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Federal Circuit Upholds Patentability Of Isolated Genes
By Albert Wang – Edited by Kassity Liu

Ass’n for Molecular Pathology v. USPTO, No. 2010-1406 (Fed. Cir. July 29, 2011)
Slip Opinion

The Federal Circuit reversed the United States District Court for the Southern District of New York on the issues of whether Myriad’s patent claims regarding the BRCA gene and BRCA screening were valid. The Circuit affirmed on the issues of standing and patentability of Myriad’s method of comparing DNA sequences.

Judge Lourie, writing for the Circuit, reasoned that the isolated BRCA gene was chemically different from the gene in its naturally occurring state. Similarly, Myriad’s patient-screening included enough transformation to be patent-eligible.

PatentlyO provides an overview of the case. Genomics Law Report provides further analysis and predicts further uncertainty to come with regard to gene patents, noting that the decision only curtails attacks based on patentability of the subject matter. PharmaPatents criticizes the court’s distinction between isolated DNA and other products extracted from nature. The Digest previously covered the district court’s decision

The patent claims at issue cover two human genes, BRCA1 and BRCA2 (collectively BRCA), which have been isolated from native DNA. Certain mutations in the BRCA gene are a predictor of breast and ovarian cancer, and thus a patient can be screened for these cancers by comparing her BRCA gene with a control. Myriad was the first to patent this diagnostic process, and has enforced its patent to prevent other entities from providing BRCA screening to women.

The plaintiffs sued for a declaratory judgment invalidating Myriad’s patents in the BRCA gene, the BRCA diagnostic process, and Myriad’s process of comparing DNA sequences. The district court held for the plaintiffs, finding Myriad’s patents drawn to non-patentable subject matter and thus invalid.

The Federal Circuit affirmed the district court on standing as Dr. Ostrer, who alleged that Myriad’s patent enforcement measures forced him to cease his BRCA-related clinical activities. The court found that Dr. Ostrer not only alleged an actual and concrete injury but would also immediately start providing BRCA testing upon a favorable judgment. Slip op. at 29-30.

The Federal Circuit reversed the district court on the patentability of the isolated BRCA gene. In doing so, it rejected the Department of Justice’s proposed “magic microscope” test, which would allow patentability of manmade DNA sequences, but not those that could be found in nature by “focus[ing] in” on live DNA inside the body. Id. at 38. The Digest previously covered the DOJ’s theory on gene patentability.

Rejecting the plaintiffs’ comparison to a “purifying” process, the court concluded that the BRCA gene as it appears in nature was not the same as the BRCA gene as isolated by Myriad. Even though the same peptide sequence appeared in both, the two molecules were chemically different entities. The court also cited the PTO’s long-standing policy in favor of the patentability of isolated DNA and other natural products. Id. at 48.

Lastly, the Federal Circuit affirmed the district court on the patentability of “comparing” gene sequences, holding mere comparison to be an “abstract mental process[]” not amenable to patent. Id. at 50. However, the court reversed the district court on the patentability of Myriad’s BRCA screening method. Myriad’s screening method involved not only abstract inspection, but also “growing” transformed cells and other transformative steps. Under Bilski v. Kappos, 130 S.Ct. 3218, 3227 (2010), such artificial transformation is an “important clue” as to patentability. Id. at 53.

Judge Moore concurred, but noted that a DNA sequence taken as a whole might be potentially less amenable to patent protection. Though chemically different from its naturally occurring counterpart, she noted that the sequence does not add any “new utility” over and above the “ends devised by nature. . . .” Slip op., concurrence, at 18 (Moore, J., concurring.) However, like the majority, she ultimately deferred to the PTO’s established practice.

Judge Bryson dissented regarding the patentability of the BRCA gene claims. While acknowledging the chemical manipulation necessary to separate out the BRCA gene, he argued that such an “incidental” change could not render the BRCA gene “materially different” or a product of invention. Slip op., dissent, at 6 (Bryson, J., dissenting). In the dissent’s view, there is nothing magical about a covalent bond; chemically excising the BRCA gene from its surrounding DNA is no more patentable than refining lithium or snapping a leaf from a tree. Id. at 7.

On its face, the Federal Circuit’s opinion reduces uncertainty by leaving most of Myriad’s patents undisturbed. However, as the dissent points out, it does so at the cost of enshrining covalent bonds over other atomic or molecular forces as a trigger for the machine-or-transformation test. It remains an open question, one that may be tested by litigation in the future, exactly which chemical changes will be enough to bring an isolation process within the realm of patent.

Posted On Aug - 12 - 2011 Comments Off

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