Federal Circuit Adds to Section 101 Jurisprudence

09 May 2014 Personalized Medicine Bulletin Blog

The U.S. Court of Appeals for the Federal Circuit, relying on U.S. Supreme Court patent-eligibility precedent, held that a claim to a live-born clone of a pre-existing, non-embryonic, donor mammal is not patent-eligible. The Court reasoned that because the clone is genetically identical to its donor parent, it is not markedly different from that found in nature and therefore not eligible for patent protection. See In re Roslin Institute (Edinburgh), Slip Op. No. 2013-1407 (Fed. Cir. May 8, 2014).

A Sheep Named Dolly

In the mid-1990′s, Campbell and Wilmut, two scientists from The Roslin Institute of Edinburgh, Scotland (Roslin) were the first to successfully clone a mammal from an adult somatic cell – Dolly the Sheep. The method, called somatic cell transfer, requires removing the nucleus of a somatic cell and implanting that nucleus into an oocyte from which the nucleus has been removed. To create Dolly, the nucleus of an adult, somatic mammary cell was fused with an enucleated oocyte. The resulting fused oocyte develops into an embryo which can then be implanted into a surrogate mammal, where it develops into a fetus. The resulting mammal is an exact genetic replica of the adult mammal from which the somatic cell nucleus was taken.

Campbell and Wilmut applied for a patent on cloned mammals in U.S. patent application Serial No. 09/225,233, entitled “Quiescent Cell Populations for Nuclear Transfer.” Claims 155 and 164 were identified as representative of the claims before the Court:

155. A live-born clone of a pre-existing, non-embryonic, 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.

The claims were rejected by the USPTO for failing the statutory requirements of novelty (Section 102), non-obviousness (Section 103) and utility (Section 101). The rejections were appealed to the Patent Trial and Appeal Board (Board) and the Board affirmed, finding that “the claimed clones were anticipated and obvious because they were indistinguishable from clones produced through prior art cloning methods, i.e., embryonic nuclear transfer and in vitro fertilization.” Slip Op. at 4. In addition, although the Board determined that the claims described a composition of matter or a manufacture, they were nevertheless ineligible for patent protection because they “constituted a natural phenomenon that did not possess markedly different characteristics than any found in nature.” Slip Op. at 4. On appeal to the Federal Circuit, the Court only addressed whether the cloned non-human mammal was patent-eligible under Section 101.

Genetically Identical and Not Markedly Different

Roslin argued that the claimed cloned mammals are patent-eligible because they are distinguishable from the donor mammals used to create them. For example, the claimed cloned mammals are phenotypically different due to environmental factors and other factors such as physiological and morphological changes associated with aging. The Court noted that such differences are not claimed and focused on the word “cloned” in the claims. The term “cloned” the Court stated, “connotes genetic identity, and the claims say nothing about a phenotypic difference between the claimed subject matter and the donor mammals. Moreover, Roslin acknowledges that any phenotypic differences came about or were produced ‘quite independently of any effort of the patentee.’” Slip Op. at 9, quoting Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127,  131 (1948).

The Court also dismissed Roslin’s argument that the cloned mammal was markedly different because the cloned mammal contains mitochondrial DNA from the donor oocyte rather than the donor nucleus. Again, the Court noted that this difference was not claimed and the application did not identify how differences in mitochondrial DNA influence or could influence the characteristics of cloned mammals.

Roslin also argued that the cloned mammals were patent-eligible because they are time-delayed versions of their donor mammals, and therefore different from their original mammals.  However, the Court affirmed the Board’s conclusion that time delay does not confer patent-eligibility because such would be true of any copy of an original.

The Federal Circuit also acknowledged the Supreme Court’s recent Myriad decision and how the holding dictates that the claims are not patentable. The Court stated:

“Here, as in Myriad, Roslin ‘did not create or alter any of the genetic information’ of its claimed clones, ‘[n]or did [Roslin] create or alter the genetic structure of [the] DNA’ used to make its clones. Myriad, 133 S. Ct. at 2116. Instead, Roslin’s chief innovation was the preservation of the donor DNA such that the clone is an exact copy of the mammal from which the somatic cell was taken. Such a copy is not eligible for patent protection.”

Slip Op. at 7-8.

Looking Ahead

It is noteworthy that the Federal Circuit could have reached the same result by holding that a claim to a cloned mammal – as an exact copy of a pre-existing mammal – would fail for lacking novelty under Section 102 or inventiveness under Section 103. The Court did not do so, however, but rather used the claims before it to expand on patent-eligibility jurisprudence under Section 101. Thus, applicants seeking to patent technology closely related to, or derived from, a natural product should articulate in the application papers and claims structural differences between the claimed subject and any naturally occurring counterpart.

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