U.S. Supreme Court – Myriad Genetics Decisionand “Isolated” Genes

Much is being written about the Supreme Court decision of 13 June 2013 regarding the patentability of naturally occurring DNA molecules.  In the words of the Court – “…genes and the information they encode are not patent eligible under [35 U.S.C.]§101 simply because they have been isolated from the surrounding genetic material.”

Claim 1 in US patent 5,747,282 assigned to Myriad Genetics, Inc. is drawn to an isolated DNA coding for a BRCA1 polypeptide having a specified amino acid sequence.  The claim encompasses naturally occurring DNA sequences that can be taken, for example, from a patient.

 The Supreme Court decision states that isolating naturally occurring DNA from its natural source is, in and of itself, not sufficient to make the isolated DNA patentable under 35 U.S.C. §101.  A claim drawn to a method involving the use of an isolated, naturally occurring gene such as BRCA1 or BRCA2 is patentable under 35 U.S.C. §101 as are claims to cDNAs made fromnaturally occurring genes such as BRCA1 and BRCA2.  For example, the ´282 patent contains claims drawn to a replicative cloning vector comprising the DNA of claim 1, an expression system comprising the DNA, host cells transformed with the DNA, a method for producing theBRCA1polypeptide, a kit for detecting mutations in the BRCA1 gene, and a method for screening potential cancer therapeutics.  The Supreme Court ruling does not state that any of these claims areunpatentable under 35 U.S.C. §101.

As a consequence of the Supreme Court’s decision, scientists will be able to conduct further basic research on naturally occurring genes without infringing patent claims to isolated DNA sequences.  The decision should not interfere with profit-motivated research because claims to diagnostic kits and methods, treatment kits and methods, and pharmaceutical preparations containing naturally occurring DNA sequences are still patentable under 35 U.S.C. §101.

One of the questions that the Myriad decision does not appear to answer is whether synthetic copies of a gene (BRCA1 and BRCA2 in this case) having the same sequence as the naturally occurring DNA are patentable subject matter under 35 U.S.C. §101.  The decision includes the statement: “…genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.”

The decision addresses the sequence structure of DNA but not its conformation or how it is packaged.  The DNA in a human chromosome is packaged in order to fit inside a cell nucleus and that packaging determines, for example, which sequences are available for expression.  Cell lysis to release DNA from the nucleus changes the DNA from its native state to an unnatural and human-made state in which the natural packaging (and therefore regulation) is disrupted.   While the Myriad decision has answered at least one important question, many more questions remain to be answered. This makes working with patent practitioners with practicalexperience as well as up-to-date knowledge of patent law more important than ever – like the patent professionals at KIPA.