“Isolated Genomic DNA” Is An Unpatentable Product of Nature

On June 13, 2013, the U.S. Supreme Court held that isolated genomic DNA molecules are not eligible for patent protection because they are products of nature. In Association For Molecular Pathology et al. v. Myriad Genetics (“Myriad”) the Court considered whether the act of isolating a DNA sequence useful in diagnosing breast cancer renders the molecule different enough to be eligible for patent protection under 35 U.S.C. Section 101.

At issue was Myriad Genetics’ patent claims directed to isolated genomic DNA (gDNA) coding for the amino acid sequence of the BRCA1 and BRCA2 genes – mutant genetic markers which indicate an increased risk for developing breast and ovarian cancer. While acknowledging that Myriad “found an important and useful gene,” the Court wrote that the “the claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.

In contrast, the court held that complementary or cDNA is patent eligible. cDNA is a form of “edited” DNA with non-coding sequences called introns removed from the gDNA. cDNA is generated from messenger RNA (mRNA), a nucleic acid template that translates the genetic code into proteins. According to the Court, “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments” because “the lab technician unquestionably creates something new when cDNA is made.”

The Court specifically identified what they did not consider in the opinion, carving out subject matter that may be considered patent eligible. For example, “methods of manipulating genes while searching for the BRCA1 and BRCA2 genes” was specifically not considered by the Court. However, the Court noted that the processes used by Myriad to isolate the genes were well understood and widely used which may influence future decisions regarding both patent eligibility and validity. The Court also did not consider “applications of knowledge about the BRCA1 and BRCA2 genes” or “scientific alteration of the genetic code.” Thus, claims to the use of a gene or human-made mutant genes may be considered patent eligible, for now.

Implications of Myriad

Myriad may invalidate thousands of issued patents with claims to isolated gDNA molecules. gDNA claims should therefore be evaluated to determine if they can be reissued in a form that meets the requirements of the Myriad decision. In particular, patent owners should consider whether their patents include claims to applications of knowledge regarding the gene or alterations of the gene sequence.

The decision also casts doubt on claims to other types of “naturally” occurring molecules including proteins (e.g., growth factors, hormones, antibodies, receptors etc.) and DNA probes (short nucleic acid sequences used to identify DNA molecules) since the reasoning in Myriad could be applied to these molecules. An “isolated” growth factor, for example, may be unchanged from a naturally occurring growth factor under the Myriad Court’s reasoning. Therefore, patent claims to proteins and other biologics should be analyzed for compliance with Myriad and for reissue proceedings to amend claims or add new claims if possible.

The Court’s statements regarding the routine nature of the techniques used to isolate DNA and make cDNA, may have implications for invalidating claims to cDNA as “obvious.” Thus, claims to cDNA, mRNA, and other nucleic acids (e.g., small interfering RNA) should also be evaluated with respect to how the nucleic acids were identified, characterized, and described.

It is unclear whether Myriad will have an impact on the cost of medical research, the availability and cost of diagnostic tests and therapeutic drugs, and investment in future research. In the short term, patent owners and inventors should revisit their patent portfolios and adjust their strategies accordingly.

Contact: Jeremy A. Cubert, Esq. at jacubert@cttg-law.com or 703-734-0484, ext. 109

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