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Isolated DNA Is Patent-Eligible Subject Matter Under 35 U.S.C. § 101

July 29, 2011

Decision icon Decision

Last Month at the Federal Circuit - August 2011

Judges: Lourie (author), Bryson (concurring-in-part and dissenting-in-part), Moore (concurring-in-part)

[Appealed from: S.D.N.Y., Senior Judge Sweet]

In Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, No. 10-1406 (Fed. Cir. July 29, 2011), the Federal Circuit held that composition claims to “isolated” DNA molecules are patentable subject matter, while method claims simply “comparing” or “analyzing” DNA sequences are not.

The plaintiffs, who include an assortment of medical organizations, researchers, genetic counselors, and patients (collectively “Association”), brought a DJ action against Myriad Genetics, Inc. (“Myriad”), challenging the patentability under 35 U.S.C. § 101 of certain composition and method claims in seven different patents directed to human genetics. The challenged composition claims cover two “isolated” human genes or DNA molecules, BRCA1 and BRCA2 (collectively “BRCA1/2”), and certain alterations in these genes associated with a predisposition to breast and ovarian cancers. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of the naturally occurring DNA molecule. All but one of the challenged method claims cover methods of “analyzing” or “comparing” a patient’s BRCA sequence with the normal sequence to identify the presence of cancer-predisposing alterations. The final method claim challenged is directed to a method of screening potential cancer therapeutics.

After the Association filed suit, Myriad moved to have the case dismissed, alleging that the Association did not have standing. The district court disagreed, finding that the plaintiffs had established Article III standing under the “all the circumstances” test. The parties moved for SJ on the merits of the § 101 challenge. The district court found that all the challenged claims were drawn to nonpatentable subject matter, and Myriad appealed.

The Federal Circuit first addressed the issue of whether the Association had standing. The Federal Circuit found that one plaintiff, researcher Dr. Harry Ostrer, had standing. Ostrer’s standing was based on two findings. First, Ostrer alleged an injury traceable to Myriad. This injury stemmed from Myriad’s demand for royalties under its patents from Ostrer at the same time Myriad was suing other, similarly situated parties for patent infringement. Second, Ostrer alleged a controversy of sufficient reality and immediacy. This was based on Ostrer’s intention and resources to undertake breast cancer diagnostic testing (that Myriad claimed required a license under its patents) if the patents are found invalid. While Myriad argued that its demand for licensing from Ostrer in 1998 was too far in the past to provide a controversy of sufficient reality and immediacy, the Federal Circuit found that the relevant circumstances had not changed despite the passage of time. Thus, although the Federal Circuit disagreed with the district court’s holding that all the plaintiffs had standing, having found one plaintiff with standing, the Court addressed the merits of the appeal, specifically, the validity of the claims under 35 U.S.C. § 101.

The Federal Circuit first addressed the § 101 challenge to Myriad’s composition claims directed to “isolated” DNA molecules. The Federal Circuit looked to Supreme Court precedent for the framework for deciding the patent eligibility of isolated DNA molecules. Specifically, “the Supreme Court has drawn a line between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given ‘markedly different,’ or ‘distinctive,’ characteristics.” Slip op. at 41. The Supreme Court found that the former remains a product of nature and is not patentable subject matter under § 101. Applying this test, the Federal Circuit found that the isolated BRCA1/2 claimed were “not the same molecules as DNA as it exists in the body; human intervention in cleaving or synthesizing a portion of a native chromosomal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA.” Id. at 42. The Federal Circuit distinguished the chemical cleaving required to obtain these isolated compositions from purification, i.e., a situation where a material existing in nature is purified from a physical mixture. The chemical differences between the isolated compositions and naturally occurring DNA were enough to satisfy the “markedly different” or “distinctive characteristic” tests, regardless of whether the two might have the same genetic information content, according to the Federal Circuit. “The ability to visualize a DNA molecule . . . when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable.” Id. at 45. Finally, the Federal Circuit noted that its decision that isolated DNA molecules are patentable comported with the long-standing practice of the PTO, and that any change to long-standing practice should come from Congress, not the courts.

Next, the Federal Circuit addressed the § 101 challenge to Myriad’s method claims. Regarding Myriad’s claims involving methods of “comparing” or “analyzing” sequences, the Federal Circuit found that these claimed only abstract mental processes and were not patentable subject matter under § 101. The claims in question recited, for example, a “method for screening a tumor sample” by “comparing” a first BRCA1 sequence from a tumor sample with a second BRCA1 sequence from a nontumor sample, wherein a difference in sequence indicates an alteration in the tumor sample. The Court found that this was nothing more than a recitation of “the abstract mental steps necessary to compare two different nucleotide sequences.” Id. at 50. The Court noted that while “the application of a formula or abstract idea in a process may describe patentable subject matter, Myriad’s claims do not apply the step of comparing two nucleotide sequences in a process. Rather, the step of comparing two DNA sequences is the entire process claimed.” Id. at 50-51 (citation omitted). This was distinguishable from a method claim upheld under § 101 where a “determining” step was both (1) transformative because it could not be completed by mere inspection, and (2) central to the purpose of the claims.

Regarding Myriad’s method claim directed to a method for screening potential cancer therapeutics via changes in cell growth rates, the Federal Circuit found that this was patentable subject matter under § 101. Stating that the machine-or-transformation test was an “important clue” to determining patent-eligible processes under Bilski, the Federal Circuit noted that the claim recited steps of “growing” transformed host cells, which was inherently transformative, and “determining” the growth rate of the host cells, which necessarily involved physical manipulation of the cells beyond a mere “comparing” step. These “growing” and “determining” steps were also central to the purpose of the process: assessing a compound’s potential as a cancer therapeutic. The Federal Circuit also emphasized that the claim was not so “manifestly abstract” that it would cover all cells, all compounds, or all methods of determining the therapeutic effect of a compound; “[r]ather, it is tied to specific host cells transformed with specific genes and grown in the presence or absence of a specific type of therapeutic. Moreover, the claim is tied to measuring a therapeutic effect on the cells solely by changes in the cells’ growth rate.” Id. at 54. Thus, the Federal Circuit found that this claim was patentable subject matter.

Judge Moore concurred with the majority with respect to the patentability of isolated DNA sequences (other than cDNA sequences) and joined the majority opinion with respect to all other issues. For her concurrence, Judge Moore relied heavily on the long-standing PTO precedent of allowing patents on isolated DNA sequences.

Judge Bryson dissented from the Court’s holding that isolated DNA was patentable, concurring with the rest of the Court’s opinion. Judge Bryson argued that the isolated DNA was not different from the native gene. Therefore, in Judge Bryson’s view, similar to the purification of a mineral, isolation of a DNA molecule would not be patent-eligible subject matter under § 101.

Summary authored by Troy A. Petersen, Esq.