Posts Tagged: "Bayh-Dole"

In going from the current “first to invent” to the new “first to file” regime mandated by the America Invents Act (AIA), much attention has been focused on the amorphous “grace period” provision provided to patent applicants for certain activities undertaken by them prior to filing for a U.S. patent. Much less attention was paid to the amendments made to sections 203(c)(2) and 203(c)(3) of the Bayh-Dole compliance obligations which were directly impacted by this change in definition from the old “statutory bar” provision (based on publication, on sale, or public use of the invention caused by the patent applicant), to this new “grace period” provision. But even more astounding (and unsettling) are the unrecognized consequences caused by the AIA in “realistically” meeting certain Bayh-Dole compliance obligations by going from the current “first to invent” to the new “first to file” regime.

Finally, we believe that in the interest of fairness a word about the person who has his name attached to this case – Dr. Mark Holodniy—is required. Rather than being a rogue inventor, or a naïve academic wandering around signing invention rights away, another portrait emerges from this case. Dr. Holodniy did exactly what he was asked to do by his employer through instructions from his superior. He dutifully signed an agreement giving Stanford rights to his inventions, and agreed to go to Cetus as he was requested to do. At Cetus he complied with their policies.

At issue in the case, essentially, was whether the extraordinarily successful Bayh-Dole legislation (enacted in 1980) automatically vested ownership of patent rights in Universities when the underlying research was federally funded. In a blow to the convention wisdom of Supreme Court patent-watchers, the Supreme Court actually affirmed the United States Court of Appeals for the Federal Circuit. Unlike some recent decisions where the result of the Federal Circuit was affirmed but a wholly new test announced, the Supreme Court simply concluded: “The judgment of the Court of Appeals for the Federal Circuit is affirmed.” Perhaps even more surprising, the Supreme Court seems to have objectively reached the correct conclusion.

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!

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.