Inre: Roslin Institute (Edinburgh)
750 F.3d 1333
| Fed. Cir. | 2014Background
- Roslin appeals a Board decision affirming rejection of claims 155-159 and 164 of the ’233 application as unpatentable under §101, and as anticipated/obvious under §§102/103.
- The ’233 application claims live-born clones of non-embryonic donor mammals (cattle, sheep, pigs, goats) produced by somatic cell nuclear transfer.
- Dolly the Sheep’s cloning used quiescent donor cells and oocytes; the process creates an embryo and a clone identical to the donor.
- The Board held the claimed clones are inherently natural phenomena lacking markedly different characteristics from nature, rendering them ineligible under §101.
- Roslin argued phenotypic and mitochondrial differences could distinguish clones from donors and render claims patentable; the Board and court rejected these arguments as unclaimed or not affecting §101 eligibility.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Is the clone-relevant subject matter eligible under §101? | Roslin: clones are human-made, not nature’s handiwork, and may be patentable. | Board: clones are exact genetic copies with no markedly different characteristics; products of nature. | No; clones are unpatentable as products of nature under §101. |
| Are the claimed clones anticipated/obvious under §§102/103? | Roslin: environmental and mitochondrial factors create distinguishable clones. | Prior art cloning methods yield indistinguishable clones; no patentable distinction. | Yes; claims anticipated and obvious in light of prior cloning methods. |
Key Cases Cited
- Diamond v. Chakrabarty, 447 U.S. 303 (U.S. 1980) (engineered organism with markedly different characteristics is patentable)
- Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (U.S. 1948) (natural phenomena not patentable; invention must alter nature's phenomena)
- Myriad Genetics, Inc. v. Association for Molecular Pathology, 133 S. Ct. 2107 (S. Ct. 2013) (naturally occurring DNA isolated is not patentable)
- In re Best, 562 F.2d 1252 (CCPA 1977) (articulates approach to anticipation when prior art products are identical)
- Sears Roebuck & Co. v. Stiffel Co., 376 U.S. 225 (U.S. 1964) (patent expiration and public domain allow copying of unpatentable articles)
- Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141 (U.S. 1989) (patent law's reach and public domain principles)