Would the Orphan Black Clones be Patentable?
By Science Consultant Cosima Herter
You may have noticed Dolly the famous cloned sheep being resurrected in the news again lately.  Why? After all these years, why do we still care about Dolly? Most of us are familiar with Dolly’s story, it’s old news now: in 1996, Keith Campbell and Ian Wilmut, at the Roslin Institute in Edinburgh, successfully cloned the first mammal (Dolly) by somatic cell transfer. They filed a patent application for the products of the cloning procedure in 1999 (09/225,233); it was rejected, and they appealed. Like many cases regarding the patentability of living subject matter their appeal remained in court for several years. Finally, on May 8, 2014 the United States Court of Appeals for Federal Circuit rejected the final appeal, concluding that the “the claimed subject matter was ineligible for patent protection … because it constituted a natural phenomenon that did not possess ‘markedly differently characteristics than any found in nature’.”  Insofar as law depends on historical precedents, and there are surprisingly few precedents by which patenting of genetic material are based on, this decision in particular contributes to that body of precedents by which other cases may be decided.
Nobody doubts that Dolly was a result of human ingenuity, and the process by which she was patented certainly constituted a scientific breakthrough for which Campbell and Wilmut did successfully obtain a patent (U.S. Patent No. 7,514,258). But being an exact replica of her naturally occurring counterpart barred Dolly from being a patentable invention. That is to say, because Dolly was genetically identical to that which was already found in nature – namely the donor ewe from which the nucleus was taken – and the DNA she was cloned from hadn’t been significantly manipulated in any way that made her markedly different from the original donor, she couldn’t be considered an eligible product for patent protection. Dolly was both structurally and functionally identical the ‘mother’ cell.
In 1952 the revised statutes for the U.S. Patent Act codified “anything under the sun that is made by man” as being patentable subject matter. This means that laws of nature, naturally occurring physical phenomena, and abstract ideas do not qualify as patentable. There are three basic criteria that an application must meet to obtain a patent: usefulness, novelty, and non-obviousness. An invention may meet some of the requirements, but to qualify for a patent it must meet all of them. It isn’t enough that something be ‘man-made’ and is radically different from anything else that already exists (ie non-obvious), it also needs to be proven that it has some kind of functional utility. So, for example, if I invent a new helicopter rotor made out of kale, certainly it would be considered novel and man-made, but it would hardly prove to be of any use. But when it comes to patenting biological material, it isn’t always entirely clear, or consistent, how those criteria can be applied to living subject matter. Indeed, patent applications for living subject matter are determined on a case-by-case basis, and each of the criteria mentioned are often interpreted in various ways as pertains to each specific case at hand. This is why precedents in patent law (any law, for that matter) are so important. History matters. It is the basis by which new legal decisions can be measured and made.
Lest there be any doubt, living matter can be patented. The U.S. Manual of Patent Examining Procedure explains that “whether or not an invention embraces living matter is irrelevant to the issue of patentability.” However, while living matter in the most general sense can be patented, there is a limitation on issuance of patents on human organisms, specifically: “Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.” That is to say, “[T]he U.S. Patent Office has already issued patents on genes, stems cells, animals with human genes, and a host of non-biologic products used by humans, but it has not issued patents on claims directed to human organisms, including human embryos and fetuses.” So, with this provision, the answer to whether human clones could be patented is quite simple: no, human clones would not qualify as patentable.
However, there is an interesting issue that arises here when organisms have been biologically engineered in such a way that their species characteristics are called into question. Dolly wasn’t patentable because her genome wasn’t structurally or functionally different. And both her creators and the courts agreed that she wasn’t a new species. Indeed, creating a new species wasn’t Campbell and Wilmut’s intent. But what her genome had been tinkered with enough to have designated her a new species? More and more we are finding press releases that announce the creation of new artificial organisms. But how many of those actually constitute new species, and not simply synthetically constructed replicas of species already occurring in nature?
How to correctly identify what constitutes a species – here one species ends’ and another ‘begins’ – is an issue that even evolutionary biologists, taxonomists and systematists (those who study and attempt to determine phylogenetic relationships amongst organisms) often hotly debate. Species are conventionally differentiated by their (in)ability to naturally reproduce with one another, but this becomes complicated when we attempt to determine taxonomic divisions on a molecular level (ie by genome alone). Exactly which parts of, and how many genetic sequences within, an organism’s genome determine that it is a unique species? Put another way, how much, and which parts, of the genome would need to be altered to determine it to be a different species than one found in nature?
Transgenic organisms, despite having their genes significantly altered to produce new properties or characteristics, do not necessarily constitute new ‘species.’ And artificially constructing (in part, or in entirety) organism alone does not necessarily designate it as a new species either – despite the tinkering and man-made bits. But if it were possible to agree on whether some DNA had been structurally and functionally altered to such a degree that while its appearance may match the species found in nature, its genome was significantly different enough to designate it a new species, could it be patentable on this fact alone? If the answer is found to be yes, then might it then be possible that a human genome could be radically altered enough so that it may still look like a human, but, genetically, can no longer taxonomically defined as homo sapian?
I don’t know the answer to that. In fact, I don’t think anyone at this point has an answer to that question. But the speed at which bioengineering produces new biological products, it’s a question that may be worth considering (despite seeming entirely far-fetched at this point).
↩ See for example the recent article by Jacob Gershman, “Dolly the Cloned Sheep Isn’t Patentable, Appeals Court Rules,” Wall Street Journal, May 9, 2014.
↩ See Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Serial No. 09/225,233. May 8, 2014. p.4.
↩ Leahy-Smith America Invents Act (AIA), Pub. L. 112-29, sec. 33(a), 125 Stat. 284.Read More