Joint Statement of BIO, AAU, ACE, APLU, AUTM and COGR

Contributed by dbking

 Earlier today, the United States Supreme Court issued its opinion in the appeal of Stanford University against Roche Diagnostics. This case is of significant interest to the Biotechnology Industry Organization (BIO), Association of American Universities (AAU), American Council on Education (ACE), Association of Public and Land-grant Universities (APLU), Association of University Technology Managers (AUTM), and Council on Governmental Relations (COGR) because of its potential impact on university technology transfer, on development and commercialization of university-generated basic technology, and on scientific collaborations between university and private-sector scientists.

The biotechnology industry and the university community rely on effective collaborations to make the products of their research and development efforts available to the public.  The university’s mission of the discovery and dissemination of new knowledge is complementary to the biotechnology industry’s mission of translating basic science into products to benefit patients, farmers, and consumers. The discoveries arising from university research are most efficiently transformed into valuable new products with the participation of companies willing to invest in the long development process that is often necessary to bring new products to market.

By all accounts, the U.S. system of public-private technology transfer that was established under the 1980 Bayh-Dole Act has been extraordinarily successful in moving university discoveries from experimental laboratories to the marketplace through collaborations with private industry. This system has provided a rich return on public funding for basic research, in the form of countless innovative products that today benefit consumers, create jobs, and contribute to U.S. technological leadership internationally.  

Although BIO and the undersigned higher education associations held different views on the Stanford v. Roche case, the organizations are united in the desire to ensure that the U.S. technology transfer system continues to generate these public benefits through the robust provisions of the Bayh-Dole statute.  We are committed to working together in light of the Supreme Court’s decision to ensure the continued vibrancy of public-private partnerships and success of our shared objectives.

MEDIA CONTACTS

Biotechnology Industry Organization:

Stephanie Fischer, Director of Communications

(202) 312-9263

sfischer@bio.org

Association of American Universities:

Barry Toic, Vice President of Public Affairs

202-898-7847

barry_toiv@aau.edu

 

American Council on Education:

Erin Hennessy, Director of Public Affairs

202-939-9367

erin_hennessy@ace.nche.edu

Association of Public and Land-grant Universities:

Paul Hassen, Vice President of Public Affairs

202-478-6073

phassen@aplu.org

Association of University Technology Managers:

Jodi Talley, Marketing and Communications Manager

(847) 559-0846 x237

jtalley@autm.net

 

Council on Governmental Relations:

Robert Hardy, Director of Contracts and Intellectual Property

(202) 289-6655

rhardy@cogr.edu

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Foley & Lardner article on the history of the Chinese Bayh-Dole Act

China Bayh-Dole Act: A Framework Fundamental to Achieving the Economic Potential of China’s National Patent Development Strategy (2011 – 2020)

By Max Lin, Foley & Lardner LLP

This article is part of our Spring 2011 edition of Legal News: China Quarterly Newsletter, Eye on China.

China’s National Patent Development Strategy (2011 – 2020) (Plan) was announced in November 2010. The proposed measures focus on enhancing China’s IP system and encouraging local individuals, institutions, and companies to pursue IP protection domestically and abroad. By the end of 2015, the number of Chinese patent applications are projected to double. Chinese authorities clearly view patents as vital commercial assets central to the country’s development.

Fully achieving the Plan’s potential economic value depends upon establishing an effective framework for the commercialization of government-sponsored technology through licensing and transfer. Those seeking to buy or license cutting-edge technologies from Chinese universities or scientific research institutes should be familiar with China’s regulation governing such technology transfers or licenses — the so-called “China Bayh-Dole Act.”

Before 2002, China’s regulatory system did not address regulating the intellectual property ownership of technology developments sponsored by government funding. As a result of China’s booming economy, there was increased demand for advanced technologies by private individuals or companies, who then sought the commercial development of technologies that remained in universities or research institutes. As a result, technology licensing or transfer activities began to emerge from universities or research institutes. The primary challenge for those activities was the intellectual property ownership of the technologies. Most Chinese universities or research institutes are state-owned, and the cost of research is sponsored by government funding. As such, it was unclear and undefined under the law who owned the involved technology.

In March 2002, the Ministry of Finance and the Ministry of Science and Technology co-issued Several Regulations Concerning Intellectual Property Management of State Scientific and Research Program Result (Regulations) to improve the process of technology licensing or transfer. The Regulations first emulated the core spirit of the U.S. Bayh-Dole Act and set forth the ownership of intellectual property. Except in cases where national security, national interests, or significant public interests are involved, the state granted the intellectual property developed in scientific research programs sponsored by government funding to the performing organization so that it can implement, license, or transfer the intellectual property independently. The state retained the right to use the intellectual property freely. If the performing organization — as the intellectual property owner — does not implement the intellectual property or obstructs the public from utilizing the intellectual property, the state can intervene by licensing a designated party to implement it freely or by paying royalties to the performing organization, depending on the specific circumstances. The Regulations do not detail the circumstances, leaving the decision up to government discretion.

In December 2007, China passed the Scientific and Technological Progress Law, which upgrades the provisions of the Regulations with respect to intellectual property ownership to the level of national law. The law sub-divides intellectual property rights into four items, namely, invention patents, computer software copyrights, exclusive rights to layout-design of integrated circuits, and new variety right of plant. Utility model patents and design patents as well as other intellectual property are excluded from the scope of intellectual property defined in the law. In addition, the law uses the name “project undertaker” to refer to units undertaking a project, such as scientific institutions, universities, enterprises, and so forth, but it does not exclude individuals.

The law grants the intellectual property ownership that is formed though a project sponsored by treasury money to the project undertaker, which encourages the project undertaker to continue being innovative. With intellectual property ownership in hand, the project undertaker has more motivation for the highly efficient commercial development of the intellectual property. Besides implementation by the project undertaker himself, the project undertaker can transfer or license the intellectual property. However, there is restriction on such transfer or license: Because the state has paid for the formation of the intellectual property, the state encourages such intellectual property to be utilized domestically. It is noted that such encouragement does not forbid transfer or license outside of China. However, the transfer of intellectual property rights to overseas organizations or individuals, or the licensing of exclusive use rights to overseas organizations or individuals, is subject to governmental approval. No approval is required for the licensing of non-exclusive use rights.

It is important for companies to secure key positions in their intellectual property. The acceleration of IP creation and protection for Chinese innovation under the Plan creates increased commercial opportunity for licensing and technology transfer. For companies seeking to acquire government-funded technology through license or technology transfer in China, it is important to become familiar with the regulations governing such transactions.

Fabry Patient Law Suit and Request to NIH for March-in Petition Rehearing

An article out of the Genomics Law Report discussing the recent law suit citing violations of the Bayh Dole Act.

A second article from Patent Docs discusses the request for rehearing of the patients petition to the NIH for march-in.

Bayh-Dole Podcast moderated by BIO with AUTM and patient advocate

Lila Feisee, Vice President for Global Intellectual Property Policy at BIO, moderated a podcast on the benefits of the Bayh-Dole Act and the need to maintain flexibility in our nation’s technology transfer system.  She was joined by:

• Dr. Ashley Stevens, Special Assistant to the Vice President for Research Technology Development and Senior Research Associate at the Institute for Technology Entrepreneurship & Commercialization at the Boston University School of Management.  He  also serves as President of the Association of University Technology Managers (AUTM), a nonprofit organization with an international membership of more than 3,000 technology managers and business executives. AUTM members come from more than 300 universities, research institutions and teaching hospitals as well as numerous businesses and government organizations.
• Betsy de Parry, a patient advocate and author of The Roller Coaster Diaries, the story of her experience with non-Hodgkin’s lymphoma.

For more information on the many benefits the Bayh-Dole Act has provided, please visit http://www.b-d30.org/.  Information on AUTM can be found at http://www.autm.net.

To listen to the podcast go to:  http://www.biotech-now.org/section/bio-matters/2011/01/12/celebrating-thirty-years-success-bayh-dole-act and press the play button at the bottom of the article.

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.