Translational Research Forum at BIO International Convention

BIO is hosting a Translation Research Forum at the BIO International ConventionNIH Director Collins keynotes an event that will explore how private, public and academic sectors can leverage meaningful partnerships, highlight emerging best practices, explore risk-sharing at the clinical research stage, and explore ways to bridge the gap in funding and know-how necessary to take university research to the next level.

Read the Press Release for more information about panels and speakers.

For registration, conference agenda and exhibitor information, visit 2011 BIO International Convention.

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University-Industry Partnering at BIO Convention Webinar by AUTM June 16, 3-4PM

Get the inside information on what industry does and does NOT want from their academic counterparts: Join us June 16, 3-4 p.m. EDT for Insider’s Guide to Effective Partnering at BIO 2011, a FREE AUTM webinar to help you prepare for the BIO convention in Washington, DC, June 27-30.

BIO has issued a strong letter of support for the Manager’s Amendment to H.R. 1249, the America Invents Act

by Stephanie D. Fischer

BIO has issued a strong letter of support for the Manager’s Amendment to H.R. 1249, the America Invents Act.  The letter is posted on our website and the text is below:

“On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our strong support for your Manager’s Amendment to H.R. 1249, the America Invents Act. It is our strong desire to see this bill, as amended, passed by the House, and then we will work with you to ensure that any final product is perfected.

This legislation is similar to the bill adopted earlier this year by the U.S. Senate by a nearly unanimous vote, and we are pleased that the Manager’s Amendment to the bill has resolved many of the remaining concerns for the life sciences industry.

Your legislation will, once and for all, end the diversion of fees collected by the U.S. Patent and Trademark Office (PTO), increase the objectivity of our patent system, and increase patent quality. It is precisely these types of reforms that should receive bipartisan support, as they are good for inventors and investors, hence good for business and jobs in America.

We thank you for all of your hard work to move the patent reform process forward in the House, and we look forward to working with you and the Senate to ensure that patent reform legislation is ultimately enacted into law this year.”

Earlier this week, BIO joined a broad coalition of organizations, universities, companies and other stakeholders to express strong support for Section 22 of the bill which would prevent future fee diversion:

“Although each of our organizations has varying views on the reforms contained in H.R. 1249, we unanimously support Section 22 and believe that it is the cornerstone of any patent reform legislation. Absent a statutory mechanism to prevent future fee diversion, as we have seen all too often in previous years, the existing and new responsibilities vested in the USPTO will suffer, the ability of the USPTO to plan long-term and build the agency our innovation economy demands will be frustrated, and the job-stifling patent application backlog will continue.”  This letter is available on our website.

USPTO Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting

Biotechnology/Chemical/Pharmaceutical Customer Partnership  

Wednesday, June 8, 2011 Meeting 
Madison Auditorium  

Starting Time of 10:00 AM

 United States Patent and Trademark Office
Alexandria, Virginia 
600 Dulany Street, Alexandria, VA, 

Accessing the event:
Double click on the link below (or copy it into your internet browser)

https://uspto.connectsolutions.com/r80345544/
Click here   for detailed login instructions in MS Word.

  Driving & Metro Directions /Hotels (Word)   Campus Map (html)   Campus Map (Power Point)

 

Morning Session    
10:00 – 10:30 AM. Greetings, TC Update and Overview Jackie Stone, George Elliott and Remy Yucel, Directors, Technology Center 1600
10:30 – 11:15 AM Microsoft v. i4i Ltd.: How potential changes in
the evidentiary standard for an invalidity defense could affect patent prosecution and litigation
Garth M. Dahlen, Ph.D., Esq. Birch, Stewart, Kolasch & Birch, LLP 
11:15 – 11:30 AM Break  
11:30 – 12:15 PM COPA (Clearing the Oldest Patent Applications) – An Overview and Implementation Briefing   John Barlow   SPE, TC2800
12:15 – 1:00 PM Expedited Examinations (Track 1, PPH, Green Tech, AE, and to Make Special) Bennett Celsa   QAS, TC1600 
1:00 – 2:00 PM  Lunch   The Roundhouse Cafe Cafeteria is inside the Madison Building  lower level.
Menu for the Week in PDF will be here. 
Afternoon Session    
2:00 – 2:45 PM Current Sequence Listing Process for Nucleic Acids and Polypeptides  Joe Woitach   SPE, Art Unit 1633 
2:45 – 3:00 PM Break  
3:00 – 3:45 PM Common Issues Examiners Face Regarding PLTs and Plant Utility Patents Anne Marie Grunberg, SPE, Art Unit 1638/1661
3:45 – 4:00 PM Closing Remarks/Discussion Jackie Stone, George Elliott and Remy Yucel, Directors, Technology Center 1600

 

Photos of the speakers  will be here.

Google Search the BCP Web Site

[Caveat – Google’s spiders have not searched through all the links to all of the Power Point slides. These results are only  partial. For example, type in Morning Session  and as of 2/20/11 you only see the Agendas for 17 meetings. Note for some of the earlier links to meetings in 2001 and 2002 they are at the PTO site as listed below and thus no agendas or slides are here for Google to find.]

Supplemental Materials:
    Carlyle Site Drawings
   
Perspective 3D drawing of the building on campus click here 
    Floor plan for a building (pdf 178K) click here
    Close-up plan view of campus map click here 
    Go to http://www.ptoinalexandria.com/index.php for more views and info

 See the BCP’s PTO web page http://www.uspto.gov/web/patents/biochempharm/  for the official announcement for the next meeting close to the final date.

For questions about obtaining these materials
contact Cecilia Tsang at Cecilia.Tsang@USPTO.GOV

To be placed on the BCP’s e-mail announcement list 
contact Cecilia Tsang at Cecilia.Tsang@USPTO.GOV

BIO’s “What Every State Should Know About Bayh-Dole” Webinar

BIO’s “What Every State Should Know About Bayh-Dole” Webinar

The Biotechnology Industry Organization (BIO) recently hosted a webinar entitled: “What Every State Should Know About Bayh-Dole: Leveraging University Research to Create Jobs and Spur Economic Development Benefits.”

The Bayh-Dole Act, enacted in 1980, placed patent ownership of federally funded research at universities in the hands of the university and enabled universities to out-license technologies for commercialization.  As a result of the Act, more than 7200 companies were created (including nearly 600 last year despite the national recession) and 8818 new products were made available to patients and other consumers.   Since the Bayh-Dole Act, university start-ups have contributed at least $187 billion to the U.S. Gross National Product, and created a minimum of 279,000 jobs within a nine year period.

The webinar provides an overview of the Bayh-Dole Act and how the Act has allowed states to leverage university funded research to spur economic growth.  It also explores recent economic data and provides several examples of successful licensing agreements.  Finally, the webinar provides an overview of the challenges to the Bayh-Dole Act and how these challenges could negatively impact job creation and economic growth at the state level. 

Lila Feisee, Vice President for Global Intellectual Property Policy at BIO, acted as moderator with Dr. Ashley J. Stevens, Special Assistant to the Vice President of Research at Boston University, and Joe Allen, former staffer to Senator Birch Bayh, as panelists.

Please follow the following links to view the webinar.

Streaming recording link:

https://biotechnology.webex.com/biotechnology/ldr.php?AT=pb&SP=MC&rID=60992482&rKey=cb4322ff92c9c107

Download recording link:

https://biotechnology.webex.com/biotechnology/lsr.php?AT=dw&SP=MC&rID=60992482&rKey=12a4f24204098489

Huffington Post: Data Exclusivity: Getting the Balance Right

Huffington Post: Data Exclusivity: Getting the Balance Right

     A great article on the downsides of cutting or removing data exclusivity provisions for biologics.  The article points out that data protection is needed to enhance safety and create incentives to research and produce new innovative drugs that cost billions of dollars.  However, the author argues that the period must be limited somehow (not 50 years) to ensure generics can entire the market and lower costs.    Finally, the author states that lowering the data exclusivity period from 12 years will only increase the costs of biologics in that period, that sharing drug data will result in an immitative and not innovative medical system, and that longer periods result in safer biosimilars because they are held to the same high standard as the innovator.

BIOtech NOW: The Role of Intellectual Property in Global Health

The Role of Intellectual Property in Global Health

BIO is committed to increase access to biologic medicines for patients throughout the world.  As BIO President and CEO Jim Greenwood said last year when announcing our policy statement on Options for Increasing Access to Medicines in the Developing World, “We believe that the goals of increasing access to medicines, respecting intellectual property rights, and maintaining commercial viability are mutually supportive.”

While there are frequent misguided calls to circumvent intellectual property (IP) rights in order to provide therapies to undeveloped countries, BIO and many policy experts understand that IP rights are necessary to bring innovative new therapies to market and into the hands of patients.  Medicines cannot be utilized if they are not developed, and IP rights are often the only asset emerging biotech companies can leverage in order to attract the investment necessary to fund the lengthy and expensive research and development and clinical review processes.

Bill Gates has been an ally in our efforts to increase access to medicines in developing countries.  In 2004, BIO launched BIO Ventures for Global Health (BVGH) with a start-up grant from the Bill & Melinda Gates Foundation to speed the development of medicines for unmet diseases of developing countries. 

In a recent interview with Intellectual Property Watch, Bill Gates discussed the important role of IP in his Foundation’s work on global health:

“We fund research and we actually ourselves or our partners create intellectual property so that anything that is invented with our foundation money that goes to richer countries, we’re actually getting a return on that money.”

“By doing that we have more money to devote for research into neglected diseases and the diseases of the poor,” he said. “Now when our medicines go into the poor countries, they are always going in without any intellectual property fee, at very lowest cost pricing.”

 “But,” he said, “the intellectual property system has worked very well to protect our investments so that when they are used in rich countries we get a payback and then we have the control to make sure that it is not creating any financial burden on the countries that are the poorest.”

You can read the full article on Intellectual Property Watch’s website (subscription required).

Chairman Bernanke’s Speach on Government R&D Spending Policy and Economic Development

FED Chairman Ben Bernanke spoke about government funding of research and development at Georgetown University for the “New Building Blocks for Jobs and Economic Growth” conference.

Highlights relating to Intellectual Property:

1.  “Economic policy affects innovation and long-run economic growth in many ways. A stable macroeconomic environment; sound public finances; and well-functioning financial, labor, and product markets all support innovation, entrepreneurship, and growth, as do effective tax, trade, and regulatory policies. Policies directed at objectives such as the protection of intellectual property rights and the promotion of research and development, or R&D, promote innovation and technological change more directly.”

2.  “As I have already suggested, the effective commercial application of new ideas involves much more than just pure research. Many other factors are relevant, including the extent of market competition, the intellectual property regime, and the availability of financing for innovative enterprises. That said, the tendency of the market to supply too little of certain types of R&D provides a rationale for government intervention; and no matter how good the policy environment, ultimately, big new ideas are often rooted in well-executed R&D.”

3.  “One possible policy response to the market underprovision problem would be to substantially strengthen the intellectual property rights regime, for example, by granting the developers of new ideas strong and long-lasting claims to the economic benefits of their discoveries–perhaps by extending and expanding patent rights. This approach has significant drawbacks of its own, however, in that strict limitations on the free use of new ideas would inhibit both further research and the development of valuable commercial applications. Thus, although patent protections and similar rules remain an important part of innovation policy, governments have also turned to direct support of R&D activities.”

4.  “We should also keep in mind that funding R&D activity is only part of what the government can do to foster innovation. As I noted, ensuring a sufficient supply of individuals with science and engineering skills is important for promoting innovation, and this need raises questions about education policy as well as immigration policy. Other key policy issues include the definition and enforcement of intellectual property rights and the setting of technical standards. Finally, as someone who spends a lot of time monitoring the economy, let me put in a plug for more work on finding better ways to measure innovation, R&D activity, and intangible capital. We will be more likely to promote innovative activity if we are able to measure it more effectively and document its role in economic growth.”

Full Speach Below


 

Chairman Ben S. Bernanke

At the Conference on “New Building Blocks for Jobs and Economic Growth,” Washington, D.C.

May 16, 2011

Promoting Research and Development: The Government’s Role

I am pleased to speak at this conference on new building blocks for jobs and economic growth. The conference organizers have gathered an outstanding group of participants and have set an ambitious agenda. The topics you will address today and tomorrow, bearing on innovation and intangible capital, are central to understanding how we can best promote robust economic growth in the long run.

I won’t have to spend much time convincing this audience of the importance of long-run economic growth. The Nobel Prize-winning economist Robert E. Lucas, Jr., wrote that once one starts thinking about long-run growth and economic development, “it is hard to think about anything else.”1  Although I don’t think I would go quite that far, it is certainly true that relatively small differences in rates of economic growth, maintained over a sustained period, can have enormous implications for material living standards. A growth rate of output per person of 2-1/2 percent per year doubles average living standards in 28 years–about one generation–whereas output per person growing at what seems a modestly slower rate of 1-1/2 percent a year leads to a doubling in average living standards in about 47 years–roughly two generations. Compound interest is powerful! Of course, factors other than aggregate economic growth contribute to changes in living standards for different segments of the population, including shifts in relative wages and in rates of labor market participation. Nonetheless, if output per person increases more rapidly, the prospects for greater and more broad-based prosperity are significantly enhanced.

Over long spans of time, economic growth and the associated improvements in living standards reflect a number of determinants, including increases in workers’ skills, rates of saving and capital accumulation, and institutional factors ranging from the flexibility of markets to the quality of the legal and regulatory frameworks. However, innovation and technological change are undoubtedly central to the growth process; over the past 200 years or so, innovation, technical advances, and investment in capital goods embodying new technologies have transformed economies around the world. In recent decades, as this audience well knows, advances in semiconductor technology have radically changed many aspects of our lives, from communication to health care. Technological developments further in the past, such as electrification or the internal combustion engine, were equally revolutionary, if not more so. In addition, recent research has highlighted the important role played by intangible capital, such as the knowledge embodied in the workforce, business plans and practices, and brand names. This research suggests that technological progress and the accumulation of intangible capital have together accounted for well over half of the increase in output per hour in the United States during the past several decades.2 

Innovation has not only led to new products and more-efficient production methods, but it has also induced dramatic changes in how businesses are organized and managed, highlighting the connections between new ideas and methods and the organizational structure needed to implement them. For example, in the 19th century, the development of the railroad and telegraph, along with a host of other technologies, were associated with the rise of large businesses with national reach. And, as transportation and communication technologies developed further in the 20th century, multinational corporations became more feasible and prevalent.

Economic policy affects innovation and long-run economic growth in many ways. A stable macroeconomic environment; sound public finances; and well-functioning financial, labor, and product markets all support innovation, entrepreneurship, and growth, as do effective tax, trade, and regulatory policies. Policies directed at objectives such as the protection of intellectual property rights and the promotion of research and development, or R&D, promote innovation and technological change more directly.

In the remainder of my remarks, I will focus on one important component of innovation policy–namely, government support for R&D. As I have already suggested, the effective commercial application of new ideas involves much more than just pure research. Many other factors are relevant, including the extent of market competition, the intellectual property regime, and the availability of financing for innovative enterprises. That said, the tendency of the market to supply too little of certain types of R&D provides a rationale for government intervention; and no matter how good the policy environment, ultimately, big new ideas are often rooted in well-executed R&D.

The Rationale for a Government Role in Research and Development
Governments in many countries directly support scientific and technical research, for example, through grant-providing agencies (like the National Science Foundation in the United States) or through tax incentives (like the R&D tax credit). In addition, the governments of the United States and many other countries run their own research facilities, including facilities focused on nonmilitary applications such as health. The primary economic rationale for a government role in R&D is that, absent such intervention, the private market would not adequately supply certain types of research.3 The argument, which applies particularly strongly to basic or fundamental research, is that the full economic value of a scientific advance is unlikely to accrue to its discoverer, especially if the new knowledge can be replicated or disseminated at low cost. For example, James Watson and Francis Crick received a minute fraction of the economic benefits that have flowed from their discovery of the structure of DNA. If many people are able to exploit, or otherwise benefit from, research done by others, then the total or social return to research may be higher on average than the private return to those who bear the costs and risks of innovation. As a result, market forces will lead to underinvestment in R&D from society’s perspective, providing a rationale for government intervention.

One possible policy response to the market underprovision problem would be to substantially strengthen the intellectual property rights regime, for example, by granting the developers of new ideas strong and long-lasting claims to the economic benefits of their discoveries–perhaps by extending and expanding patent rights. This approach has significant drawbacks of its own, however, in that strict limitations on the free use of new ideas would inhibit both further research and the development of valuable commercial applications. Thus, although patent protections and similar rules remain an important part of innovation policy, governments have also turned to direct support of R&D activities.

Of course, the rationale for government support of R&D would be weakened if governments had consistently performed poorly in this sphere. Certainly, there have been disappointments; for example, the surge in federal investment in energy technology research in the 1970s, a response to the energy crisis of that decade, achieved less than its initiators hoped. In the United States, however, we have seen many examples–in some cases extending back to the late 19th and early 20th centuries–of federal research initiatives and government support enabling the emergence of new technologies in areas that include agriculture, chemicals, health care, and information technology. A case that has been particularly well documented and closely studied is the development of hybrid seed corn in the United States during the first half of the 20th century.4  Two other examples of innovations that received critical federal support are gene splicing–federal R&D underwrote the techniques that opened up the field of genetic engineering–and the lithium-ion battery, which was developed by federally sponsored materials research in the 1980s.  And recent research on the government’s so-called war on cancer, initiated by President Nixon in 1971, finds that the effort has produced a very high social rate of return, notwithstanding its failure to achieve its original, ambitious goal of eradicating the disease.5 

What about the present? Is government support of R&D today at the “right” level? This question is not easily answered; it involves not only difficult technical assessments, but also a number of value judgments about public priorities. As background, however, a consideration of recent trends in expenditures on R&D in the United States and the rest of the world should be instructive. In the United States, total R&D spending (both public and private) has been relatively stable over the past three decades, at roughly 2-1/2 percent of gross domestic product (GDP).6  However, this apparent stability masks some important underlying trends. First, since the 1970s, R&D spending by the federal government has trended down as a share of GDP, while the share of R&D done by the private sector has correspondingly increased.7  Second, the share of R&D spending targeted to basic research, as opposed to more applied R&D activities, has also been declining.8  These two trends–the declines in the share of basic research and in the federal share of R&D spending–are related, as government R&D spending tends to be more heavily weighted toward basic research and science. The declining emphasis on basic research is somewhat concerning because fundamental research is ultimately the source of most innovation, albeit often with long lags. Indeed, some economists have argued that, because of the potentially high social return to basic research, expanded government support for R&D could, over time, significantly boost economic growth.9 That said, in a time of fiscal stringency, the Congress and the Administration will clearly need to carefully weigh competing priorities in their budgetary decisions.

Another argument sometimes made for expanding government support for R&D is the need to keep pace with technological advances in other countries. R&D has become increasingly international, thanks to improved communication and dissemination of research results, the spread of scientific and engineering talent around the world, and the transfer of technologies through trade, foreign direct investment, and the activities of multinational corporations. To be sure, R&D spending remains concentrated in the most-developed countries, with the United States still the leader in overall R&D spending.10 However, in recent years, spending on R&D has increased sharply in some emerging market economies, most notably in China and India. In particular, spending for R&D by China has increased rapidly in absolute terms, although recent estimates still show its R&D spending to be smaller relative to GDP than in the United States.11  Reflecting the increased research activity in emerging market economies, the share of world R&D expenditures by member nations of the Organisation for Economic Co-Operation and Development, which mostly comprises advanced economies, has fallen relative to non-member nations, which tend to be less developed. A similar trend is evident, by the way, with respect to science and engineering workforces.12 

How should policymakers think about the increasing globalization of R&D spending? On the one hand, the diffusion of scientific and technological research throughout the world potentially benefits everyone by increasing the pace of innovation globally. For example, the development of the polio vaccine in the United States in the 1950s provided enormous benefits to people globally, not just Americans. Moreover, in a globalized economy, product and process innovations in one country can lead to employment opportunities and improved goods and services around the world.

On the other hand, in some circumstances, the location of R&D activity can matter. For example, technological prowess may help a country reap the financial and employment benefits of leadership in a strategic industry. A cutting-edge scientific or technological center can create a variety of spillovers that promote innovation, quality, skills acquisition, and productivity in industries located nearby; such spillovers are the reason that high-tech firms often locate in clusters or near leading universities.13  To the extent that countries gain from leadership in technologically vibrant industries or from local spillovers arising from inventive activity, the case for government support of R&D within a given country is stronger.14 

How Should Governments Provide Support for Research and Development?
The economic arguments for government support of innovation generally imply that governments should focus particularly on fostering basic, or foundational, research. The most applied and commercially relevant research is likely to be done in any case by the private sector, as private firms have strong incentives to determine what the market demands and to meet those needs.15 

If the government decides to foster R&D, what policy instruments should it use? A number of potential tools exist, including direct funding of government research facilities, grants to university or private-sector researchers, contracts for specific projects, and tax incentives. Moreover, within each of these categories, many choices must be made about how to structure specific programs. Unfortunately, economists know less about how best to channel public support for research and development than we would like; it is good news, therefore, that considerable new work is being done on this topic, including recent initiatives on science policy by the National Science Foundation.16 

Certainly, the characteristics of the research to be supported are important for the choice of the policy tool. Direct government support or conduct of the research may make the most sense if the project is highly focused and large-scale, possibly involving the need for coordination of the work of many researchers and subject to relatively tight time frames. Examples of large-scale, government-funded research include the space program and the construction and operation of “atom-smashing” facilities for experiments in high-energy physics. Outside of such cases, which often are linked to national defense, a more decentralized model that relies on the ideas and initiative of individual researchers or small research groups may be most effective. Grants to, or contracts with, researchers are the typical vehicle for such an approach.

Of course, the success of decentralized models for government support depends on the quality of execution. Some critics believe that funding agencies have been too cautious, focusing on a limited number of low-risk projects and targeting funding to more-established scientists at the expense of researchers who are less established or less conventional in their approaches. Supporting multiple approaches to a given problem at the same time increases the chance of finding a solution; it also increases opportunities for cooperation or constructive competition.17  The challenge to policymakers is to encourage experimentation and a greater diversity of approaches while simultaneously ensuring that an effective peer-review process is in place to guide funding toward high-quality science.18 

However it is channeled, government support for innovation and R&D will be more effective if it is thought of as a long-run investment. Gestation lags from basic research to commercial application to the ultimate economic benefits can be very long. The Internet revolution of the 1990s was based on scientific investments made in the 1970s and 1980s. And today’s widespread commercialization of biotechnology was based, in part, on key research findings developed in the 1950s. Thus, governments that choose to provide support for R&D are likely to get better results if that support is stable, avoiding a pattern of feast or famine.19 

Government support for R&D presumes sufficient national capacity to engage in effective research at the desired scale. That capacity, in turn, depends importantly on the supply of qualified scientists, engineers, and other technical workers. Although the system of higher education in the United States remains among the finest in the world, numerous concerns have been raised about this country’s ability to ensure adequate supplies of highly skilled workers. For example, some observers have suggested that bottlenecks in the system limit the number of students receiving undergraduate degrees in science and engineering: Surveys of student intentions in the United States consistently show that the number of students who seek to major in science and engineering exceeds the number accommodated by a wide margin, and waitlists to enroll in technical courses have trended up relative to those in other fields, as has the time required to graduate with a science and engineering degree.20  Moreover, although the relative wages of science and engineering graduates have increased significantly over the past few decades, the share of undergraduate degrees awarded in science and engineering has been roughly stable.21  At the same time, critics of K-12 education in the United States have long argued that not enough is being done to encourage and support student interest in science and mathematics. Taken together, these trends suggest that more could be done to increase the number of U.S. students entering scientific and engineering professions.

At least when viewed from the perspective of a single nation, immigration is another path for increasing the supply of highly skilled scientists and researchers. The technological leadership of the United States was and continues to be built in substantial part on the contributions of foreign-born scientists and engineers, both permanent immigrants and those staying in the country only for a time. And, contrary to the notion that highly trained and talented immigrants displace native-born workers in the labor market, scientists and other highly trained professionals who come to the United States tend to enhance the productivity and employment opportunities of those already here, reflecting gains from interaction and cooperation and from the development of critical masses of researchers in technical areas. More generally, technological progress and innovation around the world would be enhanced by lowering national barriers to international scientific cooperation and collaboration.

Conclusion
In the abstract, economists have identified some persuasive justifications for government policies to promote R&D activities, especially those related to basic research. In practice, we know less than we would like about which policies work best. A reasonable strategy for now may be to continue to use a mix of policies to support R&D while taking pains to encourage diverse and even competing approaches by the scientists and engineers receiving support.

We should also keep in mind that funding R&D activity is only part of what the government can do to foster innovation. As I noted, ensuring a sufficient supply of individuals with science and engineering skills is important for promoting innovation, and this need raises questions about education policy as well as immigration policy. Other key policy issues include the definition and enforcement of intellectual property rights and the setting of technical standards. Finally, as someone who spends a lot of time monitoring the economy, let me put in a plug for more work on finding better ways to measure innovation, R&D activity, and intangible capital. We will be more likely to promote innovative activity if we are able to measure it more effectively and document its role in economic growth.


Battelle Report: $3.8 Billion Investment in Human Genome Project Drove $796 Billion in Economic Impact Creating 310,000 Jobs and Launching the Genomic Revolution

Battelle study reports the success of the Human Genome Project.  Technology Transfer at its best.

$3.8 BILLION INVESTMENT IN HUMAN GENOME PROJECT DROVE $796 BILLION IN ECONOMIC IMPACT CREATING 310,000 JOBS AND LAUNCHING THE GENOMIC REVOLUTION

“Genomic Revolution” Forging Major Breakthroughs in Medicine, Agriculture, Security & Justice, and Energy and Promises to Create Significantly More Jobs in the Future 

 

WASHINGTON, D.C. — The $3.8 billion the U.S. government invested in the Human Genome Project (HGP) from 1988 to 2003 helped drive $796 billion in economic impact and the generation of $244 billion in total personal income, according to a study released today by Battelle.  In 2010 alone, the human genome sequencing projects and associated genomics research and industry activity directly and indirectly generated $67 billion in U.S. economic output and supported 310,000 jobs that produced $20 billion in personal income.  The genomics-enabled industry also provided $3.7 billion in federal taxes during 2010.

The report also outlines significant breakthroughs the Human Genome Project, and a companion private project from Celera Genomics, have made possible in just the first ten years since the reference human genomes were published.  Advancements include new approaches to medicine, greater productivity in agriculture and potential sources of renewable energy.  The study also forecasts the creation of significantly more jobs in the future as new companies and new industries continue to form around the expanded knowledge of human DNA model organism genomes and advances in genomics technology.

“From a simple return on investment, the financial stake made in mapping the entire human genome is clearly one of the best uses of taxpayer dollars the U.S. government has ever made,” said Greg Lucier, chief executive officer of Life Technologies, whose foundation sponsored Battelle’s analysis.  “This project has been, and will continue to be, the kind of investment the government should foster…ones with tangible returns. 

“The initial dollar investment has already been returned to the government via $49 billion paid in taxes.  Now we sit at the dawn of the ‘Genomics Revolution’ and all humankind will reap the benefits as we transfer what we now know about the human genome into major breakthroughs including: new forms of ‘personalized medicine’ and genetics therapy better suited to solving the problems we all care so much about, such as cures for cancer, cardiovascular diseases, Alzheimer’s, HIV/AIDS and many more terrifying diseases.  These major advancements are rapidly creating multiple new industries and companies and those companies are creating quality jobs for thousands of people.  Life will be even better for all of us thanks to the HGP,” Lucier said.

Battelle Conclusions
Simon Tripp, Senior Director of Battelle’s Technology Partnership Practice, or TPP, (co-author of the Battelle report with TPP Research Leader Marty Grueber) noted, “What is truly impressive is the extent to which genomics technologies have advanced under the driving force of the human genome sequencing projects.  Today high-speed sequencing and advancements in genomic data analysis are empowering unprecedented advancements in biological sciences and being applied to the most pressing issues facing the world—human health and medicine, feeding a rapidly expanding global population, developing advanced biofuels, and protecting the environment.  The ability of modern science to address these large-scale issues via genomics stands as testimony to the vision and foresight shown by HGP supporters, leaders and participants.”

 The four main conclusions reached in the Battelle study are:

  • The economic and functional impacts generated by the sequencing of the human genome are already large and widespread.  Between 1988 and 2010 genome sequencing projects, associated research and industry activity—directly and indirectly—generated an economic (output) impact of $796 billion, created 3.8 million job-years of employment (310,000 jobs in 2010) with personal income exceeding $244 billion (an average of $63,700 in personal income per job-year).
  • The federal government invested $3.8 billion in the HGP from 1990–2003 ($5.6 billion in 2010 dollars).  This investment was foundational in generating the economic output of $796 billion above, and thus shows a return on investment (ROI) to the U.S. economy of 141 to 1, meaning that every $1 of federal HGP investment has contributed to the generation of $141 in the economy.
  • Overall, however, the impacts of the human genome sequencing are just beginning—large scale benefits in human medicine and many other diverse applications are still in their early stages.  The best is truly yet to come.
  • The HGP is arguably the single most influential investment to have been made in modern science and a foundation for progress in the biological sciences moving forward.

About the Human Genome Project
“Sequencing of the human genome represented the largest single undertaking in the history of biological science and stands as a signature scientific achievement,” the Battelle report states.  It took just 13 years to sequence human DNA under the Human Genome Project (HGP), an international public project led by the United States, and a complementary private program.  Sequencing the human genome involved determining the complete sequence of the three billion DNA base pairs and identifying each human gene.  It required advanced technology development and the assembly of an interdisciplinary team of biologists, physicists, chemists, computer scientists, mathematicians and engineers.  President Bill Clinton called it “the very blueprint of life” in his January 27, 2000 State of the Union address.

The “Genomics Revolution” in Action
Scientists are using the reference genome, the knowledge of genome structure, and the data from the HGP as the foundation for fundamental advancements in science and medicine and the development of applied genomics tools, techniques and technologies.
Genomics also has become a tool for applications in the field of justice and security. For homeland security, the ability to genotype suspicious infectious pathogens and trace their origin is a national security priority. Law enforcement is also using genomics in tracing illegal importation of protected animal species tissue, while the identification of human remains from disasters is another application.
Modern genomics, advanced by the HGP is not only being applied to human biomedical sciences. The “genomic revolution” is influencing renewable energy development, industrial biotechnology, agricultural biosciences, veterinary sciences, environmental science, forensic science and homeland security, and advanced studies in evolution, zoology, anthropology and other academic disciplines.

Next Steps in the “Genomics Revolution”
While the primary impacts of the “Genomics Revolution” have not yet been felt in most areas of daily clinical practice, that day is accelerating towards us.  The Battelle report lists a number of example advancements we can expect in the future due to the HGP and genomics advancements:

  • Agricultural productivity to increase considerably, working towards the challenge of feeding the world’s rapidly expanding population in a sustainable manner.
  • Not only will food availability increase, but the impact of its production on the global environment will reduce as crops and livestock are developed with traits suited to nitrogen use efficiency, no-till agriculture, water use efficiency and reduced waste production.
  • Currently low-value biomass, especially low-value cellulosic biomass, will be converted into higher-value liquid fuels, energy sources, bio-based chemicals, plastics and materials. These products will increasingly displace petroleum and other fossil-based inputs, contributing to reduced carbon emissions and associated climate and environmental benefits.
  • An increasingly two-way flow of diagnostics, therapeutics and prevention tools will move between human medicine, veterinary medicine and agriculture as the cost of genomic technologies reduces and the applications of discoveries in one area can be applied to another because of comparative genomics and other genomic advancements.
  • The legacy of pollution on the planet caused by human activity will be addressed increasingly through the application of genetically engineered, modified or synthetic organisms designed to perform remediation and mitigation functions.

To read the full report, click here.

About Battelle
As the world’s largest independent research and development organization, Battelle provides innovative solutions to the world’s most pressing needs through its four global businesses:  Laboratory Management; National Security; Health and Life Sciences; and Energy, Environment and Material Sciences. It advances scientific discovery and application by conducting $6.5 billion in global R&D annually through contract research, laboratory management and technology commercialization.  Headquartered in Columbus, Ohio, Battelle oversees 22,000 employees in more than 130 locations worldwide, including seven national laboratories which Battelle manages or co-manages for the U.S. Department of Energy and the U.S. Department of Homeland Security and a nuclear energy lab in the United Kingdom.

Battelle also is one of the nation’s leading charitable trusts focusing on societal and economic impact and actively supporting and promoting science, technology, engineering and mathematics (STEM) education.

For more information, contact Katy Delaney at (614) 424-7208 or delaneyk@battelle.org, or T.R. Massey at (614) 424-5544 or masseytr@battelle.org.

NIST Report: Federal Laboratory Technology Transfer Fiscal Year 2009

The National Institute of Standards and Technology in the U.S. Department of Commerce released a report in March discussing Federal Laboratory Technology Transfer for the fiscal year 2009.

The report concludes that from the years 2005-2009 the number of new inventions reported declined while new patent applications and issued patents increased.  Standard invention licensing declined while “other” licenses increased. 

The report cautions that the numbers do not tell the whole story and they are working to develop more accurate metrics to evaluate technology transfer of federal research and its role in economic growth.