Posts Tagged: "Bayh-Dole"

Nothing clarified the stakes in orphan drug development like hearing Ron Bartek describe how after 16 years a promising treatment for his son’s disease finally emerged with TRND’s help. The therapy demonstrated enough potential that it was licensed by a small company which took it through Phase I and II trials. Both showed very promising results. Ron choked up describing how he felt after such a long struggle to help his child and finally seeing a real glimpse of hope. Everyone in the room shared the lump in his throat. A day like that reminds you why tech transfer and intellectual property are so important. When used correctly they improve and protect lives all around the world.

Debates over economic fairness, the appropriate role of government in the economy and the value of the patent system spill over into our world. One factor that made the enactment of Bayh-Dole so difficult was the feeling in the 60’s and 70’s that patents were inherently bad. Intellectual property used to fall under the Senate Subcommittee on Antitrust and Monopolies when I joined the Judiciary Committee staff– which says much on how patents were viewed. It took the wakeup call of losing our traditional lead in innovation to Japan and Germany to start reversing this trend.

Recently I visited a Congressional office with a friend who led technology transfer at a public institution located in a mid-level city not normally associated with innovation. By skillfully using the authorities of Bayh-Dole and the patent system combined with good business judgment the program was very successful in start up formation and licensing, making it a driver of the regional economy. The Congressional staff were effusive in their praise of the results, which are well known in the state, vowing to do everything they could to support continued success. However, just before the meeting my friend confided that their new leadership made it clear that they did not consider technology transfer a profession requiring special skills and experience. The staff that labored so long and hard building the program got the hint and was leaving. Luckily their achievement is recognized by other institutions that are happy to snap them up. Unfortunately, the economy of the area they left behind will pay a high price for this boneheaded mistake.

MUIR: “There are approximately 40 countries around the world that have enacted their own version of the Bayh-Dole legislation because they have seen the numbers. They have seen the success that the United States has had in commercializing these discoveries. We truly are the envy of the rest of the world. In three or four months I’m going to be visiting about six different countries. What they want to hear about is how is the U.S. achieving this level of success. So oftentimes we look at our own backyard and don’t have a full appreciation of the beautiful flowers growing there but there are lots of beautiful flowers growing in our tech transfer profession in the United States.”

IDRI granted license rights to its world-class vaccine adjuvants to Immune Design Corporation (IDC), which was established in Seattle in 2008 with a focus on cancer, allergies and certain infectious diseases. The royalties and other funds received from IDC have helped to support IDRI’s programs, and IDC’s clinical safety data relating to the adjuvants have been vital in IDRI’s ability to accelerate the development of vaccines for tuberculosis and leishmaniasis, two diseases with an immense global health burden.

Any government truly interested in commercializing its research must realize that time is of the essence, risk is inherent in the process and deal makers should be supported by process. Napoleon adopted the motto: “Not a moment must be lost.” But quoting Napoleon may be too intimidating for times like these, so how about Larry the Cable Guy? Perhaps we still retain enough of the American spirit to embrace: “Git ‘er done!” Time will tell (perhaps sooner than we imagine). We’ve been trying to drive the federal R&D system with the parking brake on. It’s time to put product people behind the wheel, buckle the process people safely in, release the brake, hit the gas and get rolling. Those that used to be far behind are coming up fast in our rear view mirror.

The government is funding basic research at universities, not drug development. Bayh-Dole allows schools to own resulting inventions and license them for commercialization. These discoveries are more like ideas than products. The expense and risk of development falls on the private sector. A study in Nature Biotechnology on drugs commercialized from federally-funded inventions finds: “the private sector spends 100-fold or more to bring the product to market than the PSRI (public-sector research institution) spends in research directly leading to the invention.” Here’s why: for every 10,000 compounds about 250 make it to preclinical testing, 5 go to clinical trials, and one enters the marketplace. Of these just 20% turn a profit– and they must pay for all those which died in the pipeline.

First of all, congratulations! You made The Washington Post and they even spelled your name correctly. Unfortunately, AUTM was specifically called out in an article titled Patent Trolls Have a Surprising Ally: Universities… For a profession that keeps a low profile and goes out of its way not to antagonize people, you may wonder what in the world’s going on that you are gaining such notoriety. The answer is that you are in the sights of several groups who do not wish you well. Some want to weaken the patent system for their short term benefit, some believe society would be better off if inventions were freely available without patents; some don’t think it’s moral for universities to work with industry, and others believe they should determine who reaps the rewards of innovation. While operating on diverse belief systems, they all have one thing in common: they don’t like you.