By Samini Thiruchelvam & P. Kandiah
Dolly was the very first cloned animal and it carried the hopes of cloning enthusiasts for improved drug production and possibly, revival of endangered species. The fathers of Dolly – Keith Henry Stockman Campbell and Ian Wilmut from the Roslin Institute of Edinburgh (“Roslin”) – created Dolly in 1996 from the udder cells of a 6-year old lamb after 276 painstaking attempts. Sadly, Dolly did not live long as she was put to sleep due to a progressive lung disease and severe arthritis on 14th February 2003.
The cloning method which was used to create Dolly is known as somatic cell nuclear transfer (SCNT). This method is patented in many countries including the United States of America and is published as US Patent No. 7,514,258. Roslin had also filed another application, US Patent Application no. 09/225, 233 (‘233 application) which claims ownership of Dolly and other clones (cattle, sheep, pigs and goats).
However, the United States Patent and Trademark Office (USPTO) rejected the ‘233 application on the grounds that laws of nature, natural phenomena, and abstract ideas cannot be patented, citing a US federal law. Unsatisfied with the outcome, Roslin appealed the decision at the Patent Trial and Appeal Board. Once again, Roslin received an unfavourable result from the Board which upheld the ruling and alleged that the subject matter constituted a natural phenomenon which did not possess “markedly different characteristics than any found in nature”.
Roslin then proceeded to appeal to the US Court of Appeals for the Federal Circuit in Washington, DC. On 8th May 2014, the Appeal Court too, ruled against Roslin’s application for being unpatentable subject matter. In the proceedings, Roslin argued that the clones are indeed man-made and distinguishable from donor mammals based on three criteria: i) environmental factors lead to phenotypic differences of the clones, ii) clones are distinguishable from their donors due to differences in mitochondrial DNA, and iii) clones are time-delayed versions of their donor mammals. The judges decided that Roslin’s arguments were not convincing as Roslin has failed to claim the differences caused by the environmental factors and the mitochondrial DNA in their application. Further, the Court rejected the third argument on the basis that time-delayed characteristics still consist of a true copy of an original. Judge Timothy Dyk, one of the judges in the proceedings, wrote in the decision that, “Dolly’s genetic identity to her donor parent renders her unpatentable”.
The ruling brought despair to cloning proponents and researchers but it was certainly expected in view of outcome of the Association for Molecular Pathology v. Myriad Genetics case in which the US Supreme Court denied patents on isolated sequences of DNA. Also, the judges referred to the ruling of Diamond v. Chakrabarty which deems naturally occurring organisms as a non-patentable subject matter.
What does this ruling mean to the research community? Some argue that denying patents for subject matters that are identical to products of nature will impede research as private funding may be reduced. If a right to monopolise an invention is not granted, it will most likely render the invention uninteresting to potential investors. Of course, patents are still available for methods of producing a product but it is undeniable that product patents confer better protection and are considerably more valuable.
Inevitably, the ruling against patents for clones may cause dissatisfaction towards the patent system as the researchers’ efforts and talents go unacknowledged. To draw an example, a robotic sheep with wires and steel is eligible for patent but a man-made living sheep with blood and flesh does not qualify for a patent. This creates a double-standard in the patenting system as more effort and knowledge are put into perfecting the sheep and to create something close to nature’s creation but it is not acknowledged by the patent system.
We turn to the claims of ‘233 application which were in debate in order to obtain a clearer picture of the justification behind the Court’s decision.
Claim 155: A live-born clone of a pre-existing, non-embryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs and goats.
Claim 164: The clone of any of claims 155 – 159, wherein the donor mammal is non-foetal.
Claim 155 may be considered broad as it claims all clones regardless of the method of producing the clones. This means the applicant can take action on others who produce clones using not only the SCNT method but also other cloning methods. Thus, allowing this claim may deter other researchers from patenting their clones regardless of the method used. A narrower claim may be granted in this case, perhaps a product-by-process claim, which limits the product (clones) to the method through which it was produced.
The ruling on the Dolly patent does not necessarily mean that clones are not patentable. As emphasised by Roslin’s attorneys, clones are not perfect copies of the donor mammals as the presence of mitochondrial DNA will provide features that distinguish the clones from the donors. When drafting the patent claims, it is important to include the features of the clones which can distinguish them from the donors.
What about human cloning? Should the patent office allow the patenting of human clones? It would be unethical to patent human clones and should not be endorsed at all costs, as it involves ownership of a human being (or rather a human clone). A patent office that grants patents on human clones is yet unheard of. However, patenting a method of cloning a human should be allowable as it does not cover protection on human clones but only on the methods of the production. This was demonstrated in the grant of US Patent No. 6,211,429 to the University of Missouri in 2001. The patent involves the cloning of mammals (which include humans). However, the claims of this patent are directed only to a method for producing the clones and not the clones. Such patents should be allowable as it is necessary to acknowledge the talent of the researchers without turning human clones in to a commodity.
It is not certain if Roslin will appeal against the decision of Federal Court. However, it should be an interesting case to see where the line is drawn with regard to human cloning and perhaps, if the Court’s decision will be justified by antislavery enactments.
* first published in the September 2014 issue of The Petri Dish (www.bic.org.my/the-petri-dish)