Federal Circuit Reaffirms Patent Eligibility of Isolated Human Genes
By Jie Zhang – Edited by Jeffery Habenicht
Ass’n for Molecular Pathology v. USPTO, No. 2010-1406 (Fed. Cir. Aug. 16, 2012)
The Federal Circuit, on remand from the Supreme Court in light of the Court’s decision in Mayo Collaborative Servs. v. Prometheus Labs., affirmed in part and reversed in part a decision by the Southern District of New York, which had held that isolated breast cancer genes and a screening method based on such genes were non-patentable.
The Federal Circuit affirmed the district court’s ruling that it had jurisdiction to hear the declaratory judgment case, finding that at least one plaintiff had standing to challenge Myriad’s patents. On the merits, the Federal Circuit reversed the district court and reiterated its prior holding that isolated genes were patent eligible because they were compositions of matter sufficiently different from the naturally occurring genes. The court also found that the method to screen therapeutics based on the growth rate of cells containing mutated genes was patentable as it included transformative steps and was more than a restatement of the law of nature. However, the court affirmed the district court’s holding that the method to compare gene sequences was non-patentable because it involved only abstract mental steps.
JOLT Digest previously covered both this case and Prometheus. Reuters provides an overview of the case and reports on reactions of the scientific community and the biotech industry. Patently-O criticizes the court’s analysis for ignoring the impact of Prometheus and predicts an en banc rehearing or a grant of certiorari by the Supreme Court.
The challenged patents concern two human genes, BRCA1 and BRCA2. Certain mutations in these genes correlate with an increased risk of breast and ovarian cancers, and isolating and analyzing these genes from patients could play a significant role in cancer diagnosis and treatment. Myriad patented the isolated BRCA genes, the method of screening potential cancer therapeutics by analyzing the growth rate of cells containing the mutated BRCA genes, and the method of comparing a patient’s BRCA gene with the normal sequence.
Researchers and patients who were unable to engage in BRCA-based testing sued Myriad, seeking a declaratory judgment that Myriad’s patents were invalid. The district court found both the composition and the method claims to be non-patentable subject matter under 35 U.S.C. § 101 because the genes were products of nature. The Federal Circuit, however, reversed with respect to the composition and the screening method claims in an opinion issued in July 2011. The Supreme Court granted certiorari, vacated the Federal Circuit’s decision, and remanded for further consideration in light of Prometheus, which held that the use of a certain correlation to determine drug dosages because the correlation was a law of nature and thus not patent eligible under § 101.
Writing for the majority, Judge Lourie stated that Prometheus, which concerned method claims, did not control the patent eligibility of composition claims. Rather, the test remained whether the isolated DNA fragments were simply products of nature—which are not patent eligible. Judge Lourie concluded that, although the isolated genes were purified from natural materials, they were markedly different from the genes in their native states as they were chemically cleaved and not organized in a complex chromosomal structure.
Judge Moore concurred in the judgment upholding the patent eligibility of the composition claims but rested her conclusion on a different rationale. Judge Moore stated that chemical changes alone were not sufficient to support patent eligibility. Instead, Judge Moore reasoned that the new and important utility of isolated DNA was key to its patentability.
Judge Bryson dissented with respect to the composition claims, finding that isolated DNA fragments were not patentable. He reasoned that the breaking of chemical bonds incidental to the extraction of DNA fragments did not render them materially different from native genes as they contained the same genetic information. Drawing an analogy to Prometheus, Judge Bryson noted that the isolated DNA was so similar to a product of nature that there was not enough inventive contribution made by Myriad.
The Federal Circuit’s opinion makes a distinction between the law of nature exclusion in method claims and the product of nature test in composition of matter claims. Despite the Supreme Court’s effort to use § 101 to police overly broad patent claims in Prometheus (and earlier in Bilski v. Kappos, No. 08-964 (U.S. June 28, 2010), as reported by the Digest), the Federal Circuit continues to construe §101 patentable subject matter broadly.