Summary of opinion

On Dec. 17, 2014, the U.S. Court of Appeals for the Federal Circuit decided In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, No. 2014-1361, -1366. At issue in this case are different patent claims of the same Myriad patents directed to BRCA1 and BRCA2 isolated gene sequences previously at issue in the Supreme Court and Federal Circuit cases Association for Molecular Pathology v. Myriad Genetics Corp. See 133 S.Ct. 2107, 2120 (2013); 689 F.3d 1303 (Fed. Cir. 2012); 653 F.3d 1329 (Fed. Cir. 2011). In the Supreme Court and prior Federal Circuit decisions, the courts considered patent eligibility under 35 U.S.C. § 101 of isolated DNA sequences and cDNA. Here, the Federal Circuit considered the patent eligibility under 35 U.S.C. § 101 of nucleotide primers and methods of use.

After the Supreme Court ruling in the prior Myriad cases, Ambry offered medical kits to test for the BRCA1 and BRCA2 genes. In re BRCA1, No. 2014-1361, slip op. at 4. Myriad sued Ambry for patent infringement and requested a preliminary injunction. The district court denied Myriad's motion, holding that Myriad was unlikely to succeed on the merits because the asserted claims, directed to primers and methods of use, are likely directed to patent-ineligible subject matter. Id. On appeal, the Federal Circuit considered the patent eligibility of "primer claims" and "method claims."

The "primer claims" at issue are directed to short, synthetic, single-stranded DNA molecules that bind specifically to an intended target sequence. Id. at 5. The Court held that those claims fall squarely within the Supreme Court's Myriad decision that "genes and information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material." Id. at 7 (internal citation omitted). The Court held that the claimed primers are structurally identical to DNA strands found in nature and, therefore, are not distinguishable from the isolated DNA found patent ineligible under Myriad. Id. at 7-8.

The second group of claims at issue, the "method claims," are directed to comparisons of wild-type BRCA sequences with a patient's BRCA sequences. Sidestepping the issue of whether the claims are directed to natural phenomena, the Court instead held that the claims are directed to abstract ideas and, therefore, are not patent eligible. Id. at 13.

The Federal Circuit affirmed the district court's denial of Myriad's request for preliminary injunction.

Background of the case

The dispute at issue arose in the aftermath of the Supreme Court's June 13, 2013 decision in Myriad, invalidating certain claims of Myriad's patents directed to isolated DNA sequences of the BRCA1 and BRCA2 genes. Shortly after the Supreme Court ruling, Ambry offered medical kits to test for BRCA1 and BRCA2 mutations. Id. at 1220.

On July 9, 2013, Myriad sued Ambry in the United States District Court for the District of Utah for patent infringement of 15 Myriad patents and requested a preliminary injunction. On March 10, 2014, the district court denied Myriad's motion for preliminary injunction and issued a 106-page opinion in support of its decision. In re BRCA1-, BRCA2-Based Hereditary Cancer Test Patent Litigation, 3F. Supp. 3d 1213 (D. Utah 2014). The district court denied the injunction and held that, although Myriad had shown it is likely to be irreparably harmed if the injunction is denied, Ambry had raised a "substantial question" regarding the validity of Myriad's patent claims under 35 U.S.C.§ 101. Id. at 1219-20.

The district court considered patent eligibility of "primer claims," i.e., composition of matter claims comprising BRCA1 and BRCA2 primers, in view of Myriad. The district court held that the primer claims at issue "although synthetically designed, seem [ ] not markedly different from naturally occurring DNA," and are not patent eligible under § 101. Id. at 1263 (internal quotations omitted). The district court therefore concluded that Ambry had raised a "substantial question" whether the primer claims are drawn to patent-ineligible subject matter.

The district court also considered the patent eligibility of the method claims in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc.,132 S.Ct 1289 (2012). Analyzing the claims under Mayo, the Court held that "the only inventive concepts of the method claims are the patent ineligible naturally occurring BRCA1 and BRCA2 sequences themselves. The claims contain no otherwise new process for designing or using probes, primers, or arrays beyond the use of BRCA1 or BRCA2 sequences in those processes." Id. at 1269 (internal citation omitted). The Court further concluded that if allowed, the method claims at issue would preempt or "essentially foreclose the most widely used means to study and test for BRCA1 and BRCA2 genes." Id. at 1270-71.Thus, the district court concluded that Ambry had raised a "substantial question" regarding the patent eligibility of the asserted method claims.

Patent eligibility of primers

In its review of the district court decision, the Federal Circuit considered the question of patent eligibility under 35 U.S.C. § 101 de novo. The Court considered two categories of claims: (1) "primer" claims directed to short, synthetic single-stranded DNA molecules that bind specifically to target nucleotide sequences; and (2) method claims involving comparisons of wild-type BRCA sequences to a patient's BRCA sequences. In re BRCA1, No. 2014-1361, slip op. at 5.

The primer claims at issue include claims 16 and 17 of U.S. Patent No. 5, 747,282 and claims 29 and 30 of U.S. Patent No. 5, 837,492. These claims relate to synthetic DNA sequences created to bind a target sequence of the BRCA gene and serve as a starting material for DNA polymerization.1

The Court conducted its analysis of patent eligibility under the Supreme Court's Myriad decision. The Court cited Myriad as holding that claims directed to isolated DNA molecules are not patent-eligible subject matter and quoted the Supreme Court's statement that "genes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material." Id. at 6-7 (internal citation omitted). The Court further cited Myriad as holding that cDNA -- isolated synthetically created DNA molecules containing only exons -- are patent eligible because human intervention "unquestionably creates something new when cDNA is made." Id. at 7 (internal citation omitted).

The Court held:

The primers before us are not distinguishable from the isolated DNA found patent-ineligible in Myriad and are not similar to the cDNA found to be patent-eligible. Primers necessarily contain the identical sequence of the BRCA sequence directly opposite to the strand to which they bind. They are structurally identical to the ends of DNA strands found in nature.

Id. at 7. In finding the primers similar to patent-ineligible isolated DNA and distinguishable from patenteligible cDNA, the Court rejected Myriad's arguments that primers are patent eligible because (1) single-stranded DNA is not found in the human body, and (2) primers have a fundamentally different function when extracted as compared to when they are part of a DNA strand. Id. at 7-9. The Court read Myriad as holding that "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. With respect to function, the Court found that synthetic primers do not perform a significantly different function as naturally occurring DNA. Id. at 9.

Broadly describing its position with respect to primers, the Court held 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. Primers do not have such a different structure and are patent ineligible." Id. at 9 (internal citations omitted).

Patent eligibility of methods using primers

The method claims at issue included claims 7 and 8 of U.S. Patent No. 5, 753,441; claim 4 of U.S. Patent No. 6, 033,857; claim 5 of U.S. Patent No. 6, 951,721 and claims 2 and 4 of U.S. Patent No. 5, 654,155.2 The method claims are directed to a method of screening for BRCA mutations by comparing a patient's BRCA gene sequence with wild type BRCA genes. Id. at 6.

In reaching its decision regarding the patentability of the method claims, the Court sidestepped the question of whether the claimed methods are directed to "natural phenomena." Id. at 12-13. Instead, the Court found it need not consider that question because the claims are directed to abstract ideas and are therefore patent ineligible under the recent Supreme Court decision Alice Corp. v. CLS Bank Int'l., 134 S. Ct. 2347 (2014). Id. at 13 (internal citation omitted).

The Court conducted the two-step analysis previously introduced in Mayo and reiterated in Alice. Under the first prong of the Alice test, the Court determined the method claims at issue recite "the patent-ineligible abstract idea of comparing BRCA sequences and determining the existence of alterations." Id. at 15. Under the second prong of Alice, the Court considered whether the remaining elements of the claim are sufficient to "transform the nature of the claim into a patent-eligible invention." Id. at 16 (internal citation omitted). The Court found that the non-patent-ineligible elements of the claims "do nothing more than spell out what practitioners already knew--how to compare gene sequences using routine, ordinary techniques." Id. at 17. Therefore, the Court held that because the other elements of the claims recited conventional, well-understood techniques, they "do not add 'enough' to make the claims as a whole patent-eligible." Id.

Conclusion

Following the Supreme Court decision in Myriad, the Federal Circuit arguably further narrowed the patent eligibility of biotech inventions. In contrast to the claims invalidated in Myriad, the primers at issue here are wholly synthetically-created DNA sequences not isolated from naturally occurring DNA. The decision has potentially far-reaching consequences on the patent eligibility of short syntheticallyproduced DNA sequences. Given the importance of this legal decision to the biotech industry, it is likely that the patentability of DNA sequences will continue to be a topic for judicial consideration. Myriad, however, appears unlikely to further appeal this decision, as it has reportedly settled or is currently negotiating settlement with companies accused of infringing its patents, including Ambry.3

Click here to read the Court's full decision.

The Intellectual Property Team

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1 The Court cited claim 16 of the '282 patent as representative of the "primer" claims: A pair of single-stranded primers for determination of a nucleotide sequence of a BRCA1 gene by a polymerase chain reaction, the sequence of said primers being derived from human chromosome 17q, wherein the use of said primers in a polymerase chain reaction results in the synthesis of DNA having all or part of the sequence of the BRCA1 gene. Id. at 6.

2 The Court cited claim 8 of the '441 patent as one of the representative method claims: A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject, wherein a germline nucleic acid sequence is compared by amplifying all or part of a BRCA1 gene from said sample using a set of primers to produce amplified nucleic acids and sequencing the amplified nucleic acids. Id. at 10-11.

3 Andrew Pollack, Myriad Genetics Ending Patent Dispute on Breast Cancer Risk Testing, N.Y. Times, Jan. 27, 2015.