Thursday, December 23, 2010

Lawsuit Alleging Infringement of Canine Genotyping Patent Raise Interesting Patent Eligibility Issues

On December 17 Fred Hutchinson Cancer Research Center and its licensees (Argus Genetics and Mars, Inc.) sued MMI Genomics for infringement of a patent directed towards methods of using genetic testing to identify the breed of the dog (US patent 7,729,863). According to the complaint, MMI Genomics is a company based in Davis, California that provides dog breed identification services associated with its Canine Heritage XL Breed Test product.

Some of the claims in the asserted patent raise interesting issues of patent eligibility, particularly in view of the recent Bilski and Prometheus decisions, both discussed extensively on this blog, and the pending appeal of AMP v. PTO (the ACLU challenge to Myriad’s BRCA gene patents). For example, consider claim 1.

1. A method for determining the contributions of canid populations to a canid genome, comprising: (a) genotyping a sample obtained from a test canid to determine the identity of one or both alleles present in the test canid genome for each of a set of markers, wherein the set of markers is indicative of the contributions of canid populations to the genome of the test canid; (b) using a specifically programmed computer comprising an algorithm to compare the identity of one or both alleles for each of the set of markers determined to be present in the test canid genome to a database comprising a plurality of canid population profiles, wherein each canid population profile comprises genotype information for the set of markers in the canid population; and (c) determining the contributions of canid populations to the test canid genome.

The heart of the claimed method seems to reside in applying an algorithm to genotype information using information derived there from to determine the contribution various dog breeds to dog being tested. If that were all the claim covered, I think under Bilski and Prometheus a court would likely find the claim patent ineligible for embodying a fundamental principle. The fundamental principle might be characterized as an abstract idea, or as a natural phenomenon, either would work.

But the claim includes two elements that might be sufficient to render the claim patent eligible: (1) the step of genotyping a sample taken from the dog, and (2) the use of a "specifically programmed computer." In Prometheus, the Federal Circuit relied heavily on the machine or transformation test in arriving at the conclusion that the claims at issue in that case were patent eligible. I believe that even though the Supreme Court clarified in Bilski that the machine or transformation test is not the only test for patent eligibility, it did acknowledge that the test can be a useful and informative tool for assessing patent eligibility, and I predict that the Federal Circuit will continue to rely heavily on the machine or transformation test when faced with claims such as this, as it did in Prometheus.

Under Prometheus and Bilski, I think this one could come out either way. On the one hand, a court could find that genotyping is inherently transformative, because it necessarily involves physical manipulation of biological samples, in the same way that the step of "determining drug metabolite level” was found transformative in Prometheus, and sufficient to render the claim patent eligible. A court could also find that the use of a "specifically programmed computer" satisfies the machine prong of the machine or transformation test.

On the other hand, a court could characterize the genotyping step as mere data-gathering, i.e., "insubstantial extra-solution activity,” and thus ignore it in the analysis. This is what the Federal Circuit did in In re Grams, and as noted in my previous blog post the Federal Circuit explicitly held in Prometheus that Grams is still good law. In Prometheus, the Federal Circuit distinguish the two cases by pointing out that in Grams the focus of the invention is on the algorithm itself, and that the data-gathering step generically covered many different types of clinical diagnostic tests, whereas the Prometheus claims were targeted to specific drugs and specific diseases. The dog breed testing claim seems to fall somewhere in between. I think a court could go either way, by either stressing that the claim focuses on the algorithm and is not limited to any specific genotype or genetic test, in which case the claim is patent ineligible under Grams, or by stressing that the genotyping step is "central to the purpose" of the claim and thus sufficient to render the claim patent eligible under Prometheus.

Regarding the use of a computer, it is important to note that under In re Bilski the machine or transformation test requires the involvement of a "particular" machine, and many have speculated that a general-purpose computer would not satisfy this requirement of "particularity." Whoever drafted the dog breed testing claim wisely specified that the computer used in the method is "specifically programmed," but I'm not sure if that will be sufficient. A court could dismiss the "specifically programmed" language and find that the mere involvement of the computer does not satisfy the "particularity” aspect of the machine or transformation test.

Claim 35 is similar to claim 1, but instead of reciting the use of a computer, includes a step of "applying a computer-implemented statistical model.” This claim could be more vulnerable than claim 1, since it does not appear to explicitly recite the use of a particular machine.

There are also a number of dependent claims limited to specific SNP markers, specific dog breeds, etc., and these claims should face less of a threat of invalidation for lack of patent eligibility. Patent eligibility analysis often hinges on an assessment of whether the claim preempts all substantial practical uses of an abstract idea or natural phenomenon, so logically the narrower a claim is the more likely it is not preemptive, and thus patent eligible. Although in Bilski the Supreme Court apparently rejected this logic, because it held even relatively narrow dependent claims to be patent ineligible even though they clearly did not preempt all uses of risk hedging (the fundamental principle at issue in that case).

Claim 36 appears to be a Beauregard claim, a claim directed toward computer readable medium on which a computer program is inscribed. It would be interesting to see how this claim holds up, it is my understanding that the status of this sort of claim has not been entirely resolved post-Bilski, I saw some posts on this topic on Patently-O a while back.

36. A computer readable medium comprising stored thereon: (a) a data structure stored thereon for use in distinguishing canid populations, the data structure comprising: (i) a marker field, which is capable of storing the name of a marker or of an allele of the marker; and (ii) a genotype information field, which is capable of storing genotype information for the marker in a canid population, wherein a record comprises an instantiation of the marker field and an instantiation of the genotype information field and a set of records represents a canid population profile; and (b) computer-executable instructions for implementing a method for determining the contributions of canid populations to a canid genome, comprising: (i) obtaining the identity of one or both alleles in a test canid genome for each of a set of markers; and (ii) determining the contributions of canid populations to the test canid genome by comparing the alleles in the test canid genome to a database comprising canid population profiles, wherein each canid population profile comprises genotype information for the set of markers in the canid population.

Claim 37 seems even more problematic to me. I don't know that it can be called a Beauregard claim, it appears to basically be directed toward a computer readable medium on which a data structure is stored, which I am guessing is not the same thing as a computer program. I would be particularly interested in seeing how court deals with this claim.

37. A computer-readable medium comprising a data structure stored thereon for use in distinguishing canid populations, the data structure comprising: (a) a marker field, which is capable of storing the name of a marker or of an allele of the marker; and (b) a genotype information field, which is capable of storing genotype information for the marker in a canid population, wherein a record comprises an instantiation of the marker field and an instantiation of the genotype information field and a set of records represents a canid population profile, wherein the marker field comprises a set of markers indicative of the contributions of canid populations to the genome of a test canid.

2 comments:

Penny Stock Selections said...

If the so called conservative congress is so very concerned about excessive regulation of business than they ought to revamp the entire patent and tradmark system to make it harder for the holders of these patents and trademarke to sue for violations. Everybody pays for the legation one way or another. Many business are harmed by all of these unreasonable patents and trademarks. Consumers are forced to pay much higher prices for the patented and trademarked services and products than would otherwise be the case. Now the legation is starting to spread to products and services on the internet like a viris.

hermes birkin said...

Nice job. Very important issue. Thanks for sharing your views.