The patentability of living things: the latest in the BRCA gene saga

298x232-dna_genetic_test-298x232_dna_genetic_testD’Arcy v Myriad Genetics Inc [2014] FCAFC 115 (5 September 2014) – read judgment The recent ruling from the Full Federal Court of Australia allowing the breast cancer gene isolated in the laboratory to be patented contrasts sharply with the ruling by the US Supreme Court last year that a naturally occurring DNA segment is a “product of nature” and therefore not patent eligible merely because it has been isolated. The implications of this ruling for gene testing and patenting of biological products have been eloquently discussed elsewhere and I will not attempt to cover the same ground – see for example the excellent discussion posted by the Enhanced Genetic Services Project. All I want to point up in this post – apart from the obvious need for intellectual property law to encompass the development of science and technology – is the Australian court’s focus on how easily misled one may be by semantics in this sort of dispute. This ruling upholds an earlier decision that gene patenting is permissible under Australian law, declaring that “the boundaries of the conception of patentability are not dictated only by deductive logic from the linguistic premises formulated in the scientific knowledge of a particular age”. The concept of patentability has been broadening since the first quarter of the 17th century, and there is no reason why it should reach an artificial wall erected by unfathomable and unexplained “laws of nature” (a premise much relied upon by the US Supreme Court). I posted last year on the decision of the US Supreme Court in Association for Molecular Pathology v Myriad Genetics Inc. It will be remembered that that Court held that a sequence of DNA mimicking the BRCA breast cancer mutation could not be patented because DNA’s information sequences and  all the other processes that allow the information to manufacture bodily tissues occur naturally within human cells.  The US Court concluded as follows:

Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes) by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome.

Myriad had not, in their view, created or altered any of the genetic information encoded in BRCA1 and BRCA2 or the location and order of the nucleotides. It had merely “found” an important and useful gene. But the US Court found that the separating the gene from its surrounding genetic material was not sufficiently an act of invention to attract patent protection. The Australian Court expresses some puzzlement with the US Court’s rejection of the claim over isolated nucleic acids for much the same reasons as those pressed by the appellant in this case.

With respect, the Supreme Court’s emphasis on the similarity of ‘the location and order of the nucleotides’ existing within the nucleic acid in nature before Myriad found them is misplaced. It is the chemical changes in the isolated nucleic acid which are of critical importance, as this is what distinguishes the product as artificial and economically useful.

The US Supreme Court accepted that cDNA (“complementary DNA”, i.e. that which is completely synthesised in the laboratory) is patentable. But it rejected the isolated nucleic acid of the first claim  because it was of the view that the isolated nucleic acid was a “product of nature”. The Full Federal Court of Australia did not agree with this view and in any event, that exclusion was not in accordance with the principles of patent law in Australia.  A previous case in the High Court of Australia had deemed patentable a product found in nature,  provided that it involved an ‘artificially created state of affairs’ and had ‘utility in a field of economic significance’. It is possible to isolate pure DNA from a tissue sample by a series of techniques and applications of chemicals that break down the nuclear cell wall, the proteins and RNA associated with the DNA molecules.  Once a DNA sample has been isolated, the DNA sequence can be mapped using a variety of methods. Genetic testing is completed by comparing the relevant DNA sequence of the sample to a normal reference sequence, such that variations can be determined in a specific region of DNA. By this method Myriad had identified the exact location of the BRCA1 and BRCA2 genes, allowing Myriad to determine their typical nucleotide sequence. That information in turn enabled the company to develop medical tests useful for detecting mutations in the genes and thereby assessing whether the patient has an increased risk of cancer. This was good enough for Australian patent law. Expressions such as “the work of nature” or “the laws of nature” are not found in the Australian statute; nor were they “useful tools of analysis”. As the primary judge observed (whose conclusions were being upheld by the Full Federal Court):

the claims are for tangible materials. Genomic DNA sequence does not exist outside the cell and in that sense it can be said that an isolated chemical is not the same as the chemical in situ. One difference is that the isolated chemical can be manipulated and utilised in ways that the other cannot. That is, they may have different uses or functions, including those set out in the specification. Treating the claim as one to chemical entities, they are not the same as the nucleic acid sequence encoding the BRCA1 polypeptide in situ. They have different beginnings and different ends. …There is no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent. However, the disputed claims do not cover naturally occurring DNA and RNA as they exist inside such cells. The disputed claims extend only to naturally occurring DNA and RNA which have been extracted from cells obtained from the human body and purged of other biological materials with which they were associated.

Intellectual property in a world of fast changing technology The importance of not limiting patentability to tangible things that have been manufactured was emphasised by the House of Lords in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKHL 46 (NB the citation given in the Australian judgment is incorrect) where Lord Hoffman said (at 77) that an invention is a practical product or process, not information about the natural world. It confuses the issue to use such terms as “the work of nature” and the “laws of nature”. It is not decisive or helpful to point out that the suggestion is that nature, in its newly ascertained aspect, be allowed to work in its own way. Expressions such as the “work of nature” or the “laws of nature” could fairly be employed to challenge almost any patent. As the Australian court concluded, this case was not about the wisdom of the patent system.  It was about the application of Australian patent law, as set out in the Act and as developed by the courts since the Statute of Monopolies:

It is not about whether, for policy or moral or social reasons, patents for gene sequences should be excluded from patentability. … It is not a matter for the court, but for Parliament to decide. Parliament has considered the question of the patentability of gene sequences and has chosen not to exclude them but to make amendments to the Act to address, in part, the balance between the benefits of the patent system and the incentive thereby created, and the restriction on, for example, subsequent research. (204 – 205)

In short, modern patent law should focus on an analysis of the products as products and not on the information that they contain. The history of patentability of biological products in Australian law is instructive: in 2010 the Australian government rejected a private member’s bill which recommended that patents be excluded for “biological materials [such as DNA and RNA] including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature” The court acknowledged the appellant’s argument that isolated DNA could be characterised as material derived from naturally occurring material. What they were not prepared to accept that it was therefore excluded from patentability:

The use of a living organism to produce a substance such as an antibiotic is patentable. It is not a question whether there is any overlap between what occurs in nature and that which is claimed. If so, all biological material would be inherently unpatentable.

This ruling is not the last word in the story;  leave to appeal may be sought from the Australian High Court. Related posts: