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Case Note
Association for Molecular Pathology v Myriad Genetics Inc: Are Genes Information or Molecules?
Jack Orford[&]
Abstract
This case note considers the recent landmark decision of the US Supreme Court on the patentability of genes in the United States. It does not seek to reopen the wide debate as to the propriety of such patents. Instead, it places the decision in the context of existing jurisprudence about the patent eligibility of naturally occurring chemicals. The Myriad decision is scrutinised from the point of view of the underlying science; its consistency with prior case law; the coherence of the distinctions drawn to support the Court’s conclusion; and the manner in which the Court discharged its role as a court of final appeal.
In 1990, a research group led by Dr Mary-Claire King reported, in the journal Science, statistical evidence strongly linking the 17q21 region of human chromosome 17 to early-onset familial breast cancer.[1] In the wake of Dr King’s publication, Myriad Genetics Inc (‘Myriad’) was formed by Dr Mark Skolnick, a geneticist, and a venture capital firm with an interest in the area.[2]
In 1994, Myriad and its collaborators were able to locate (beginning with the known region), and eventually sequence, the precise gene in question.[3] An iterative process, known as gene mapping, was used to correlate the inheritance of known and discovered DNA ‘markers’ with the incidence of cancer among kindreds, thereby progressively narrowing the location of the gene.[4] Sweet DJ described Myriad’s work as involving ‘considerable effort’ and ‘ingenuity’, but nonetheless based on techniques well-understood, and uniform, in the art.[5]
This gene is now known as ‘BRCA1’ (Breast Cancer Susceptibility Gene 1), and is the subject of a US patent held by Myriad.[6] In 1995, as the result of further work and collaboration, Myriad filed for a patent on a second gene linked to breast cancer, unimaginatively called ‘BRCA2’.[7]
Myriad discovered that the ‘wild-type’ (most frequent) form of BRCA1 is not correlated with breast cancer incidence, but that certain mutated versions of the gene are.[8] This discovery formed the basis of a number of genetic predisposition tests for women, subsequently offered by Myriad commercially.[9]
Myriad’s patents, which claimed the isolated and purified DNA molecules representing the BRCA1 and BRCA2 genes, were challenged in the present litigation as directed to inherently unpatentable subject matter. Before considering the claims in issue, it is convenient to define some important biomolecules — DNA, cDNA, and RNA — and explain their significance to modern biotechnology.
The gene is the fundamental unit of heredity in living organisms. There is no universal definition of the gene, which remains fluid, but it suffices for present purposes that a gene is ‘[a] locatable region of genomic sequence, corresponding to a unit of inheritance’.[10] Almost all cells in the human body contain, in their nuclei, the 23 pairs of chromosomes that constitute the human genome. Each chromosome is a tightly bound continuous chain of DNA (which plays host to many individual genes) and associated proteins.[11] This will be referred to as ‘gDNA’ (genomic DNA).
DNA is a polymer of individual units known as ‘nucleotides’.[12] Each nucleotide carries one of four bases, designated A, T, C and G for short.[13] They consist of the natural pairs A and T, and C and G. A single strand of DNA (ssDNA) is not helical; but when combined with a complementary strand (where the base A aligns with T, and C with G), the now-famous double-helical structure is formed.[14] ‘Gene’ can thus refer to the DNA molecule carrying a sequence, or the nucleotide sequence itself.
DNA is the ultimate ‘source code’ for the vast array of proteins manufactured by each cell in the human body — this is part of the so-called ‘central dogma’ of molecular biology.[15] Proteins are incredibly diverse, make up most of the dry mass of the human body, and are the ‘workhorses of the cell’ and, by extension, of life.[16] The process of producing a protein from DNA is referred to as ‘expression’ of the gene that codes for the protein. It begins with transcription of the sequence into ‘precursor messenger RNA’ (pre-mRNA), a molecule structurally very similar to DNA.[17] Pre-mRNA then undergoes post-transcriptional modification, including a process known as ‘splicing’, whereby sections of RNA are excised.[18] Parts of a gene that are excised by splicing are referred to as ‘introns’; the retained segments are known as ‘exons’.[19] The mature mRNA, consisting only of exons, then carries the sequence information to ribosomes in the cell, which produce the corresponding protein. Proteins are themselves polymers, but of amino acids. Each series of three nucleotides on the mRNA chain is an instruction to add one of 20 amino acids to the nascent protein.[20]
Since the 1970s, scientific discovery has gradually eroded the prevailing ‘one gene–one protein’ hypothesis.[21] It is now accepted that single genes may code for several, hundreds, or even thousands of different proteins by ‘alternative splicing’ of pre-mRNA: various exons may be skipped or extended, and introns may be retained.[22]
Messenger RNA is useful for geneticists because it omits large portions of the genetic code that are not essential for production of the encoded protein (conventionally, introns). They have already been removed by splicing. It is also common in the art to artificially produce complementary DNA (cDNA) using mRNA as the template. This yields a much smaller portion of DNA that ‘corresponds’ to native DNA — in the sense of coding the same protein — but with a significantly shorter nucleotide sequence.
This process is important for the ubiquitous practice of gene cloning, essential to modern bioscience; and, in particular, to recombinant DNA technologies.[23] These techniques permit a host organism’s cells to be co-opted into expression of artificial proteins through the introduction and insertion (‘transfection’) of foreign DNA into the host genome. A living host will then express the encoded protein. It ‘enabl[es] the development of living protein factories’[24] that may be put to work to serve a greater purpose. For example, today a great deal of insulin — a human protein — used for treatment of diabetes is manufactured by artificial expression in simple organisms. Synthesis from scratch is far less economic, even though insulin consists of a mere 51 amino acids (paltry by proteomic standards). The global litigation in Kirin-Amgen considered Amgen’s ‘highly valuable’[25] patent for isolated DNA encoding erythropoietin (EPO), a significantly larger protein that stimulates red blood cell production and is used to treat anaemia.[26]
In Myriad (Supreme Court), only nine claims — all composition (that is, product) claims — were in issue.[27] The Supreme Court specifically disavowed any intention to speak to the law governing method claims. The representative claims (all of the ‘282 patent) were:[28]
• Claim 1 — ‘“An isolated DNA coding for a BRCA1 polypeptide [protein],” which has “the amino acid sequence set forth in SEQ ID NO:2.”’ SEQ ID NO:2 was a list of the 1,863 amino acids ordinarily encoded by the wild-type BRCA1 gene. As the Supreme Court observed, this claim covered any isolated DNA sequence that would cause a cell to produce the described ‘BRCA1 amino acids’ — that is, the BRCA1 protein.
• Claim 2 — ‘“The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.”’ SEQ ID NO:1 was the cDNA sequence coding for the BRCA1 amino acids — that is, the exon-only sequence. Claim 2 was thus for a sub-set of claim 1.
• Claim 5 — ‘“An isolated DNA having at least 15 nucleotides of the DNA of claim 1”’, which the Court took to mean a contiguous series of 15 nucleotides.
• Claim 6 — ‘“An isolated DNA having at least 15 nucleotides of the DNA of claim 2.”’
Myriad’s claims to methods of analysing patient DNA sequences to discover cancerpredisposing mutations were unanimously held invalid by the Court of Appeals as directed only to abstract mental processes.[29] According to the plaintiffs, Myriad’s product claims still obstructed diagnostic testing employing methods that were different to Myriad’s, but which nonetheless needed to use the isolated DNA claimed.[30]
The United States Patent Act 1952 provides, by § 101, for grants of patents to:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof ... subject to the conditions and requirements of this title.[31]
Myriad’s product claims were challenged as not directed to patentable subject matter, a requirement § 101 is said to embody by implication. In its recent decision in Mayo, the US Supreme Court recounted the longstanding exclusion of ‘laws of nature, natural phenomena, and abstract ideas’ from the patent domain.[32] The exception is itself subject to ill-defined limits, since at some level every invention must ‘rest upon, or apply laws of nature’.[33] In Chakrabarty, the Supreme Court expressed the consequences of the rule in this way:
a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E = mc2; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of ... nature, free to all men and reserved exclusively to none.’[34]
The principle that such things are not the proper subject of letters patent is as widely acknowledged in patent law globally as it is obscure. In Chakrabarty, the Supreme Court concluded that Congress’ intention was that patentable subject matter should include ‘anything under the sun that is made by man’.[35] Demaine and Fellmeth observe that even if everything under the sun made by man is patentable, not everything ‘found or learned’ need be.[36] The fundamental issue as it relates to gene patenting is that:[37]
the extent to which ... biological research is patentable depends on whether the resulting products and processes are treated as discoveries or inventions. The reason for this is that discoveries as such are excluded from the remit of patentable subject matter.
The scope of the exception has for a long time, yet surprisingly infrequently, occasioned dispute in relation to pharmaceuticals and other useful chemicals that have been discovered, isolated, and/or purified from nature. Myriad tested the application of this principle to isolated and purified DNA, and to cDNA with sequences that code for natural proteins. While the rule in its application to simple pharmaceuticals seems to have been of largely academic interest,[38] by addressing DNA itself Myriad was positioned at the centre of the raging public and political debate over the propriety of allowing monopolisation of the building blocks of life.[39] Such patents are viewed by some as ‘amount[ing] to ownership of the essence of humanity’.[40]
In the District Court, Sweet DJ carried out an extensive (by comparison with the Supreme Court) examination of the case law on purified natural products. His Honour took American Wood-Paper as authority that purified natural compounds, without more, are not patentable; and referred with apparent approval to a case invalidating a patent claiming the element tungsten (General Electric).[42] His Honour also referred to the Supreme Court in American Fruit Growers, holding that a manufacture must involve transformation: ‘a new and different article must emerge having a distinct name, character, or use’.[43] Merck, which held vitamin B12 — a known compound — was patentable as ‘more than a “mere advance in the degree of purity of a known product”’,[44] fortified Sweet DJ’s view that the ultimate question was whether ‘a new or distinctive form, quality, or property’[45] had emerged.[46]
1 Isolated DNA
Unlike natural products useful as drugs, DNA ‘serves as the physical embodiment of laws of nature — those that define the construction of the human body’.[47] Natural products like adrenaline — the subject of patent claims previously enforced in Parke-Davis[48] — instead only embody ‘information about [their] own molecular structure incidental to [their] biological function’.[49] His Honour held that the comparison was to be made by considering the similarities between isolated DNA and gDNA, excluding associated proteins from the latter.[50] The ‘overriding importance’ of DNA’s function meant mere isolation of the DNA by severing of chemical bonds could not make the isolated DNA ‘markedly different’ from gDNA and so could not take it beyond the exception.[51] Myriad argued the isolated DNA was ‘markedly different’ because, unlike gDNA, it was suitable and useful as a primer or sequence probe.[52] The argument received short shrift because ‘the cited utility ... is primarily a function of the nucleotide sequence identity between native and isolated ... DNA’.[53]
2 Complementary DNA (cDNA)
His Honour’s approach to cDNA belied treatment of DNA and RNA as information, rather than molecules: the ‘splice variants represented by these [claimed] cDNAs are the result of the naturally-occurring splicing of pre-mRNA into mature mRNA’.[54] It did not matter that the claimed cDNA does not normally occur naturally[55] — the information does, in the form of mRNA. The nucleotide sequence, if not the molecule itself, is dictated by nature.[56] The cDNA was therefore not patentable.
1 Lourie J (Moore J concurring)
Lourie J held the isolated DNA claims patent-eligible since ‘the claims cover molecules that are markedly different — have a distinctive chemical structure and identity — from those found in nature’.[57] His Honour thought ‘isolated DNA is not just purified DNA’, and on that basis distinguished Re Marden and Parke-Davis.[58] It was a different molecule, ‘obtained by human intervention’.[59] It was not their informational content, physiological use, or function that needed to be distinctive (as Sweet DJ had held), but their distinctiveness as ‘isolated compositions of matter’.[60]
We recognize that biologists may think of molecules in terms of their uses, but genes are in fact materials having a chemical structure and, as such, are best described in patents by their structures rather than by their functions. In fact, many different materials may have the same function (e.g., aspirin, ibuprofen, naproxen).[61]
A fortiori, cDNAs were regarded as patenteligible.
Moore J concurred in the outcome, but was more comfortable situating cases like Parke-Davis and Re Marden along a spectrum where (at least) one critical factor was an ‘enlargement of the range of ... utility’ of the claimed product relative to its natural counterpart.[62]
2 Bryson J (dissenting)
Bryson J dissented on the eligibility of Myriad’s isolated DNA claims, and was the only judge vindicated by the outcome in the Supreme Court. His difficulty was that the ‘only material change made to those genes from their natural state is the change that is necessarily incidental to the extraction of the genes’.[63] The mineral analogy was apposite: ‘[l]ike some minerals, [genes] are hard to extract from their natural setting ... [a]lso like minerals, they can be used for purposes that would be infeasible if they remained in their natural setting’.[64] Metallic lithium is so reactive it occurs in nature only in the form of a salt: Li+ ionically bound to other elements; but that does not make ‘isolated and purified’ lithium metal patentable.[65] His Honour deprecated the apparent ‘magic’ of the chemical bond under the majority reasoning, and observed that the better nomenclature was that of genetics, not chemistry.[66]
His Honour rejected both claims to 15 nucleotide subsequences, which he described as ‘breathtakingly broad’ in the case of claim 5.[67] Even the cDNA subsequence claim would cover parts of the cDNA of ‘more than 4% of human genes’, to knowledge of which Myriad had ‘contributed nothing’.[68] Here his Honour seems to traverse the boundary of pure patentable subject matter analysis. If Myriad had made an effort to confine its claims to such sequences as were actually suitable and useful as probes (for example, tagged subsequences) or primers, it might have fared better on Bryson J’s reasoning.[69]
Thomas J delivered the (perhaps surprisingly brief) opinion of a unanimous court.[70] Scalia J concurred in the outcome and reasoning, but issued a single paragraph separate opinion distancing himself from the ‘fine details of molecular biology’ which he felt ‘unable to affirm ... on [his] own knowledge or even [his] own belief’.[71] The Court held Myriad’s cDNA claims valid, but invalidated the isolated DNA claims.
Myriad argued that the Patent and Trademark Office’s (PTO) longstanding practice of granting patents claiming ‘isolated and purified’ genes was entitled to deference. As Moore J observed in the Court of Appeals below, the PTO’s policy that isolated and purified DNA was patenteligible had stood for more than a decade.[72] The Supreme Court held it was not entitled to deference. Unlike the case cited to it — JEM Ag Supply Inc[73] — here Congress had done nothing to recognise or endorse PTO practice.[74] A single line in a Consolidated Appropriations Act of 2004 carving out ‘claims directed to or encompassing a human organism’ simply did not speak to isolated or purified DNA.[75]
The Court referred to § 101 of the Patent Act 1952 (US),[76] the implicit exceptions, and the recent decision in Mayo. It observed that it is not enough for an invention to be the product of great labour or even deep insight — ‘[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry’.[77]
1 Isolated DNA
The Court went on to identify a fundamental tension in the area of gene patents — whether to conceptualise genes as information, or as ordinary molecules.[78] (Arguably, only in the latter case might the analogy with pharmaceutical patent cases justifiably be drawn.) Myriad argued that the isolated DNA for a gene is not naturally occurring (and so patenteligible) because it has been ‘cut out’ of the larger naturally-occurring DNA molecule. To this the Court responded that:[79]
Myriad’s claims are not simply expressed in terms of chemical composition, nor do they rely in anyway on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded ... .
The Court pointed out that if Myriad had truly claimed a defined, specific molecule, a would-be infringer could evade the patent through use of slightly extended sequences falling outside the scope of Myriad’s claims.[80]
2 Complementary DNA (cDNA)
The Supreme Court went on to describe cDNA as ‘not naturally occurring’, concluding that for this reason those claims did ‘not present the same obstacles to patentability as naturally occurring, isolated DNA segments’.[81] Of course, this argument is premised on the assumption that isolated DNA is naturally occurring, even though it does not exist in isolated form in nature. Even if the cDNA sequence was ultimately ‘dictated by nature’, it was still regarded as ‘something new’, in the sense of being a ‘distinct’ and artificial creation.[82] The Court relied on Chakrabarty for the proposition that a new product of human ingenuity ‘having a distinctive name, character [and] use’ could be patentable subject matter.[83] The only codicil was that where a DNA sequence is so short that it does not contain introns, cDNA ‘may be indistinguishable’ from (patent ineligible) natural DNA.[84]
In concluding, the Court disavowed any intention to address or comment upon the eligibility of method claims, claims for ‘applications of knowledge about the BRCA1 and BRCA2 genes’,[85] or claims involving ‘alteration of the genetic code’.[86] Thomas J summarised the holding as that ‘genes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material’.[87]
Although fundamental to all known life — the so-called ‘creator’s code’ — DNAs are, after all, simply biomolecules. As early as 1991, Lourie J had observed that ‘[a] gene is a chemical compound, albeit a complex one’.[88] For this reason it is natural to seek analogy, as the District Court and Court of Appeals did, with the case law respecting other naturally occurring chemicals.[89] Nature has long proven a rich source of valuable pharmaceuticals.
Today, patents exist on the register for DNA sequences associated with a plethora of diseases, including multiple sclerosis, Alzheimer’s disease, diabetes and tuberculosis.[90] The entire genomes of some disease-causing bacteria have been claimed by enterprising biotechnologists.[91] The propriety of such patents, and the case for treating DNA patents as sui generis, is disputed on such a wide variety of grounds that this case note cannot hope to canvass them.[92] Instead, this case note seeks to place Myriad squarely in the most appropriate legal context — the extensive jurisprudence on chemical patents to which, in at least some ways, gene patents are the 21st century successor. It scrutinises the contribution of Myriad to that body of law. As will be shown, the value of that contribution is doubtful.
1 The Case Law
The progenitor of modern jurisprudence on natural products is American WoodPaper, an 1874 decision of the US Supreme Court, where the patentee claimed ‘a pulp suitable for the manufacture of paper’ (refined cellulose) that was produced by improved means from natural sources.[93] The Court opined that ‘many things well known and valuable in medicine ... may be extracted from divers substances’, and that such process of extraction may be patentable, but the ‘thing itself when obtained cannot be called a new manufacture’.[94]
Not unnaturally, this has been taken, including by Sweet DJ, to indicate that a purified or processed natural product is not patentable per se.[95] But the basis for the decision is perhaps not so clear-cut, for the judgment of Strong J continued: ‘[the product] may have been in existence and common use before the new means of obtaining it was invented, and possibly before it was known that it could be extracted from the subject to which the new process is applied’.[96] Was the fatal flaw that it was not ‘new’, or not a ‘manufacture’ at all? This question looms large over many of the important decisions in this area. It is simply not clear that Strong J contemplated the discovery of altogether new compounds together with some practical use.[97] The same can be said of another decision from the same period, Cochrane, where the patentee’s synthetic method for producing a dye was set against a backdrop in which it had been discovered and extracted from madder roots.[98] One thorough and detailed review concludes from these 19th century cases that: ‘Mere purification of a substance disclosed in the prior art or occurring in nature would not support a patent without a significant change in the character or function of the product’.[99] The italicised portion of this assertion is contestable on the basis of the 19th century cases. On one view, it does not necessarily follow from them.[100]
In any event, by the early 20th century two important lower court decisions tended the opposite way. In Kuehmsted, the patentee’s purified aspirin was held ‘therapeutically different’ from an alleged infringer’s relatively impure composition, and thus a new product entitled to protection.[101] Once again, the question arose in the guise of novelty. In Parke-Davis, Learned Hand J held the patentee’s claim to purified adrenaline was good because he ‘was the first to isolate any base whatever, all other products existing in the form of a salt’.[102] Thus, the purified adrenaline was, in effect, a new product. His Honour went on to offer the opinion that ‘even if it were merely an extract product without change, there is no rule that such products are not patentable’.[103] There was a distinction ‘not in degree, but in kind’,[104] for the ‘difficulties of the old products were so great as made any substantial advance ... important’.[105] Kuehmsted was cited with apparent approval.[106] Merck, decided under the Patent Act 1952 (US), followed the ParkeDavis logic in relation to isolated and purified vitamin B12.[107]
Gipstein rightly observes that Parke-Davis was a turning point, for it was ‘impossible to logically deduce [Hand J’s] holding [by] combining the precedents that he cited’.[108] Parke-Davis suggested that the therapeutic (or industrial) value approach to novelty, previously applied in relation to purely synthetic chemicals,[109] might also govern the patent eligibility of natural products.[110] The apparent conflict between American Wood-Paper, and Kuehmsted and Parke-Davis, thereafter opened an enduring rift between the Circuit Court of Patent Appeals (taking a narrow view of eligible subject matter), and some Circuit Courts (seizing on Kuehmsted and Parke-Davis).[111]
2 The Shifting Sands of the Patent Acts
The lack of any clear distinction in the early cases between consideration of subject matter eligibility, novelty, and non-obviousness is to a large extent explicable by the terms of the relevant statutes. Prior to the Patent Act 1952 (US), the words ‘new’ and ‘invention’, both capable of several meanings, were alone required to do considerable work. The operative provision referred to: ‘any person who has invented or discovered any new and useful art, machine, manufacture, or composition of matter, or any new and useful improvement thereof, not known or used by others’.[112]
The Patent Act 1952 (US) was particularly transformative because it endeavoured to spell out the individual elements of ‘newness’ and ‘invention’, with separate sections relating to novelty[113] and non-obviousness.[114] One view is that:
By attempting to divide the concept of ‘invention’ into separate components of novelty and non-obviousness, Congress overlooked or, more accurately, oversimplified the substantial case law that had developed an invention requirement going beyond mere ‘novelty’ with regard to prior human knowledge.[115]
Partly for this reason courts have not succeeded in clearly distinguishing the loci of the various conditions for the grant of patents.[116]
A ‘natural phenomena’ exception of broad ambit is also difficult to reconcile with the reference in § 101 to discoveries, supposing the invention is otherwise within a patentable class (for example, compositions of matter). Courts, like the Seventh Circuit in Dennis v Pitner, which have sought to limit the scope of the rule, have taken refuge in this aspect of the statutory language.[117]
1 Lower Court Reasoning
Sweet DJ attempted to distinguish cDNA from natural drugs like adrenaline, considered patentable in Parke-Davis, on the basis that cDNA’s utility is primarily a function of its (exon) sequence homology with gDNA. This distinction fails. The utility of adrenaline is as a neurotransmitter that binds adrenergic receptors in humans. This binding relationship is eminently dictated by nature. His Honour’s characterisation of adrenaline as merely embodying ‘information about its own molecular structure incidental to its biological function’[118] is, with respect, specious. It is a distinction without a difference. Of course the biological functions of DNA and adrenaline are markedly different, but relevantly they are both biological, determined by nature, and are ultimately the locus of the claimed utility. Should DNA be treated differently simply because the informational content it embodies is so much more readily conceptualised? It is, we know, a code. That is not the inquiry. The question is whether the claim is directed to an ineligible ‘product of nature’ (for want of a better shorthand). We rapidly approach the problem alluded to earlier, and put succinctly by Frankfurter J in Funk Bros:
Everything that happens may be deemed ‘the work of nature’, and any patentable composite exemplifies in its properties ‘the laws of nature’. Arguments drawn from such terms for ascertaining patentability could fairly be employed to challenge almost any patent.[119]
There is force in the criticism that the ‘therapeutic value’ approach to patentability ‘mistakes utility for newness’.[120] But equally it could be said that reliance on American Wood-Paper mistakes lack of newness for lack of patentable subject matter. This was the view of Lourie J.[121] Simply put, the distinction between absolute newness (that is, artificial invention) and relative newness (first human to isolate or discover) was never clearly laid out.[122] Thus, Sweet DJ was able to take the very opposite view of American Wood-Paper.[123]
A number of cases have refused patents claiming purified elements, even where, owing to their reactivity, those elements exist in nature only as metal oxides or other salts.[124] Both ‘pure tungsten’ itself, and its characteristics (ductility, high tensile strength), were ‘created by nature’; the patentee simply discovered them.[125] Probably there was a visceral reaction — much as there seems to be in the case of DNA patents — to a claim for an element itself, a fundamental building block of matter. But the position is otherwise where the element does not exist on Earth and is synthesised by nuclear fusion.[126]
Lourie J appears, with respect, to have fundamentally misunderstood the factual context of these cases. In support of his argument that isolated DNA was more than purified DNA, Lourie J wrote: ‘Parke-Davis and Marden address a situation in which claimed compound A is purified from a physical mixture that contains compound A’.[127] The Marden cases considered claims to metallic uranium and vanadium.[128] Vanadium is a reasonably reactive metal and thus exists in significant quantities in nature only as a component of minerals — that is, compounds containing vanadium oxides. The same can be said for tungsten (W), which exists as tungsten oxides like WO3.[129] As Bryson J realised, the analogy with Marden is perhaps the most apposite of all. In neither case — for tungsten, nor DNA — does the claimed thing exist per se in nature; but this does not mean isolating it converts it, in substance, to anything other than a product of nature. On one persuasive view of it, the essence of the conversion of WO3 into tungsten, and of gDNA into a strand of isolated DNA, is in fact the same: the severance of chemical bonds by what is (in modern times) regarded as a relatively trivial process for those skilled in the art.
2 Supreme Court Reasoning
In the eight pages of substantive reasoning in the Supreme Court’s broadly margined slip opinion, these cases did not rate a mention. However, its disposition of Myriad’s isolated DNA claims must throw enormous doubt on Kuehmsted and Parke-Davis. Unlike Myriad, those cases did not even involve chemical modification (by severance of bonds) of the molecules in question as a preliminary step to isolation. If Myriad was supposed to mark a resolution of this issue, it is a most unsatisfactory one. The Supreme Court perfunctorily dismissed Myriad’s argument that isolating DNA from the human genome creates a non-naturally occurring molecule by severing chemical bonds:
Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded ... .[130]
This author does not understand this reasoning. Claim 1 of the ‘282 patent was expressed by reference to the encoded protein. But this was just one concise way of claiming a set of molecules. Why must a claim ‘rely’ on chemical changes resulting from isolation? The entire claim was qualified by ‘isolated’. Is the Court blurring the divide between patentable subject matter and inventiveness analysis by, in effect, complaining that the claim did not disclose any significance to the act of isolation? The Court continued:
If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad’s patent claims on entire genes ... by isolating a DNA sequence that included both the ... gene and one additional nucleotide pair.[131]
The purpose of such a claim is to capture all functionally equivalent DNA sequences by effectively ignoring: (a) introns; and (b) variations in sequence that, because of the redundant DNA code, still produce the same protein. No doubt Myriad required its ‘isolation’ stipulation to do considerable work, but what is not clear is why an ‘information-oriented’ claim should, on that score alone, be more likely to offend the rule. The Court appears to have grappled with the claim for a set of molecules in most curious fashion. If the form of the claim is this significant, where is the line to be drawn? If Myriad had claimed an isolated DNA with the consensus (that is, most frequent) nucleotide sequence for a BRCA gene, would the claim be eligible?
The second glaring difficulty is why the same reasoning should not apply to functionally (and informationally) equivalent cDNA, which the Court found patenteligible. To say that X is, or is not, ‘naturally-occurring’ is only meaningful with respect to a given sense. The Court appears to have concluded that isolated DNA is naturally occurring in the informational sense and not patent-eligible,[132] while at the same time finding cDNA patent-eligible on the ground that is does not naturally occur in the molecular sense, despite its informational equivalence.[133] That informational equivalence arises because, as explained, the expression of cDNA leads to production of the very same protein encoded by the corresponding genomic DNA.
3 Practical Consequences
At first glance, by allowing patents claiming cDNA, it appears that powerful protection of an important method of modern biotechnology remains intact. cDNA is a very important tool by which the protein-producing function of genes can be harnessed. But intriguingly, the Court’s conclusion in respect of isolated and purified DNA might now permit entrepreneuring biologists to circumvent existing monopolies by expressing pharmaceutically valuable proteins in eukaryotic cells by transfection of intron-containing native DNA, rather than cDNA, if it is technically possible. (For one, longer DNA sequences are generally harder to clone). This kind of lacuna is to be expected when the question of patentability is decided without any real regard being had to the informational and functional content of the molecules in question.
Amgen’s patent, relating to its method for producing EPO, claims ‘purified and isolated DNA sequence[s] consisting essentially of a DNA sequence encoding human [EPO]’, and ‘procaryotic or eucaryotic host cell[s] transformed or transfected’ with such a sequence.[134] The former claim must surely be regarded as too broad in light of Myriad. Indeed, the particular infringement alleged by Amgen was ‘by use of transformed mammalian [eukaryotic] host cells containing vectors with DNA coding for the production of human EPO’.[135] As we have mentioned, eukaryotes possess the molecular machinery necessary to remove introns and, thus, in theory, the use of isolated DNA may suffice for this purpose.
Ultimately Chakrabarty — where the Supreme Court held genetically modified bacteria capable of breaking down the components of crude oil patentable — seems to compel the conclusion that cells so transfected may be the subject of valid patent claims.[136] This throws up difficult and interesting questions of inventiveness (non-obviousness in the American parlance),[137] and of the role of discovery simpliciter (of a useful gene itself) in assessing the inventiveness of a cell line deriving its claimed utility therefrom.
4 An Important Caveat
There is some danger in supposing that much of value can be divined from century-old cases on chemical product claims. It seems insufficiently appreciated in the literature that the object of a chemical patent is the ‘product’ as a legal rather than chemical object, as described (and circumscribed) by the claims. This is not necessarily coextensive with the active pharmaceutical ingredient. Thus, in ParkeDavis, an illustrative claim was for: ‘A substance possessing the herein-described physiological characteristics and reactions of the suprarenal glands in a stable and concentrated form’.[138]
So too in Kuehmsted, Grosscup J thought that the ‘fact that the [chemical] formulae are identical cuts little figure’.[139] The purport of such cases is complicated by the rudimentary state of chemistry at the time; in Cochrane, the Court noted that if the claim was ‘construed to cover all artificial alizarine, whatever its ingredients ... we then have a patent for a product or composition of matter which gives no information as to how it is to be identified.’[140]
Analogy with early cases may be altogether unhelpful in an era where the distinction between legal and chemical object has effectively collapsed, for modern patents invariably claim chemicals in the abstract, solely by reference to molecular structure. Thus, a product claim takes on an altogether different complexion. The real dimensions of any claim can only be tested by hypothetical infringement, and presumably the crude material disclosed in the prior art in Parke-Davis would not have infringed the patents in suit. By contrast, today biotechnologists have gone so far as claiming that plant DNA present only in trace quantities as dead matter in imported soy meal, but derived from plants carrying the gene, represent infringement of patents claiming that DNA.[141] The rise of the attitude of ‘absolute protection’ has substantially recoloured claims to products of nature.[142]
5 The Scope of the Modern Patent Claim
No court has acknowledged the impact on the basic principles of patentable subject matter of the transition to claims written in the modern way and incorporating chemical formulae. Nor would a court be likely to engage in such a broad-ranging academic exercise.[143] Instead, Myriad has provoked various superficial attempts to distinguish the older cases. It is, however, not clear that those distinctions make any sense.
One basic disagreement, manifest equally in the early cases on natural products, and seemingly rooted in policy and ideology more than law is whether ‘discovery ... of a quality or attribute of a well-known [or even new] article, which discovery is of value to mankind’[144] should ground a product claim that may preempt uses not discovered by the inventor. Where the article is naturally occurring, but discovered or isolated by the inventor, the argument in favour is that he or she should be compensated for making it available: ‘[T]he opposition division [of the European Patent Office] finds it perfectly justified to grant broad protection in view of the fact that H2-relaxin has been made available to the public for the first time’.[145]
The grant of a product patent in such cases appears to work a transparent end-run around judicial hostility to patents based in only speculative utility.[146] If an inventor who sequences, isolates and characterises gene or protein X suspecting it may be therapeutically useful — or even knowing that it will be useful for further research — cannot obtain any protection,[147] why should the inventor who discovers one use be protected for other uses that at the time were (if anything) merely speculative? This approach distorts the relation between the protection afforded by such patents and what has really been invented (or even disclosed). Hubicki writes that:
Per se claims to genes therefore reveal a tension between two competing concepts of invention: one which focuses on the material contribution of the inventor; and another which attributes priority to the intangible contribution of the inventor.[148]
The material contribution is the substance being made available, possibly for the first time; the intangible contribution of the inventor is usually (a) the discovery of at least one valuable use or application; and (b) the discovery of one method of producing the substance. In perverse fashion, the obsession with a physical embodiment of the invention, while ensuring the claim is not for a discovery or abstract idea, has unhitched the scope of patent protection from the inventive contribution involved in it by dwelling on the material thing, instead of the invention.
1 European Community
With Myriad, the United States has broken ranks with the European Community (EC) where a more permissive attitude to DNA patentability prevails. As early as 1995 in Relaxin, the European Patent Office (EPO) held that while ‘a substance freely occurring in nature is a mere discovery and therefore unpatentable’, if it is isolated, characterised, and is ‘new in the absolute sense of having no previously recognised existence’, then it may be the subject of a per se claim.[149] This view was subsequently entrenched by the Biotechnology Directive, and sch A2 to the Patents Act 1977 (UK).[150] Biological material ‘isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature’.[151] The Supreme Court took a fundamentally different view: ‘separating [the] gene from its surrounding genetic material is not an act of invention’.[152]
It is worth observing that, in privileging the existence of some ‘technical process’, the Biotechnology Directive (were it not limited to biotechnology) would arguably be compatible with claims to isolated and purified elemental tungsten.[153]
2 Counterpart Litigation in Australia
In February 2013, Nicholas J in the Federal Court of Australia delivered judgment in the Cancer Voices case, the Australian counterpart to Myriad.[154] In Australia, the patentable subject matter requirement is that the invention be ‘a manner of manufacture within the meaning of section 6 of the Statute of Monopolies’.[155] In the leading authority (‘NRDC’), the High Court emphasised that this is no literal test, but instead a historical and organic one; the question is whether something is ‘a proper subject of letters patent according to the principles which have been developed for the application of s 6’.[156] The High Court held that a method of eradicating weeds from crops by applying certain herbicides:
is a “product” because it consists in an artificially created state of affairs, discernable by observing over a period the growth of weeds and crops respectively on sown land on which the method has been put into practice. And the significance of the product is economic; for it provides a remarkable advantage ... .[157]
To a large extent the curious description of this method as a ‘product’ has been aimed at undoing the now-defunct ‘vendible product’ requirement for patentable subject matter.[158]
In Cancer Voices, Nicholas J asked whether isolated DNA ‘constitutes an artificial state of affairs in the sense those words should be understood in the present context’.[159] In the first place, his Honour relied upon the ‘broad sweep’ of the concept emphasised by the High Court. Second, that isolated DNA is the ‘product of human intervention’ leading to removal of other cellular materials. Last, his Honour thought it would be ‘odd’ if the ‘intensive research effort’ involved went unrewarded regardless of its economic utility, because of ‘inherent non-patentab[ility]’.[160] In this vein, in England courts have been counselled to put aside ‘their intuitive sense of what constitutes an invention until they have considered the questions of novelty, inventiveness, and so forth’.[161] Probably this applies with equal force in Australia. But often it is not possible in the United States, where the course of litigation is influenced by the desire to avoid a jury trial of underlying factual issues, including those relevant to obviousness.[162]
Nicholas J took a rather different view of Myriad’s claims, which were drafted differently than those in its US patents. The broadest covered ‘isolated nucleic acid[s] coding for a mutant or polymorphic BRCA1 polypeptide [protein]’, carrying at least one mutation as defined in various tables, by comparison to the wild-type exon-only DNA sequence given in SEQ.ID No:1.[163]
Unlike the US Supreme Court, his Honour was not impressed by the fact that in form the claim was expressed in terms of genetic sequence information: ‘Each of the disputed claims is to a chemical composition. That is to say, they claim substances that are defined by the presence of particular atoms that are arranged in particular ways.’[164] His Honour formed the firm view that there was no claim to ‘genetic information per se’, and therefore he could not see the relevance of the ‘informational character of DNA as a storehouse of genetic information’ urged by Cancer Voices.[165] Perhaps due to deficiencies in the way the technical evidence was presented, Nicholas J was not convinced that the ‘isolation’ of nucleic acids covered by the claim necessarily involved the severance of covalent bonds.[166] For this reason he distinguished the reasons of Lourie J in Myriad. His Honour was content for it to be, in Lourie J’s parlance, purified (and not necessarily chemically excised) DNA.[167] This in itself illustrates a vast difference in attitude — for his Honour mere removal of DNA from its cellular environment was enough to create the required artificial state of affairs.[168] In this Nicholas J had some support; the Deputy Commissioner of Patents took the same view in KirenAmgen in the 1990s.[169] It is akin to saying that physical isolation of adrenaline, naturally occurring in the adrenal gland, and without chemical alteration to its structure, is enough to make it patenteligible. In the result, Nicholas J thought both isolated DNA and cDNA (and RNA for that matter) patentable. His Honour was at pains to emphasise that, because of the adjective ‘isolated’, none of Myriad’s claims reached DNA or RNA existing inside cells.[170]
The Full Federal Court (sitting with five, rather than three, judges) heard the appeal from the decision of Nicholas J in August 2013. At the time of going to print, judgment had been reserved for about 12 months, perhaps reflecting the difficulties involved. There is a real possibility that the Full Federal Court will avoid the difficulties that plagued the US Supreme Court (and the unsatisfactory reasoning resulting) since Australia has, at least since NRDC, adopted a more permissive approach to patentability of natural materials where a new human application has been identified. An ‘artificially created state of affairs with economic significance’ is not a particularly high bar.
One commentator wryly suggests that the ‘takeaway’ message from Myriad is:
not only that human genes are not patentable in and of themselves but that the Federal US Circuit Court of Appeals isn’t very good at interpreting patent eligibility under Section 101 of the Patent Act.[171]
In the three different courts through which Myriad progressed, three different answers were given. Only Bryson J, dissenting in the Court of Appeals, anticipated the ultimate result. This tends to prove that the ambit of the principle is more intuitive than normative. While the Supreme Court has split the difference by finding isolated natural DNA unpatentable, but allowing claims to corresponding cDNA — which will no doubt please some — its sparsely reasoned judgment is likely to send shockwaves through the biotechnology industry, which is in many respects built on such patents.[172] The Court’s stated reasons for distinguishing isolated DNA from cDNA are not at all compelling.
The true scope of the ‘natural phenomena’ rule remains at least as obscure as (if not more than) it was prior to Myriad. The brevity of the opinion might have been intended as a shield against criticism. However, courts of last resort should not suppose they can make reliable decisions when they do not even discuss prior case law. The case represents a squandered opportunity to settle authoritatively the confusing line of authority spawned by American Wood-Paper;[173] and, perhaps, to consider repositioning the law regarding product claims in a way geared to better reflect inventive contribution.
[*]BSc (Chem) (Hons I), LLB (Syd). This case note was written when I was a final year law student at the University of Sydney in late 2013. It was prepared under the guidance of Associate Professor Kimberlee Weatherall, to whom I am indebted for many useful conversations and comments on drafts. I also thank Associate Professor Peter Rutledge for his comments. Any errors remaining are my own.
[1] Jeff M Hall et al, ‘Linkage of Early-Onset Familial Breast Cancer to Chromosome 17q21’ (1990) 250(4988) Science 1684.
[2] Association for Molecular Pathology v United States Patent and Trademark Office, 702 F Supp 2d 181, 201 (2010) (‘Myriad (District Court)’).
[3] Mark H Skolnick et al, ‘17q-Linked Breast and Ovarian Cancer Susceptibility Gene’ (US Patent 5,747,282, 5 May 1998) 7–11; Yoshio Miki et al, ‘A Strong Candidate for the Breast and Ovarian Cancer Susceptibility Gene BRCA1’ (1994) 266(5182) Science 66.
[4] Skolnick et al, above n 3, 7; Myriad (District Court), 702 F Supp 2d 181, 201 (2010); Association for Molecular Pathology v Myriad Genetics Inc, 569 US __ (2013) (US Supreme Court, No 12398, 13 June 2013) slip op 14 n 6 (‘Myriad (Supreme Court)’).
[5] Uniform in the sense that ‘any scientist engaged in the search for a gene would likely have utilized a similar approach’: Myriad (District Court), 702 F Supp 2d 181, 202–3 (2010).
[6] Skolnick et al, above n 3; Myriad (District Court), 702 F Supp 2d 181, 201 (2010).
[7] Myriad (District Court), 702 F Supp 2d 181, 202 (2010).
[8] Skolnick et al, above n 3, 16–17.
[9] Myriad (District Court), 702 F Supp 2d 181, 203 (2010).
[10] Helen Pearson, ‘What Is a Gene?’ (2006) 441 Nature 398, 401. See also Elizabeth Pennisi, ‘DNA Study Forces Rethink of What It Means to Be a Gene’ (2007) 316(5831) Science 1556.
[11] James D Watson et al, Molecular Biology of the Gene (Benjamin Cummings, 6th ed, 2008) 135.
[12] Ibid 102 ff.
[13] Adenine (A), thymine (T), cytosine (C), guanine (G). RNA uses uracil (U) in place of thymine.
[14] JD Watson and FHC Crick, ‘Molecular Structure of Nucleic Acids: A Structure for Deoxyribose Nucleic Acid’ (1953) 171 Nature 737; Watson et al, above n 11, 105 ff.
[15] Watson et al, above n 11, 32.
[16] Harvey Lodish et al, Molecular Cell Biology (W H Freeman, 4th ed, 2000) § 1.2.
[17] Watson et al, above n 11, 30, 73, 378 ff.
[18] Ibid 415 ff.
[19] Ibid.
[20] Ibid 521–2.
[21] Walter Gilbert, ‘Why Genes in Pieces?’ (1978) 271 Nature 501; Walter Gilbert, ‘Genes-in-Pieces Revisited’ (1985) 228(4701) Science 823; Stephen Hubicki, ‘“DNA Neither Cares Nor Knows. DNA Just Is”: The Problem of Embodiment in Biotechnology Patents’ (Paper presented at the Third Annual Workshop of the International Society for the History and Theory of Intellectual Property (ISHTIP), Brisbane, 6 July 2011), 35–8.
[22] Watson et al, above n 11, 432–5.
[23] Prokaryotic organisms (archaea and bacteria) do not possess the cellular machinery necessary to remove introns by splicing. Thus, transfection of prokaryotes with eukaryotic genes (including human genes) requires a DNA sample that does not contain introns. This is obtained by creating cDNA from mature mRNA.
[24] Linda J Demaine and Aaron Xavier Fellmeth, ‘Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent’ (2002) 55(2) Stanford Law Review 303, 306 n 11.
[25] Lionel Bently and Brad Sherman, Intellectual Property Law (Oxford University Press, 3rd ed, 2009) 423.
[26] Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46; [2005] RPC 9 (United Kingdom); Amgen Inc v Chugai Pharmaceutical Co Ltd, [1991] USCAFED 309; 927 F 2d 1200 (1991) (United States).
[27] Those claims were: claims 1, 2, 5, 6, and 7 of US Patent 5,747,282; claim 1 of US Patent 5,693,473; and claims 1, 6 and 7 of US Patent 5,837,492: Myriad (Supreme Court), 569 US __ (2013) slip op 5 n 2.
[28] Ibid 5–6.
[29] Association for Molecular Pathology v United States Patent and Trademark Office, 689 F 3d 1303, 1335 (Lourie J) (2012) (‘Myriad (Court of Appeals II)’).
[30] Myriad (District Court), 702 F Supp 2d 181, 204 ff (2010).
[31] Patent Act, 35 USC § 101 (West, 1952).
[32] Myriad (Supreme Court), 569 US __ (2013) slip op 11; Mayo Collaborative Services v Prometheus Laboratories Inc, 132 S Ct 1289, 1293 [1] (2012), citing Diamond v Diehr, [1981] USSC 40; 450 US 175 (1981).
[33] Mayo Collaborative Services v Prometheus Laboratories Inc, 132 S Ct 1289, 1293 [2] (2012). Some courts have carried this observation to greater extremes than others. In Merck & Co Inc v Olin Mathieson Chemical Co, [1958] USCA4 73; 253 F 2d 156, 161–2 (1958), the Court wrote that:
All of the tangible things with which man deals and for which patent protection is granted are products of nature in the sense that nature provides the basic source materials. The “matter” of which patentable new and useful compositions are composed necessarily includes existing elements and materials.
This reasoning was used to justify a patent claiming an isolated natural vitamin in the face of an argument that it was a product of nature. See Demaine and Fellmeth, above n 24, 349–50.
[34] Diamond v Chakrabarty, [1980] USSC 119; 447 US 303, 309 (1980), citing Funk Brothers Seed Co v Kalo Inoculant Co, [1948] USSC 22; 333 US 127, 130 (1948).
[35] Ibid (emphasis added), citing Congressional Committee Reports accompanying the 1952 Patent Act; some have criticised the frequency with which this quote has been taken out of context: Demaine and Fellmeth, above n 24, 373 n 329. The words that followed were ‘but it is not necessarily patentable under section 101 unless the conditions of the title are fulfilled’.
[36] Demaine and Fellmeth, above n 24, 373 (emphasis in original).
[37] Bently and Sherman, above n 25, 420 (emphasis added).
[38] See, eg, Richard Seth Gipstein, ‘The Isolation and Purification Exception to the General Unpatentability of Products of Nature’ (2003) 4 Columbia Science and Technology Law Review 1.
[39] See, eg, Dianne Nicol, ‘Implications of DNA Patenting: Reviewing the Evidence’ (2011) 21(1) Journal of Law, Information and Science 7.
[40] Demaine and Fellmeth, above n 24, 329.
[41] This case note discusses the opinions of the courts below only insofar as they concern Myriad’s product claims, the subject of appeal to the Supreme Court. On the first petition for a writ of certiorari, the Supreme Court vacated the Court of Appeals’ first judgment (653 F 3d 1329 (2011)) and remanded the case back for ‘further consideration in light of Mayo’: Association for Molecular Pathology v Myriad Genetics Inc, 132 S Ct 1794 (2012). Unsurprisingly, a majority of the Court of Appeals held that reconsideration of Mayo, addressing method claims, did not alter their conclusions on Myriad’s product claims: Myriad (Court of Appeals II), 689 F 3d 1303, 1325–6 (Lourie J), 1340 (Moore J) (2012). The appeal discussed herein then followed.
[42] Myriad (District Court), 702 F Supp 2d 181, 223–4 (2010) citing American Wood-Paper Co v Fibre Disintegrating Co, [1874] USSC 189; 90 US 566, 594 (1874) (‘American Wood-Paper’); General Electric Co v De Forest Radio Co, 28 F 2d 641 (1928) (‘General Electric’).
[43] American Fruit Growers Inc v Brogdex Co, 283 US 1, 11 (1931) (‘American Fruit Growers’): treatment of the outer skin of fruit with mould inhibitor did not convert the treated fruit into an article of manufacture.
[44] Merck & Co Inc v Olin Mathieson Chemical Co, [1958] USCA4 73; 253 F 2d 156, 164 (1958).
[45] American Fruit Growers, 283 US 1, 11 (1931).
[46] Myriad (District Court), 702 F Supp 2d 181, 227 (2010).
[47] Ibid 228.
[48] Parke-Davis & Co v HK Mulford Co, 189 F 95, 102 (1911) (‘Parke-Davis’).
[49] Myriad (District Court), 702 F Supp 2d 181, 228 (2010).
[50] Ibid 229–30.
[51] Ibid 229.
[52] Primers and probes are short sequences of DNA that exploit one of its fundamental features: complementary base pairing. Thus, ATCGT...CTGGC might act as a primer or probe for DNA containing the complementary sequence TAGCA...GACCG. Probes are used to test for the presence of a sequence; primers are essential to begin certain processes, like reverse transcription of mRNA into cDNA.
[53] Myriad (District Court), 702 F Supp 2d 181, 231 (2010).
[54] Ibid 230.
[55] Later, Sweet DJ also relied on the existence of BRCA1 pseudogenes. A pseudogene occurs as the result of two steps: (a) the action of a reverse transcriptase (an enzyme which converts mRNA into a corresponding cDNA molecule); and (b) random and slow integration of the resulting DNA molecule into gDNA. Reverse transcriptases are only produced by viruses that use them to reproduce; viral infection may therefore eventually lead to integration of an exon-only BRCA pseudogene. See generally Watson, above n 11, 142 ff.
[56] Myriad (District Court), 702 F Supp 2d 181, 230 (2010).
[57] Myriad (Court of Appeals II), 689 F 3d 1303, 1327–8 (2012).
[58] Ibid 1328 (emphasis added).
[59] Ibid 1329.
[60] Ibid 1330.
[61] Ibid.
[62] Ibid 1338.
[63] Ibid 1350 (emphasis added).
[64] Ibid.
[65] Ibid 1351.
[66] Ibid.
[67] Ibid 1356.
[68] Ibid.
[69] Ibid.
[70] The Court’s slip opinion is 18 pages long.
[71] Myriad (Supreme Court), 569 US __ (2013) slip op 1 (Scalia J).
[72] Myriad (Court of Appeals II), 689 F 3d 1303, 1343–4 (Moore J) (2012).
[73] JEM Ag Supply Inc v Pioneer Hi-Bred International Inc, [2001] USSC 69; 534 US 124 (2001).
[74] Myriad (Supreme Court), 569 US __ (2013) slip op 15.
[75] Ibid 15–6.
[76] Patent Act, 35 USC § 101 (West, 1952).
[77] Myriad (Supreme Court), 569 US __ (2013) slip op 12.
[78] See also Myriad (District Court), 702 F Supp 2d 181, 228 (2010): ‘Genes are of double nature...’.
[79] Myriad (Supreme Court), 569 US __ (2013) slip op 14.
[80] Ibid 15.
[81] Ibid 16.
[82] Ibid 17.
[83] Ibid 12; Diamond v Chakrabarty, [1980] USSC 119; 447 US 303, 309–10 (1980) citing Hartranft v Wiegmann, [1898] USSC 78; 121 US 609, 615 (1887).
[84] Myriad (Supreme Court), 569 US __ (2013) slip op 17.
[85] Ibid (emphasis in original).
[86] Ibid 18.
[87] Ibid.
[88] Amgen Inc v Chugai Pharmaceutical Co Ltd, [1991] USCAFED 309; 927 F 2d 1200, 1206 (Lourie J) (1991).
[89] So too in Europe: Howard Florey Institute/Relaxin [1995] OJ EPO 388, 400 [6.3.4].
[90] Demaine and Fellmeth, above n 24, 307 n 16.
[91] Ibid 307 n 18.
[92] See, eg, Nicol, above n 39.
[93] American Wood-Paper[1874] USSC 189; , 90 US 566, 594 (1874).
[94] Ibid 593–4.
[95] Myriad (District Court), 702 F Supp 2d 181, 223 (2010); Demaine and Fellmeth, above n 24, 332.
[96] American Wood-Paper[1874] USSC 189; , 90 US 566, 594 (1874).
[97] ‘Thus, if one should discover a mode or contrive a process by which prussic acid could be obtained from a subject in which it is not now known to exist, he might have a patent for his process, but not for prussic acid.’: Ibid. Also expressing this sentiment: Association for Molecular Pathology v United States Patent and Trademark Office, 653 F 3d 1329, 1350 n 6 (Lourie J) (2011).
[98] Cochrane v Badische Anilin & Soda Fabrik, [1884] USSC 142; 111 US 293 (1884).
[99] Demaine and Fellmeth, above n 24, 333 (emphasis added).
[100] Ibid. For example, Demaine and Fellmeth cite the Commissioner’s view that he was ‘not aware of any instance in which it has been held that a natural product is the subject of a patent, although it may have existed from creation without being discovered’: Ex parte Latimer, 1889 Dec Commr Patents 123 (1889) (emphasis added). This is some distance from an affirmative statement that the law was otherwise.
[101] Kuehmsted v Farbenfabriken of Elberfeld Co, 179 F 701, 704 (Grosscup J) (1910) (emphasis added).
[102] Parke-Davis, 189 F 95, 102 (emphasis added) (1911).
[103] Ibid 103 (emphasis added), after mentioning some conjecture that adrenaline only existed as a salt in nature and not as a free base (the argument being that it was thus an entirely new composition of matter).
[104] Ibid.
[105] Ibid 102.
[106] Ibid 103.
[107] Merck & Co Inc v Olin Mathieson Chemical Co, [1958] USCA4 73; 253 F 2d 156 (1958).
[108] Gipstein, above n 38, 12.
[109] Kuehmsted, 179 F 701 (1910); Union Carbide Co v American Carbide Co, 181 F 104 (1910).
[110] Gipstein, above n 38, 15–16. It is perhaps going too far to say this was what Parke-Davis ‘held’: cf ibid 16.
[111] Demaine and Fellmeth, above n 24, 343 ff. For eg, Re King, 107 F 2d 618 (1939), rejecting a patent claiming purified vitamin C, distinguishing Parke-Davis because there prior adrenaline sources were unsatisfactory; here prior sources were adequate. Compare Dennis v Pitner, 106 F 2d 142, 144, 146 (1939).
[112] Patent Act 1870 (US) § 24 (emphasis added).
[113] Patent Act, 35 USC § 102 (West, 1952).
[114] Ibid § 103.
[115] Demaine and Fellmeth, above n 24, 365–6 (emphasis added).
[116] See Myriad (District Court), 702 F Supp 2d 181, 226 (Sweet DJ) (2010). On the relation between ‘new’ in § 101 and novelty under § 102: Re Bergstrom, 427 F 2d 1394, 1400 (1970); Re Bergy, 596 F 2d 952, 961 (1979).
[117] Dennis v Pitner, 106 F 2d 142, 145 (1939): ‘[t]he statute ... evidently intended to include all worthwhile discoveries, for it includes inventions and discoveries. The words “invented” and “discovered” are not synonymous ...’ (emphasis in original). For a detailed discussion of this topic, and the legislative history, the reader is referred to the work of Demaine and Fellmeth, above n 24.
[118] Myriad (District Court), 702 F Supp 2d 181, 228 (Sweet DJ) (2010).
[119] Funk Bros Seed Co v Kalo Inoculant Co, [1948] USSC 22; 333 US 127, 135 (1948); National Research Development Corporation v Commissioner of Patents [1959] HCA 67; (1959) 102 CLR 252, 264 (‘NRDC’); see also Alain Pottage and Brad Sherman, Figures of Invention: A History of Modern Patent Law (Oxford University Press, 2010) 173–4.
[120] Demaine and Fellmeth, above n 24, 338.
[121] Myriad (Court of Appeals II), 689 F 3d 1303, 1326–7 n 10 (Lourie J) (2012).
[122] See, for eg, Myriad (District Court), 702 F Supp 2d 181, 225–6 (Sweet DJ) (2010), distinguishing Parke-Davis as speaking principally to novelty, not patentable subject matter (and ‘dubious’ beyond novelty in light of American Wood-Paper[1874] USSC 189; , 90 US 566, 594 (1874)).
[123] Ibid 223 (Sweet DJ).
[124] General Electric, 28 F 2d 641 (1928); Re Marden (No 1), 47 F 2d 957 (1931); Re Marden (No 2), 47 F 2d 958 (1931).
[125] General Electric, 28 F 2d 641, 643 (1928).
[126] Re Seaborg, 328 F 2d 993 (1964).
[127] Myriad (Court of Appeals II), 689 F 3d 1303, 1329 (2012).
[128] Re Marden (No 1), 47 F 2d 957 (1931); Re Marden (No 2), 47 F 2d 958 (1931).
[129] General Electric, 28 F 2d 641 (1928).
[130] Myriad (Supreme Court), 569 US __ (2013) slip op 14.
[131] Ibid 15.
[132] Myriad (Supreme Court), 569 US __ (2013) slip op 12: ‘The location and order of the nucleotides existed in nature before Myriad found them’. ‘[Myriad’s] claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition...’: at 15 (emphasis in original).
[133] Ibid 17: ‘[T]he lab technician unquestionably creates something new when cDNA is made.’
[134] Amgen Inc v Chugai Pharmaceutical Co Ltd, [1991] USCAFED 309; 927 F 2d 1200, 1203–4 (1991) (emphasis added).
[135] Ibid 1204 (emphasis added).
[136] Diamond v Chakrabarty, [1980] USSC 119; 447 US 303 (1980).
[137] Especially where the majority of the patentee’s efforts may have been devoted to simply identifying a gene.
[138] Parke-Davis, 189 F 95 (1911).
[139] Kuehmsted, 179 F 701, 703 (Grosscup J) (1910). For this Grosscup J has come in for criticism: Demaine and Fellmeth, above n 24, 334–5. But how meaningful is a mechanical comparison of assigned formulae independently of information about the true composition of some matter? The emphasis on physical properties is well emphasised by Union Carbide, 181 F 104 (1910), where crystalline calcium carbide was held novel over the amorphous product disclosed in the prior art. That the major component of both products was probably the very same molecule did not trouble the court. See Gipstein, above n 38, 13.
[140] Cochrane v Badische Anilin & Soda Fabrik, [1884] USSC 142; 111 US 293, 310 (1884). The claim also sat uncomfortably between a product claim and a product-by-process claim — the inventors claimed the product by the described process ‘or by any other method which will produce a like result’: at 296.
[141] Monsanto Technology LLC v Cefetra BV (European Court of Justice, C-428/08, 6 July 2010), noted Hubicki, above n 21.
[142] See generally Hubicki, above n 21.
[143] Pottage and Sherman, above n 119.
[144] Dennis v Pitner, 106 F 2d 142, 144 (1939) (emphasis added); the Court answered this affirmatively.
[145] Howard Florey Institute/Relaxin [1995] OJ EPO 388, 396 [5.3].
[146] See, eg, United States Patent and Trademark Office, Manual of Patent Examining Procedure (9th ed, 2012) § 2107.01.
[147] See, eg, ICOS Corporation/Novel V28 seven transmembrane receptor [2002] OJ EPO 293, 304 [9].
[148] Hubicki, above n 21, 43.
[149] Howard Florey Institute/Relaxin [1995] OJ EPO 388, 396 [5.1], affirmed Relaxin/Howard Florey Institute (Technical Board of Appeal of the European Patent Office, T-272/95, 23 October 2002).
[150] Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions [1998] OJ L 213/13, art 3(2); Patents Act 1977 (UK) sch A2 cl 2.
[151] Patents Act 1977 (UK) sch A2 cl 2 (emphasis added).
[152] Myriad (Supreme Court), 569 US __ (2013) slip op 12 (emphasis added).
[153] Of course such claims would now surely fail for want of novelty.
[154] Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65; (2013) 99 IPR 567 (‘Cancer Voices’).
[155] Patents Act 1990 (Cth) s 18(1)(a).
[156] NRDC [1959] HCA 67; (1959) 102 CLR 252, 269 (emphasis added).
[157] Ibid 277.
[158] Justine Pila, ‘Inherent Patentability in Anglo-Australian Law: A History’ (2003) 14 Australian Intellectual Property Journal 109, 132 ff.
[159] Cancer Voices [2013] FCA 65; (2013) 99 IPR 567, [106].
[160] Ibid [107]–[109].
[161] Biogen Inc v Medeva Plc [1996] UKHL 18; [1997] RPC 1, 42 (Lord Hoffmann).
[162] Philippe Signore, ‘On the Role of Juries in Patent Litigation (Part 1)’ (2001) 83 Journal of the Patent and Trademark Office Society 791; Philippe Signore, ‘On the Role of Juries in Patent Litigation (Part II)’ (2001) 83 Journal of the Patent and Trademark Office Society 896; Ben Mee, ‘A Judicial Axe for Sharp Drafting: The “Natural Phenomenon” Dilemma’ (2012) 22(1) Journal of Law, Information and Science 55, 74; Amy Tindell, ‘Toward a More Reliable Fact-Finder in Patent Litigation’ (2009) 13 Marquette Intellectual Property Law Review 309; Theresa Weisenberger, ‘An “Absence of Meaningful Appellate Review”: Juries and Patent Obviousness’ (2010) 12 Vanderbilt Journal of Entertainment and Technology Law 641.
[163] Cancer Voices [2013] FCA 65; (2013) 99 IPR 567, [69]–[70].
[164] Ibid [72].
[165] Ibid [76].
[166] Ibid [72]–[74], [105].
[167] Cf Myriad (Court of Appeals II), 689 F 3d 1303, 1329 (2012).
[168] Cancer Voices [2013] FCA 65; (2013) 99 IPR 567, [135].
[169] Kiren-Amgen Inc v Board of Regents of University of Washington [1995] APO 61; (1995) 33 IPR 557, noted in Pila, above n 158, 151.
[170] Cancer Voices [2013] FCA 65; (2013) 99 IPR 567, [136].
[171] Alison Frankel, ‘SCOTUS in Myriad: Federal Circuit Doesn’t Know What’s Patent-eligible’ on Opinion: Alison Frankel, Reuters Analysis & Opinion (13 June 2013) <http://blogs.reuters.com/
alison-frankel/2013/06/13/scotus-in-myriad-federal-circuit-doesnt-know-whats-patent-eligible/>.
[172] Myriad (Court of Appeals II), 689 F 3d 1303, 1344 (Moore J) (2012).
[173] American Wood-Paper Co[1874] USSC 189; , 90 US 566, 594 (1874).
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