Posts Tagged: "Joe Allen"

If patent reform goes wrong

A truism in politics is that issues are driven by stories. One of the most successful is the saga of the patent troll. That’s driving the current debate creating a sense of a malfunctioning patent system which is a danger to the public. If one side’s story frames the argument, those in opposition are at a real disadvantage and many times never recover. We have done a poor job as a community over the years presenting the importance of the patent system to the American public and our political leaders. That’s now come back to bite us.

NIH Gets It Right: Bayh-Dole is not for Price Controls

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.

A Reply to the New England Journal of Medicine

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.

Reforming the Federal R&D System

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.

High Noon for Bayh-Dole

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.