- Sequenom, Inc., v. Ariosa Diagnostics, Inc., et al., (No. 15-1182), 20 April 2016
- Cuozzo Speed v. Lee (No. 15-446), 29 February 2016
- Lighting Ballast v. Philips Electronics (No. 2012-1014), 28 May 2013
- AMP v. Myriad (No. 2010-1406), 15 June 2012
- Mayo v. Prometheus (No. 10-1150), 7 November 2011
- Microsoft v. i4i (No. 10-290), 18, March 2011
- Stanford v. Roche (No. 09-1159), 26 April 2010
AMP v. Myriad
The Supreme Court unanimously held that human genes cannot be patented, even when isolated from the body, a ruling expected to quickly expand access to genetic testing while potentially allowing inventors to retain rights to artificially created DNA. Read the decision.
AUTM’s Position: AUTM agrees with both parties and the Court that diagnostic tests should be available for the benefit of the public. It supports the encouragement of rapid medical innovation, applied and practical biotechnology, university basic genetic research, collaboration among universities and the medical community and translation of genetic discoveries into tangible medical tests. AUTM believes in the importance of intellectual property protection and remaining competitive with other countries in developing lifesaving technologies. Read more.
- AUTM, BIO and the Coalition for 21st Century Medicine filed an amicus brief in support of Myriad. Read more.
- The AMP v. USPTO Remand: Déjà Vu as Federal Circuit Majority Reaffirms that Myriad’s Isolated DNA Sequences Are Patent-Eligible, Read the full analysis by Eric W. Guttag, Eric W. Guttag IP Law Office.
- Supreme Court Says Human Genes Aren't Patentable by Jess Bravin and Brent Kendall of the Wall Street Journal, 13 June 2013. Read more.
- A U.S. federal appeals court has once again affirmed the right of Myriad Genetics Inc to patent two genes linked to breast and ovarian cancer, Reuters, Aug. 16. Read more.
Mayo v. Prometheus
The Supreme Court’s March 20, 2012 decision in Mayo v. Prometheus, 566 U.S. (2012), invalidates patent claims when they invoke a law of nature but do not “confine their reach to particular applications of those laws.” This case involves claims for optimizing therapeutic efficiency of a treatment, but the principles enunciated may have impact outside of medical arts.
Mayo v. Prometheus marks a challenge to draft patent claims for any industry interested in application of a law of nature, or even an algorithm. The impact of this case may extend from medical arts to electrical technologies, business methods, and other technologies.
Going forward, claims applying a law of nature should separately recite method steps that are novel and non-obvious in the absence the law of nature. This should be done to frame application of the law of nature as restricted to the particular “inventive concept” embodied in the separately recited method steps.
Microsoft v. i4i
Under the Patent Act of 1952, a patent is presumed valid. If someone challenges the validity, they must show that it is invalid; the person or company that has the patent does not have to show that it is valid.
Microsoft was accused of violating i4i's patent. Microsoft argued that the patent was invalid, which raised the question: what standard of proof is necessary to overturn the presumption of validity? Microsoft argued that "a preponderance of the evidence" is sufficient. i4i argued for a more demanding requirement of "clear and convincing evidence".
In their ruling on June 9, 2011, the U.S. Supreme Court agreed with i4i, and unanimously (with Chief Justice Roberts recused) explained that because a simple "preponderance of the evidence" standard would be too easy to meet, Congress intended to adopt the tougher "clear and convincing" evidence standard when it enacted the Patent Act.
Stanford v. Roche
The court held that title in a patented invention vests first in the inventor, even if the inventor is a researcher at a federally funded lab subject to the Bayh-Dole Act. In the opinion in the appeal of Stanford University against Roche Diagnostics, the Supreme Court judges affirmed the common understanding of U.S. Constitutional law that inventors originally own inventions they make, and contractual obligations to assign those rights to third parties are secondary.
AUTM’s Position: 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.
- AUTM contributed to the case through the brief of amici curiae that was filed.
- A joint statement was issued by AUTM as well as Biotechnology Industry Organization (BIO), Association of American Universities (AAU), American Council on Education (ACE), Association of Public and Land-grant Universities (APLU), and Council on Governmental Relations (COGR).