Assoc. for Molecular Pathology v. Myriad Genetics, No. 2010-1426 (Fed. Cir. 2011)
In a decision last Friday, the Federal Circuit confirmed that isolated DNA may be patented. Judge Lourie brought his considerable chemistry background to bear in writing the court's opinion in a case presenting the question of whether isolated DNA is patent-eligible subject matter.
Myriad appealed a district court decision that held, on summary judgment, that the claims of a number of patents relating to the breast and ovarian cancer genes BRCA1 and BRCA2 were invalid because the gene sequences were products of nature and therefore unpatentable. The Federal Circuit addressed this question, and it also addressed whether the plethora of plaintiffs had standing to challenge the patents. The following précis discusses the merits of the patent eligibility of isolated DNA molecules and methods of diagnosis. The opinion clearly answered the first question in the affirmative for isolated DNA molecules and provided a "maybe" for diagnostic methods, but not in the form presented by Myriad.
In reviewing the patent eligibility of DNA-related claims, the court reverted to the reasoning from the Supreme Court's decision in Chakrobarty, 447 US 1981, the ancestor of most biotechnology decisions in the area of 35 U.S.C. 101. The test fashioned since that decision focuses on whether a man-made composition is patent-eligible subject matter and answers that it is if the claimed subject matter is a non-naturally occurring composition of matter having a distinct name, character and use.
Applying the test to isolated DNAs, the Federal Circuit concluded here that the challenged claims are drawn to patentable subject matter because the claims cover molecules that are markedly different–-they have distinctive chemical identity and nature--from molecules that exist in nature. The DNA molecules claimed by Myriad are in an isolated state: they are not the same molecules as those existing in the body. It took human intervention in cleaving or synthesizing these new chemicals and this human intervention imparts on that isolated DNA a distinctive chemical identify from that possessed by such a chemical within native DNA.
The court took pains to explain that isolated DNA is not merely purified DNA but rather it is a distinct chemical entity defined by separate molecular species joined together by an all-important chemical bond. In addressing the patent eligibility of the underlying DNA claims, the court dismissed the argument that the DNA should not be patent-eligible because it does not have markedly different characteristics from the characteristics of the DNA in native form. The court again reiterated that the subject matter is a distinct chemical entity and that focusing on the properties or use of that chemical entity improperly conflates the patent eligibility inquiry with an obviousness inquiry.
In the same vein, the Federal Circuit dismissed the middle-ground arguments advanced by the Patent Office: that isolated DNAs should not be patentable because they can be seen using a "magic microscope" whereas cDNAs cannot. The court rejected the Patent Office’s argument as it fails to understand the difference between science and invention and fails to recognize that the DNA molecules are separate chemical entities regardless of whether they are cDNA molecules or isolated genomic DNA molecules. The court noted that the ability to visualize a DNA molecule is "worlds apart" from possession of an isolated DNA. Noting that this is the difference between knowledge of nature and a reduction of that knowledge to a concrete form, the latter activity being the very ingenuity that the patent laws seek to encourage through protection, the court provided its imprimatur to DNA composition-of-matter claims regardless of whether they are cDNA claims or isolated genomic DNA claims.
The court was not so forthcoming with the same endorsement for the diagnostic method claims as presented in the patents. All but one of the method claims at issue covered "analyzing" or "comparing" a patient's DNA sequence with the DNA sequence from wild-type or normal patients that do not have cancer to effectively correlate a difference in the DNAs with a cancer. The court noted that the "analyzing" or "comparing" step is the entire process claimed, and can in fact be a mental step without being tied to some additional transformative test--and hence these method claims fail the test of patent eligibility. However, that is not to say that Myriad provides the death knell for diagnostic method claims. Rather, the court stated that "isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect."
With the above encouragement in mind, it is still possible to obtain claims to methods of diagnosis of a disease as long as the diagnostic methods that involve analysis or comparison of a diseased state with a wild-type or normal state are crafted to include a physical step such as "extraction" or other manipulation of the underlying chemical to be analyzed or compared in the diagnostic step. Crafting the appropriate language for this additional element in diagnostic method claims will become ever more important with the dawning of the age of personalized medicine and the need for protection of underlying intellectual property focused on personalized medicine.
The court seems to have applied well-established law under 35 U.S.C. 101, including the recent guidance provided by the Supreme Court in Bilski, making it a more remote possibility that the Supreme Court would accept the case review.