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.

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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 Amicus Brief: Microsoft v. i4i

The Biotechnology Industry Organization, along with AUTM and CropLife International, filed an amicus brief in the Microsoft v. i4i Supreme Court case.

This case is widely viewed as one of the most fundamental and important patent cases to reach the Supreme Court in probably a decade. Most basically, this case is about the level of certainty a jury or judge must have before finding a patent invalid in litigation. Historically, the law has required a high level of proof, “clear and convincing evidence,” before a patent that has been examined and issued by the US Patent and Trademark Office can be declared invalid by a court. In the Microsoft v. i4i case, the Supreme Court is now being asked to adopt a lower burden of proof, under which patents can more easily be found invalid by a lower “preponderance of the evidence.”

In our joint brief, BIO, AUTM and CLI explain that the current high burden of proof has deep historic roots in Supreme Court law, and has been consistently applied by the lower courts for many decades. Under the current standard, issued patents benefit from a clear and meaningful presumption of validity that cannot be easily overcome. In this way, patents play their intended role as enduring legal instruments that confer real rights, and that developers and investors can rely on for investment and product development decisions. The importance of being able to rely on patent rights is illustrated very clearly in the biotech industry, which would not be able to make large investments over very long development times without assurances that the fruits of their investments are protected by robust patent rights. Lowering the standard for patent validity would frustrate decades of investment-backed reliance interests and would negatively impact biotechnology innovation going forward. Our brief explains that the existing high burden of proof to invalidate a patent is entirely consistent with other instances where the law imposes high burdens of proof to protect the public’s reliance on existing property rights.

In our brief, we also point out that Congress permits patents to be invalidated on a lower burden of proof only by the expert Patent Office, and then only on certain kinds of reliable evidence. Litigants who prefer to argue to a lay jury or generalist judge, or who want to use less reliable evidence, can do so only under a higher burden of proof. Any change to this carefully-crafted balance would have to be made by Congress, not the courts.

The United States’ brief in this case forcefully argues against changing the current standard of patent validity.

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.

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. 

 

AUTM Bayh-Dole 30th Anniversary Event

Association of University Technology Managers Press Release

Deerfield, IL — December 12, 2010 will mark the 30th anniversary of the Bayh-Dole Act. This legislation changed fundamentally the way America develops technologies from federally funded university research and effectively secured the country’s leadership position in innovation.

As a result of Bayh-Dole, more than 6,000 new U.S. companies formed from university technologies, approximately 5,000 new products are on the market, 153 new drugs, vaccines or in vitro devices are protecting public health, and in just nine years 279,000 new jobs were created as part of a $187 billion dollar impact on U.S. gross domestic product.

AUTM, joined by the American Council on Education, Association of American Universities, Association of Public and Land-grant Universities, and BIO, is celebrating the occasion with an event in Washington, DC on the morning of Wednesday, December 1. The first half of the event will be moderated by former Rep. Jim Greenwood, CEO of BIO (Biotechnology Industry Organization), and will include remarks from original congressional sponsors of the Act, such as Sen. Birch Bayh. Sen. Bayh and Rep. John Conyers will comment on the importance of maintaining Bayh-Dole to secure America’s leadership position in innovation for the future.

The second half of the event will be a panel discussion among business, university and policy leaders who will discuss the current impact of the Bayh-Dole Act and how to build upon the success of the Act going forward.

Members of the news media and the public are invited, and coverage of the event is welcome.  For more information about the event, contact Jodi Talley, AUTM Communications Director, at +1-847-559-0846 or jtalley@autm.net.

WHAT: Event to celebrate the 30^th Anniversary of the Bayh-Dole Act

DETAILS: Wednesday, Dec. 1, 10 a.m. to 12 p.m. at the Washington Convention Center, 801 Mt. Vernon Place, NW, Washington, DC, Room 140

FOR MORE INFORMATION: Visit http://www.B-D30.org 

                                                                      

 

About the Event Organizers

Founded in 1918, ACE (www.acenet.edu) is the major coordinating body for all the nation’s higher education institutions, representing more than 1,600 college and university presidents, and more than 200 related associations, nationwide.

The Association of American Universities (www.aau.edu) is an association of 61 U.S. and two Canadian research universities organized to develop and implement effective national and institutional policies supporting research and scholarship, graduate and professional education, undergraduate education, and public service in research universities.
Association of Public and Land-grant Universities (www.aplu.org) is an association of public research universities, land-grant institutions, and state university systems, founding in 1887. A۰P۰L۰U member campuses enroll more than 3.5 million undergraduate and 1.1 million graduate students, employ more than 645,000 faculty members, and conduct nearly two-thirds of all academic research, totaling more than $34 billion annually. As the nation’s oldest higher education association, A۰P۰L۰U is dedicated to excellence in learning, discovery and engagement.

The Association of University Technology Managers (www.autm.net) is a nonprofit organization with an international membership of more than 3,000 technology managers and business executives. AUTM members — managers of intellectual property, one of the most active growth sectors of the global economy —come from more than 300 universities, research institutions and teaching hospitals as well as numerous businesses and government organizations.

BIO (www.bio.org) represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

BIO Press Release: BIO and AUTM file Amicus Brief in Myriad Case

The Biotechnology Industry Organization (BIO) filed an amicus brief in the U.S. Court of Appeals for the Federal Circuit on Friday, October 29^th, in an appeal of a lawsuit brought by the American Civil Liberties Union on behalf of a number of plaintiffs against Myriad Genetics, the U.S. Patent and Trademark Office, and others.

The brief, filed jointly with the Association of University Technology Managers (AUTM), supports the patentability of isolated DNA molecules, noting that invalidating the patentability of these molecules would discourage future biotechnological innovation.  DNA-based patents are a critical tool that help enable the fundamental research and development of new biotech products, therapies and technologies to fight deadly diseases, expand agricultural production, clean the environment, and reduce our dependence on foreign sources of oil. 

Isolating a DNA molecule, in addition to creating a new chemical molecule that does not exist in nature, imparts new utilities and functions that are not available from native DNA.  The utility of isolated DNA molecules derives from their chemical structure, which is developed by human ingenuity using complex scientific expertise and equipment. As a result, isolated DNA molecules are patentable subject matter based on decades of U.S. case law.

 “Unless reversed, the district court’s ruling will seriously harm the U.S. biotechnology industry, which consists largely of small firms that are engaged in foundational research and dependent on private investment to fund their work,” stated BIO President & CEO Jim Greenwood.  “Patent protection is critical for the ability of biotechnology firms to secure the private investment necessary for the research and development of innovative diagnostic, therapeutic, environmental and agricultural products. This innovation will lead to domestic job creation and help sustain our country’s global competitiveness.”

 If the Court of Appeals affirms the district court’s categorical rejection of the patentability of isolated DNA molecules, it would cast a cloud of uncertainty over thousands of similar patents and compromise the ability of biotechnology firms to pursue groundbreaking discoveries in human healthcare, renewable energy, and sustainable agriculture. 

 “Patentability of isolated DNA molecules is critical to the translation of university research discoveries for the public good. Without this, many promising discoveries would not make their way from the university research lab and into the hands of companies for development of products which improve the public health,” stated AUTM President Ashley J. Stevens.

“From the mass production of life-saving medicines by cell cultures to the screening of our blood supply for life-threatening viruses, patented DNA molecules have been put to countless uses that have benefited society,” concluded BIO President and CEO Jim Greenwood. 

The joint BIO-AUTM amicus brief is available at http://bio.org/ip/amicus/BIO_AUTM_Amicus_Brief_AMP_v_USPTO_2010-1406_FedCir.pdf.  Additional background materials are available at http://bio.org/ip/genepat