Canada: Myriad Genetics Holding That CDNA Is Patent-Eligible Subject Matter Is Good News For Those Seeking Or Enforcing Patents For Computer-Implemented Technologies

Last Updated: October 1 2013
Article by Ian C. McMillan and Matthew Cahill (Summer Student)

On June 13, 2013, the Supreme Court of the United States issued its decision in the Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al. (Myriad). Although this decision concerns the validity of patent claims in biotechnology, it may be relevant to other fields where courts must often distinguish between patent eligible subject matter and "laws of nature, natural phenomena, and abstract ideas", which are not eligible for patent protection.  Our interest is in the implications of the Myriad decision for computer-implemented inventions, particularly when contrasted with the decision in Mayo Collaborative Services v. Prometheus Laboratories (Prometheus).

Where inventiveness lies entirely in mathematical algorithms, and not in the possibly routine steps of programming computers to implement them, Prometheus suggests that the corresponding patent claims would be invalid. However, we argue that Myriad has the opposite implication. By further blurring the test for patent eligible subject matter, the chances that such claims would be found valid has been improved, although the issue remains very much in doubt as  Myriad and Prometheus point to opposing results.

Laws of nature and natural phenomena

Myriad considered whether the claimed subject matter was ineligible for patent protection as a natural phenomenon ( summary and possible implications). Myriad Genetics Inc. (Myriad) obtained several patents after discovering the precise location and sequence of the human genes BRCA1 and BRCA2. The challenged claims covered "isolated DNA" corresponding to the BRCA genes as they exist in the chromosome as well as BRCA complementary-DNA (cDNA). In nature, genes are transcribed to produce messenger RNA (mRNA). Using well-established laboratory techniques, mRNA can be reverse-transcribed to yield cDNA.

With respect to the BRCA genes, the Supreme Court held that "a naturally occurring DNA segment is a product of nature, and not patent eligible merely because it has been isolated". The Court took a more favourable view of the claims related to BRCA cDNAs. They were of the view that "...the lab technician unquestionably creates something new when cDNA is made" and went on to conclude that claims to cDNA are patent eligible under § 101. This is notable because, once a gene of interest has been identified, synthesizing the corresponding cDNA is straightforward.

Prometheus ( summary) holds that a process that relies on unpatentable subject matter must "also contain other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself." These other elements, or combination of elements, must not be "obvious, already in use, or purely conventional". In Prometheus, the unpatentable subject matter was a law of nature, specifically the relationship between metabolite concentrations and the effectiveness or toxicity of a drug. The claimed process that incorporated this natural law – instructions for doctors to apply the relationship when treating patients – was not sufficient to "transform unpatentable natural correlations into patentable applications."

In Myriad, the unpatentable subject matter was a natural phenomenon, specifically the naturally occurring DNA corresponding to a BRCA gene. Simply isolating this DNA was, apparently, not sufficient to transform the otherwise patent ineligible subject matter into a patent eligible composition. However, cDNA was found to be patent eligible, despite being derived from ineligible subject matter using steps that are arguably "obvious, already in use or purely conventional".

Abstract Ideas

We cannot easily reconcile the need for "something more" in Prometheus with the Court's holding in Myriad with respect to cDNA. In Myriad, the Court did not seem concerned with "other elements" or an "inventive concept". They accepted that cDNA did not exist in nature and this sufficed to render it patent eligible. This may reflect a difference in how the Court approaches the various kinds of patent ineligible subject matter, though this was not stated explicitly.

The decision in Myriad arguably supports patent claims for computer-implementations of abstract ideas or mathematical algorithms. Programming a computer to execute a method according to a mathematical algorithm may be analogous to synthesizing cDNA corresponding to a known gene. The mathematical algorithm, like natural DNA, is not, on its own, eligible for patent protection. However, the computer configured to execute a method according to a mathematical algorithm is not a mere abstraction, and thus should not for that reason alone be ineligible for patent protection. What's more, programming a computer is arguably no more "obvious" or "purely conventional" than cDNA synthesis.

If computer-implemented subject matter is novel and inventive, then, following Myriad, it may well be patent eligible, even if a great deal of the novelty and inventiveness is a consequence of the underlying mathematical algorithm, just as the novelty and inventiveness of cDNA derives from the newly discovered DNA.  On the other hand, Prometheus suggests that such computer-implemented subject matter may not be patent eligible as the mere programming of a computer to implement the mathematical algorithm would likely be characterized in many cases as obvious or purely conventional. Additionally, the Supreme Court has expressed concern about patents that may pre-empt the use of mathematical algorithms in many fields. Thus, to have the best chance of being eligible for patent protection, a claim for a computer implementation of a mathematical algorithm should not cover all possible implementations of the mathematical algorithm, but instead should be limited to a particular application, and recite hardware relevant to that application.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Ian C. McMillan
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