United States: Methods Exploiting Junk DNA May Be Useful But Lack Patent Eligibility

Striking another blow against patent eligibility in the field of biotechnology, the Federal Circuit agreed with the district court that methods that use “junk DNA” to detect genetic variations lack patent eligibility under 35 USC § 101. Although Judge Dyk found the claims at issue to be similar to claims held invalid in other Federal Circuit decisions, the finding in Genetic Technologies Ltd. v. Merial LLC  seems to go one step further down the road of ineligibility.

The Patent At Issue

The patent at issue was GTG’s U.S. Patent No. 5,612,179. The court focused on claim 1:

1. A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising:
a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and
b) analyzing the amplified DNA sequence to detect the allele.

As explained by the Federal Circuit, the method was based on the discovery “that certain DNA sequences in coding regions (exons) of certain genes are correlated with … non-coding regions … that are not part of any gene,” i.e., "junk DNA." Thus, “alleles of a particular gene may be detected … by amplifying and analyzing non-coding regions known to be linked to the coding region.” According to GTG, the method permits the use of shorter sequences which are more amenable to amplification and analysis.

This article by Matthew Rimmer provides an interesting look at this technology, GTG’s licensing practices, and related controversies.

The district court held the ‘179 patent invalid on motions to dismiss, applying the two-step Mayo/Alice test for assessing patent eligibility under § 101. GTG appealed.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Dyk and joined by Chief Judge Prost and Judge Taranto.

The Federal Circuit first approved the practice of assessing patent eligibility on a Rule 12(b)(6) motion, without undertaking “a formal claim construction.” The court then applied what it refers to as the “now well-established two-step test for patent eligibility,” i.e., the two-step Mayo/Alice test.

  1. “We begin at step one of the Mayo/Alice test and ask first whether claim 1 is directed to a patent-ineligible concept—e.g., a law of nature, natural phenomenon, or abstract idea. …. We find that it is. Claim 1 is directed to the relationship between non-coding and coding sequences … and the tendency of such non-coding DNA sequences to be representative of the linked coding sequences—a law of nature.
  2. “At step two …. ‘we must examine the elements of the claim to determine whether it contains an inventive concept sufficient to transform the claimed abstract idea [or law of nature] into a patent-eligible application.’ …. [T]he physical steps of DNA amplification and analysis of the amplified DNA … do not, individually or in combination, provide sufficient inventive concept to render claim 1 patent eligible.”

The Federal Circuit rejected GTG’s arguments that the use of junk DNA to detect a coding region allele amounted to “something more” eligible for a patent, focusing on the mental aspect of that feature:

The term "to detect the allele" (in the sense of examining the non-coding region to detect an allele in the coding region) is a mental process step, one that provides claim 1 with a purpose but does not create the requisite inventive concept, because it merely sets forth a routine comparison that can be performed by the human mind.

Thus, the Federal Circuit affirmed the district court decision and awarded costs to the appellees.

Similar But Different

Judge Dyk explains how the method at issue is similar to those invalidated in Mayo, Sequenom, and In re BRCA1- & BRCA2-Based Hereditary Cancer Test, but I think it is different enough that this decision takes patent eligibility jurisprudence a step further. Indeed, when I wrote about the district court decision, I outlined ways in which Judge Stark may have gone astray. I stand by those points, and raise an additional one here.

In Myriad, the Supreme Court told us that “[h]ad Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent.” In invalidating Myriad’s DNA claims, the Court emphasized that “the processes used by Myriad to isolate DNA … ‘were well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach,.'”

Here, GTG did claim an “innovative method” of detecting a coding region allele, and the method at issue was not being used by “any scientist engaged in the search for a gene.” In his opinion, Judge Dyk appears to limit the Supreme Court guidance pertaining to “new” methods to methods that use new “physical” laboratory techniques.

A New Machine-Or-Transformation Test?

Another comment in Judge Dyk’s opinion that caught my mind is this one:

The product of the method of claim 1 is information ….

In drawing parallels to previous § 101 decisions, Judge Dyk states that the method claims at issue in Mayo, Sequenom and here all relate to “allegedly newly discovered information about human biology,” and resulted in obtaning information.

Is Judge Dyk saying that methods that do not result in a new physical product are not patent eligible? Are we back to the future with a more stringent “machine or transformation” test? Is the state of § 101 jurisprudence such that methods that use a new machine or that result in a new product can be patented, as long as the new product does not merely embody new information that is the real “concern” of the claimed method? Is that a test for patent eligibility that the diagnostic method industry could live with?

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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