By Elizabeth Spar, Ph.D. A member of our Patent Practice Group
On May 8, 2014, the Federal Circuit released its opinion in In re Roslin Institute, addressing whether Dolly, the cloned sheep, was patentable. The Court held that in the absence of claim elements encompassing “markedly different characteristics from the donor animals of which they are copies” cloned animals are not patent eligible under 35 U.S.C. §101.
Campbell and Wilmut applied for patent protection for the somatic method of cloning mammals, as well as the clones themselves. They received a patent on their innovative method of cloning mammals in 2009 (U.S. 7,514,258). They also applied for a patent to the actual cloned animals —U.S. Patent Application No. 09/225,233 (the ’233 application). Claims of the ’233 application were directed towards the live-born clones of “cattle, sheep, pigs, and goats,” including these claims:
The examiner of the’233 patent application rejected all of the application’s claims, as directed to patent ineligible subject matter. The PTAB upheld the examiner’s rejection on February 7, 2013. Following that ruling, the Roslin Institute appealed to the Federal Circuit.
In arguing that Dolly was a patentable invention, Roslin said that “Copies (clones) are eligible for protection because they are ‘the product of human ingenuity’ and not nature’s handiwork, but [their] own”. Roslin also argued that the claimed clones are distinct from the donor mammals from which they are created. In support of that argument, Roslin pointed out that:
The court responded to Roslin’s arguments about the differences between the clone animals and the original donor animals by noting that neither of the “phenotypic differences” or any “difference in mitochondrial DNA between the donor and claimed mammals” were claimed in the patent application.
Roslin also argued that “its clones are patent eligible because they are time-delayed versions of their donor mammals, and therefore distinct from their original mammals” to which the court responded, “[t]he difficulty with the time-delayed characteristic is that it is true of any copy of an original.”
Having rejected all of Rosin’s arguments, the court affirmed the finding of the PTAB that Roslin’s clones are unpatentable subject matter under §101. (More)
Background
On July 5, 1996, Keith Henry Stockman Campbell and Ian Wilmut successfully produced the first mammal ever cloned from an adult somatic cell: Dolly the sheep. The cloning method used by Campbell and Wilmut, known as somatic cell nuclear transfer, involves creating a clone embryo by removing the nucleus of a somatic cell of a donor and fusing that nucleus with an enucleated (non-nucleated) ooctye (egg cell), from which an embryo develops. The embryo is implanted into a surrogate mammal and develops into a baby animal. Dolly was cloned from the fusion of a nucleus of an adult, somatic mammary cell with an enucleated oocyte. According to the court, “[t]he resulting cloned animal is an exact genetic replica of the adult mammal from which the somatic cell nucleus was taken.”Campbell and Wilmut applied for patent protection for the somatic method of cloning mammals, as well as the clones themselves. They received a patent on their innovative method of cloning mammals in 2009 (U.S. 7,514,258). They also applied for a patent to the actual cloned animals —U.S. Patent Application No. 09/225,233 (the ’233 application). Claims of the ’233 application were directed towards the live-born clones of “cattle, sheep, pigs, and goats,” including these claims:
- A live-born clone of a pre-existing, non-embryonic, donor mammal wherein the mammal is selected from cattle, sheep, pigs, and goats.
- The clone of any one of claims 155-159, wherein the donor mammal is non-foetal.
Is Dolly Patent Eligible Subject Matter?
Section 101 of the Patent Act allows an inventor to obtain a patent for any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof. However, over the years the courts have ruled that laws of nature, natural phenomena, and abstract ideas are not eligible for patent protection even if they appear to fall within the scope of Section 101.The examiner of the’233 patent application rejected all of the application’s claims, as directed to patent ineligible subject matter. The PTAB upheld the examiner’s rejection on February 7, 2013. Following that ruling, the Roslin Institute appealed to the Federal Circuit.
In arguing that Dolly was a patentable invention, Roslin said that “Copies (clones) are eligible for protection because they are ‘the product of human ingenuity’ and not nature’s handiwork, but [their] own”. Roslin also argued that the claimed clones are distinct from the donor mammals from which they are created. In support of that argument, Roslin pointed out that:
- “environmental factors lead to phenotypic differences [observable characteristics such as shape, size, color and behavior] between its clones and their donor mammals that render their claimed subject matter patentable”; and
- “its clones are distinguishable from their original donor mammals because of differences in mitochondrial DNA, which originates from the donor oocyte rather than the donor nucleus.” (Mitochondria are organelles present in multiple copies inside a cell that convert chemical energy from food into a form that can be used by cells.)
The court responded to Roslin’s arguments about the differences between the clone animals and the original donor animals by noting that neither of the “phenotypic differences” or any “difference in mitochondrial DNA between the donor and claimed mammals” were claimed in the patent application.
Roslin also argued that “its clones are patent eligible because they are time-delayed versions of their donor mammals, and therefore distinct from their original mammals” to which the court responded, “[t]he difficulty with the time-delayed characteristic is that it is true of any copy of an original.”
Having rejected all of Rosin’s arguments, the court affirmed the finding of the PTAB that Roslin’s clones are unpatentable subject matter under §101. (More)
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