10 May, 2014

Can You Patent Clones?

As this humble writer is an identical twin, the existence of two things which are at least genetically almost exactly the same, was never in doubt and almost seemed mundane at times. Yet for others this may not be this easy to comprehend, and can almost act as a novelty of sorts. A subject matter of pure science fiction, cloning has always been a topic of great discussion, even outside of genetic oddities such as identical twins. Although personally this writer has never indulged in the idea of patenting his own sibling, the question has risen with regards to clones in the United States in a recent case a mere few days ago.

The decision in question is In Re Roslin Institute, which was dealt with in the US Court of Appeals early this month. The case concerned the creation of a woolly mammal, Dolly the Sheep, by Keith Henry Stockman Campbell and Ian Wilmut in Edinburgh Scotland in the mid-1990s. Dolly was cloned through a method called somatic cell nuclear transfer, where the nucleus of a cell is removed and planted into an enucleated oocyte; the female's egg cell prior to it maturing. By fusing the two Mr. Campbell and Mr. Wilmut could create an embryo, which could subsequently be implanted into a surrogate mammal, creating a cloned copy of the animal from which the original nucleus is taken from as a baby animal. The creator's of this new cloned mammal were awarded a patent for the process in 2009; however the patent was not at issue in this case. What was at issue was their US Patent Application No. 09/225,233, which was initially rejected by the Patent Trial and Appeal Board and then appealed.

Lauren was disappointed not being able to patent her sister
Under contention in their '233 application were a few claims, more specifically claims 155 and 164: "155. live-born clone of a pre-existing, nonembryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats... [and] 166. The clone of any of claims 155-159, wherein the donor mammal is non-foetal". The case is one of the first to apply the new Myriad Genetics Supreme Court decision (more on which can be found here and here), where the Court saw that isolated genes cannot be patented as they were naturally occurring and not "...markedly different" from their natural forms. Roslin did argue that clones "...[are] the product of human ingenuity... [and] not nature’s handiwork, but [their] own". Clearly on the outset one can argue that a genetic clone, although clones by humans, is still the handiwork of nature as the clone is still a near identical copy to the original cell donor. Further proving this very point, the court pointed out that Dolly does not have "...markedly different characteristics from any [farm animals] found in nature", even though the process of cloning was one done by man. To put things bluntly: "Roslin did not create or alter any of the genetic information... of its claimed clones... [n]or did [Roslin] create or alter the genetic structure of [the] DNA used to make its clones". Clearly therefore the clone cannot be patented, as it is not markedly different from the original cell donor.

The Roslin Institute did argue that the resulting animal would be different from the donor animal in terms of phenotypic differences, such as size, color and shape. The claims contain nothing pertaining to differences in phenotype, and what is claimed still maintains the genetic copy, which would be natural and have no marked differences. This was discussed in the Funk Bros. Seed v Kalo Inoculation: "[t]heir qualities [i.e. phenotypes] are the work of nature. Those qualities are of course not patentable. For patents cannot issue for the discovery of the phenomena of nature".

Justices Dyk, Moore and Wallace dismissed the appeal, and therefore closed the door on patenting clones, at least to some extent: "To be clear, having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case. Here, however, the claims do not describe clones that have markedly different characteristics from the donor animals of which they are copies[, therefore making them ineligible]". Some opinions have been given against this decision, such as Pilar Ossorio who saw that "[t]his ruling is taking away an incentive for research organizations to pursue more research into cloning, at least on the margins".

The impact of this decision can be said to potentially negatively affect the future of cloning, and more so cloning either in agriculture or medicine. The court did still leave the patentability of clones open for future consideration, however on the face of the decision it seems highly unlikely unless the new clones are markedly different from the original organism from which they are cloned.

Source: JDSupra

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