Posts Tagged: "Senator Birch Bayh"

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.

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.

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.

HyperSolar, Inc. has developed a technology that they claim will produce hydrogen that is renewable and utilizes natural power sources: sunlight and water. Who knows whether the HyperSolar/UC technology will ultimately lead to the dawn of a hydrogen energy economy. What we do know is that without the forward-thinking legislation that gives Universities incentive to partner with the private sector there would be no such potential. As alluring as alternative, cheap, clean energy is, efforts to get from where we are to where we ultimately need to go will be extremely expensive and the research highly speculative. Such high cost and extremely speculative research is realistically only carried out by Universities.

The Bayh-Dole Act unlocked those discoveries that were made with taxpayer money. It allowed businesses and nonprofits, such as universities, to retain title to their inventions that were made with federal funds and to license them to private companies for commercialization. It was a brilliant piece of bipartisan legislation that set the stage for commercializing hundreds of products, including life-saving treatments to which many of us cancer survivors owe our lives.

By SENATOR BIRCH BAYH — What should we say about a steward that manages billions of dollars in public research funds not aimed at finding commercial products and turns them in to hundreds of billions of dollars in economic impact while supporting millions of jobs? You would think that a sincere “thank you” was in order. But many are saying that the system producing such riches is broken. Remarkable. The Bayh-Dole Act created no new bureaucracy, costs taxpayers nothing, and decentralized technology management out of Washington. It’s widely touted as a key in turning the U.S. economy around.

It would be bad enough if politicians did nothing once elected, but it seems that they have a knack for doing those things that will do the most harm. That is why one of the recommendations in the interim report has me rather concerned. On page 21 of the report the Jobs Council recommends: “the Administration should test an ‘open source’ approach to tech transfer and commercializations.” What does that even mean? It might sound good to some, and certainly is the “in thing” to recommend I suppose. After all, “open source” is the solution to all the problems of the world, right? Never mind that the open source community has yet to identify a long term, stable business model that makes money.

If you’re in the profession of technology transfer, you just lost a close friend. Whether you knew him or not, you are a beneficiary of Norman J. Latker who passed away last weekend. Concerned that new innovations were driving up health care costs (a familiar sounding theme), the Carter Administration terminated the program. Norm, Howard Bremer, and Ralph Davis of Purdue set up a meeting with Senator Birch Bayh’s office asking that the program be made the basis for a uniform government patent policy. This request led to the introduction of the Bayh-Dole Act.

This morning the first panel discussion is focusing on Stanford v. Roche, titled Who’s Rights Are They Anyway? The first speaker, Maggie Shafmaster, Ph.D., Vice President and Chief Patent Counsel, Genzyme Corporation, lead off by pointing out something that everyone largely seems to agree with, namely that the facts of the case are still largely in dispute, which makes me wonder why would the Supreme Court take such a case. Be that as it may, Shafmaster went on to say that this case is one that makes in-house attorneys and those representing Universities lay awake at night. She characterized the case as “an academic/industry collaboration gone wrong.” And we are off to the races!

I am pleased to announce that IPWatchdog.com was selected by the readers of the ABA Journal as their favorite IP Law blog for 2010 ABA. I am also pleased to announce that for 2010 we had over 2,000,000 visits, delivered nearly 11.8 million pages, our homepage was viewed 3.06 million times and we averaged over 67,000 unique monthly visitors! Thanks to all our readers for coming back day after day, and thanks to all of our Guest Contributors!

The Supreme Court agreed to hear the appeal of Stanford University v. Roche Molecular Systems, Inc.; faculty and student inventors, the public, and American industry have an enormous stake in the Court’s decision. The appeal pits university patent administrators against university inventors. If the administrators win, university inventors will have no invention rights—not in the work they do at the university, and not in the work they do in the community. This is a crucial juncture for every researcher who has ever or might someday work in federally funded research. Likewise, it presents a tipping point for innovative industry and anyone with a vested interest in American research.

Today marks the 30th Anniversary of the most forward thinking patent legislation since Thomas Jefferson wrote the Patent Act in 1790, which was the third Act of Congress. Truthfully, the Bayh-Dole legislation is likely more forward thinking and inspired than even Jefferson’s work, given that the patent law written by Jefferson was merely an attempt to codify and improve upon the patent regime of Great Britain. The Bayh-Dole Act, which was enacted on December 12, 1980, has lead to the creation of 7,000 new businesses based on the research conducted at U.S. universities. As a direct result of the passage of Bayh-Dole countless technologies have been developed, including life saving cures and treatments for a variety of diseases and afflictions.