Monday, 20 August 2012 14:22

MYRIAD PART II: ISOLATED DNA CLAIMS STILL PATENT ELIGIBLE

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Composition claims to "isolated" DNA molecules are patent eligible under 35 USC 101 as nonnaturally occurring compositions of matter -- this, among other decisions, is what the Court of Appeals for the Federal Circuit ("CAFC") published in its opinion of August 16, 2012.

To refresh your memory, this case was first decided in the Southern District of New York, where it was determined that the claims were not patent eligible under 35 USC 101. On appeal to the CAFC (the first time), the Court reversed in part, finding that "isolated" DNA claims are sufficiently different from DNA as it occurs in nature. It also affirmed in part the ruling that certain method claims for "comparing" or "analyzing" DNA sequences were not patent eligible since they were not transformative. The case was appealed to the U.S. Supreme Court, who granted certiorari, reversed and remanded back to the CAFC for reconsideration in view of its recent decision Mayo v. Prometheus, which held that diagnostic claims involved only steps of "analyzing" and "determining" were not patent eligible.

The CAFC therefore heard a second round of oral arguments recently, and once again ruled as it did before, even in view of Mayo. Determining first that there was standing for the plaintiff’s to bring the suit, the Court moved on to the merits of patent eligibility of various claims for “isolated” DNA concerning BRCA1 and BRCA2 genes, and methods of their use.

As to the isolated DNA claims, the CAFC decided that Mayo does not control whether composition of matter claims are patent eligible. It finds, as it did previously, that isolated DNA molecules are not found in nature, but rather are markedly different from naturally occurring DNA, as they have distinct chemical structures and identities. Human intervention is needed to impart these distinct structures, such as by breaking covalent bonds. That they are prepared from products of nature does not change this, since every composition of matter is in some way or another derived from natural products. This is in line with longstanding precedent established under Diamond v. Chakrabarty and Funk Brothers. Also, cDNAs were noted to be clearly distinctive molecules, since they lack introns, and therefore are unquestionably patent eligible.

The court also expressly stated that isolated DNA molecules are not simply purified DNA, but are chemically changed and therefore are different from anything occurring in nature. Correctly recognizing that, chemically speaking, covalent bonds define the boundaries between different molecules, the Court noted that the breaking of these bonds to create “isolated” DNA significantly and meaningfully change the identity of the resulting molecule, even if it is a molecule as important DNA. This is not like snapping a leaf off a tree, which is a physical transformation, but rather is a chemical transformation to a different molecule. Any high school chemistry student would appreciate this distinction. Moreover, the Court noted that patent eiligibility of isolated DNA is not negated by any similarity in nucleotide sequence between it and the more complex chromosomal DNA. The uses and coding functions of isolated DNA are also irrelevant to determinations of patent eligibility under 35 USC 101, which focus more appropriately on structure rather than function.

The Court also rejected the government's earlier posited "magic microscope" test as an improper test according to both science and the laws of invention. This is perhaps for the best, since the "magic microscope" has only been confusing since its arrival.

Regarding the method claims, the CAFC once again found most of the asserted method claims to be not patent eligible as being merely abstract mental processes. The Court considered Mayo to be instructive to their analysis of the method claims, which were similarly directed to method claims, and their holding is in agreement with Mayo. One claim, however, included the step of growing transformed cells before comparing the growth rates, and this claim was held to be patent eligible, even under Mayo, since the step of growing cells is transformative and not merely abstract.

The Court was also very explicit that its decision was of limited scope – to patent eligibility – and not to any other consideration such as patentability or breadth under 35 USC 102, 103, or 112. Moreover, their decision expressly did not address whether patents on medical methods and novel biological molecules are appropriate for patents, or the appropriateness of Myriad's use the patents, as these are policy questions for Congress to address. They did note, however, that patents on life-saving materials and processes that require a great deal of risk to develop seem to be precisely the type of inventions that would benefit from the exclusive rights offered by patent protection.

Given the contentious nature of this case thus far, it would not be surprising if this decision gets appealed to the U.S. Supreme Court for their final word. Check back for more updates as they occur.

Read 2192 times Last modified on Tuesday, 30 April 2013 18:03
Jessica Hauth

Ms. Hauth earned her bachelor's degree in Chemistry and her master's degree in Biochemistry, Cell and Developmental Biology from Emory University, and her law degree from the University of Miami School of Law. She has published her research in the areas of developmental biology, genetics, heterochromatin assembly and maintenance, and RNAi use and characterization. She is a member of the American Chemical Society, American Intellectual Property Law Association, Dade County Bar Association, and Phi Alpha Delta. She is admitted to practice law in Florida state courts, as well as in the United States District Court for the Southern District of Florida. As a Registered Patent Attorney, she concentrates her practice on Patent Prosecution and Intellectual Property Litigation.