The Federal Circuit has again rejected patent claims relating to DNA sequences and methods of screening, holding that the claims are not eligible for patent protection. In 2013, the Supreme Court significantly limited the scope of patent protection available to inventions directed to DNA and information encoded in human genes. The Federal Circuit’s recent decision extends the Supreme Court’s holding to even more classes of DNA-related patents, including DNA primers. In re BRCA1– and BRCA2-Based Hereditary Cancer Test Patent Litigation (Fed. Cir. Dec. 17, 2014).
In the 1990s, Myriad Genetics discovered the precise location and sequence of two genes: BRCA1 and BRCA2, mutations of which were strongly associated with breast and ovarian cancer. Following that discovery, Myriad obtained patents related to the BRCA1/2 genes.
In 2013, the Supreme Court invalidated claims from three Myriad patents. Association for Molecular Pathology v. Myriad, 133 S.Ct. 2107 (2013). The Court found Myriad’s claims to a “composition” of DNA isolated from a BRCA1/2 genes were not directed to patentable subject matter because the DNA sequences were naturally occurring. However, the Court held that certain claims to cDNA – complementary DNA – were patentable because cDNA is synthetically derived from natural genes to contain only the “exons,” or the portions of the genes actually expressed as proteins. The Court explained that, except for very small DNA sequences containing only exons, cDNA never exists in nature and therefore a technician “unquestionably creates something new when cDNA is made.” Id. at 1220.
Following the Supreme Court’s decision, several companies, including Ambry Genetics, began manufacturing genetic tests to detect mutations in the BRCA1/2 genes. Myriad filed suit to stop Ambry, alleging infringement of claims from 15 patents, including patents involved in the previous Myriad case decided by the Supreme Court.
The Federal Circuit examined two groups of claims from the asserted patents to determine whether the claims were directed to patent-eligible subject matter. The first group claimed DNA primers – small synthetic DNA sequences used in the artificial replication of DNA. The second group claimed methods for screening a sample for BRCA1/2 mutations. The Federal Circuit held that neither set of claims recited patentable subject matter.
The Federal Circuit held that DNA primers are not patentable subject matter. The court found that DNA primers are not distinguishable from the isolated DNA the Supreme Court previously found to be not patentable. Even though DNA primers typically differ from naturally occurring DNA, in that they are very short, synthetically manufactured and single-stranded, the court held that they are still products of nature and are not patent eligible. “Primers necessarily contain the identical sequence of the BRCA sequence directly opposite to the strand to which they are designed to bind. They are structurally identical to the ends of DNA strands found in nature.” In re BRCA1/2 at *7.
Myriad attempted to argue that DNA primers perform a very different function from naturally occurring genetic information because of their role in artificial DNA replication, but the Federal Circuit disagreed. One of the primary functions of DNA, according to the court, is to bind to complementary sequences, and this is exactly the way primers are used. “Thus, just as in nature, primers utilize the innate ability of DNA to bind to itself.” Id. at *9.
The court concluded that a patent eligible DNA structure must have a unique structure, different from structures found in nature:
We do not read the Supreme Court’s opinion in Myriad as conferring patent eligibility on composition of matter claims directed to naturally occurring DNA strands under such circumstances. 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.
The Federal Circuit has extended the Supreme Court’s Myriad decision to find DNA primers unpatentable. Although DNA primers may function differently in the laboratory than in nature, the court focused on the structure of the DNA as the key to patentability.
The Federal Circuit also found Myriad’s screening method claims to be unpatentable based on the Supreme Court’s recent Alice decision. Id. at *13 (citing to Alice Corp. v. CLS Bank International, 134 S.Ct. 2347 (2014)). Using the Supreme Court’s two-step analysis in Alice, the Federal Circuit first held that the screening claims are “directed to the patent-ineligible abstract idea of comparing BRCA sequences and determining the existence of alterations.” Next, the court looked to see whether the remaining claim elements were sufficient to “transform the nature of the claim into a patent-eligible application,” and found they were not. The remaining claim elements merely set forth well-understood and routine methods used by scientists to compare two gene sequences:
The [remaining claim elements] do nothing more than spell out what practitioners already knew—how to compare gene sequences using routine, ordinary techniques. 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.
Id. at *17. These routine and conventional steps cannot help make an abstract concept patent eligible. Accordingly, the Federal Circuit held the claims ineligible for patent protection.
Patent practitioners should look to Myriad and In re BRCA1/2 for guidance when determining whether genetic information or methods of genetic testing claim patentable subject matter. The Federal Circuit continues to endorse the patentability of specific DNA sequences that are not known to exist in nature. Naturally occurring sequences, regardless of their intended use or function, are likely to face strong challenges in the courts and in the Patent Office. Practitioners should also be aware that the Supreme Court’s subject matter eligibility test from Alice will be applied to method claims in biotechnology patents, particularly methods for genetic testing.