American Civil Liberties Union - ACLU

Briefing: Celebrate one big human advancement that happened in the last 10 years.

Fact: Naturally-occurring genes patents ruled invalid by NYC Court, 2010.

Idea: To show this moment in history where more than 150,000 scientists made a complaint against Myriad Genetics and the Patent Office to invalidate patents on naturally-occurring genes.

For years, the U.S. Patent Office has taken the position that extracted genes, or “isolated DNA,” can be patented. And, in fact, it has issued thousands of patents on human genes, with perhaps one of every five human genes now under patent. Patent rights to a gene, of course, give the owner the exclusive right to study, test and experiment on the gene to see how its natural characteristics work.

A complaint against Myriad Genetics and the U.S. Patent and Trademark Office filed in 2009 by professional medical organizations, doctors, and patients, all represented by the American Civil Liberties Union (representing more than 150,000 people) sought to invalidate and discontinue all patents for naturally-occurring genes, which have thus far been issued on the grounds that such genes are “isolated and purified” to a non-naturally-occurring state. Myriad owns some of its patents; some were licensed from University of Utah. Specific claims, but not all claims, in seven of Myriad’s 23 patents on BRCA1 and BRCA2 were challenged in the complaint. The challenged claims covered the isolated genes as well as diagnostic methods. Many people working in the patent field had predicted that the courts would throw out this case. However, the case was accepted, and all the challenged claims were ruled invalid on March 29, 2010 by United States District Court Judge Robert W. Sweet, a judge in the U.S. District Court for the Southern District of New York. The claims that had not been challenged still stand. Judge Sweet’s 152–page decision concluded that “genomic DNA that has merely been isolated from the human body without further alteration.” To satisfy the requiement of patent law that an invention not be something that exists in nature, it added, “requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be.”