Wednesday, July 24, 2013

Gene Silencing?

The Supreme Court of the United States decided that discovery and isolation of genes is not sufficient to make naturally occurring genes patentable. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ____ (2013). However, DNA may be patentable if it is changed in a way that makes it new, useful and nonobvious, potentially saving issued patents claiming synthetic DNA sequences including, without limitation, sequences of complementary DNA (cDNA). What will be the impact of this historic decision? Will the decision extend patents in the chemical arts? The specific holding is that a "naturally occurring DNA sequence is a product of nature and not patent eligible merely because it is isolated, but cDNA is patent eligible because it is not naturally occurring." The decision does not have a direct impact on patent eligibility of methods or applications stemming from knowledge relating to DNA. However, the decision does imply, at least, patent eligibility of any DNA sequence in which the order of the naturally occurring sequence is altered, as a new composition of matter that is not naturally occurring. The decision upholds its earlier decision in Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980). Therefore, a bacterium modified by adding a genetic sequence is patent eligible, because it never existed in nature. Presumably, this logic extends patent eligibility to any alternations in genetic sequences that do not exist in nature. In contrast, merely combining complementary products of nature in a mixture, such as different naturally existing bacteria, is not patent eligible. Citing Funk Brothers v. Kalo Inoculant, 333 U.S. 127 (1948). The bottom line is that DNA sequences that are not naturally occurring are patent eligible, if new, useful and nonobvious. This decision has wider implications for composition of matter claims for naturally occurring chemical compositions isolated from plants and other organisms. While the decision focuses on naturally occurring DNA sequences, the decision is likely to influence future decisions on other products or chemicals that are isolated from nature. Unless purification alters the properties or structure of a substance, mere isolation from nature might be insufficient to render it patent eligible. Side Bar: Interestingly, the decision suggests that the practices of the patent office, absent any endorsement by Congressional enactment of legislation, is entitled to little or no deference.

No comments: