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 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.

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 .