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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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

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.

BIO’s IP Priorities for 2011

As we start a new year, the BIO Intellectual Property Department has determined their 2011 priorities.  Intellectual Property remains a foundational priority for BIO and our 1100 biotechnology company members.

BIO’s IP department has approved the following priorities for 2011:

1) PTO reforms to improve efficient, timely and quality examination

2) Congressional patent reform legislation

3) Improving IP protection in key foreign markets

4) IP legal developments in the courts

5) Protecting the breadth and flexibility of the patent and technology transfer system.

AUTM U.S. Licensing Survey 2009

AUTM released their 2009 report for technology transfer licensing activities.  Of particular interest is the 596 start-up companies that were created in the middle of an economic recessision.  This Survey suggests that in 2009 Bayh-Dole contributed to growth in an otherwise declining economy, created jobs, and helped fund future research. 

Here are the U.S. Highlights:

Economic Impact

The number of licenses executed increased 5.6 percent, whereas the number of options decreased 3.4 percent. Total licenses and options increased 3.8 percent. The number of startups was essentially unchanged.

Products, startups and licenses/options:

• 658 new commercial products launched

• 5,328 total licenses and options executed, 4,374 of which were licenses

• 596 startup companies formed, 435 of which had their primary place of business in the licensing institution’s home state

• 3,423 startups still operating as of the end of 2009

 

Technology Transfer Pipeline

Research expenditures continued to increase: total research and development spending increased 4.7 percent, federal expenditures increased 1.9 percent, and given the financial downturn, an 8.2 percent surge in industrial research funding was especially significant.

Research expenditures:

• $53.9 billion total sponsored research expenditures

• $33.3 billion in federally funded sponsored research expenditures

• $4.0 billion in industry-sponsored research expenditures

 

Intellectual Property Management

The number of disclosures received increased 1 percent.

Disclosures:

• 20,309 disclosures

AUTM analyzed, in great depth — the areas within which the disclosures fell and was able to categorize 66 percent of the disclosures or 13,376.

Total U.S. patent applications filed decreased almost 4 percent, while new patent applications declined almost 1 percent. However, the number of foreign filings increased significantly, up almost 56 percent.

Patents filed:

• 18,214 total U.S. patent applications

• 12,109 new patent applications

• 1,322 non-U.S. patent applications

The number of patents issued increased nearly 4 percent.

Patents issued:

• 3,417 issued patents

 

License Income

Total license income decreased 32.5 percent in 2009. This decrease is largely due to 2008’s figures including substantial one time payments received by Northwestern University, City of Hope National Medical Center and Beckman Research Institute, Sloan Kettering Institute for Cancer Research and Children’s Hospital of Philadelphia. The decrease was across the board: Running royalties dropped 29.7 percent, cashed-in equity dropped 45 percent, and other income dropped 35.5 percent.

• Total income: $2.3 billion

• Running royalty: $1.6 billion

• Cashed-in equity: $24.4 million

• Other income: $362 million

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;”