Federal Circuit rules that cloned animals are not patentable

Author: Eddy D. Ventose (School for Graduate Studies and Research, University of West Indies)

In Re Roslin Institute (Edinburgh) Fed Cir 2014, 8 May 2014

Journal of Intellectual Property Law & Practice (2014) doi: 10.1093/jiplp/jpu151, first published online: September 30, 2014

The Federal Circuit has held that a cloned animal, namely Dolly the Sheep, is not patent-eligible under s 101 of the US Patents Act.

Legal context

The claims at issue related to the '233 patent application, entitled ‘Quiescent Cell Populations for Nuclear Transfer’. The '233 patent application claimed the products of a particular cloning method for cattle, sheep, pigs and goats. Claims 155 and 164 were representative of the claims found in the '233 application. Claim 155 claimed 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 claimed the clone of any of claims 155–159, wherein the donor mammal is non-foetal.

On 10 November 2008, the examiner issued a non-final rejection of the '233 application holding that they were directed to non-statutory subject matter under s 101 of the US Patents Act as well as anticipated and obvious under ss 102 and 103. The Patent Trial and Appeal Board (Board) affirmed this decision on 7 February 2013. Although noting that the claimed clones ‘may be called a composition of matter or a manufacture’ as required by s 101, the Board concluded that the claimed subject matter was ineligible for patent protection under s 101 because it constituted a natural phenomenon that did not possess ‘markedly different characteristics than any found in nature.’ The applicant, Roslin Institute, appealed to the United States Court of Appeals for the Federal Circuit.

The opinion of the Federal Circuit

The technology

The Federal Circuit noted that Keith Henry Stockman Campbell and Ian Wilmut successfully produced the first mammal ever cloned from an adult somatic cell: Dolly the Sheep. It explained the technology used to create Dolly the Sheep as follows: a clone is an identical genetic copy of a cell, cell part or organism. The cloning method Campbell and Wilmut used to create Dolly constituted a breakthrough in scientific discovery. Known as somatic cell nuclear transfer, this process involves removing the nucleus of a somatic cell and implanting that nucleus into an enucleated (ie without a nucleus) oocyte. A somatic cell is any body cell other than gametes (egg or sperm). An oocyte is a female gametocyte (an egg cell prior to maturation), and a nucleus is the organelle that holds a cell's genetic material (its DNA). Often referred to as ‘adult’ cells, somatic cells are differentiated, ie, they are specialized to perform specific functions. For example, liver, heart and muscle cells are all differentiated, somatic cells. To create Dolly, Campbell and Wilmut fused the nucleus of an adult, somatic mammary cell with an enucleated oocyte. Specifically, Campbell and Wilmut found that if the donor, somatic cell is arrested in the stage of the cell cycle where it is dormant and non-replicating (the quiescent phase) prior to nuclear transfer, the resulting fused cell will develop into a reconstituted embryo. Once the nucleus of a somatic, donor cell is removed, that nucleus is fused with an oocyte, which develops into an embryo. The embryo can then be implanted into a surrogate mammal, where it develops into a baby animal. The resulting cloned animal is an exact genetic replica of the adult mammal from which the somatic cell nucleus was taken.

Patentability: first principles

The Federal Circuit observed, citing Mayo Collaborative Servs v Prometheus Labs, Inc, 132 S Ct 1289 (2012), that an invention that fell within one of the categories of patentable subject matter enumerated in s 101 of the Patents Act might still be ineligible for patent protection if it met one of three exceptions. Laws of nature, natural phenomena and abstract ideas, in its view, were not eligible for patent protection. It noted that, as recently as 2013, the Supreme Court in Association for Molecular Pathology v Myriad Genetics, Inc, 133 S Ct 2107 (2013) made clear that naturally occurring organisms were not patentable. And, as early as 1948, in Funk Bros Seed Co v Kalo Inoculant Co, 333 US 127 (1948), the Supreme Court held that a patent that claimed a mixture of naturally occurring strains of bacteria that helped leguminous plants extract nitrogen from the air and fix it in soil was not patent-eligible because the patentee did not alter the bacteria in any way. In other words, while the method of selecting the strains of bacteria might have been patent-eligible, the natural organism itself—the mixture of bacteria—was unpatentable because its ‘qualities are the work of nature’ unaltered by the hand of man.

In Diamond v Chakrabarty, 447 US 303, 309 (1980), the Supreme Court held that a claim to a genetically engineered bacterium (that was capable of breaking down various components of crude oil), which was created by adding four plasmids to a specific strain of bacteria, was patentable because it was ‘new’ with ‘markedly different characteristics from any found in nature and one having the potential for significant utility.’ In other words, the patentee's ‘discovery [was] not nature's handiwork, but his own.’

After reviewing Mayo, Funk and Chakrabarty, the Federal Circuit observed that discoveries that possess ‘markedly different characteristics from any found in nature’ were eligible for patent protection, adding that, in contrast, any existing organism or newly discovered plant found in the wild was not patentable. It also noted that, in Myriad, the Supreme Court held that claims for two naturally occurring, isolated genes (BRCA1 and BRCA2), which could be examined to determine whether a person might develop breast cancer, were invalid under s 101. In the Supreme Court's view, the BRCA genes themselves were unpatentable products of nature.

Application of first principles

The applicant, while not disputing that the donor sheep whose genetic material was used to create Dolly could not be patented, argued that the copies (clones) were eligible for protection because they were ‘the product of human ingenuity’ and ‘not nature's handiwork, but [their] own’. In addition, it argued that such copies were either compositions of matter or manufactures within the scope of s 101. However, the Federal Circuit countered that Dolly herself was an exact genetic replica of another sheep and did not possess ‘markedly different characteristics from any [farm animals] found in nature.’ It held that Dolly's genetic identity to her donor parent rendered her unpatentable. The Federal Circuit referred to the decision of the Supreme Court in Myriad that concluded that ‘isolated’, naturally occurring DNA strands were ineligible for patent protection. It explained that this case, as in Myriad, 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. Instead, Roslin's chief innovation was the preservation of the donor DNA in such a way that the clone was an exact copy of the mammal from which the somatic cell was taken. Consequently, such a copy was not eligible for patent protection.

The applicant stated that, for three reasons, the clones were patent-eligible because they were distinguishable from the donor mammals used to create them. The first was that ‘environmental factors’ lead to phenotypic differences that distinguished its clones from their donor mammals. In the Federal Circuit's opinion, these phenotypic differences (which were the result of environmental factors uninfluenced by Roslin's efforts) did not confer eligibility on their claimed subject matter. The second reason was that there existed differences in mitochondrial DNA, which originated from the donor oocyte rather than the donor nucleus. The Federal Circuit replied that (a) there was nothing in the claims, or even in the specification, that suggested that the clones were distinct in any relevant way from the donor animals of which they were copies and (b) the clones were defined in terms of the identity of their nuclear DNA to that of the donor mammals. It continued by emphasizing that having the same nuclear DNA as the donor mammal might not necessarily result in patent ineligibility in every case. However, in this case, the claims did not describe clones that had markedly different characteristics from the donor animals of which they were copies. The third was that the clones were time-delayed versions of their donor mammals, and therefore different from their original mammals. The Federal Circuit, applying the reasoning of the Board that the time-delayed characteristic simply meant that the clone was a true of any copy of an original, held that this distinction alone did not confer patentability.

Practical significance

The decision of the Federal Circuit reaffirms salient principles of patent eligibility emerging from the recent jurisprudence of the Supreme Court, namely (a) laws of nature, natural phenomena and abstract ideas are not eligible for patent protection; (b) naturally occurring organisms/products of nature are not patentable and (c) to be patentable, the claimed naturally occurring organism/product of nature must have ‘markedly different characteristics’ from any found in nature and must have the potential for significant utility. In the instant case, Dolly the Sheep was an exact replica of another sheep and it did not have any ‘markedly different characteristics’ from any of the farm animals found in nature. In other words, there was no new or changed genetic structure of the DNA used to make the clones—the claimed method was simply a process to preserve the donor DNA so that the clone was an exact copy of the mammal from which the DNA was derived.

The important point about this decision is that products of nature/naturally occurring organisms are not patentable per se but, to be patentable, the claimed invention must contain ‘markedly different characteristics’ from that found in nature and have potential for significant utility. The critical question, then, is: what are the criteria for determining when a clone would have those ‘markedly different characteristics’? Patentees should recite what those differences are in the patent specification, and even minor differences should be noted, even though they might prove insignificant if they are only meaningless limitations. Future Federal Circuit decisions might provide the necessary guidance on the criterion relating to ‘markedly different characteristics’. If the reasoning of the Federal Circuit is applied fully, there might arguably be no patent protection for stem cells grown in a laboratory (that replicate human stem cells) or even human organs also grown in a laboratory (if it were possible).

The Federal Circuit did however leave open the possibility that, notwithstanding this decision, patent protection might be available for clones when it remarked that ‘having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case’.

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