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Juhasz argues for change in focus from “is it new” to “is it an invention or discovery” in deciding § 101 subject matter patentability of isolated DNA

The Juhasz Law Firm filed an amicus brief before the U.S. Supreme Court on January 28 in Ass’n for Molecular Pathology v. U.S.P.T.O., concerning the subject matter patentability of isolated DNA. The brief urges a shift in focus to the “invention or discovery” requirements in § 101 in deciding the subject matter patentability of isolated DNA.

The Juhasz Law amicus brief points out that excessive attention in this case has been given to the question whether or not “isolated DNA is ‘new’ and ‘useful’,” which it has been found to be under  the U.S. Supreme Court Chakrabarty case. The Juhasz Law amicus brief argues that more is required under § 101 for isolated DNA to be patent eligible; it must also be an “invention” or “discovery.”

“The issue before the U.S. Supreme Court 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,” said Paul R. Juhasz.

The Juhasz Law amicus brief points out that the DNA in isolated form has the same effect it had before isolation, and the correlation of the BRCA1 and BRCA2 DNA SEQ to a predisposition to breast and ovarian cancers is nature’s handiwork and, thus, not patentable.

Preemption Doctrine of The U.S. Supreme Court

The Juhasz Law amicus brief outlines the underpinnings of the preemption doctrine found in prior Supreme Court decisions, and explains the justification why preemption in the Ass’n for Molecular Pathology case should be decided on the basis of “invention” or “discovery” rather than on the basis of being “new.” Under U.S. Supreme precedent, a composition which is “new” and “useful” must still satisfy the § 101 requirements of “invention” or “discovery.”

Even a product decidedly “new” and “useful” may nonetheless fail the § 101 test if it “preempts” a fundamental principle, such as laws of nature. In this case, the isolated DNA that are identical to naturally occurring gene sequences fail the § 101 test because absent the BRCA1 and BRCA2 DNA SEQ, all that remains is known cleaved packaging; an insignificant extra-solution activity.  So there is no invention or discover beyond what is found in nature.  For isolated cDNA molecules, however, 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 a copy of this amicus brief, see the Publications Page.

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 licensing matters including strategic monetization of intellectual property.