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May 9, 2014

Ewe Cannot Patent Clones, Court Tells Dolly Researchers

Ewe Cannot Patent Clones, Court Tells Dolly Researchers

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  • Cloned animals like Dolly the sheep cannot be patented, though the research institution that created her can receive patents for the methods used to create them, the U.S. Court of Appeals for the Federal Circuit (CAFC) decided yesterday. 

    CAFC upheld a U.S. Patent Trial and Appeal Board decision that affirmed the rejection of six claims in a patent application for Dolly by The Roslin Institute. The appellate court that specializes in hearing patent cases agreed with the board in upholding a patent examiner’s decision that the claims covered subject matter that is unpatentable under Section 101 of Title 35 of the U.S. Code (35 U.S.C. § 101) – and that Dolly was an anticipated and obvious discovery under Sections 102 and 103 of the same Code. 

    Application No. 09/225,233 was filed by Roslin Institute and two researchers listed as inventors, Keith H.S. Campbell, Ph.D. (1954-2012) and Sir Ian Wilmut, Ph.D. The institute did not argue that the donor sheep whose genetic material was used to create Dolly could not be patented. Instead, Roslin argued that clones of the donor sheep were eligible for protection, contending they were “the product of human ingenuity” and “not nature’s handiwork, but [their] own.” The institute also contended that such copies were either compositions of matter or manufactures within the scope of Section 101.

    “However, Dolly herself is an exact genetic replica of another sheep and does not possess ‘markedly different characteristics from any [farm animals] found in nature,’ concluded Circuit Judge Timothy Dyk, writing for the three-judge panel that heard the care for CAFC.

    The phrase comes from the landmark Diamond v. Chakrabarty decision, in which the U.S. Supreme Court decided 5-4 to uphold the patentability of human-made microorganisms as a valid new and useful “manufacture or composition of matter” under 35 U.S.C. § 101.

    The panel also cited the nature of the clones as genetic copies. As a result, the panel found, “Dolly’s genetic identity to her donor parent renders her unpatentable.”

    “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,” the CAFC panel added.

    The court cited Chakrabarty and a 1948 federal court case, Funk Bros. Seed Co. v. Kalo Inoculant Co., in arguing that even before the principle was declared by the Supreme Court last year in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013), federal courts have long believed that naturally occurring organisms are not patentable. In Myriad, the high court unanimously overturned seven of Myriad Genetics’ 24 patents related to its discovery of the precise location and sequence of breast cancer susceptibility genes BRCA 1 and 2.

    Drs. Campbell and Wilmut were awarded U.S. Patent No. 7,514,258 for the somatic cell nuclear transfer method used for producing Dolly. The '233 application was directed, instead, to the product of the cloning method.  Claim 155, for example, described the product as “a live-born clone of a pre-existing, nonembryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.”

    Roslin argued in its appeal that the clones covered by its application had two features distinguishing them from the donor mammals used to create them: Phenotypic differences attributed to environmental factors, and differences in mitochondrial DNA, which originates from the donor oocyte rather than the donor nucleus.  The CAFC countered that neither distinction was claimed in the application, as well as Roslin’s acknowledgement that any phenotypic differences came about or were produced “quite independently of any effort of the patentee.”


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