In the recent decision of the US Distinct Court for the Southern District of New York, Justice Robert Sweet ruled that composition and method claims directed to isolated DNA sequences and the uses thereof are not patentable subject under the U.S. Patent Act.

Myriad Genetics Inc. ("Myriad") and its collaborators reported the discovery of mutations in two genes that result in a predisposition to breast and ovarian cancers. Myriad was eventually awarded a series of patents in the United States, Canada and elsewhere that gave the company exclusive rights to isolated DNA sequences related to the BRCA1 and BRCA2 genes and methods of use. The District Court action was commenced by several parties who were concerned about Myriad's patents and their impact on science and health care.

According to Justice Sweet, "…purification of a product of nature, without more, cannot transform it into patentable subject matter." The purified product must possess "markedly different characteristics" in order to be patentable. In finding that the claimed DNA sequences were not markedly different from those sequences existing in nature, the Court found that the claims did not define patentable subject matter.

In citing the Federal Circuit decision in Bilski, the District Court also found that Myriad's method claims were invalid. According to Justice Sweet, the essence of what was claimed was the "…identification of a predisposition of cancer…" and the "… 'comparing' [of] the growth rates of cells in the presence or absence of a potential cancer therapeutic." Under the "machine or transformation test" provided in Bilski, the Court found that neither sets of method claims were directed to either a particular machine or provided a transformation of one article to a different state or thing. As such, the method claims were also found to be invalid.

Comment - As a result of this decision, life science companies should consider reviewing their U.S. patent portfolio and any potential impact this decision may have. While it may be overturned on appeal, particularly in view of the recent U.S. Supreme Court ruling in Bilski, the full impact of this decision is yet to be determined.