U.S. Federal Circuit Reaffirms Patentability of Isolated DNA Sequences and Related Methods

Yesterday the U.S. Court of Appeals for the Federal Circuit appeared to lift, at least temporarily, a cloud of uncertainty that has hung over the validity of certain patents involving isolated DNA molecules since the U.S. Supreme Court’s decision earlier this year in Mayo Collaborative Services v. Prometheus, Inc., 132  S. Ct. 1289 (2012). In Association for Molecular Pathology v. U.S. Patent Office, No. 2010-1406 (Fed. Cir. Aug. 16, 2012), the Federal Circuit reversed a lower court’s invalidation of multiple claims in patents owned by the University of Utah and licensed to Myriad Genetics, Inc., relating to diagnostic tests to determine a person’s genetic disposition to breast cancer. By a 2-1 vote, the panel decided that:

  • The patents’ composition of matter claims to isolated DNA, including complementary DNA (strands of DNA constructed from mRNA, which do not contain non-coding introns), fall within the scope of patentable subject matter. Rejecting the contention that isolated DNA is a non-patentable “product of nature,” the court wrote:

The isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity. While they are prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decomposition, are made from natural materials. For example, virtually every medicine utilized by today’s medical practitioners, and every manufactured plastic product, is either synthesized from natural materials (most often petroleum fractions) or derived from natural plant materials. But, as such, they are different from natural materials, even if they are ultimately derived from them. The same is true of isolated DNA molecules. . . .

While purified natural products thus may or may not qualify for patent under § 101, the isolated DNAs of the present patents constitute an a fortiori situation, where they are not only purified; they are different from the natural products in “name, character, and use.”

  • A claim to a method of screening potential cancer therapeutics through changes in cell growth rates of transformed cells also was within the realm of patentable subject matter.
  • The patents’ method claims directed to “comparing” or “analyzing” DNA sequences were ineligible for patents. According to the Federal Circuit, those claims included “no transformative steps and cover only patent-ineligible abstract, mental steps.”

In a dissenting opinion, Circuit Judge William C. Bryson wrote that he disagreed that the claims to isolated DNA were directed to patentable subject matter. Among the arguments presented by Judge Bryson for patent ineligibility of isolated DNA are the following:

 The essence of Myriad’s argument in this case is to say that it has not patented a human gene, but something quite different – an isolated human gene, which differs from a native gene because the process of extracting it results in changes in its molecular structure (although not in its genetic code).  We are therefore required to decide whether the process of isolating genetic material from a human DNA molecule makes the isolated genetic material a patentable invention.  The court concludes that it does; I conclude that it does not….

The majority characterizes the isolated genes as new molecules and considers them different substances from the corresponding native DNA. Because the native BRCA genes are chemically bonded to other genes and histone proteins, the majority concludes that cleaving those bonds to isolate the BRCA genes turns the isolated genes into “different materials.”  Yet there is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken, but not when other atomic or molecular forces are altered….

The structural differences between the claimed “isolated” genes and the corresponding portion of the native genes are irrelevant to the claim limitations, to the functioning of the genes, and to their utility in their isolated form. The use to which the genetic material can be put, i.e., determining its sequence in a clinical setting, is not a new use; it is only a consequence of possession.  In order to sequence an isolated gene, each gene must function in the same manner in the laboratory as it does in the human body.  Indeed, that identity of function in the isolated gene is the key to its value.  The naturally occurring genetic material thus has not been altered in a way that would matter under the standard set forth in Chakrabarty.  For that reason, the isolation of the naturally occurring genetic material does not make the claims to the isolated BRCA genes patent-eligible.

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