The Federal Circuit Still Doesn't Get Diagnostic Claims

December 12, 2018 – Article

In Roche Diagnostics the Federal Circuit continued its failure to recognize that diagnostic claims were not patent ineligible because they used a natural law.  Roche involved claims detecting the Mycobacterium tuberculosis strains (MTB) quickly and accurately.  Prior to the invention delays often occurred in diagnosing tuberculosis because of the time necessary to detect its presence involved a three to eight week cell culture.  Roche discovered that the MTB strains could be quickly identified by identifying the presence of specific nucleotide sequence which functioned as a signature for the MTB.  The technique used to identify the presence or absence of the signature nucleotide was conventional PCR analysis.  The Federal Circuit affirmed a finding the diagnostic claims to be patent ineligible because the PCR technique was conventional and nucleotides naturally occurring.

The Federal Circuit described the diagnostic claim 1 as:

Claim 1 establishes that the method claims are directed to a relationship between the eleven naturally occurring position-specific signature nucleotides and the presence of MTB in a sample. In other words, the method claims assert that if an investigator detects a signature nucleotide from a sample, she knows the sample contains MTB.

Claim 1 read:

1. A method for detecting Mycobacterium tuberculosis in a biological sample suspected of containing M. tuberculosis comprising:

(a) subjecting DNA from the biological sample to polymerase chain reaction [PCR] using a plurality of primers under reaction conditions sufficient to simplify a portion of a M. tuberculosis rpoB [gene] to produce an amplification product, wherein the plurality of primers comprises at least one primer that hybridizes under hybridizing conditions to the amplified portion of the [gene] at a site comprising at least one position-specific M. tuberculosis signature nucleotide selected, with reference to FIG. 3 (SEQ ID NO: 1), from the group consisting a [List of nucleotides omitted]; and

(b) detecting the presence or absence of an amplification product, wherein the presence of an amplification product is indicative of the presence of M. tuberculosis in the biological sample and wherein the absence of the amplification product is indicative of the absence of M. tuberculosis in the biological sample.

’The Federal Circuit noted that the claim did not contain any inventive concept that transformed the eleven position-specific signatures into patent eligible subject matter. It focussed on the fact that neither the claims nor the specification made any improvement to the PCR process itself.  The Court considered the detecting step to be “a simple mental determination of the presence of MTB based on the presence or absence of PCR amplification product.”  The Court ignored the fact that it solved a significant problem with its discovery of the signature nucleotides. 

Once this discovery was made the solution was obvious, amplify and detect.  The Supreme Court long ago held that the discovery of the source of a problem made IRC’s solution patentable even though obvious once the source of the problem was known.  See Eibel Processing v. Minnesota & Ontario Paper Co., 261 U.S. 45 (1923) (Use of gravity to speed up flow of pulp)Here the concept was the discovery of the signature nucleotides and their use to identify a sample as containing MTB so that treatment could begin quickly.  This makes the use of the “obvious” PCR method an inventive concept in the context of the claimed subject matter.  That is, the claim involves the use of the natural law to solve a problem not unlike Eibel’s use of gravity.  The Supreme Court noted in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 6671, 72 (2012) that:

It [Diehr] added that “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” Diehr, supra, at 187, 101 S.Ct. 1048. And it emphasized Justice Stone's similar observation in Mackay Radio & Telegraph Co. v. Radio Corp. of America, 306 U.S. 86,

59 S.Ct. 427, 83 L.Ed. 506 (1939):
“ ‘While a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.’ “ 450 U.S., at 188, 101 S.Ct. 1048 (quoting Mackay Radio, supra, at 94, 59 S.Ct. 427).

Here there can be no doubt that a useful process for detecting MTB was created using a previously unknown natural law coupled with the known PCR process, a concept the Supreme Court has recognized may be patent eligible.

When will the Federal Circuit consider the policy expressed the Supreme Court over many decades that the application of a law of nature is patent eligible?