Remember Dolly the sheep? She was the first mammal to be cloned from an adult somatic cell (a cell other than a sperm or egg cell) – that was in 1996. Well, Dolly is back again in the news, even though she passed away prematurely in 2003.
Last Thursday (May 8, 2014) the Court of Appeals for the Federal Circuit affirmed a ruling by the US Patent and Trademark Office’s Appeal Board that cloned animals are ineligible for patent protection under 35 USC § 101. The Court determined that “Dolly herself is an exact genetic replica of another sheep and does not possess markedly different characteristics from any [farm animals] found in nature.” The Court went on to say, “Dolly’s genetic identify to her donor parent renders her unpatentable.” See In re Roslin Institute (Edinburgh), 2013-1407.
The timing of this Federal Circuit decision is uncanny, because it came literally on the eve of a public forum held at the US Patent and Trademark Office on the very topic of the recent Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products (the Guidance). I was invited to present at this Forum, where I provided comments before the USPTO on the necessity for the guidance, how the guidance can be improved, and also provided cautions to prevent its misapplication. I had previously written about the Guidance in an earlier article on this site (see, How to Patent Grapefruit Juice: the New USPTO Guidance for Patent Eligible Subject Matter is Both Sticky and Sour).
The method for cloning Dolly was not at issue in this Federal Circuit case. In fact, the cloning method is described in the inventors’ previously issued US Patent No. 7,514,258. What was at issue was a further patent application, U.S. Serial No. 09/225,233, with claims directed to the cloned animals themselves. In rendering its decision, the Court relied on the recent Myriad and Mayo Supreme Court decisions, as well as the earlier Chakrabarty and Funk Bros. decisions. The Court even used a somewhat disturbing analogy, in explaining that a cloned farm animal would not be patentable just as a copy of a lamp already in the public domain would not be patentable. See Sears Roebuck & Co. v Stiffel Co., 376 U.S. 225 (1964).
In a somewhat feeble attempt to support their case, the patent applicants did proffer, what I would describe as three after-the-fact arguments. Firstly, the applicants argued that their clones are patent eligible because they are phenotypically distinguishable from their donor parent. (An animal’s phenotype is its observable characteristics such as shape, size, color, etc., which even though genetically determined can be affected by the animal’s interaction with its environment – e.g., diet, climate, etc.) Next, the applicants further argued that their clones are distinguishable from their donor parent because the mitochondrial DNA is different. [Without going into a lengthy discussion of molecular biology, suffice it to say that Dolly was produced by removing the nucleus (where the genetic material is stored) from an adult donor cell, and implanting that nucleus (along with the genetic material) into an egg cell from which its nucleus had been previously removed. However, the recipient egg cell still contains its own mitochondrial DNA which is necessary for providing the very energy for keeping the egg cell alive.] The Court did not buy either of these first two arguments, and pointed out that the patent claims did not recite either this phenotypic or mitochondrial DNA difference, which the applicants were now arguing to be so important. Finally, the applicants argued that their clones are “time-delayed” copies of their donor parent, and therefore different from and distinct from their original. In response the Court pointed out that the USPTO had correctly noted that “[t]he difficultly with the time-delay characteristic is that it is true of any copy of an original” [even of a photocopy, I might add]. Net, based on all of the foregoing, and in a rather short opinion, the Court held that the clones are unpatentable subject matter under § 101. It is likely this case will be appealed and that the Supreme Court will further weigh in.