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Roche Molecular Systems Inc. v. Cepheid

Representative Claim(s)

Primer Claims (claims 17-20):

  1. A primer having 14-50 nucleotides that hybridizes under hybridizing conditions to an M. tuberculosis rpoB [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 of [the same 11 nucleotides at the positions disclosed in claim 1].

Method Claims (claims 1-13):

  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 using a plurality of primers under reaction conditions sufficient to simplify a portion of a M. tuberculosis rpoB gone 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 gone at a site comprising at least one position-specific M. tuberculosis signature nucleotide selected, with reference to FIG. 3 (SEQ D NO:1), from the group consisting

a G at nucleotide position 2312,

a T at nucleotide position 2313,

an A at nucleotide position 2373,

a G at nucleotide position 2374,

an A at nucleotide position 2378,

a G at nucleotide position 2408,

a T at nucleotide position 2409,

an A at nucleotide position 2426,

a G at nucleotide position 2441,

an A at nucleotide position 2456, and

a T at nucleotide position 2465; 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.

Posture:

Appeal from Northern District of California Grant of Summary Judgment

Exception Category: Natural Phenomenon

Natural Phenomenon (primer claims 17-20)

The Court cited In re BRCA1 in holding the claimed primers patent-ineligible:

As this court found in BRCA1, “[p]rimers necessarily contain the identical sequence of the [nucleotide] sequence directly opposite to the [DNA] strand to which they are designed to bind. They are structurally identical to the ends of DNA strands found in nature.” 774 F.3d at 760.

Roche Molecular Sys. v. Cepheid, 905 F.3d 1363, 1369 (2018).The court further held:

A DNA structure with a function similar to that found in nature can only be patent eligible as a composition of matter if it has a unique structure, different from anything found in nature. Myriad, 133 S. Ct. at 2116-17. Primers do not have such a different structure and are patent ineligible. Id. at 761 (citation omitted).

Id.  Further,

[…] the subject matter eligibility inquiry of primer claims hinges on comparing a claimed primer to its corresponding DNA segment on the chromosome—not the whole chromosome. 774 F.3d at 760-61 (emphasizing the appropriate comparison being between the primers and “the relevant portion of the naturally occurring sequence” (emphasis added)).

905 F.3d at 1370. Therefore, “at Alice/ Mayo step one, we find that the asserted primers are indistinguishable from naturally occurring DNA and that the primer claims are directed to a natural phenomenon.”  Id.

With respect to Alice/ Mayo step two [arguments made by Roche]:

[a] primer that is otherwise patent-ineligible does not gain subject matter eligibility simply because it can selectively hybridize to a certain position of naturally occurring DNA, because a primer having an identical nucleotide sequence to naturally occurring DNA without further chemical modification is a natural phenomenon. See BRCA1, 774 F.3d at 760. Here, the primers before us have no further chemical modification.

Id.

 

Naturally Occurring Phenomenon (method claims 1-13)

The Court, analyzing for Alice/Mayo step one, found that the method of

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. This relationship between the signature nucleotides and MTB is a phenomenon that exists in nature apart from any human action, meaning the method claims are directed to a natural phenomenon, which itself is ineligible for patenting.

Roche Molecular Sys. v. Cepheid, 905 F.3d 1363, 1371 (2018). With respect to Alice/Mayo step two, the Court found that neither the amplification step nor the detection step of Claim 1 transforms the claim into patent-eligible subject matter:

The district court found, and Roche does not challenge, that the background techniques of PCR amplification and detection were routine when the patent application was filed in 1994.

[…]

The detecting step of claim 1 is similarly devoid of an inventive concept because it involves a simple mental determination of the presence of MTB based on the presence or absence of a PCR amplification product.

905 F.3d 1363, 1372 (2018) (citations omitted).  Further, the Court distinguished from CellzDirect:

Unlike the method claims of the ʼ723 patent, the invention in CellzDirect went beyond applying a known laboratory technique to a newly discovered natural phenomenon, and instead created an entirely new laboratory technique that “is not simply an observation or detection” based on the natural phenomenon. Id. (emphasis added). In contrast, the ʼ723 patent claims a method of detection based on a natural phenomenon and employs only conventional, well-known laboratory techniques, which are the opposite of those at issue in CellzDirect.

Id. at 1373.