In Fall 2009 and Spring 2010, we reported that the American Civil Liberties Union (ACLU) and others filed suit against the U.S. Patent and Trademark Office (USPTO), Myriad Genetics and others, alleging that “human gene patents” were patent ineligible. The Plaintiffs were successful at the district court level, invalidating claims in several BRCA1 and BRCA2 patents (Patentable Subject Matter and Medical Diagnostic Patents in the Wake of In re Bilski and Life Science-Related Invention Patent Decisions; Genes and Genetic Testing Held Not Patentable in the U.S.).

On July 29, 2011, the United States Court of Appeals for the Federal Circuit (the Court), in a 2-1 decision, reversed the lower court’s decision that Myriad’s composition claims to “isolated” DNA molecules cover patent ineligible products of nature under Section 101 since the molecules as claimed do not exist in nature. Further, the Court also reversed the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates is directed to a patent ineligible scientific principle. Unfortunately for the Biotech community, the Court upheld the district court’s decision that the diagnostic method claims in question, as written, were patent ineligible.

Interestingly, the U.S. government who had submitted an amicus brief, argued that DNA molecules engineered by man, including cDNAs, were patent eligible but that isolated and unmodified genomic DNA were not patent eligible since their nucleotide sequences exist because of evolution and not man. The Court disagreed and definitively stated that isolated DNAs, whether limited to cDNAs or not, are directed to patent eligible subject matter under Section 101. The Court indicated that isolated DNA is not purified DNA, isolated DNA is markedly different from that which exists in nature, it is a distinct chemical entity which has been cleaved or synthesized to consist of a fraction of a naturally occurring DNA molecule. The Court further noted that it is the distinctive nature of the DNA molecule as an isolated composition of matter that determines its patent eligibility rather than its physiological use or benefit, the latter of which may be relevant to non-obviousness. As such isolated DNA is patent eligible under Section 101.

The diagnostic method claims directed to “comparing” or “analyzing” DNA sequences were held to be patent ineligible as such claims were found to include no transformative steps, thus failing the machine-or-transformation test indicated to be useful and important under Bilski v. Kappos (Bilski). The Court indicated that extracting DNA from a human sample and sequencing the BRCA DNA molecule were transformative steps, providing an indication for the drafting of diagnostic method claims going forward. Myriad had argued that these steps necessarily preceded the step of comparing DNA sequences. However, as neither of these steps were recited in the claims, the Court held the claims to be patent ineligible. The comparison between the two sequences can, according to the Court, be accomplished by mere inspection alone.

The Court’s decision is relatively favourable to the Biotech community as it confirms the longstanding practice of the USPTO to allow claims to isolated DNA molecules and it provides lessons for drafting diagnostic method claims to include transformative steps such as a “determining” step. It is unfortunate that the Court refused to accept that sequencing of DNA is a prerequisite to and implied by analyzing and comparing DNA sequences. However, the Court did recognize that “sequencing” would be sufficient to meet the transformative prong of the machine-or-transformation test outlined in Bilski. The Court’s suggestion that using “determining” instead of “analyzing” would make the diagnostic claim patent eligible, again highlights the awkward implications of the machine-or-transformation test of Bilski when applied to Biotechnology.