit Research to Profit.” I expected a huge audience of professors eager to learn how to commercialize their discoveries but I was ahead of my time, and the meager audience was mostly lonely patent attorneys looking for clients and company. I also spoke at AUTM for the first time in 1989, when it was still the “Society of University Patent Administrators.” I was part of a plenary session and there were probably 50 people in the room, but it was a start, both for me and for university tech transfer. ‘Happy, happy birthday, baby.” You’ve come a long way.
On Monday, November 1st, the Supreme Court granted certiorari in Stanford v. Roche, 583 F.3d 832 (Fed. Cir. 2009), in which the Fed. Cir. decided that a professor could void his University-employer’s rights under the Bayh-Dole act to elect title to an invention he made with government grant support, by assigning his rights in the invention to a third-party, prior to the University’s electing title. The Solicitor General, at the Invitation of the Court, has filed an persuasive and informative amicus brief, which contains a very clear summary of the history and features of the Bayh-Dole Act, that should be perused by any patent attorney who has a substantial university-institutional practice. A copy of that amicus brief can be found at the end of this post.
Prior to enactment of the Act in 1980 – note that Chakrabarty was decided in 1980 and the Cohen-Boyer patent issued in 1980 – few university inventions made with Government grant support ever made it from “bench to bedside,” due to a patchwork of regulations on ownership and patent rights that differed from agency to agency. The Act founded the “industry” of modern university “tech transfer.” After passage of the Bayh-Dole Act, a university could elect to take title to an invention made with, say, NIH grant support, usually by filing a patent application on it, reporting it and making its election to the appropriate agency. The inventor(s) had no personal rights to inventions made with such grant support, but they were not left out in the cold. The Act required sharing of any royalties earned by licensing the patent with the inventor(s), and the university was required to use some of the funds to support research; often a portion of the royalties were returned to the inventor’s department. If a professor wished to patent, he/she was required to work with the university tech transfer office, who would in turn work with outside counsel to file patent applications and hopefully, license them to industry or to a v.c.-funded start –up. Over the last 30 years, this system has yielded hundreds of millions of dollars to universities and other non-profit organizations, and led to the commercialization of inventions as diverse as anti-HIV drugs (Ziagen), therapeutic enzymes (Myozyme), medical software, organic herbicides and a shrub willow bioenergy source. See http://www.betterworldproject.net/. A few universities even show up in annual lists of top patent-obtaining organizations.