Posts Tagged: "Bayh-Dole"

“Patent trolls have a surprising ally: universities” ran in the Washington Post on November 30, 2013. Two days later “Techdirt” threw the follow up: “Patenting University Research Has Been A Dismal Failure, Enabling Patent Trolling. It’s Time to Stop.” Their titles and parallel arguments suggest that both articles arise from shared talking points. Both immediately set up their victims by linking them with patent trolls. Casting anyone as an “ally of patent trolls” after huge amounts of money have been invested vilifying the term in the public mind is meant to quickly knock opponents to their knees and drive them from the field. Ostensibly the focus of their wrath is university patent licensing, but the real target is the patent system itself.

The National Institutes of Health recently made its long anticipated ruling on a petition seeking to use the “march in” provisions of the Bayh-Dole Act as a mechanism for the government to control prices on drugs derived from federally-funded research by issuing compulsory licenses. The petition was a reiteration of one dismissed in 2004 seeking to have the government march in to control the price of Norvir, part of the AIDS “cocktail.” … Before Bayh-Dole not a single drug was commercialized when the government took patent rights away from inventing organizations. Under the law at least 153 new drugs and vaccines are now alleviating human suffering world-wide.

Unfortunately, I’ve known for a couple of weeks what this month’s column was likely to be about. After a brief illness, my friend Howard Bremer died last Friday… Working through WARF, Howard’s efforts were critical in our eventual success enacting Bayh-Dole despite long odds. Over the years, he remained a steadfast defender pushing back against the critics of the patent system… Howard attended the Association of University Technology Managers meeting this year—an organization he helped found in the 1970’s to foster the profession. Howard knew it was his last as he was not physically able to travel any longer. But there was no sadness; he enjoyed seeing many of his friends for what he knew was the final time…

The Bayh-Dole Act was passed because Congress was rightly concerned that potential benefits from billions of dollars of federally funded research were lying dormant on the shelves of government. Government funded inventions tend to be very early stage discoveries—more like ideas than products—requiring considerable private sector risk and investment to turn them into products that can be used by the public. Under prior patent polices government agencies took such inventions away from their creators and offered them non-exclusively for development. There were no incentives for the inventors to remain engaged in product development. Not surprisingly, few such inventions were ever commercialized even though billions of dollars were being spent annually on government R&D.

Senate Judiciary Committee Chairman Patrick Leahy (D-VT) asked NIH in a July 12 letter to force compulsory licensing of Myriad’s BRCA breast and ovarian cancer genetic test under the “march-in rights” provision of the Bayh-Dole Act. Myriad received an exclusive license to develop the test from universities operating under Bayh-Dole Act. The law allows nonprofit institutions receiving federal R&D funds to own and license resulting inventions so they can be commercialized for use by the public. Critics of Bayh-Dole have long sought to reinterpret its statutory standards under which the government can compel universities to issue compulsory licenses as a weapon to control prices. This was not the intent of the law.

We have made significant strides over the past 30 years through laws like the Bayh-Dole Act, the Federal Technology Transfer Act, and supporting Executive Orders leading to the creation of 9,000 new companies around university inventions, the development of 153 new drugs from federal funding now protecting public health world-wide, the leadership of the U.S. biotechnology industry, the addition of $836 billion to our gross domestic product supporting 3 million good jobs from university patent licensing between 1996-2012, etc. Still as far as we have come, it’s clear that we could be doing even more to reward the hard earned taxpayer dollars spent on public R&D.

Normally when we discuss the impact of the Bayh-Dole Act, allowing universities and small companies to commercialize inventions made with federal support, we focus on the life sciences where the resulting new drugs and therapies dramatically improved lives for millions around the world. However, the celebration of Earth Day is an appropriate time to consider the contributions our publicly funded research organizations– partnering with an entrepreneurial private sector– make in protecting our environment.

Senator Ron Wyden (D- OR) is a man with an idea for lowering health care costs. Unfortunately, it’s an idea which proved disastrous the last time it was forced on the National Institutes of Health. But that hasn’t dissuaded the Senator from trotting it out again. He seems sincere in his concern with the ever escalating costs of medicine. Unfortunately, his proposed solution empowering the government bureaucracy to second guess industry drug pricing decisions simply because they worked with NIH would make things worse. We could see fewer new drugs at any price.

I spend a lot of time every day and my staff also spends time every day looking through press releases, looking for stories. And I can’t tell you how many times I have come across something that I knew was good but I couldn’t get any information on. I mean literally no information other than the self-congratulating, back slapping stuff that you see in two or three paragraphs in a press release. So that is one of the things I want to talk to you about today. How do you get your story to those journalists and reporters out there who care? Continually there are calls from detractors who want to change the technology transfer system regardless of how wildly successful it has been.

If you’re paying attention at all, you must have noticed that there are forces out there who just don’t like what you do. Some say you’re too focused on making money, some say you’re not focused enough (we really should introduce these folks to each other), some don’t believe it’s moral for universities to work with industry, and many have built very successful careers launching attack after attack on Bayh-Dole and the very patent system itself.

The report ignores actual practice. Universities rarely have multiple companies fighting to license their inventions. They’re lucky to find one. The rule of thumb is that a promising university technology requires 5-7 years of private sector development to turn into a product. For a drug, double the time and add a billion dollars in costs. Exclusive licenses are often essential to justify such risks.

Todd Sherer: “And what we’re seeing, what the AUTM survey is showing, is that patent budgets are going down. And that’s of concern to me, because everything has to go through that funnel. You can do a lot of research, basic and then applied research and have translational funding, but that technology has to come through the Tech Transfer Office and through the patent budget. So it doesn’t do us a lot of good just to have funding targeted at programs at the front end of that funnel to try to shove it through, through the right limiting step, or pull it out the other side. We need to also be mindful of the fact that we need to invest in those fundamentals, that patent and licensing part. Because we’ve also seen that the number of licensing professionals has gone down over the last couple of years in the Tech Transfer Offices. So, what we don’t want to see is that trend continue. We don’t want to see the number of our staff go down and the patent budgets go down at a time when we want to improve impact.”

Todd Sherer, Ph.D. is the director of technology transfer at Emory University, and is also currently President of the Association of University Technology Managers (AUTM). Recently AUTM concluded its annual survey and found, not surprisingly, that University technology licensing has substantial positive impact on the U.S. economy. On the heels of that survey I reached out to my friends at AUTM and requested an interview with Sherer. Our interview took place on Friday, December 14, 2012. During our interview we talked about the nearly constant challenges to gut Bayh-Dole, which is the very foundation of university technology licensing and the piece of legislation called the most successful domestic legislation in the post World War II era by none other than The Economist. We also discussed what it is that universities do and how, despite what the critics say, the basic research done by universities is hardly ready for the marketplace.