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.”
Archive for the ‘Tech Transfer’ Category
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.
On July 29th, Rep. Frank Wolf (D.-Va.) introduced H.R. 5980 that would give priority to examination of patent applications filed by U.S. universities and by their “patent holding companies.” The definition of the latter seems a bit vague, but is apparently intended to cover entities like the Wisconsin Alumni Research Foundation (WARF) that finances prep/pros of patents by University of Wisconsin inventors and licenses them to provide income to both entities. The patents are assigned to WARF when they issue. The bill would also limit the early publication of U.S. patents to their abstracts. The bill is clearly an attempt to levy an IP “tariff” on foreign inventors but, for those of us with big university practices, it is an intriguing concept (if not a good idea).
In a somewhat related news item, a group of patients afflicted with Fabry’s disease have asked The U.S. Department of Health and Human Services (DHHS) to “march in” under the provisions of the Bayh-Dole Act, and permit/require Mt. Sinai School of Medicine, the owner of two patents (U.S. Pat. Nos. 5356804 and 5580757) covering the drug Fabrazyme, to grant additional licenses to manufacture and market the drug. This request is made under the “march in” provisions of the Bayh-Dole act, which founded the entire “industry” of university technology transfer in the 80’s. It is based on the allegation that Genzyme cannot meet the need for the drug, given its recent quality control problems. During the early years of the AIDS epidemic, such requests were made regarding the few anti-HIV drugs that were then available. As far as I know, none of the prior requests were granted.