Status Quo: The Federal Circuit Affirms Gene Patentability In Myriad

A 2-1 split panel of the Federal Circuit issued its decision today in the closely-watched Myriad case, Association for Molecular Pathology v. Myriad Genetics, Inc., __F.3d __ (Fed. Cir. 2012) (Lourie, J.).

Background of the Case

Myriad originated in the District Court of the Southern District of New York when a coalition of groups and individuals brought a declaratory judgment action against Myriad Genetics, Inc. (“Myriad”) and other parties over several U.S. patents with claims directed to products comprising and methods using the human breast cancer genes BRCA1 and BRCA2. Genetic tests from Myriad are available to determine if a person carries one of these mutations.

The patents at issue contain three types of claims:

1. Isolated DNA;
2. Methods of analyzing/comparing a patient’s BRCA gene with mutated versions; and
3. Method of screening cancer therapeutics

District Court Judge Robert W. Sweet issued a 156-page decision declaring the patents invalid. Judge Sweet stated that “DNA's existence in an ‘isolated’ form alters neither [the] fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore [claims directed to isolated DNA] are deemed unpatentable under 35 U.S.C. §101.” The decision also found that the method claims based on comparing DNA sequences were unpatentable as abstract mental processes.

The decision was appealed to the Federal Circuit, and a three-judge panel reversed the district court’s decision, finding that claims covering isolated DNA sequences are patent-eligible subject matter under 35 U.S.C. § 101. The court held that because the isolated DNA molecules are chemically cleaved from native DNA, they have markedly different characteristics and therefore do not fall within the products of nature exception to 35 U.S.C. § 101. The claims directed to methods of screening potential cancer therapeutics via changes in cell growth rates were also held to be valid. Conversely, the court ruled all other method claims invalid, alleging these method claims are directed to abstract mental processes.

The case was appealed to the Supreme Court, and while the petition for certiorari was pending, the Supreme Court issued its decision in Mayo Collaborative Services v. Prometheus Labs., Inc. (132 S. Ct. 1289, 101 U.S.P.Q.2d (BNA) 1961 (U.S. 2012)) (“Prometheus”), a decision squarely addressing patentability under 35 U.S.C. § 101.

In light of the Prometheus decision, the Supreme Court issued a “GVR” in the Myriad case, granting certiorari, vacating the Federal Circuit’s judgment, and remanding the case back to the Federal Circuit for further consideration in light of Prometheus.

Summary of the Law

Patent-eligible subject matter is specified in 35 U.S.C. § 101, which states “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent…”The Supreme Court has consistently construed 35 U.S.C. § 101 broadly.However, there are three judicially created exceptions to patent-eligibility, including laws of nature, natural phenomena, and abstract ideas.

The USPTO, the Federal Circuit, and the Supreme Court have struggled with establishing clear standards for determining patent-eligible subject matter. In the recent Supreme Court case Bilski v. Kappos the widely-used “machine or transformation test” was held to be merely a clue, and not the sole test, for determining eligibility under 35 U.S.C. § 101. 130 S. Ct. 3218, 561 US __ (2010). The Prometheus case provided some additional guidance for method claims, indicating that simply reciting well-known steps would be insufficient to transform the unpatentability of a natural law or abstract idea into patent-eligible subject matter.

However, the application of the Prometheus decision to biotechnology patents remained unclear, and was further muddied by the Supreme Court’s GVR decision inMyriad, which suggested that Prometheus may have implications for product claims as well.

Today’s Federal Circuit Decision

The holding of the split-panel’s 62-page decision remains the same as in the original appeal. In short, claims to isolated DNA are patent-eligible, the method for screening cancer therapeutics is patent-eligible, but methods directed to “comparing” or “analyzing” DNA sequences are not patent-eligible subject matter.

Isolated DNA:

The Federal Circuit stated that Prometheus does not apply to the isolated DNA claims (including both natural DNA sequences and cDNA sequences), and came to the same conclusion it did previously:

The principal claims of the patents before us on remand relate to isolated DNA molecules. [Prometheus]does not control the question of patent-eligibility of such claims. They are claims to compositions of matter, expressly authorized as suitable patent-eligible subject matter in § 101. As to those claims, the issue of patent-eligibility remains, as it was on the first appeal to this court, whether they claim patent-ineligible products of nature. We hold that they do not. The isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity. While they are prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decomposition, are made from natural materials.

Slip op. at 38-39.

The Court dismissed arguments based on Prometheus by distinguishing products of nature and laws of nature, pointing out that the Supreme Court’s concern that patents on particular subject matter (a cause and effect correlation in Prometheus) would preempt all other uses are inapplicable to Myriad. Specifically, although the Plaintiffs argued that they are preempted from using the patented DNA molecules, the Court stated “the answer to that concern is that permitting patents on isolated genes does not preempt a law of nature. A composition of matter is not a law of nature.” Slip op. at 51.

Last, the Court noted that thousands of patents claiming “isolated DNA” have been issued over the last 30 years, and “if the law is to be changed, and DNA inventions excluded from the broad scope of § 101, contrary to the settled expectation of the inventing and investing communities, the decision must come, not from the courts, but from Congress.” Slip op. at 54.

“Comparing” and “Analyzing” Methods:

The Court emphasized application of an abstract idea in a process may be patentable, but that upon properly reading the claims, “the step of comparing two DNA sequences is the entire process that is claimed.” Slip op. at 57. Thus, these claims are merely directed to an abstract idea. Myriad attempted to avoid this result by arguing that the claims should be interpreted to include additional transformative steps such as extracting the DNA and sequencing the DNA molecule. Slip op. at 58. However, the Court stated that since the claims do not explicitly include these steps, the claims are analogous (though even less descriptive) to those inPrometheus, where arguably transformative steps were not sufficiently transformative of what was otherwise a claim to a natural law, stating “that holding governs Myriad’s claims to methods of “comparing” and “analyzing” DNA sequences.” Slip op. at 59. Thus, these claims were held patent-ineligible under 35 U.S.C. § 101.

Method of Screening Cancer Therapeutics:

The Federal Circuit noted that the cells used in this method are not naturally occurring, but are “derived by altering a cell to include a foreign gene, resulting in a man-made, transformed cell with enhanced function and utility.” Slip op. at 60. Based on this transformation (and ostensibly relying on the machine or transformation test) the Court held thatthe claim includes more than the abstract mental step of looking at two numbers and “comparing” two host cells’ growth rates.

In considering the guidance of Prometheus, the Court determined that the method claim does more than “simply state the law of nature while adding the words ‘apply it’.” Whereas the Prometheus Court suggests that most well-known steps would be insufficient to confer patent-eligibility, the Federal Circuit noted that “it is rare that a new reaction or method is invented; much process activity is to make new compounds or products using established processes” and that “in situations where the objects or results of such steps are novel and nonobvious, they should be patent-eligible.” Slip op. at 61.

Additional Opinions

Judge Moore contributed a lengthy concurring opinion explaining her rationale underlying the patent-eligibility of isolated DNA sequences (although she agrees with the majority opinion in relation to isolated cDNA sequences).

Judge Bryson dissented with respect to gene and gene fragment claims, although agreed that cDNA is patent-eligible. The dissent is essentially based on the position that “Myriad is claiming the genes themselves, which appear in nature on the chromosomes of living human beings.” Slip op., dissent, at 6.

Furthermore, Judge Bryson would also extend the logic underlying the Prometheus decision to gene patents, alleging these types of claims lack inventiveness:

Just as a patent involving a law of nature must have an “inventive concept” that does “significantly more than simply describe . . . natural relations,” [Prometheus], 132 S. Ct. at 1294, 1297, a patent involving a product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product. In cases such as this one, in which the applicant claims a composition of matter that is nearly identical to a product of nature, it is appropriate to ask whether the applicant has done “enough” to distinguish his alleged invention from the similar product of nature.

Slip op., dissent, at 15.