By guest blogger Doug Calhoun
In a decision : delivered on15 February 2013, nearly a year after the oral hearing, Federal Court of Australia Justice JohnNicholas held that the Myriad Genetics patent for “An isolated nucleic acid coding for a mutant orpolymorphic BRCA1 polypeptide … ” was an invention under Australian patent law.
The case was solely about whether or not the isolated nucleic acids claimed were “manners ofmanufacture” as required under the Australian Patents Act 1990. It was not about policy issues,such as access to medicines, or what the law ought to be in future. I discussed these issues in anearlier
The governing case on the interpretation of the words ”manner of manufacture” in Australia(and in New Zealand) is the 1959 decision of the High Court (Australia’s highest appeal court) inthe case of National Research and Development Corporation v Commissioner of Patents (NRDC). NRDC wasabout a patent application that claimed a process for selectively eradicating weeds using aherbicide of known chemical composition.
In reaching its decision that the process claims were indeed patentable, the High Court took aninnovative approach.
The words “manner of manufacture” originated in the 1623 English Statute of Monopolies.
The High Court observed that the intention of patent legislation is to protect inventions - andwhat would constitute an invention in 1959 was well beyond the imagination of the English Parliamentof the 17th century. In order to interpret the words in a contemporary context they should not begiven a literal meaning – rather they should be interpreted to ask the question: “is this anartificially created state of affairs in an economic field?”
Justice Nicholas reviewed the NRDC decision and then considered how it should be applied in thiscase:
86 There are three important points that emerge from these passages. First,the Court identified the question that must be addressed for the purpose of determining whether ornot subject matter is patentable, viz. “[i]s this a proper subject of letters patent according tothe principles which have been developed for the application of s. 6 of the Statute ofMonopolies?” Secondly, this question involves a conceptual inquiry as opposed to a considerationof the etymology of the expression “manner of manufacture”. Thirdly, the concept of manner ofmanufacture has a “broad sweep” intended to encourage developments that are by their natureoften unpredictable.
88 It is apparent from this passage that a product that consists of an artificiallycreated state of affairs which has economic significance will constitute a “manner ofmanufacture”.
103 There are two further points to be made concerning NRDC. First, it is importantto note that NRDC does not require the Court to ask whether a composition of matter is a “productof nature” for the purpose of deciding whether or not it constitutes patentable subject matter.NRDC recognises that it may be unhelpful to approach the problem in this way. I think this isespecially so in the field of biotechnology in which micro-organisms play a critical role in thedevelopment, manufacture and use of diagnostic and therapeutic products and techniques. And second,NRDC does not require the Court to ask whether a micro-organism is “markedly different” tosomething that already exists in nature for the purpose of deciding whether it constitutespatentable subject matter (cf. Chakrabarty at 310).
Justice Nicholas observed what the claims did not cover, in spite of the submissionsof Cancer Voices to the contrary:
76 First, the disputed claims are not to genetic information per se. They claimtangible materials. Much emphasis was placed by the applicants [Cancer voices] upon theinformational character of DNA as a storehouse of genetic information. But the disputed claims arenot to information as such. They could never be infringed by someone who merely reproduced a DNAsequence in written or digitised form.77 Secondly, because each of the claims is to an isolated chemical composition, naturallyoccurring DNA and RNA as they exist in cells are not within the scope of any of the disputed claimsand could never, at least not until they had been isolated, result in the infringement of any suchclaim.
The substance of the decision is set out in four paragraphs:
106 Accordingly, the issue in this case turns upon whether an isolated nucleic acid,which may be assumed to have precisely the same chemical composition and structure as that found inthe cells of some human beings, constitutes an artificial state of affairs in the sense those wordsshould be understood in the present context. There are three considerations which lead me to thinkthat it does.107 First, in explaining the concept of manner of manufacture as one involving the creation of anartificial state of affairs, it is apparent that the High Court in NRDC was deliberate in its use ofvery expansive language. Not only did the High Court emphasise the “broad sweep” of the conceptinvolved, it also made clear that metaphorical analysis may not be helpful in determining whether ornot something constitutes patentable subject matter.
108 Secondly, in the absence of human intervention, naturally occurring nucleic acid does notexist outside the cell, and “isolated” nucleic acid does not exist inside the cell. Isolatednucleic acid is the product of human intervention involving the extraction and purification of thenucleic acid found in the cell. Extraction of nucleic acid requires human intervention thatnecessarily results in the rupture of the cell membrane and the physical destruction of the cellitself. And purification of the extracted nucleic acid requires human intervention that results inthe removal of other materials which were also originally present in the cell. It is only after boththese steps are performed that the extracted and purified product may be properly described as“isolated” in the sense that word is used in the disputed claims.
109 Thirdly, as Dann’s Patent demonstrates, the isolation of a particularmicroorganism may require immense research and intellectual effort. In that case, it was only as aresult of an intensive research effort that the isolated micro-organism in question could be madeavailable for use in the manufacture of the new antibiotic.It was fortuitous for the patentee thatit was its employees who were first to isolate the new micro-organism and first to deploy it in themanufacture of the new drug. That will not always be so. It would lead to very odd results if aperson whose skill and effort culminated in the isolation of a micro-organism (a fortiori, anisolated DNA sequence) could not be independently rewarded by the grant of a patent because theisolated micro-organism, no matter how practically useful or economically significant, was held tobe inherently non-patentable. In my view it would be a mistake, and inconsistent with the purposesof the Act, not to give full effect in such situations to the broad language used by the High Courtin NRDC.
Justice Nicholas, after completing the reasons for his decision also referred to thevarious reviews conducted in Australia and the enquiry and bill not passed in the Australian Senate.He pointed out that none of these had any bearing on his decision – he had to interpret patent lawas it now existed.The applicants who sought to revoke the Myriad Australian patent have 21 days to appeal thedecision.
Justice Nicholas also commented upon the US cases considering the validity of the US patentsequivalent to the one he was considering:
134 On 30 November 2012, the US Supreme Court announced that it would hear an appealin the Myriad case. The US law in relation to the patentability is therefore not likely to besettled until the Supreme Court reaches it own decision on the issue.135 In any event, it seems to me that the Myriad decision does not provide any direct assistanceto either side in the present case. I say this for two reasons. First, the law in Australia isdifferent. I must apply the law as explained in NRDC. It must also be recognised, especially as theMyriad case heads to the US Supreme Court, that the constitutional setting in which patentlegislation operates in the US is quite different to that in which patent legislation operates inthis country: Grain Pool of Western Australia v Commonwealth of Australia (2000) 202 CLR 479 atparas [28]-[32]. Secondly, the evidence in the Myriad case was not the same as the evidence in thepresent case. And at least in relation to the matter of covalent bonds, I have taken a differentview of the facts to that taken by Judge Lourie.
For more on the first and second US Federal Court of Appeal Cases see my earlier posts
here and here: The date set for the oral hearing before the US Supreme Court is 15 April 2013. A decision can beexpected by the end of June 2013 when the court’s 2013 term ends.
And in an interesting twist, if the US Supreme Court says “no” to gene patents, will theAustralian negotiators of the Trans Pacific Partnership agreement insist on a change to the IPchapter so that isolated nucleic acids are eligible for patents in the US?