Posts Tagged: "Bayh-Dole"

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!

During fiscal year 2009, 596 new companies were formed as a result of university research, which is one more than the 595 formed in 2008 and 41 more than the 555 formed in 2007. The increase, while modest, does come despite a downturn in the U.S. and global economy, proving that even during a down economy good technology and innovation can and does create jobs. The AUTM survey also shows that invention disclosures continue to rise, patent applications are up, and during fiscal year 2009 there was a surprisingly high increase in foreign filings over fiscal year 2008.

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.

Bayh-Dole was created because of a glaring problem– billions of hard earned tax dollars invested annually in government R&D were being squandered by ineffective government patent policies. If this research cannot be taken out of the labs and turned into products, the public is being short changed. Even so, it was a long, tough road to travel, and we only succeeded by the smallest of margins. Turning around long standing government policies, no matter how ineffective, is never easy.

We caught the tide– but just barely. That the Bayh-Dole Act passed was amazing. That it passed in a lame duck session of Congress with its principal author defeated, the US Senate changing hands, and a sitting president thrown out, was a miracle. Even then success was not assured. Fortunately, we launched and caught the tide. This is my “staff’s eye view” of how it happened.

On October 12, 2010, I had the honor of interviewing retired United States Senator Birch Bayh, who was the primary architect of the landmark Bayh-Dole Act. In this second and final installment of my interview with Senator Bayh we will discuss the aforementioned loft praise for Bayh-Dole, which came from The Economist. We will also discuss statements of Vice President Biden (when he was a United States Senator) regarding the tremendous success of Bayh-Dole, how the United States can stay on the cutting edge of technology, and how to successfully lobby for changes in the patent system.

At IPWatchdog.com we will spend the next month celebrating Bayh-Dole. We kick off our month long celebration of Bayh-Dole with an exclusive interview with the chief architect of the legislation — The Honorable Birch Bayh, a former three-term United States Senator from the State of Indiana. Senator Bayh is now with Venable LLP, which is located in Washington, DC, and where I conducted my interview with him on October 13, 2010.

During this first installment of my two-part interview with Senator Bayh we discuss some of the accomplishments of Bayh-Dole and Senator Bayh tells the story of how Bayh-Dole came to be. I suspect many, if not most, will be amazed to learn just how close we came to not have this monumentally successful legislation. But for another Senator lifting a hold with an hour left in the 1980 lame duck session there would never have been a Bayh-Dole Act.

I understand the objections to embryonic stem cell research, but I simply cannot understand anyone that has a moral objection to embryonic stem cell research. How is it moral to watch those with crippling diseases agonize without trying to do everything we possibly can to find cures and treatments? Simply put, there is nothing moral about watching the suffering of another human being and doing nothing.

There is an important role that open source could play moving forward, and that role is to set the foundation of innovation and technology, which is no small task in terms of importance and seems to perfectly fit with open sources strengths. But too many open source regimes are like the Borg of Star Trek fame, or a little like the Mafia. Once you are a member you simply cannot get out. With too many open source regimes once you join and take then anything that you produce must be free to be taken by other members of the consortium. It really is akin to a patent deal with the devil, and ignores human tendencies. Ingrained in almost everyone is a feeling they should be able to profit from their own work, and most would feel injured if they worked and others were allowed to take without some kind of in kind return.

A packed room of at least 200 individuals, including the newly retired Chief Judge Paul Michel, former USPTO Director Q. Todd Dickinson, former USPTO Director Bruce Lehman and others listened to Kappos give an impassioned speech about how innovation can create jobs, how the Patent Office is unfortunately continuing to hold jobs hostage due to a staggering backlog of pending patent applications and how American economic security depends upon development of a comprehensive national IP strategy. I have heard Kappos talk about the job creating power of innovation and the role the USPTO can and should play, but there was something different about his speech today.

There are few things in this world that irritate me more than hypocrisy. Did you know that since 1976 Duke University has had 716 issued US patents, 266 of which in some way, shape or form relate to genetics and 156 of which relate in some way, shape or form relate to both genetics AND cancer. While Duke University throws Myriad Genetics under the bus over its patents on the BRCA1 and BRCA2 genes tied to breast and ovarian cancer, Duke has its own patent on identification and sequencing of the BRCA2 cancer susceptibility gene. How convenient!

Last week, on Thursday, April 15, 2010, while many individuals were scrambling at the last minute to file income tax returns in the US, Duke University released a study that, not surprisingly, says patents block competition. WOW! Thank you so much for clearing that up Duke! What would we have ever done without the learned elite at Duke University telling us that patents block competition. Seriously… what was your first clue? For goodness sakes I hope you didn’t take much time or energy coming to that conclusion, given that is exactly what patents are supposed to do. You see, they provide exclusive rights, which means the owner of the right has the ability to exclude. So let’s all breath a sigh of relief that the money spent on an academic study actually reached a conclusion that is true and accurate. Now, if the conclusions drawn from the study were only as commonsensical as the discovery of patents conveying exclusive rights.

I do have a suggested alternative on the patenting of gene sequences that is far more sensible (and won’t kill our biotech sector) than the “all or nothing” approach of the new Becerra bill. Instead of banning the patenting of gene sequences, why not provide the U.S. government with something similar to the “march-in-rights” provision that currently exists in Bayh-Dole for patented technology developed through federally-sponsored research that is underutilized? Admittedly, this “march-in-rights” provision would have to be carefully structured so it isn’t abused by the federal government, as well as those who would push for its too frequent use because they feel “entitled.”

A study released today by the Biotechnology Industry Organization (BIO) provides first-of-its-kind data on the importance of university/industry research and development partnerships to the U.S. economy. The study of university technology licensing from 1996 to 2007 shows a $187 billion dollar positive impact on the U.S. Gross National Product (GNP) and a $457 billion addition to gross industrial output, using…