Posts Tagged: "Joe Allen"

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.

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.

There’s nothing in the world like the U.S. public research system which is on the cutting edge of every field of science. However, to fully benefit from this investment discoveries must move from the laboratory into the marketplace. This can only happen when partnerships with U.S. industry are be made on terms conducive to commercialization. Additionally, in a time of tight budgets federal research must be efficiently managed even if that means crossing traditional agency borders to leverage resources and increase impact. Someone must be charged with insuring that the system is running as Congress, the President, and most importantly, the American people intend.

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.

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.

Bowman v Monsanto involves a farmer who figured out how to get Monsanto’s patented seeds cheaper from a grain elevator than from the company. I won’t attempt to delve into the intricacies of the litigation or the doctrine of patent exhaustion, but do want to consider a larger point. What happens if our innovators lose confidence in the patent system? Some apparently believe this is a desirable outcome