Baaaaad News for Patenting Cloned Sheep

09 May 2014 PharmaPatents Blog

In a unanimous panel decision, the Federal Circuit affirmed the finding of the USPTO Patent Trial and Appeal Board (PTAB) that claims directed to cloned cattle, sheep, pigs and goats were directed to non-patent eligible subject matter under 35 USC § 101. The court in effect held that while methods of making Dolly the sheep may be patentable, Dolly herself is not. 

The Patent Application at Issue

The patent application at issue was 09/225,233, assigned to the Roslin Institute of Edinburgh, Scotland. The court identified claims 155 and 164 as representative:

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. 

The inventors are the same inventors who made Dolly the sheep (the first mammal cloned from an adult somatic cell). The Federal Circuit points out that the inventors were granted a patent on their cloning methods (U.S. 7,514,258) that was not at issue in this case.

In a decision rendered February 7, 2013 (before the Supreme Court’s Myriad decision), the PTAB affirmed the § 101 rejection because the claimed subject matter “constituted a natural phenomenon that did not possess ‘markedly different characteristics than any found in nature.’”

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Dyk and joined by Judges Moore and Wallach. The claims were rejected under 35 USC §§ 101, 102 and 103, but the court focused on the § 101 rejection.

The decision opens by stating that the Supreme Court decisions in Myriad, Chakrabarty and Funk Bros. ”made clear that naturally occurring organisms are not patentable.” The court characterizes Funk Bros. as finding that “the mixture of bacteria … was unpatentable because its ‘qualities are the work of nature’ unaltered by the hand of man.” The court characterizes Chakrabarty as finding that “the modified bacterium was patentable because it was ‘new’ with ‘markedly different characteristics from any found in nature and one having the potential for significant utility.’”

Accordingly, discoveries that possess “markedly different characteristics from any found in nature,” … are eligible for patent protection. In contrast, any existing organism or newly discovered plant found in the wild is not patentable.

The court also cites Myriad, and characterizes that decision as holding that “claims on two naturally occurring, isolated genes … were invalid under § 101″ because ”the BRCA genes themselves were unpatentable products of nature.”

Turning to the claims at issue, the court noted Roslin’s arguments, based on language from Chakrabarty, that the clones are patent eligible because they are “the product of human ingenuity” and “not nature’s handiwork, but [their] own.” The court responded by citing a different passage of Chakrabarty, stating 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.’”

The court concludes simply:

Dolly’s genetic identity to her donor parent renders her unpatentable.

The court explained further:

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.

*****

Roslin’s claimed clones are exact genetic copies of patent ineligible subject matter. Accordingly, they are not eligible for patent protection.

The court rejected Roslin’s arguments that phenotypic differences in the cloned animals supported patent eligibility because the phenotypic differences (i) were not recited in the claims and (ii) arose “quite independently of any effort of the [would-be] patentee.”

The court also rejected Roslin’s arguments that differences in mitochondrial DNA supported patent eligibility because any such differences (i) were not recited in the claims and (ii) had not been shown to impart and differences to the cloned animal.

The court left open the possibility that “having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case,” but emphasized that the claims at issue “do not describe clones that have markedly different characteristics from the donor animals of which they are copies.”

The USPTO § 101 Forum 

The USTPO is hosting a forum to receive public feedback on its recently issued Patent Eligibility Guidance document today (May 9, 2014). While most speakers like myself have planned to discuss Funk Bros., Chakrabarty and Myriad, it is likely that this case also will get some attention.

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