On November 30, 2012 the US Supreme Court agreed to hear the appeal in the case of Association for Molecular Pathology v Myriad Genetics Inc. In particular, the Court limited its grant of the appeal to the first question posed by the petitioners: “Are human genes patentable?”

Is there a Material Difference Between a Gene that Has Been Isolated from a Human and One that Has Not?

As previously covered by the IPilogue (here, here, and here), at issue is a pair of genes known as BRCA1 and BRCA2.  Mutations in these genes have been positively correlated with an increased risk in the development of breast and ovarian cancer in women.  The University of Utah owned the patent rights to both (1) the method of analyzing and comparing the isolated DNA sequences in order to detect mutation in the BRCA genes and (2) the composition of matter that included the genes themselves.  Myriad Genetics was the exclusive licensee of these patents and was responsible for chemically isolating that genetic sequence.  The bulk of the method patents were deemed invalid by the Federal Circuit Court and that decision is now final given the USSC’s refusal to revisit the issue.

Instead, the Court will focus on the main point of disagreement in the decision of the Court of Appeals for the Federal Circuit. In that ruling, the 2-1 majority (which consisted of Judges Lourie and Moore) upheld their previous ruling that isolated DNA molecules are indeed patentable subject matter. It is a well-entrenched principle of American patent law that substances found in nature are not patentable; however the USSC’s decision in Diamond v Chakrabarty also established that a product of nature that is “markedly different from naturally occurring ones” with a “distinctive name, character and use” may be patentable as it is a “non-naturally occurring composition of matter”.  Because the native BRCA genes are chemically bonded to other genes and histone proteins, the majority concluded that breaking those bonds to isolate the BRCA genes turned the isolated genes into materials that are markedly different from the naturally occurring genes in humans and thus eligible for patent protection.

Judge Bryson dissented with the majority on this point stating: “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”  (at 7 of Bryson’s ruling). Judge Bryson then goes on to compare the isolation of human genes with the extraction of newly discovered minerals from the earth’s crust.

“In this respect, the genes are analogous to the ‘new minerals discovered in the earth’ or the ‘new plant found in the wild’ that the SC referred to in Chakrabarty.  It may be very difficult to extract the newly found mineral or to find, extract, and propagate the newly discovered plant.  But that does not make those naturally occurring items the products of invention.”

Like some minerals, Bryson J argues, genes are hard to extract from their natural setting.  Also like minerals, genes can be used for purposes that would be infeasible if they remained in their natural setting.  Furthermore, the process of extracting minerals or the picking of plants, like the process of isolating genetic material, can result in some physical or chemical changes to the natural substance.  But such changes do not make extracted minerals or plant pickings patentable. Thus they should not have that effect for isolated genes.  In each case, merely isolating products of nature by extracting them from their natural location and making alterations attendant to the extraction process does not give the extractor the right to patent the products themselves.

Looks Like It’s Going to Be An Interesting Summer For The American Genetic Industry

It is expected that the Supreme Court will hand down its ruling in June of 2013. By granting this appeal, the Supreme Court may finally settle the central point of dispute in a series of lengthy rulings that have wound through the Federal Circuit since 2010. Whichever way the USSC rules, it seems the summer of 2013 will be an interesting one for the American Genetic Industry.

Beatrice Sze is a JD Candidate at Osgoode Hall Law School.

Posted in Access to Medicines, Patentability, Patents, US