Australia: Isolated genetic material: invention or land grab? The D'Arcy v Myriad Genetics case

Key Points

• The Full Federal Court has upheld the lower court decision in the BRCA 1 and 2 gene patent cases, the 5 appeal judges holding unanimously that genetic materials in their isolated form (whether DNA (genomic or cDNA) or RNA) are patentable in Australia.
• This places the Australian and US position directly at odds on the question of whether or not an isolated gene sequence is or is not currently patentable.
• The policy debate continues about whether amendments to the Patents Act 1990 (Cth) are needed in light of the Australian decisions.
• The High Court has yet to hear an application for leave to appeal from this decision so watch this space.

How we got here, biotechnically speaking

When the writer was studying biochemistry as an undergraduate, it was in the days when the techniques for isolating human genetic material has just beendeveloped, and it was before the whole human genomehad been sequenced.

It was in fact thought at that time that it would be many years hence that computing power would have the capacity to map the whole human genome.

History has shown that the Human Genome Project was in fact completed years earlier than originally predicted¹. Both before and after that time the process of mapping various mutations in human genes and uncovering their significance continued apace.

The diagnostic implications of this new technology are, of course, huge, as are the implications for treatment of a wide range of illnesses and ailments based on gene therapy. The impetus for large scale investment in these technologies is the potential commercial rewards to be delivered via patenting it².

The argument against granting these patents is on the basis that since genes are naturally occurring substances it should not be possible to obtain a patent over a gene sequence that one discovers to have special significance,as in the case of the BRCA1 and BRAC2 genes, (the patents for which incidentally expire in August and December next year respectively).

The Australian story to date

In our last article on this topic³ we predicted that the full Federal Court in the landmark Australian appeal case of D'Arcy v Myriad Genetics Inc (D'Arcy)⁴ (5 September 2014) would not overturn the decision of Nicholas J⁵ at first instance. Indeed, they did not. The enlarged bench of five judges were in fact unanimous in their dismissal of the appeal.

We also argued the wind had largely gone out of the whole debate - with patent filings related to isolated human gene sequence patents declining sharply since 2003, new filings tending to be based on modified gene sequences or method claims⁶, and the BRCA1 and BRCA2 genes patents heading for expiry. In this we appear to have been mistaken as the lawyers for the appellant have recently announced that they will be seeking leave to appeal this decision to the High Court.⁷

Why the US position is so different

Perhaps encouraging them is the fact that, as we have previously canvassed, the position in the US remains starkly at odds with the above. The leading decision there remains that of the Supreme Court in Association for Molecular Pathology v Myriad Genetics⁸ of last year.

As we have previously pointed out, the tests to determine patentability in the US and Australia are different and in the US, the question of whether or not the isolated DNA is a "product of nature" is akin to asking whether human genes are more like chemicals, or computers,⁹ and is by its nature a more philosophical question. The question of whether the isolated DNA is an "artificially created state of affairs", which is the question that our courts are considering, seems altogether a more practical question to answer, and allows consideration of the methods and techniques that are developed and used to isolate the gene or genes in question.

The Court in D'Arcy was at pains to point out that "expressions such as 'the work of nature' or 'the laws ofnature' are not found in (our) statute; nor are they useful tools of analysis".¹⁰ The Court felt that these expressions could in fact "fairly be employed to challenge almost any patent".¹¹

The Court made the point that the claims in the US cases and the Australian cases were markedly different, the US claims focusing on the genetic information itself, whereas the Australian claims focus on the preparation of a polypeptide product.

It must also be said that the Court was more persuaded by the reasoning of Lourie J in the earlier decision of the Court of Appeals for the Federal Circuit,¹² in which he considered that the breaking of the covalent bonds in the isolation of the gene had the effect of producing a markedly different compound than that which was "found in nature". The judgment also refers with some approval to her Honour Moore J's judgment in that regard.¹³

It must also be remembered that even the US Supreme Court decision does not generally apply to cDNA versions of naturally occurring genes, which are accepted as synthetically produced molecules that are not naturally occurring (except where they are short strands of DNA that may be indistinguishable from naturally occurring DNA).

The differences between the approach of the US Supreme Court and the Australian courts will be discussed in more detail in a forthcoming Australian Intellectual Property Law Bulletin article.

What has been exposed by these two different lines of cases is a patent system which has at its core concepts which could be described as somewhat philosophical (the US) and our patent system which is more rooted in the concepts of innovation and manufacturing, rather than philosophy.

The policy question which then arises is which is the more appropriate? If one accepts that the purpose of a functioning patent system is to encourage investment into invention and innovation by granting patent monopolies, then we would argue the more pragmatic considerations in the Australian system are the more proper considerations.

As long as the "discovery" is also a product which can also be described as an "artificially created state of affairs which has economic significance"¹⁴ and has the requisite elements of "utility, ingenuity and inventiveness",¹⁵ or as more commonly expressed, novelty and inventiveness, then why should it not be worthy of a patent?

WhytheFullFederalCourtdecisionisunlikely to be overturned

The unanimous judgment is carefully worded andrelies on a number of factual findings about the patent,based on a detailed analysis of the scientific background,including that:

• The isolated nucleic acid (gene) should be considered a chemical compound which is a product,¹⁵ and should not be considered merely as information or a code. This is "consistent with patent law, and persuasive".¹⁷
• Once isolated from the cell, the compound has structural and, more importantly, said the Court,¹⁸ functional differences from that nucleic acid as it exists in the human body. The Court gave the example of a cap and poly-A tail which exist in naturally occurring mRNA but are absent in isolated mRNA. This chemically alters that nucleic acid, as "the cap protects the mRNA molecules from any genetic degradation and assists in transport to the cytoplasm where translation occurs".¹⁹
• The compound has valuable economic use, as it contains a sequence identified by "comparison with tables created following extensive epidemiological research which describes the location of the mutations or polymorphisms as they exist in DNA" and "The DNA was constructed and these locations identified by the work of the inventors".²⁰
• The National Research Development Corp (NRDC) principles and Australian law require that the "analysis should focus on differences in structure and function effected by the intervention of man and not on the similarities".²¹
• Naturally occurring DNA and RNA as they exist in human cells cannot be patentable subject matter, but material derived from it such as the isolated compounds under consideration can be.

The Court eschewed the nevertheless "customarily persuasive"²² argument presented by David Catterns, QC, counsel for the appellant, that the process of isolation of the nucleic acid should be viewed as a metaphorical microscope enabling one to see into the relevant gene of a particular subject whose vulnerability or susceptibility to cancer was being assessed.

The Court also expounded on the worthiness of not setting the boundaries of "the conception of patentability" by reference to the scientific knowledge of a particular age and asserted that this "explained the broadening concept of patentability since the first quarter ofthe17th century".²³ Their Honours had noproblem basing their analysis on the principles expoundedin the NRDC case,²⁴ the principles of which have been applied in many cases over the years involving new technologies not even conceived of in 1959.²⁵

As a long ago student of biochemistry, the reasoning of the Court relating to the fact that "a fragment of a DNA sequence has different properties to the parent molecule from which it is derived" by virtue of the factthat DNA is a polymer, with "a different molecular charge, different chemical bonds and a different chemical composition as compared to the monomers in aggregate", has a particular appeal for this author.²⁶

As the Australian Law Reform Commission (ALRC) commented in its report into gene patenting back in 2004 that a ban on gene patenting was not advisable, because, among other things, it may fail to deliver the anticipated benefits as "many pure and isolated genetic sequences do not exist in exactly the same form in nature-for example, patented sequences may not contain the introns that are found in the naturally occurring material".²⁷

The decision appears to be consistent with this type of thinking.

The Court did not accept Ms D'Arcy's submission that the NRDC principles were inapplicable to this case, and commented that the submission failed to recognise that the NRDC principles were applicable to products like the isolated nucleic acid in this case, as well as to processes.²⁸

Why the Full Federal Court decision is of limited application

This case only considered:

1. the patent²⁹ claims that related to the genetic material itself (claims 1-3); and
2. the narrow threshold question of whether that genetic material is prima facie patentable within the meaning and boundaries of s 6 of the Statute of Monopolies.

In relation to 1 above, the patent also included claims for methods of diagnosis, and these were not considered, but the judgment does mention the 2013 High Court decision of Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd³⁰ which reaffirmed that a method or process for treatment of the human body is just as prima facie patentable as a product for the same.

As to 2 above, the patent law concepts of novelty and inventiveness in the context of patenting isolated genetic material were not considered in this case, as novelty was not challenged and there was no dispute that an inventive step was involved in the inventions.³¹

Why the Patents Act is unlikely to be amended as a result of this decision or others like it

The most compelling policy argument for exempting isolated genetic material from the Patents Act is that to allow such patents will restrict the right of medical researchers to access them.

The new s 199C to the Act, introduced by the Raising the Bar reforms of 2012, of course is intended to address this issue, and we have commented on it in a previous article.³²

The text of the section is set out below:

119C Infringement exemptions: acts for experimental purposes

1. A person may, without infringing a patent for an invention, do an act that would infringe the patent apart from this subsection, if the act is done for experimental purposes relating to the subject matter of the invention.
2. For the purposes of this section, experimental purposes relating to the subject matter of the invention include, but are not limited to, the following:
3. 1. determining the properties of the invention;
   2. determining the scope of a claim relating to the invention;
   3. improving or modifying the invention;
   4. determining the validity of the patent or of a claim relating to the invention; and
   5. determining whether the patent for the invention would be, or has been, infringed by the doing of an act.

As far as patenting the human body itself is concerned, the Act has recognised this as an area unsuitable for patenting for some time. Section 18(2) of the Act reads as follows:

Human beings, and the biological processes for their generation, are not patentable inventions.

Specific exclusion of genes from patentability has been considered by both the ALRC (in 2004) and Parliament (in 2010) and it has not occurred.

Conclusion

The reasoning in D'Arcy, with its emphasis on the "work and effort"³³ involved in both obtaining the isolated product and in creating the cDNA sequence to which it is to be compared for the purpose of the diagnosis, chimes with other Australian appellate court decisions in the field of copyright, in which the "sweat of the brow" expended in, say, the compilation of a database,³⁴ was of primary significance in deciding the threshold question of subsistence of copyright. The pragmatic jurisprudence of the Australian courts is consistent in both strands of authority.

On a more fundamental and factual level, the Court in D'Arcy simply did not agree with either of the metaphors which appear to have found favour in the US line of cases, in particular the one in which an isolated nucleic acid is akin to a branch that has been snapped off a tree. The Court in D'Arcy held that:That is inapposite. The branch has not changed - it is simply divorced from the tree, whereas the chemical and physical makeup of the isolated nucleic acid renders it not only artificial but also different from its natural counterpart.³⁵

That is inapposite. The branch has not changed - it is simply divorced from the tree, whereas the chemical and physical makeup of the isolated nucleic acid renders it not only artificial but also different from its natural counterpart.³⁵

The Court went further and said this means that the US Supreme Court was wrong when it held that the isolated nucleic acid is a "product of nature", however "in any event that exclusion is not in accordance with the principles of patent law in Australia and has been specifically rejected as a reason for exclusion in NRDC."³⁶

That is a conclusion with which this former student of biochemistry respectfully concurs.

Footnotes

¹ The Human Genome Project was completed in 2003.
² Centre for International Economics Final Report: Economic Analysis of the Impactof Isolated Human GenePatents May 2013.
³ C Lau and C Logan "Patentability of genetic material - where does it stand today?" (2013) 26(3) Australian Intellectual Property Law Bulletin.
⁴ D'Arcy v Myriad Genetics Inc (2014) 313 ALR 627; 107 IPR 478; [2014] FCAFC 115; BC201407309
⁵ Cancer Voices Australia v Myriad Genetics Inc (2013) 99 IPR 567; [2013] FCA 65; BC201300552.
⁶Above, n 2.
⁷ Maurice Blackburn Lawyers, Maurice Blackburn files leave to appeal to High Court in breast cancer gene patent case, 17 September 2014, accessed 1 December 2014, http:// www.mauriceblackburn.com.au/about/media-centre/media- statements/2014/maurice-blackburn-files-leave-to-appeal-to- high-court-in-breast-cancer-gene-patent-case/.
⁸ Association for Molecular Pathology v Myriad Genetics (2013) 569 US 12-398.
⁹ A Selleck "Human Genes: chemicals or computers?" (2010) 23(3) Australian Intellectual Property Law Bulletin.
¹⁰ D'Arcy v Myriad Genetics Inc (2014) 313 ALR 627; 107 IPR 478; [2014] FCAFC 115; BC201407309 at [13]. ¹¹ Above, n 10, at [115].
¹² Association for Molecular Pathology v United States Patent and Trademark Off?ce and Myriad Genetics, Inc, (2012) 689 F.3d 1903.
¹³Above, n 10, at [145]-[149].
¹⁴ This type of product was held in the leading case of National Research Development Corp v Cmr of Patents (1959) 102 CLR 252; [1960] ALR 114; [1961] RPC 134; BC5900480 to be included in the definition of "method of manufacture".
¹⁵Above, n 10, at [12].
¹⁶ Above, n 10, at [143].
¹⁷ Above, n 10, at [155].
¹⁸ Above, n 10, at [212].
¹⁹ Above, n 10, at [177].
²⁰ Above, n 10, at [210].
²¹ Above, n 17.
²² Above, n 10, at [6].
²³ Above, n 10, at [10].
²⁴ Above, n 10, at [106]-[110].
²⁵ For example, in Re Sheng-Ping Fang (2011) 96 IPR 134; [2011] APO 102, about a patent application for a system to represent and identify prizes for an online award or loyalty program.
²⁶ Above, n 10, at [146].
²⁷ Extract from ALRC report as quoted in D'Arcy, above, n 9, at [158].
²⁸ Above, n 10,at [166].
²⁹ Patent number 686004
³⁰ Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 304 ALR 1; 88 ALJR 261; [2013] HCA 50; BC201315312.
³¹ Above, n 10, at [206].
³²P Ng and W Liu "Raising the bar? The new patent law reforms and their impact on patentability of genetic material" (2011) 24(4) Australian Intellectual Property Law Bulletin.
³³Above, n 10, at [8].
³⁴ See IceTV Pty Ltd v Nine Network Australia Pty Ltd (2009) 239 CLR 458; 254 ALR 386; [2009] HCA 14; BC200902942 and also Telstra Corp Ltd v Phone Directories Co Pty Ltd (2010) 194 FCR 142; 273ALR 725; [2010] FCAFC 149; BC201009581.
³⁵ Above, n 10, at [211].
³⁶ Above, n 10, at [217].

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