Subject Matter Patentability of Isolated DNA, Now For the U.S. Supreme Court to Decide
In its serpentine path from U.S. Supreme Court to Fed Circuit and now back again, in the matter of Ass’n for Molecular Pathology, excessive attention has been given to the question whether or not isolated DNA is ‘new’ and ‘useful’. But actually, more is required under § 101 for isolated DNA to be patent eligible; it must also be an “invention” or “discovery.”
So it is not enough simply to impute to isolated DNA that it is a “human invention” deserving of a patent because of markedly different characteristics from any found in nature as the Fed Circuit did when it decided the subject matter patentability of the isolated DNA claims largely under Chakrabarty. As §101 and the Supreme Court Mayo and Funk Bros. decisions make clear, the patent eligibility of isolated DNA depends as much upon satisfying the “invention” or “discovery” requirement as it does upon satisfying the requirement that it be “new” and “useful.”
The issue before the U.S. Supreme Court in Ass’n for Molecular Pathology is “Are human genes patentable?” Under Mayo, the issue before the U.S. Supreme Court in Ass’n for Molecular Pathology really boils down to the question: “Is a chemically engineered package of DNA derived by engineering the edges of the DNA sequence an ‘insignificant extra-solution activity’ or is it a ‘human invention’ deserving of a patent?”
On January 28, The Juhasz Law Firm filed an amicus brief before the U.S. Supreme Court in Ass’n for Molecular Pathology v. U.S.P.T.O., concerning the subject matter patentability of isolated DNA, and urging the U.S. Supreme Court to clarify its preemption doctrine.
The Juhasz Law amicus brief outlines the underpinnings of the preemption doctrine found in Supreme Court decisions in Mayo and its predecessor decisions. A composition which is “new” and “useful” must also satisfy the § 101 requirement that it be an “invention” or “discovery.” Even a product decidedly “new” and “useful” may nonetheless fail § 101 if the composition preempts the fundamental principle itself. In that case, the product may fail the § 101 requirement of invention not because there is no invention, but because the invention is the result of the handiwork of nature and not the result of human ingenuity. The isolated DNA claims now before the U.S. Supreme Court trigger the preemption question not under the requirement that they be “new,” which they are. The preemption question in the case of isolated DNA is triggered under the § 101 requirement of “invention.”
In essence, isolated DNA is human engineering done “at the edges” of DNA for the purpose of providing a chemical package for containing the naturally occurring DNA useful for diagnostic testing. Since the remaining portion of DNA (inside the isolating package and useful for diagnostic targeting) is the work of nature, the question under § 101 thus turns on whether that new packaging of DNA can be called an invention deserving of a patent under § 101.
The Juhasz Law amicus brief argues that the DNA in isolated form has the same effect it had before isolation, and the correlation of the BRCA1 and BRCA2 human genes to a predisposition to breast and ovarian cancers is nature’s handiwork and, thus, not patentable. Absent the DNA SEQ, all that remains is the isolated packaging of the DNA SEQ. In the case where the DNA SEQ chemically packaged by isolating is identical to naturally-occurring gene sequences, the chemical packaging of that DNA SEQ amounts to an insignificant extra-solution activity that is not patent eligible matter under Mayo since doing this was a matter of known practice. Where, however, the DNA SEQ packaged involves isolated cDNA molecules, more briefing is required to determine whether the packaging of the DNA SEQ into cDNA molecules is an insignificant extra-solution activity or “human invention” deserving of a patent.
For more insight on isolated DNA and Chakrabarty, read prior blogs September 2012 and August 2011.
About The Juhasz Law Firm
The Juhasz Law Firm is a patent and intellectual property (IP) protection, counseling, licensing and litigation firm. Combining deep patent/IP experience, broad capabilities across a wide spectrum of industries and technologies, and extensive expertise in strategic counseling, The Juhasz Law Firm collaborates with clients to help them better see, understand and realize the potential strategic value from their patents and intellectual property.
Paul R. Juhasz has written extensively on matters of software patents, including the Bilski software patent decision; matters of diagnostic method patents, including an amicus brief filed in the Mayo case decided by the U.S. Supreme Court and now in the Ass’n for Molecular Pathology case; and licensing matters including strategic monetization of intellectual property.