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.

Supreme Court Affirms: High Level of Proof Needed to Invalidate A Patent

Posted by Stephanie Fischer on June 10, 2011 at 3:29pm EDT on BIOtech Now

The U.S. Supreme Court issued a favorable decision yesterday in the critical case of Microsoft v. i4i, in which Microsoft challenged the “clear and convincing evidence” standard traditionally used by courts in determining whether to invalidate an issued U.S. patent.   Microsoft argued for a lower “preponderance of the evidence” standard, under which patents could be invalidated by a mere “more likely than not” determination by a court or jury.  In a joint amicus brief with CropLife International and the Association of University Technology Managers (AUTM),  BIO argued that there are strong legal and policy justifications for a heightened standard in terms of investment in and reliance on patents to fuel R&D and innovation.

BIO also joined 260 other stakeholders representing U.S. innovation in all 50 states and the District of Columbia to express concerns about potentially negative consequences for domestic innovation, job growth and our nation’s technology leadership internationally in a letter to the Attorney General and Acting Solicitor General which likely helped persuade the U.S. Solicitor General to file a strongly supportive and influential brief.

The Court ruled 8-0 (with Chief Justice Roberts recusing himself) against Microsoft, holding that the standard for invalidating a patent in the courts remains “clear and convincing evidence,” regardless of whether the precise prior art cited to support invalidation was considered by the PTO or not.

This decision is a huge relief for the biotechnology industry, which relies heavily on the presumed validity of patents to generate investment and a reasonable return thereon.

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

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

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).