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 Joins 261 Business, Research Institutions and Organizations to Urge Caution in Microsoft v. i4i Case*

*UPDATE – 90 more organizations have decided to add their names to the letter sent to the Department of Justice.  Please find the new letter.

Please find attached an open letter to Attorney General Holder and Acting Solicitor General Katyal, signed by 171 businesses, research institutions and organizations of all sizes, representing U.S. innovation in all 50 states and the District of Columbia. The signatories include leading innovators in agriculture, biotechnology, consumer products, electrical, mechanical  and chemical engineering, green energy, manufacturing, pharmaceuticals, semiconductors, software, telecommunication and other sectors.

In signing this letter, BIO calls on the U.S. Department of Justice to proceed cautiously in developing the U.S. Government’s position in the ongoing high-profile patent litigation between Microsoft and i4i, a small software company. This case has recently been accepted for review by the United States Supreme Court and is being closely watched by domestic and foreign businesses from every technology sector, including biotechnology.

 

In this case, the Supreme Court is being asked to reconsider a longstanding rule of patent law, according to which those who challenge a patent before a lay jury or judge must carry a heightened burden of proof.  Under the current law, infringers who seek to overturn a patent must prove the facts of their case to a high degree of probability, by “clear and convincing evidence.” The rule ensures that patents that have been examined and issued by the U.S. Patent and Trademark Office (USPTO), and that have been relied on by patentees and the public, can only be overturned on strong, reliable, and convincing evidence.

In Microsoft v. i4i, the U.S. Supreme Court is now being asked to lower this burden of proof. As now proposed, patents could be invalidated more easily in district court litigation by using evidence that was not noted in the USPTO’s patent examination file. Effectively, patents that are challenged on such evidence would carry only the weakest possible presumption of validity – a “preponderance” standard according to which courts could overturn patents even if the facts of the case are established only to a 51% likelihood. This would be a big change in longstanding law that could make it significantly more difficult to rely on strong patent rights for licensing, partnering, investment, and product development decisions in all industry sectors.

We believe this case to be of critical importance to U.S. innovation policy, and are greatly concerned about its potentially negative consequences for domestic innovation, job growth, and U.S. technological leadership internationally. Because the U.S. Government’s position is likely to be very influential in this Supreme Court case, we ask that the Department of Justice weigh these implications carefully, and arrive at any official position only after consulting a broad range of stakeholders whose perspectives differ from those of a narrow group of big companies who would benefit from such a shift in the law.

A comprehensive collection of documents in this case can be found at http://www.scotusblog.com/case-files/cases/microsoft-v-i4i-limited-partnership/ and http://www.i4ilp.com/papers.php .

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.

BIO Commends Supreme Court for Expansive View of Patentability in Bilski Decision

Decision Recognizes ‘Machine or Transformation” Test May Not Apply To Biotech and Other New Technologies

Washington, D.C. (June 28, 2010) – The Biotechnology Industry Organization (BIO) released the following statement in reaction to the Supreme Court’s decision to uphold the lower court’s ruling in Bilski v. Kappos.

“In our amicus brief, BIO urged the Supreme Court to overturn the lower court’s rigid new test for determining whether a method or process is eligible for patenting. We are pleased that the Justices crafted a narrow opinion that does just that. The Court was clearly conscious of the potential negative and unforeseeable consequences of a broad and sweeping decision,” stated BIO President and CEO Jim Greenwood.  “This ruling specifically states that the ‘machine-or-transformation test is not the sole test for patent eligibility’ and recognized that the lower court’s ruling could have created uncertainty in fields such as advanced diagnostic medicine techniques.”

“In the Diamond v. Chakrabarty decision in 1980, the Supreme Court defined patent-eligible subject matter in a flexible and inclusive way that has fostered the tremendous growth of biotechnology for the benefit of millions of patients, farmers, and other consumers around the world,” continued Greenwood.  “We are pleased that the Court made it clear in today’s decision that the patent system was designed to be broad and inclusive in order to promote innovation.  Strong intellectual property protection is critical to our nation’s economy and global competitiveness.”

In an amicus brief filed last year, BIO urged the Supreme Court to overturn the decision of the U.S. Court of Appeals for the Federal Circuit which created a new test under which a method or process is only patent-eligible if it is tied to a specific machine or if it transforms a particular article or substance to a different state or thing. This “machine-or-transformation” test was, until today, the only way to determine the patent-eligibility of a patent application before it is examined for novelty, inventiveness, and usefulness.

BIO’s amicus brief is available at http://bio.org/ip/amicus/documents/08-964tsacBiotechnologyIndustryOrganizationetal.pdf.

About BIO

BIO represents more than 1,200 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 also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.