In re Roslin Institute: Products of Nature and Source Limitations

Abstract

The Federal Circuit’s recent opinion in In re Roslin Institute 2 is the court’s first decision on the patent-eligibility of natural products after the Supreme Court’s Myriad decision, which denied patent-eligibility to isolated genomic DNA. The holding itself is probably not significant; cloned animals have little commercial significance at present. But the court’s requirement that inventions be “markedly different” from their natural sources casts doubt the patent-eligibility of other biotechnological inventions, such as isolated human stem cells. This comment addresses two issues with the Federal Circuit’s analysis in Roslin: the court’s interpretation of Chakrabarty 3 and Funk Brothers, 4 and Roslin’s requirement that structural or functional differences between natural and synthetic products must be explicitly recited by the claims. Unaltered by the hand of man: Judge Dyk’s opinion in Roslin unfortunately perpetuates the view, now found in the PTO’s Myriad guidelines, that Chakrabarty requires a claimed invention to be “markedly different” from a natural product for patent-eligibility under § 101. Myriad itself imposed no such requirement: the Court found BRCA cDNAs patent-eligible without determining that they were “markedly different” from natural sequences. And though Myriad reiterated the “markedly different” language from Chakrabarty, Chakrabarty’s discussion of “products of nature” was entirely dictum. Only the question of whether living organisms were patent-eligible was before the Court in Chakrabarty; the “product of nature” rejection in the case had not been sustained by the Patent Office Board of Appeals. The Chakrabarty Court noted the claimed bacteria differed “markedly”