January 2015

Synthesized DNA Primers Identical to Natural DNA and Conventional Methods of Comparing DNA Sequences Are Patent Ineligible
Yieyie Yang

In In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation, Nos. 14-1361, -1366
(Fed. Cir. Dec. 17, 2014), the Federal Circuit held that the claims were directed to patent-ineligible subject matter, affirmed the district court’s denial of Myriad Genetics, Inc.’s (“Myriad”) motion for preliminary injunction, and remanded for further proceedings.

Myriad owns U.S. Patent Nos. 5,753,441 (“the ’441 patent”); 5,747,282 (“the ’282 patent”); and 5,837,492 (“the ’492 patent”).  Myriad sued Ambry Genetics Corporation (“Ambry”), alleging patent infringement of numerous claims, six of which were at issue in the appeal, and requesting a preliminary injunction.  Four of the six claims on appeal are directed to DNA primers, which are “short, synthetic, single-stranded DNA molecule[s] that bind[] specifically to . . . intended target nucleotide sequence[s]” (“the primer claims”).  Slip op. at 5 (alterations in original) (citation omitted).  The remaining two claims are method claims reciting comparisons of the wild-type BRCA sequences with the patient’s BRCA sequences. 

The district court found the primer claims were not patent eligible under 35 U.S.C. § 101 because they claim products of nature, and also found that the two method claims were not patent eligible because they recited conventional activities that were well understood and uniformly employed when the patents were filed.  Myriad appealed.

“Nothing is added by identifying the techniques to be used in making the comparison because those comparison techniques were the well-understood, routine, and conventional techniques that a scientist would have thought of when instructed to compare two gene sequences.”  Slip op. at 17.

On appeal, the Federal Circuit first considered the primer claims.  Relying on the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (“Myriad”), the Court explained that isolated DNA was not patent eligible, but to “the extent that” a DNA sequence “does not exist in nature, the lab technician ‘unquestionably creates something new . . . .’” 
Slip op. at 7 (quoting Myriad, 133 S. Ct. at 2119).  Against this framework, the Court determined that the claimed primers “are not distinguishable from the isolated DNA found patent-ineligible in Myriad,” and that they “necessarily contain the identical sequence of the BRCA sequence directly opposite to the strand to which they are designed to bind.”  Id.  The Court then concluded that the claimed primers were “structurally identical to the ends of DNA strands found in nature.”  Id.

The Court then considered and rejected Myriad’s arguments that the primer claims should be patent eligible.  The Court first rejected Myriad’s position that the identified gene sequences were synthetically replicated rather than naturally occurring.   According to the Court, “neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.”  Id. at 8.  The Court next rejected Myriad’s position that the primers were not naturally occurring because single-stranded DNA cannot be found in the human body, explaining that separating DNA from the surrounding material does not render the claims patent eligible.  The Court analogized the primer claims to its decision in In re Roslin Institute (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014), which held a genetic copy of a cloned sheep patent ineligible because it was an exact copy of a naturally occurring organism.  The Court then considered and rejected Myriad’s position that the extracted primers “have a fundamentally different function than when they are part of the DNA strand,” explaining that the natural DNA performed a similar function to bind to complementary nucleotide sequences.  Slip op. at 9.  The Court concluded that 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.”  Id.  The Court thus held that primers did not have such a different structure and were therefore patent ineligible.

Turning next to the method claims, the Court declined to “decide if Mayo [Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012),] is directly on point,” and instead applied the Supreme Court’s abstract idea test from Alice Corp. v. CLS Bank International, 134 S. Ct. 2347, 2355 (2014).  Slip op. at 13.  The Court noted that, in a prior decision related to the ’441 patent, it held that the sequence comparison recited in claim 1, from which the method claims on appeal depend, was patent ineligible for claiming an abstract mental process of “comparing” and “analyzing” two gene sequences.  Id. at 14-15.  The Court explained that the method claims on appeal are “directed to the patent-ineligible abstract idea of comparing BRCA sequences and determining the existence of alterations,” which “require merely comparing the patient’s gene with the wild-type [sequences] and identifying any differences that arise.”  Id. at 15.  The Court also explained that the number of comparisons was unlimited and would cover “yet-undiscovered alterations” and alterations for purposes other than those described in the ’441 patent.  Id.  The Court expressed concern that “allowing a patent on the comparison step could impede a great swath of research relating to the BRCA genes, and . . . allow these basic building blocks of scientific research to be monopolized.”  Id. at 15-16.  The Court thus concluded that the method claims were directed to unpatentable abstract ideas. 

Next, the Court considered whether the remaining elements of the method claims “‘transform the nature of the claim’ into a patent-eligible application.”  Id. at 16 (quoting Alice, 134 S. Ct. at 2355).  Although the Court identified several techniques recited in each of the method claims, it determined that they did not add “enough” to make the claims patent eligible because the recited techniques were the well-understood, routine, and conventional techniques at the time of the applications.  In reaching this conclusion, the Court noted that “Myriad [did] not challenge the district court’s finding that ‘the claims contain no otherwise new process for designing or using probes, primers, or arrays beyond the use of the BRCA1 and BRCA2 sequences in those processes.’”  Id. at 17 (citation omitted).

The Court also rejected Myriad’s argument that the method claims should be patent eligible because they are similar to a claim that Judge Bryson suggested was patent eligible in an earlier opinion.  The Court explained, however, that the method claims “are significantly broader and more abstract” than the claim discussed by Judge Bryson while also declining to express an opinion of the patentability of the claim discussed by Judge Bryson.  Id. at 19.  The Court then held that the method claims recited only routine and conventional steps, and are therefore directed to patent-ineligible subject matter under § 101.