Association for Molecular Pathology v United States Patent and Trademark Office and Myriad Genetics, Inc, 689 F.3d 1903 (2012)
139 It is worth also examining some of the reasoning in the Court of Appeals for the Federal Circuit, in particular because it contains a more detailed analysis of the underlying chemistry, which is not in dispute in this proceeding. The arguments before the Federal Circuit were similar to those presently advanced.
140 The question was, similarly, the extent to which isolated nucleic acid, whether limited to cDNA or not, falls within the patentability exception for products of nature.
141 In coming to the conclusion that isolated DNAs, including cDNAs, are patent eligible subject matter under s 101, Lourie J cited the US Supreme Court decisions in Chakrabarty and Funk Brothers.
142 His Honour decided that the relevant question was whether a change in the claimed composition's identity compared to what exists in nature is such that when combined or altered in a manner not found in nature, the two compositions have similar characteristics or whether human intervention has given the composition 'markedly different or distinctive characteristics'. This has some similarity to the reasoning in NRDC.
143 As his Honour observed, some derision had been directed to his reliance on the fact of the breaking of chemical bonds to conclude that the isolated nucleic acid is in fact a different compound. That, as we read his Honour's reasons, does them injustice. The subject matter of the claims is a chemical compound, not pure information content. It cannot be inappropriate to view it as such. Judge Lourie said (at 1329) that a covalent bond is the defining boundary between one molecule and another, but that was not the sole basis for his Honour's reasoning. His Honour's conclusion was that, chemically, the isolated DNA molecule is a distinct chemical entity. It is not a purified form of a natural material. The claimed isolated DNA molecule does not exist as in nature. The point, as his Honour says at 1328, is that the claim is to a composition 'having a distinctive chemical structure and identity' from that of a native element, molecule or structure such that it has a markedly different chemical nature from the native DNA. In describing a distinction between an isolated gene and a leaf snapped from a tree, Lourie J incorporated matters that are reflected in NRDC, namely that isolated genes provide useful diagnostic tools and medicines - and so are within the concept of economic significance considered important by the High Court.
144 In dealing with the submission that the claims were to mere reflections of a law of nature, Lourie J said that they are not so any more than any product of man reflects and is consistent with the law of nature: 'everything and everyone comes from nature, following its laws', whereas these claims are to 'the products of man'. These words bear resemblance to the High Court's reasoning in NRDC.
145 Judge Moore was also alive, with respect, to the distinction between claims to subject matter that had previously existed in nature exactly as claimed, and the present case. Apart from citing Funk Brothers and Chakrabarty, her Honour referred to Parke-Davis & Co v HK Mulford Co, 189 F 95, 103 (SDNY 1911) where purified adrenaline was considered patentable subject matter because it was 'for every practical purpose a new thing commercially and therapeutically'. Similarly, in Merck & Co. v Olin Mathieson Chemical Corp, 253 F.2d 156 (1958), the Fourth Circuit found purified vitamin B12 to be patentable, because it had 'such advantageous characteristics as to replace [the naturally occurring] liver products. What was produced was, in no sense, an old product'; this was in contrast to "mere" purification, where the purified subject matter was of a naturally occurring element with inherent physical properties unchanged upon purification. Judge Moore applied Funk Brothers and Chakrabarty and said that she found 'no reason to deviate from this longstanding flexible approach in this case'.
146 Again, turning to the chemistry, her Honour noted that DNA is a polymer, made up of repeating monomer units connected by chemical bonds to form one larger molecule. The process of polymerisation of the monomer units results in a new molecule, as polymerisation changes the monomers to result in a molecule with a different molecular charge, different chemical bonds and a different chemical composition as compared to the monomers in aggregate. A fragment of a DNA sequence has different properties to that of the parent molecule from which it is derived. These considerations led her Honour to conclude (at 1341) that just because the same series of amino acids appears in both the chromosome and an isolated DNA sequence does not mean that they are the same molecule. Her Honour said that man must create these isolated DNA molecules. This can be accomplished by constructing them using biochemical means, or by chemically altering the larger polymer to cleave off adjacent portions.
147 Her Honour pointed to other differences between isolated DNA and the nucleic acid sequence as it exists as part of the chromosome. Creating isolated DNA allows a scientist to remove potentially confounding sequences that are naturally present in a larger chromosome or polymer and instead to focus just on the sequence of interest (at 1342). Isolation also results in a substantially smaller molecule. Her Honour criticised a simple structural comparison as failing to recognise that chemical changes to the isolated DNA sequences, as compared to the natural state, could result in markedly different uses.
148 The removal of the DNA from the chromosome also has, as Moore J observed at 1342, important practical consequences leading to additional utility, for example, use of the DNA as a primer. Her Honour's use of language is of some interest. cDNA has a unique sequence of DNA bases which is not actually present in nature and does not include introns. In discussing cDNA, her Honour recognised that it is "inspired by nature", noting that naturally occurring RNA is the template upon which cDNA is constructed. However, the differences have a consequence even apart from the chemical structure to that of DNA. These include:
greater stability for the DNA sequences compared to the RNA sequence;
a distinctive name, character and use;
different chemical characteristics from either the naturally occurring RNA or in a continuous DNA sequence found in the chromosome; and
that cDNA sequences are the creation of man.
149 Judge Moore did not think that the differences in the chemical structure of isolated DNAs as compared to the corresponding native DNA was alone sufficient to make isolated DNA so markedly different from chromosomal DNA so as to be per se patentable subject matter (at 1343). Her Honour also said that the mere fact that the larger chromosome or polymer includes the same sequence of nucleotides as the smaller isolated DNA is not enough to make it per se a law of nature and to remove it from the scope of patentable subject matter. Judge Moore said that the appropriate course was to consider whether the differences impart a new utility which makes the molecules markedly different from nature. Judge Moore summarised the differences in function and utility of the isolated nucleic acids and the greater range of utility they provide as relevant to patent eligibility. Her Honour noted that the shorter isolated DNA sequences have a variety of applications and uses in isolation that are new and distinct as compared to the sequence as it occurs in nature. For example, they can be used as primers in diagnostic screening processes to detect gene mutations and as probes. As she noted, naturally occurring DNA cannot be used to accomplish these same goals because 'unlike the isolated DNA, naturally occurring DNA simply does not have the requisite chemical and physical properties needed to perform these functions' (at 1341).
150 Judge Bryson, in dissent, concluded that 'Myriad is claiming the genes themselves'. His Honour looked to what he regarded as the only material change made to those genes, which he said was necessarily incidental to the extraction of the genes from the environment in which they are found in nature. He concluded that this meant that the isolated genes were not materially different than the native genes and drew on the metaphors of a "new mineral discovered in the earth", "a new plant found in the wild" compared to a baseball bat that is "extracted" or "isolated" from an ash tree, necessarily changing the nature, form and use of the ash tree and thus results in a man-made manufacture, with a function entirely different from that of the raw material from which it was obtained and not a naturally occurring product.
151 The breaking of the chemical bonds was, in his Honour's view, simply necessary to uphold the gene in its place in the body while the genetic coding sequence remained the same. The isolation process was, he said, 'according to nature's predefined boundaries; i.e., at points that preserve the ability of the gene to express the protein for which it is coded' (at 1352). That is, his Honour held that they were not "the products of invention". In that regard, he likened the new uses to which an isolated nucleic acid sequence could be put to extracting minerals or taking plant cuttings from wild plants.
152 Noting that the claim covers all isolated DNAs coding for the BRCA1 protein, with the protein being defined by the amino acid sequence encoded by the naturally occurring BRCA1 gene, Judge Bryson noted the very large number of molecules that were thereby claimed, which included variations that Myriad had not yet discovered. His Honour noted that the unifying characteristic was the naturally occurring BRCA1 gene. His Honour turned to the similarities and pointed out that the isolated genes and the naturally occurring genes have the same sequence code to the same proteins and represent the same units of heredity.
153 Judge Bryson focussed on the similarity in structure and the similarity in utility between the isolated nucleic acid and its naturally occurring counterpart, whereas Lourie and Moore JJ focussed on the differences between the isolated and naturally occurring DNAs. Judge Bryson formed the view that the informational content of the nucleotide sequences was the critical aspect of the molecules.
154 Judge Bryson agreed with the majority that cDNA was patent eligible despite the fact that, as his Honour characterised it, 'that process occurs with natural machinery'. The end product was, in his Honour's view, a human made invention with a distinct structure, with the introns that are found in the native gene removed from the cDNA segment and where the cDNA has additional utility.
155 With respect, we find the reasoning of Lourie J and Moore J, based on an analysis of the products as products and not on the information that they contain, to be consistent with patent law, and persuasive. Similarly, we agree that, consistent with NRDC and Australian law, the analysis should focus on differences in structure and function effected by the intervention of man and not on the similarities.