AUTM’s 2010 Better World Report Highlights

 AUTM released their Better World Report for 2010 highlighting academic innovations commercially developed through technology transfer that are improving the quality of life.  Here is a quote from their press release.

A device that allows the blind to ―see‖ via electrical pulses applied to the tongue…a collagen scaffold to treat damaged joints…a new vaccine to prevent shingles…an artificial lung that provides patients with both mobility and comfort during treatment…a program that vastly improves literacy among middle and high-school age students…a device that transforms wheelchairs into all-terrain vehicles…a vaccine to prevent HPV…

These are just a few of the discoveries featured in the 2010 edition of the AUTM Better World Report, a collection of stories about technologies that originated in academic research and were brought to the public through technology transfer, the process of licensing and commercializing academic research so it can become real products that make the world a healthier and safer place.

Senator Birch Bayh writes the foreword and includes impressive evidence of Bayh-Dole’s success.

• More than 6,000 new U.S. companies were formed from university inventions.

• 4,350 new university licensed products are in the market.

• 5,000 active university-industry licenses are in effect, mostly with small companies.

• More than 153 new drugs, vaccines or in vitro devices have been commercialized from federally funded research since enactment of Bayh-Dole.

• Between 1996 and 2007 university patent licensing made:

❍ a $187 billion impact on the U.S. gross domestic product,

❍ a $457 billion impact on U.S. gross industrial output; and

❍ 279,000 new jobs in the United States.

A fairly impressive accomplishment considering before Bayh-Dole Senator Bayh states:

 “We found 28,000 government-funded inventions gathering dust on agency shelves with not a single drug commercialized when the government owned the patent.”

The report is an interesting read as it includes a small snapshot of what the academic and private sector can do when patent ownership incentives are properly aligned. 

 

Representative Conyers speech at AUTM’s 30th Anniversary Bayh-Dole event

Statement of the Honorable John Conyers, Jr. appearing at the Association of University Technology Managers 30th Anniversary of the Bayh-Dole Act Wednesday, December 1, 2010, at 10:00 a.m. Washington Convention Center

I would like to thank you for inviting me to speak before this distinguished group of professionals today.

America has always been a nation of dreamers and innovators. Edison’s lightbulb illuminated the world and the Wright brothers showed us that we could fly. We split the atom, broke the sound barrier, and put a man on the moon. For generations, America has been a leader in scientific discovery and the useful application of technology.

Our patent laws have helped to develop this culture of innovation by providing incentives for researchers to push the envelope of what we think is possible. And for the last 30 years, the Bayh-Dole Act has contributed significantly to the success of our innovation system.

Genius of the Legislation

In 2005, the Economist magazine called the Bayh-Dole Act “perhaps the most inspired piece of legislation to be enacted in America over the past half-century.” I agree.

The Bayh-Dole Act put ownership of patents into the hands of universities, and gave universities a free hand to work with private industry to see their new discoveries turn into useful products and processes. At the same time, it also ensured that the faculty and student inventors would be rewarded for their contributions.

The genius of this legislation was aligning of interests of faculty inventors, universities, and the private sector.

Technological Advance

The Bayh-Dole Act has been a major boon for the creation of technology in this country.

In the biomedical field, Bayh-Dole has helped move vaccines, cancer treatments, and medical devices from university labs to the public.

In the information technology sector, the software backbone on which Google and Yahoo are based came out of university computer labs.

Similar examples can be found in all technological fields, including very important emerging areas like green tech, nanotechnology, and advance manufacturing.

Thanks to Bayh-Dole, research done at the University of Michigan formed the basis of FluMist, a nasal spray influenza vaccine. Bayh-Dole has also helped move a technology from the labs at my alma mater, Wayne State University, that uses sonic infrared to detect cracks in airplanes.

These are just two examples of the real world application of technology first developed in universities, then licensed to the private sector for further development, and which ultimately were incorporated into new products and methods that benefit society.

Economic Benefits

Since the passage of Bayh-Dole, more than 6,000 companies have been formed to commercialize products developed through university research.

These companies are more than just centers of innovation. They create jobs that employ thousands of Americans and have helped to revitalize communities across the country.

In the state of Michigan, in just the last 5 years, over 80 start up companies have been formed based on technology licensed from my State’s three largest universities: University of Michigan, Michigan State and Wayne State University.

I want to note that the Supreme Court has recently taken up the case of Stanford v. Roche. This case involves the assignment of inventions by faculty inventors in instances where the Bayh-Dole Act applies. I will be keeping a close eye on this case, and I sincerely hope the Supreme Court develops a resolution that does not disturb the phenomenally successful balance of rights that the Bayh-Dole Act provides.

Conclusion

I recently introduced a Resolution recognizing the Bayh-Dole Act on its 30th Anniversary. The Resolution highlights the contributions this legislation has made to our country, and honors those who sought its passage.

I would like to reiterate my thanks to the legislation’s name sakes, Senators Birch Bayh and Robert Dole, as well as give thinks to my former House colleagues who guided this legislation through, including Representatives Peter Rodino, Hamilton Fish, Robert Kastenmeier, Tom Railsback, and Don Fuqua.

The Bayh-Dole Act was an elegantly simple piece of legislation, that forever has changed this country’s research and development landscape for the better. I eagerly await to see what new technologies and innovations come as a result of the Bayh-Dole Act in the next 30 years.

USPTO Economic Research Agenda

The USPTO has a new Office of the Chief Economist and they have recently published their research agenda.

USPTO Economic Research Agenda

The OCE is embarking upon an aggressive economic research program to provide evidence on a range of matters relevant to policymaking and the effect of IP on economic outcomes more generally.  These include:

(1) Relating IP to economic growth, performance and employment, including:             

            (a)  IP and entrepreneurship                                 

            (b)  IP and wider economy-wide growth.                              

(2) IP in de facto standards, standard setting, and standards policy.

(3) Researching the economics of trademarks and trademark examination.

(4) Understanding the economics of USPTO initiatives, including initiatives to reduce application backlogs, by better understanding their costs, benefits, and effects.

(5) Analyzing the role that IP plays in the markets for technology and knowledge 

Report on a conference discussing the “Research Agenda”  at the University of California (09/10/2010)

For more specifics from the PTO website click here.

Pathogens and the Nagoya Protocol of the Convention on Biological Diversity

          Some nations have argued that the recent Nagoya Protocol of the Convention of Biological Diversity (CBD) includes pathogens. The inclusion of pathogens in the Nagoya Protocol could adversely affect the world’s ability to control outbreaks of infectious disease.  The following reasons demonstrate why pathogens are not and should not be included in the Nagoya Protocol.

Contrary to the Mission of the CBD:

  1. “The conservation of biological diversity,
  2. The sustainable use of the components of biological diversity, and
  3. The fair and equitable sharing of the benefits arising out of the utilization of genetic resources.” 

 

  • The objective for preventing pathogen-borne illness is to eliminate and not conserve the pathogen.  Therefore, conserving and sustaining pathogens seems like a tenuous application in light of the first two objectives of the CBD.  

 

  • Some might argue that pathogens fall under the 3rd objective, addressed by the Nagoya Protocol.  However, analyzing the 3rd objective requires consideration of the other two objectives.  Benefit sharing is intrinsically linked to those genetic resources worthy of protection and sustainable use.  The following points clarify why the Nagoya Protocol does not cover pathogens.

 

 Nagoya Protocol Language

Mindful of the International Health Regulations (2005) of the World Health Organization and the importance of ensuring access to human pathogens for public health preparedness and response purposes.”  

  • The reference to the World Health Organization and the importance of access to pathogens indicates the intent that the WHO, not the CBD, is the place to address human pathogens.  

 

  •  In fact, the clause reinforces the idea that access, not benefit, is paramount in an outbreak of infectious disease.  The CBD recognizes that WHO has the appropriate level of technical expertise and experience to handle pathogen access issues.   

 

  • Some might argue Article 8(b) implies the inclusion of pathogens in the Protocol. 

Parties must “pay due regard to cases of present or imminent emergencies that threaten or damage human, animal, or plant health, as determined nationally or internationally.  Parties may take into consideration the need for expeditious access to genetic resources and expeditious fair and equitable sharing of benefits arising out of the use of such genetic resources, including access to affordable treatments by those in need, especially in developing countries.” 

  • If Article 8(b) were interpreted to include pathogens, the language “the need for expeditious access to genetic resources” in times of emergencies strongly argues for the circumvention or inapplicability of access and benefit sharing laws to pathogens.

 

Applying the Protocol to Pathogens is highly problematic

  • Interpreting the Nagoya Protocol to include pathogens creates numerous practical and policy problems. 

 

  • Prior drafts both included and excluded pathogens in the Protocol indicating no agreement on the inclusion of pathogens.  Including pathogens would be a disingenuous reading of the intent of the contracting parties.

 

  • How do you identify the origin of a pathogen?  Pathogens are not bound by geography, quickly spreading globally by infected persons traveling on airplanes or infected birds flying across borders.  How can we identify who owns the next HIV clade, SARS virus, or the next variation of any pathogen?    

 

  • Infectious disease outbreaks require instantaneous action.  Any delay caused by nations negotiating ‘fair’ prices for pathogens harms both the local and global population needing immediate protection. 

 

  • Including pathogens in an access and benefit sharing system rewards bad luck.  The designers of the Nagoya Protocol sought to create a monetary incentive to conserve biodiversity and sustainability; not to create a system that allows nations to profit from misfortune. 

AUTM Bayh-Dole 30th Anniversary Event – Senator Bayh’s Speech

Statement of Senator Birch Bayh
On the 30th Anniversary of the Bayh-Dole Act

I’m delighted to be here today to say “Happy Birthday” to the Bayh-Dole Act on its 30th anniversary. It’s great to look around the room and see so many friends who worked so hard to make this day possible along with those who appreciate what the law means to our country, and indeed, the world.

Bayh-Dole teaches several lessons worth recalling:
• A handful of motivated citizens really can change the course of a nation;
• An idea whose time has come can bridge the partisan divide; and
• Each generation must cherish and protect the entrepreneurial spirit that built America for it is our greatest national asset, but can also be lost if neglected or discouraged.

The story of Bayh-Dole began one day in 1978 when I received a call from Ralph Davis who ran the technology transfer office at Purdue University. When Ralph told me that potentially important discoveries made on campus were being prevented from fully benefiting the taxpayers supporting the research, he had my full attention. When he said that Purdue’s experience was shared by universities and small companies across the nation, I told him to let me know what needed to be done. He did, and set the wheels in motion for what was to become the University and Small Business Patent Procedures Act of 1980, commonly known as Bayh-Dole.

So we might say that Bayh-Dole is another gift of the Boilermakers to a grateful nation!

Thus, 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.

Bayh-Dole reflects the American spirit. It shows that innovation thrives when we honor the intellectual property system the Founding Fathers handed down to us. Bayh-Dole allows the entrepreneurial spirit in the public and private sectors to join together turning early stage research into products benefiting our own citizens– and indeed, those around the world.
It is appropriate that government funds the long range research which simply cannot be performed by industry. But commercial development must be done by the private sector. This is a very arduous, expensive endeavor. It is best accomplished when those making the inventions are trusted to know best how their discoveries should be managed.

Some then and now scoffed at such a concept as hopelessly naive. They find the siren call of centralized government management irresistible. Perhaps this is because they fancy themselves as the central managers. But bitter experience proves that a “Washington knows best attitude” when it comes to innovation leads to disaster. Unfortunately, our critics never seem to learn this lesson.

So the burden is on us to constantly educate policy makers how valuable Bayh-Dole is to the continued health and wealth of the United States. We must show that the Bayh-Dole system is delicately balanced. That the law remains unchanged over 30 years is a testimony to its careful craftsmanship. Anyone urging that it be amended must face a daunting burden of proof supported by facts, not emotion, before they are taken seriously.

And in this debate, you must not underestimate the impact you can make. Many always moan that citizens really can’t change government. Yet Bayh-Dole shows that this is simply not true. That doesn’t mean that the process is easy or quick– but what in life that’s worthwhile ever is? A handful of determined men and women made the law a reality and have preserved it for 30 years. Later today we will honor several key people who worked so hard behind the scenes to pass and protect Bayh-Dole. Now we need new hands to help carry the banner that they have borne for so long.

I also want to say a word about my friend and colleague Senator Bob Dole who unfortunately could not be with us today. Bob is a true representative of “The Greatest Generation” that literally saved the world, and then came home to build the most prosperous nation in history.

In 1942, Bob joined the army and was assigned to the Italian front. Today we don’t hear much about the vicious fighting in Italy. It was not glamorous. The campaign consisted of pushing the German’s off a seemingly endless series of fortified mountains at great personal cost. The farther we advanced, the tougher it became. As a 22 year old Second Lieutenant, Bob was doing what Second Lieutenant’s do– leading from the front. Just weeks before the surrender, Bob Dole was hit by fire from a German machine gun. He was hurt so badly that another GI gave him the largest dose of morphine possible, then wrote “M” on Bob’s forehead in his own blood, because if following squads gave Lt. Dole another shot he would die. Bob lay on the battlefield for nine hours before being evacuated. He remained hospitalized for more than three years. Upon recovery he studied law and dedicated his life to public service.

It was an honor to serve with Senator Dole for so many years. He and I were on different sides of the aisle, and fought hard for our beliefs. Yet, we developed a deep respect for each other. We shared a common goal: that ground breaking inventions would no longer waste away on the shelves of government, and teamed up to make our vision a reality. It was only because our political partnership effectively bridged the partisan divide that Bayh-Dole was passed. We were able to show our colleagues that our bill reflected fundamental concepts upon which both the right and left could agree. And even then, we barely made it across the finish line before time ran out.

The basis of Bayh-Dole is believing that American innovation flourishes best when the incentives and protections of the patent system are allowed to operate as intended. In this belief, we shared good company. Abraham Lincoln said there were three great events that advanced humanity:
• The discovery of America
• The invention of the printing press, and
• the development of the patent system

If you look at the top of the Department of Commerce facing the White House you can read Lincoln’s words: The patent system adds the fuel of interest to the fires of genius. And he knew what he was talking about. Abe Lincoln is the only president who owned a patented invention.

Unfortunately, before Bayh-Dole his wise counsel went unheeded in federal R&D policies. And America paid a great price.

As Bob and I looked at what was being generated from the billions of dollars spent annually on government supported research we found a very meager return. There were more than 20 federal patent policies then in place across the various agencies, but all were based on the premise that inventions made with government support should be taken away from the inventing organization and licensed non-exclusively by the bureaucracy. We asked the Comptroller General how this system was working. He reported that there were 28,000 inventions caught in this web with less than 5% ever licensed for development.

We also found that not a single new drug has been commercialized when the government owned the patent.

The reason was readily apparent. When government takes inventions away from the creators, it extinguishes the fuel of interest the patent system was intended to create. As inventor Frederick Cottrell said:” A number of meritorious patents given to the public absolutely free have never come upon the market chiefly because what is everyone’s business is nobody’s business.”

These policies effectively disconnected university and federal laboratory research from the U.S. economy. They caused our most innovative small companies to shun government research because accepting federal dollars meant giving up any hope of developing innovative products they might invent.

We also saw the United States’ traditional lead in technology fading away across the board. Some said we should be resigned to being a service based economy since the U.S. simply could not create competitive products any longer. Beltway pundits confidently predicted that centralized economic planning like that of “Japan, Inc.” was the new model we should adopt. Such ideas always find receptive ears in Washington.
But Bayh-Dole offered a different way out of the swamp.

We chose to listen to Lincoln, not those then in fashion. Bayh-Dole introduced patent incentives to federal research. Our bill was based on the premise that government should do what it does best– fund basic and long range research that industry simply cannot afford to do, and then rely on those making inventions to manage them in the public interest by providing a few simple rules.

We recognized that industry is accepting tremendous risk developing early stage university and federal laboratory inventions, and must be protected by strong patent licensing agreements. We believed that the best approach was relying on those actually making the discoveries to know best how these deals should be structured. We said the universities must share royalties with their inventors so all would benefit from successful partnerships.

And we did not create any new bureaucracy.

At the time, many considered our approach lacking in sophistication and nuance. Some still do. However, the results speak for themselves. The Economist Technology Quarterly said it best:

Possibly the most inspired piece of legislation to be enacted in America over the past half- century was the Bayh-Dole Act of 1980… More than anything, this single policy helped reverse America’s precipitous slide into industrial irrelevance.

And such claims are not mere jargon; the facts bear them out. Here’s just a sample of what Bayh-Dole has done:
• Created more than 6,500 new companies with about 600 created last year in the midst of a serious economic recession, or an average of about two new companies every working day of the year;
• Created more than 5,000 new products;
• Spawned more than 130 new drugs, vaccines or devices protecting public health around the world;
• Helped create entire new industries like biotechnology;
• Contributed at least $187 billion to the US Gross National Product while creating a minimum of 279,000 new jobs in just a nine year period, and
• A new report by the National Academy of Sciences found that the critics were wrong when they claimed that Bayh-Dole would undermine traditional academic norms.
Perhaps it’s only appropriate to add here how ironic it is that some now look down their noses at university technology transfer officials given the contribution they have made to the nation.

Perhaps the best evidence of our success is that other nations are rapidly adopting Bayh-Dole laws of their own to better compete with us. They rightly view Bayh-Dole as a proven best practice. Their seriousness of purpose was demonstrated to me when I spent my birthday in Beijing a few years ago being quizzed by Chinese leaders why our system worked so well. It seems sometimes that the law is better appreciated abroad than here at home.

Let me conclude with a few words of warning. We never seem to run short of ivory tower theorists who fault Bayh-Dole and urge us to adopt their latest pipe dreams instead. What they lack in practical experience and solid data they make up in emotion and rhetoric. As General Grant observed about the arm chair experts constantly sniping at him while he was slowly but surely bringing the Civil War to a successful end:
“The most confident critics are generally those who know the least about the matter criticized.”

Our critics are now urging that government be empowered to impose licensing restrictions on universities to meet fancied dangers. They claim that some fields of technology should even be exempted from Bayh-Dole because patenting should be discouraged. They criticize the university technology transfer model as hopelessly out of date. They would take us back to the failed policies of the past. We have been down this road before and know where it leads– and it’s not a good place. So it is up to us to constantly remind policy makers of our prior hard learned lessons, or they may be repeated.

However, a serious problem was identified by the National Academy report. The oversight authority Bob and I established in the bill is not functioning as Congress intended. Unfortunately, the report wrongly faults the law for this lapse. Bayh-Dole clearly established a high level policy oversight function with enough teeth to insure uniform implementation by all agencies. The system successfully operated for the first 15 years of Bayh-Dole. It was led by those familiar and supportive of the law. An effective policy office developed and implemented the regulations for Bayh-Dole, prevented agencies from misusing the exceptional circumstance provision to take research out from under the law, halted attempts to override Bayh-Dole in international agreements, helped craft Executive Order 12591 making Bayh-Dole the centerpiece of innovation policy, and worked with Congress to expand the principals of Bayh-Dole to the federal laboratory system. That sounds pretty effective to me.

The real cause of the current problem came as the expert staff left, succeeding policy officials appeared disinterested in Bayh-Dole, and oversight gradually fell off the radar screen. If not corrected, such neglect will create serious problems because the law cannot run on auto pilot much longer. Otherwise the essential principal of Bayh-Dole — creating a uniform patent policy across all agencies– falls by the wayside. This simply must not be allowed to happen. Which reminds me of a story.
Late in his life Benjamin Franklin was asked by a young person what the Founding Fathers were leaving to posterity. Franklin replied: “A republic, if you can keep it.” So let me close with this paraphrase on behalf of all of us who worked to enact the law all those years ago:

We’ve given you Bayh-Dole. It’s now up to you to keep it.

Thank you

IPWatchdog.com interview of Bayh-Dole insider

A great article from IPWatchdog.com giving Joe Allen’s (a Birch Bayh staffer) insider perspective on the passage of the Bayh-Dole Act. 

The Article’s Introduction:

William Shakespeare once wrote:

There is a tide in the affairs of men
Which taken at the flood, leads on to fortune;
Omitted, all the voyage of their life
Is bound in shallows and in miseries.

See Julius Caesar.

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. The bureaucracy was waiting to undermine the implementing regulations. Yet the new law survived, strengthening the economy while improving public health and well-being.

U.S. House passes Bayh-Dole 30th Anniversary Concurrent Resolution

On November 15th, the United States House of Representatives voted 385-1 for the Bayh-Dole 30th Anniversary Concurrent Resolution.  

Here are some interesting quotes from the Resolution on the need for and the successes of Bayh-Dole.

“the United States Government is one of the largest funders of research in the world, but that research does not fully benefit American taxpayers unless it contributes new products and processes to the marketplace, thereby creating new companies and jobs, and solving societal problems;”

“the commercial development of discoveries and inventions falls upon private sector entrepreneurs, often requiring millions of dollars in development funding over many years, and even then commercial success is uncertain at best”

“ before the enactment of that Act, few inventions arising from the billions of taxpayer dollars granted each year to American research universities, nonprofit organizations, and Federal laboratories were being translated into commercial products of benefit to the public and the United States economy;”

“a critical factor in developing federally funded inventions into commercial products is the continued involvement of the inventor in the process, and Government patent policies before the enactment of the Bayh-Dole Act chilled the intended incentives of the patent system in this regard;”

“the ability to obtain a reliable patent license for commercial development is needed to justify private sector investments, and Government patent policies before the enactment of the Bayh-Dole Act made negotiating and obtaining such licenses difficult, if not impossible;

“patent ownership of potentially important inventions is crucial in the formation of many start-up companies, which form vital parts of an innovation economy, and ownership rights were discouraged by Government patent policies before the enactment of the Bayh-Dole Act;”

“the success of the Bayh-Dole Act became apparent with the creation and dominance of the United States biotechnology and information technology industries, that remain largely dependent on university research;”

“the Bayh-Dole Act has been widely recognized as a best practice and is now being adopted by other countries (both developed and developing) around the world to better integrate their own research universities into their economies in order to be more competitive;”

“objective examples of how the Bayh-Dole Act has not only benefitted the United States but has also created a better world include the creation of over 150 new drugs, vaccines, or in vitro devices, including the hepatitis B vaccine, cisplatin, carboplatin and taxol anticancer therapeutics, laser eye surgery devices, the Palmaz balloon expandable stent, and many more; and

“economic activity spurred on by the Bayh-Dole Act include the formation of more than 6,500 new companies from the inventions created under the Act, an estimated contribution of $450,000,000,000 to United States gross industrial output, and the creation of 280,000 new high technology jobs between 1999 and 2007:”

“(1) it is the sense of the Congress that— (A) the Bayh-Dole Act (Public Law 96– 517), as amended by Public Law 98–620, has made substantial contributions to the advancement of scientific and technological knowledge, fostered dramatic improvements in public health and safety, strengthened the higher education system, led to the development of new domestic industries and hundreds of thousands of new private sector jobs, and benefitted the economic and trade policies of the United States;”