Dolly is not patentable without its mitochondria DNA—the unpatentability of Myriad’s gene and beyond

Last year June 13, the Supreme Court issued a decision in Association of Molecular Pathology v. Myriad Genetics holding that naturally occurring DNA sequences are not patentable. To recap, at the center of the controversy in the Myriad case was Myriad’s so-called gene patents--Myriad’s BRCA1 and BRCA2 genes. The Court ruled that the isolation and identification of naturally occurring DNA sequences was unpatentable and therefore the BRCA1 and BRCA2 genes were ineligible for patent protection because they were products of nature.

A year late, Dolly, the famous cloned sheep, became a casualty of Myriad’s holding.  The case of In re Roslin Institute (Fed. Cir. No. 2013-1407, May 8, 2014) involved an appeal from a Patent Trial and Appeal Board decision rejecting claims to “cloned mammals.”  The Roslin Institute created Dolly the cloned sheep.  The invention using somatic cell nuclear transfer to create clones was described and claimed in U.S. Application No. 09/225,233.  Claims 155-159 and 164 are directed to cloned mammals. Representative claims 155 and 164 recite:

155.  A live-born clone of a pre-existing, nonembryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.
164.  The clone of any of claims 155-159, wherein the donor mammal is non-foetal.

Citing the Supreme Court's decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) and the Federal Circuit’s opinion in Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), the Federal Circuit reiterates that naturally occurring organisms are not patentable."  Responding to Roslin’s argument that, unlike the donor sheep used to create Dolly, clones like Dolly are eligible for protection because they are "the product of human ingenuity" and "not nature's handiwork," the Court states that "Dolly herself is an exact genetic replica of another sheep and does not possess 'markedly different characteristics from any [farm animals] found in nature,'" and thus, "Dolly's genetic identity to her donor parent renders her unpatentable." 

Well, technically, Dolly is not really an exact copy of her donor parent.  In somatic cell nuclear transfer process, the nucleus of a somatic cell is implanted into an enucleated oocyte.  Therefore, the clone has its original donor’s chromosomal genetic materials and the oocyte donor’s mitochondrial DNA.  Also, recent epigenetics research has indicated that environmental factors lead to phenotypic differences, which further distinguish the clones from their donor mammals.  Unfortunately for Roslin, the Court noted that neither the phenotypic differences nor the differences in mitochondrial DNA were claimed.  

The Court made an interesting point on phenotypic differences.  The Court opines that "Roslin acknowledges that any phenotypic differences came about or were produced 'quite independently of any effort of the patentee.'"  Thus, "[such] phenotypic differences do not confer eligibility on their claimed subject matter [because a]ny phenotypic differences between Roslin's donor mammals and its claimed clones are the result of 'environmental factors,' uninfluenced by Roslin's efforts."  In a nutshell, phenotypic difference is a natural phenomenon and therefore will not render a clone patentable.

However, the Court did indicate that “having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case.”  It seems that Dolly will have to be claimed as a combination of its chromosomal donor and mitochondria donor in order to be eligible for patenting.

Thanks for reading.

Connie
cwan@patentonomy.com