Archive for the ‘Tech Transfer’ Category

Bayh-Dole Act Turns Thirty – Dec. 1st Fete Planned

Thursday, November 18th, 2010

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.

AUTM b-d30

Supreme Court To Address Scope Of Bayh-Dole Act

Wednesday, November 3rd, 2010

Supreme Court chambersOn 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.

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University IP In The News – Expedited Examination And March-In Request

Thursday, August 12th, 2010

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.

BACK TO THE O.K. CORRAL – SHOULD PROFESSORS MANAGE IP LICENSING?

Wednesday, January 13th, 2010

Last summer, Bob Litan and Lesa Mitchell of the Kauffman Foundation sent a short memo to Esther Lee at the Dept. of Commerce entitled “Accelerating the Commercialization of Government-Funded University-Based Research.” Although the Foundation, based in Kansas City MO, has been interested in university tech transfer at least since 2003 when it issued a report “Accelerating Technology Transfer & Commercialization in the Life & Health Sciences” (PDF at end of posting), this memo attracted little attention until, in December, The Harvard Business Review named it as containing one of the “Ten Breakthrough Ideas for 2010.” The alleged breakthrough is the proposal in the memo that, while universities will continue to own inventions made with Federal funding, professors should be free to not use their university’s technology transfer office (TTO), but to have the option of licensing their inventions through whatever agency they prefer. The Kauffman premise, to put it bluntly, is that most TTOs are “suboptimal” and that professors would be better off, in many cases, shopping their technology to faster-moving licensing entities (of some sort). The stated goal is to speed up the commercialization of new technologies while allowing universities to collect the same royalties as under the current system.

So the Kauffman team feels that there are lots of professors with under-appreciated technologies who would benefit by being able to leave the corral of their institution’s TTO and ride off, if not into the sunset, into the arms of a third-party licensing entity who would make the translational connection needed to get the technology “from bench to bedside.” Really?

To begin with, it is difficult to see how this would work in practice. The Kauffman memo suggests that the professor might have the option to prevent the TTO from even trying to license the technology while he or she shops it. Or will we now have dueling TTOs trying to license the same technology? (The memo suggests that a professor with an automotive invention who lives in, say, Kansas might want to use a TTO in Detroit.) And what will prevent third-parties from taking most of the licensing royalties? The memo mentions ownership, but it does not seem to consider who will pay for the patent costs, especially if a statutory bar date looms. A system in which the professor’s TTO is paying the patent costs while the professor is out trying to license the IP portfolio via a different organization is difficult to imagine. And about conflicts of interest….

The Kauffman fellows seem to have no sense of the chaotic history of tech transfer prior to Bayh-Dole (BD) (or in its early years). When I was doing patent prosecution at a big IP firm, one client I was given was a professor from a prestigious university that did not have a tech transfer policy. Since he was free to do what he wanted with his new method of cancer treatment pre-BD, he had paid the firm to file applications on it, and eventually licensed them to big pharma for a lot of money (in those days). The university got nothing at all. The first talk I ever gave was about the BD Act and the audience was professors, not administrators.

Also, there were a number of “for-profit non-profit” entities gathering up loose technologies from universities without technology policies (let alone TTOs). Research Corp. Technologies (RCT) was one of the most successful. RCT would not take on a technology unless it could get an assignment (not a license) from the inventor(s) and institution(s) in question (if the university even asserted any ownership rights). RCT would then front all the patent costs and attempt to license the technology. If it was successful, the inventor(s), and sometimes the institution (if it cared), would get some of the royalties. Before the rise of TTOs that developed their own licensing expertise, RCT and other organizations like it scored some major tech transfer homeruns, but they could only handle so many proposals at once. BD has been referred to as an “unfunded mandate,” but it did motivate universities and other institutions getting NIH and other Federal funding to step up to the plate and swing, at least at the fat pitches.

There are still a few lone wolves out there trying to make it as “hired guns” (pardon the metaphors). Believe it or not, I am still approached by small companies that want to file on inventions brought to them by university professors who are either unaware that their universities have TTOs (or at least tech transfer policies) or think they can ignore them. They can’t. The present system is not “optimal,” but at least it is organized. A few years ago, a prominent researcher told me that his colleagues used to look down on him because he was patenting his discoveries and licensing them (often to start-ups). He was using a TTO, incidentally. He said that today it is the professors who are not patenting and licensing who are considered to be out of step. I don’t believe that there are hoards of break-through technologies languishing in dusty lab notebooks in academe and, if there are, I don’t believe that loosing professors trained in life sciences to bring them to market is going to change anything for the better.

TechTranPanel_Report.pdf