Federal Circuit Renders Decision in “Gene Patenting” Case: Claims To Isolated DNA And Drug-Screening Method Claims Remain Patent Eligible, While Certain Diagnostic Method Claims Are Not Patentable Subject Matter

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On August 16, 2012, the Federal Circuit once again held that claims to isolated DNA are within the purview of 35
U.S.C. § 101 (“§ 101”), which defines subject matter that is eligible for patent protection. This decision (Ass’n for
Molecular Pathology et al. v. USPTO and Myriad Genetics, Inc., et al.), informally known as the “gene patenting” case, also held that § 101 confers patent eligibility for certain drug-screening methods, while methods consisting of “analyzing and comparing certain DNA sequences” are outside the scope of patent protection.

Notwithstanding the import of this decision with respect to the interests of biotech companies and research
institutions alike, this case has received its share of media attention due to its controversial nature and
the underlying policy concerns regarding the availability of breast/ovarian cancer screening. To this end, the opinion explicitly detailed at the outset that it was important to delimit “what this appeal is not about.” The Federal Circuit explained that questions about the propriety of an individual’s desire to obtain breast cancer susceptibility information, in concert with whether exclusionary rights should be afforded to owners of patents directed to life saving medical tests, were not before the court.

The focal questions that were before the court concerned whether claims to (i) isolated DNA, (ii) drug-screening
methods, and (iii) analytical diagnostic methods fall within the judicially created “products of nature” exception to § 101 eligibility. These questions were posed to the Federal Circuit on remand from the Supreme Court in view of their March 20, 2012 decision in Mayo Collaborative Services v. Prometheus, Inc. (holding that certain methods
involving laws of nature, natural phenomena, or naturally occurring correlations are not patent eligible). In answering these questions, each member of the three judge panel issued separate opinions, with the opinion of the court filed by Judge Lourie. The decision largely follows the decision previously released by the same panel on July 29, 2011, following an appeal from the March 29, 2010 decision of the U.S. District Court for the Southern District of New York that invalidated claims in seven Myriad patents.

After determining that at least one plaintiff had standing, the majority explained that claims to isolated DNA impart the process of removing DNA from the human body, which therefore creates “a new chemical entity” via “human transformation, requiring skill, knowledge, and effort.” Citing Supreme Court precedent as setting forth a “markedly different test” for distinguishing between patent eligible compositions and ineligible products of nature, theFederal Circuit outlined that:

[i]t is undisputed that Myriad’s claimed isolated DNAs exist in a distinctive chemical form—as distinctive chemical molecules—from DNAs in the human body, i.e., native DNA. Natural DNA exists in the body as one of forty-six large, contiguous DNA molecules. Each of those DNA molecules is condensed and intertwined with various proteins, including histones, to form a complex tertiary structure known as chromatin that makes up a larger structural complex, a chromosome …. Isolated DNA, in contrast, is a free-standing portion of a larger, natural DNA molecule. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule.


Accordingly, BRCA1 and BRCA2 in their isolated states are different molecules from DNA that exists in the body; isolated DNA results from human intervention to cleave or synthesize a discrete portion of a native  chromosomal DNA, imparting on that isolated DNA a distinctive chemical identity as compared to native DNA.

Concerning the applicability of Mayo to the isolated DNA claims, the Federal Circuit noted that the “Supreme Court
in Mayo focused on its concern that permitting patents on particular subject matter would prevent use by others of, in Mayo, the correlation recited in the method claims.” While, in the present case, the plaintiffs argued that they were “preempted” from using the patented sequences, the court responded by explaining that patents directed to isolated genes do not preempt a law of nature. According to the court, “[a] composition of matter is not a law of nature.” Within this context, the majority decision disregards Mayo insofar as the “principal claims of the patents before us on remand relate to isolated DNA molecules[, and therefore] Mayo does not control.” As noted above, claims directed to isolated DNA were consequently found to be patentable subject matter.

The Mayo decision was controlling, however, with respect to the method claims. Nevertheless, the drug-screening claim at issue (claim 20) falls within the scope of § 101. As noted by the court:


Claim 20 recites a method that comprises the steps of (1) growing host cells transformed with an altered BRCA1 gene in the presence or absence of a potential cancer therapeutic, (2) determining the growth rate of the host cells with or without the potential therapeutic, and (3) comparing the growth rate of the host cells. Claim 20 thus recites a screening method premised on the use of “transformed” host cells. Those cells, like the patent-eligible cells in Chakrabarty, are not naturally occurring. Rather, they are derived by altering a cell to include a foreign gene, resulting in a man-made, transformed cell with enhanced function and utility. The claim thus includes more than the abstract mental step of looking at two numbers and “comparing” two host cells’ growth rates.

Methods drawn to “analyzing and comparing certain DNA sequences” are nonetheless “indistinguishable from the
claims the Supreme Court found invalid under § 101 in Mayo,” according to the Federal Circuit. Indeed, all three
judges agreed that:

Myriad’s other claims do not even include a Mayo-like step of “determining” the sequence of BRCA genes by, e.g., isolating the genes from a blood sample and sequencing them, or any other putatively transformative step. Rather, the comparison between the two sequences can be accomplished by mere inspection alone. Accordingly, Myriad’s claimed methods of comparing or analyzing nucleotide sequences are only directed to the abstract mental process of comparing two nucleotide sequences.

Consequently, such claims are not eligible subject matter under § 101.

In sum, on August 16, 2012, the Federal Circuit rendered the following decisions on remand from the Supreme
Court:

(1) Jurisdiction over the case was proper.
(2) Myriad’s isolated DNA composition claims are patentable subject matter.
(3) Myriad’s drug-screening method claim–via in vitro alterations/transformation–is subject matter eligible.
(4) Myriad’s method claims reciting “comparing or analyzing” gene sequences are not subject matter eligible.

Finally, there appears to be general consensus that the plaintiffs will–again–petition for certiorari at the Supreme
Court. Stay tuned.

The Federal Circuit’s opinion can be found at the following website. http://www.cafc.uscourts.gov/images/stories/
opinions-orders/10-1406.pdf

If you have any questions, or for additional information, please contact Randy Clower at (716) 847-5421 or rclower@phillipslytle.com.