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Federal Circuit Finds Clones Unpatentable

May 12, 2014
Post by Blog Staff

The Federal Circuit issued its opinion in In re Roslin Institute, a case involving cloned animals. The Roslin Institute (Roslin) owns a patent for methods of cloning animals, based on the work that created Dolly the Sheep. The inventors of that patent also assigned to Roslin an application claiming protection for the clones themselves. During prosecution, the USPTO deemed the claims to the clones contained in that application to be directed to non-statutory subject matter under 35 U.S.C. § 101 because the clones constituted a natural phenomenon that did not possess markedly different characteristics than any found in nature. The USPTO decision was appealed to the Patent Trial and Appeal Board, which upheld the rejection.

On appeal to the Federal Circuit, the appellate court affirmed the PTAB decision, concluding that genetic identity of a clone to a progenitor/donor animal precludes it from patent protection, despite the fact that such a clone itself does not exist in nature. The court held that "clones are exact genetic copies of patent ineligible subject matter, [and as a result] they are not eligible for patent protection."

Interestingly, the court dismissed Roslin's arguments that environmental factors lead to phenotypic differences between its clones and their donor mammals that render their claimed subject matter patentable, stating that any such differences were not claimed. In contrast, the court focused on the genetic aspect of the clones—which although similarly unclaimed—the court determined was implicit in the use of the term "clones". The court further discounted any phenotypic differences as being the result of "environmental factors" uninfluenced by Roslin's efforts.

The court ultimately qualified it's holding, stating that "having the same nuclear DNA as the donor . . . may not necessarily result in patent ineligibility in every case," but that in this case "the claims do not describe clones that have markedly different characteristics from the donor animals of which they are copies."

The full opinion is available here.


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