Enter to open, tab to navigate, enter to select
No Patent Protection for Cloned Sheep: Federal Circuit
Practical Law Legal Update 6-567-8605 (Approx. 3 pages)
No Patent Protection for Cloned Sheep: Federal Circuit
by Practical Law Intellectual Property & Technology
| Published on 12 May 2014 • USA (National/Federal) |
In In re Roslin Institute, the US Court of Appeals for the Federal Circuit affirmed the Patent Trial and Appeal Board's rejection of Roslin's claims to cloned animals produced by Roslin's patented cloning method, holding that exact genetic copies of patent ineligible subject matter are not patent eligible.
On May 8, 2014, in In re Roslin Institute, the US Court of Appeals for the Federal Circuit affirmed the Patent Trial and Appeal Board's (PTAB) rejection of all of Roslin Institute's claims to cloned mammals resulting from Roslin's patented somatic cloning method. The Federal Circuit held that the claimed clones are not patent eligible because they are exact genetic copies of patent ineligible subject matter that do not possess markedly different characteristics from their donor parent farm animals (No. 2013-1407, (Fed. Cir. May 9, 2014)).
Roslin is the assignee of US Patent No. 7,514,258 (the '258 patent) directed to the somatic method of cloning animals and US Patent Application No. 09/225,233 (the '233 application) directed to the resulting cloned mammals. The PTAB rejected the '233 application's claimed subject matter as patent ineligible under 35 U.S.C. § 101 because it constituted a natural phenomenon that does not possess markedly different characteristics than any found in nature, and Roslin appealed.
The Federal Circuit affirmed the PTAB's rejection of the pending claims based on US Supreme Court precedent establishing that:
- Naturally occurring organisms are not patentable.
- Discoveries that possess markedly different characteristics from any found in nature are eligible for patent protection.
In affirming the PTAB's rejection, the Federal Circuit emphasized that the claimed cloned mammals are patent ineligible because they are exact genetic copies of their donor parent animals that do not have any characteristics markedly different from the donor parents. The Federal Circuit also rejected Roslin's arguments that:
- Environmental factors lead to phenotypic differences between the donor parents and the claimed clones because the environmental factors were not claimed.
- Differences in mitochondrial DNA distinguish the cloned mammals from their donor parents because:
- the differences were not claimed; and
- the '233 application did not identify how differences in mitochondrial DNA influence or could influence the characteristics of cloned mammals.
- The clones are time-delayed versions of their donor mammals, agreeing with the PTAB's conclusion that this distinction is insufficient to confer patent eligibility because it would apply to any copy of an original.
Although the Federal Circuit found Roslin's claimed clones to be patent ineligible because they were exact genetic copies of their donor parents, the Federal Circuit noted that clones having the same nuclear DNA as the donor may not lead to patent ineligibility in every case. The court emphasized that the claimed clones in this case were defined in terms of their nuclear DNA's identity to that of the donor's DNA and that the claims did not describe any differences between the clones and the donor parents.