Gene Patents

Large parts of your genome, the genetic code that is the distinct code that defines your humanity,  have been patented and commodified. Exclusive property rights over that information have been awarded to private companies, locking up important research and depriving patients of life saving medical treatment.

 The Patents Act 1990 Cth  provides patents for inventions,  not discoveries.  A Patent can be obtained for a device, substance, method or process or combination of them, in any field of technology.

Patents are the oldest and most powerful form of intellectual property, bestowing upon the inventor the exclusive right to commercially exploit an invention for a limited period of time. The concept of what can be patented under the legislation is derived from the Statute of Monopolies 1623.  An invention is defined in the Schedule to the Act as “any manner of new manufacture the subject of letters patent or grant of privilege within S6 of the Statute of Monopolies”. 

The phrase “manner of new manufacture” includes both products and processes which are capable of industrial application. (see the NRDC case). “Manner of manufacture” is an evolving and dynamic concept, having been interpreted in subsequent cases. (See CCOM Pty Ltd v Jiejing Pty Ltd). To be eligible as patentable subject matter an invention must be one that offers some advantage which is material in the sense that the process belongs to a useful art as distinct from a fine art, that its value to the country is in the field of economic endeavour.

In April 2009 the Intellectual Property Research Institute of Australia was engaged in a discussion before a Senate Inquiry on the topic as to whether or not Genes should be patented.

Many organisations and eminent Scientists have made submissions including the Cancer Council of Australia.

Their view is set out as follows:

Gene sequences (and genetic mutations linked to specific diseases) are not an invention, but rather the discovery and isolation of naturally occurring substances. As a fundamental part of human biology, gene sequences are increasingly pivotal to an extraordinarily important, burgeoning field of health science – and one that must not be restricted by measures ostensibly designed to reward invention which may lead to the establishment of commercial monopolies….Rather than rewarding innovation, gene patenting is contrary to patent law as developed by the courts and, if allowed, can actively discourage scientific research and discovery….Under current arrangements in Australia, there is no adequate legal protection to ensure genetic testing for cancer risk remains freely accessible and at reasonable cost to the health system and consumers

It is seen as fundamentally flawed to grant monopolies to materials that are identical to those found in the human body. As genes were never specifically created there are no firm rules on the patenting of gene sequences that are ‘discovered’. 

Yet companies have managed to monopolise both the test for isolating gene sequences in addition to the raw genes themselves.  You might ask the question how an  isolated and purified gene differs from the same gene in the human body?

Proponents of gene patents argue that their right to inventions arise legitimately through the discovery and extraction process.  However, the concept of a single gene is an artifact,  an abstract concept,  so the argument goes.  Genes do not exist as discrete entities in the human body or in nature, but a part of our entire complement of genomic DNA.

What the particular inventor has done is identified a particular group of letters that have a particular function that is useful. They say they have been able to identify and extract that and define it as having a function. In isolating a gene sequence, it becomes a discrete entity,  maintained in a vector, where it can be replicated easily and manipulated easily. Whilst analogous to what we have in our human body, it is something quite different when it is in an isolated form, and it is the isolation process which is the useful information they would argue. The gene itself is merely a research tool.

As IP Watchdog  point out  this is as “inventive” as marking the boudaries of natural features, like mountains, on a map. It gives the mapmaker no right to the mountain, nor to preclude others from depicting that mountain. Whilst that concept relates to old copyright cases, the same reasoning is applicable. Like any natural phenomenon there should be firm rules in place to distinguish between rewards for discoveries and patents for inventions. We have seen how the major genetic database vendors human gene sequences have lobbied for misappropriation principles to be incorporated into legislative database proposals to try to  package these sequences into databases, granting them potentially protection in perpetuity. Those which to use them for research purposes face having to pay huge licence fees for access to them.

As with any natural phenomenon there should be firm rules in place to distinguish between rewards for discoveries and patents for inventions.

When the human genome was mapped in 2000 both Clinton and Blair stated the raw data should be free, yet patents are placing control on the raw data, data that should be free to realise the promise of this research in advancing the knowledge of human disease. It is a fiction that once you remove the gene from it’s natural environment, the body,  you have an invention.

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4 Responses to Gene Patents

  1. Patent Application, Need some resources and price comparisons. The one bookmarked here cost several hundred from inception to completion. Is that the going price ?

  2. pacelegal says:

    The Senate Enquiry into Gene Patents in Australia will be handing down it’s report in June 2010. It is a contentious debate as to whether genes are discovered or created. There have been some interesting cases in both the UK and the US recently. In the Myriad Genetics case (Association for Molecular Pathology v Myriad Genetics and the Director of the University of Utah), a case brought by the ACLU heard in the district court in New York, Judge Robert Sweet invalidated certain aspects of seven gene patents owned by Myriad, who had claimed the exclusive right to test for BRCA1 and BRCA2 (the two genes which when mutated indicate an increased risk for specific forms of breast and ovarian cancer). The District Court found that merely removing the gene from its natural environment, the body, is not sufficiently different to what is found in nature, and such processes are therefore a “discovery” and rather than an “invention”. The ruling brings into question the rights of biotech companies’ claims to be able to exclusively commercialise specific pieces of DNA gene patents. You might remember there was a lot of controversy over their monopoly over the sale of the diagnostic tests for screening purposes.

    The Myriad Genetics case is the first legal challenge to gene patents and their effects in the US and sent shockwaves through the pharma and biotech industry. The USPTO had previously stated that descriptive sequence information alone isn’t patentable, there was a distinction between this and a new and useful purified and isolated DNA compound described by a sequence. The response of the Judge was to simply that gene patents are inherently unpatentable irrespective of their practical impact. The case will probably end up in the Supreme Court as Myriad has already decided to appeal to the Federal Circuit.

    Contrast this approach with a recent decision in Eli Lilly and Company v. Human Genome Sciences where the English Court of Appeal has ruled on the patentability of a protein called HGS Neutrokine, the antibodies to it, in addition to the polynucleotide sequence encoding for it. Research using bioinformatics enabled HGS to be the first to discover it’s existence. The Court was reviewing a judgement at first instance by a lower court which found that the patents were invalid on three grounds, being insufficiency, obviousness and lack of industrial application or utility.

    The Court held that the question of whether the patent was “susceptible of industrial application” was the most important issue, citing the European Patent Convention Art.52(1). Art 57. The Judge found that one can patent an isolated gene sequence subject to being able to being able to disclose the industrial application of the protein for which it encodes ie how it can be used. Therefore merely discovering a particular gene sequence isn’t enough. The Court acknowledging there was no english case law, acknowledged the significance of previous case law involving DNA sequences discovered through the process of bioinformatics, involving the Technical Board of Appeal of the European Patent Office, namely Max-Planck T 0870/04 (May 2005), Johns Hopkins T 1329/04 (June 2005) Genentech T 0604/04 (March 2006), ZymoGenetics T 0898/05 (July 2006), Bayer T 1452/06 (May 2007) and Schering T 1165/06 (July 2007).

    Having reviewed the claims the subject of the patent against existing case law, the Judge found that there were numerous claims made to the use of Neutrokine in the patent which were purely speculative. The judgement highlights differences in approach between the English Courts and the European Patent Office. The European Patent Office had come to a different decision only a couple of months earlier about the potential uses of Neutrokine based on the same disclosures in the patent application, however the Judge explained that he had reached a different factual conclusion. The Judge put this down to procedural differences and approaches to evidence in the English Courts and the EPO proceedings which are largely administrative in nature.

    There is a lot of contention around gene patents and opinion is polarised.

    However I think that the accessibility and exchange of information about genes in human disease is the most important consideration. The basic data or information must therefore be available to all to interpret and develop to advance medical research and science. It shouldn’t be locked up and held by one private entity.

  3. pacelegal says:

    Thanks for your kind comments. It is an interesting question and there is a lot of discussion on it. I think it raises broader related issues. The case of Moore v. Regents of the University of California, a 1988 California 2nd District Court of Appeals ruling raises the question of whether we actually own the cells in our own body.

    Moore was a leukemia patient who claimed profits derived from patents on a cell line generated from his spleen tissue. The patient had given permission to Doctors to withdraw samples of blood, blood serum, skin, bone marrow aspirate, and sperm which was part of commercially valuable cell research researchers were conducting on his cells which were unusual. However Moore had been under the impression that this was necessary to his treatment. The researchers concealed this from the Defendant and set out to benefit financially by exploiting his T-lymphocyte cells, developing a cell line and gaining exclusive access over it by claiming a patent over it. When Moore discovered that unnecessary procedures had been conducted, which he travelled a long way to have performed, under cover of a doctor-patient relationship, without his informed consent being obtained he brought action.

    The case and the whole question of gene patents raises broader philosophical questions about a human being’s autonomy, their control over their own bodies and the commoditisation of bodily parts and tissues. It also has implications for medical research.

    The researchers wouldn’t necessarily have had the patient’s co-operation had they not concealed these various activities from him. ‘Ownership’ disputes have arisen over the property in human tissues, eg tissue samples leading to the development of the prostrate-specific antigen test. The dispute over ownership of the tissues/cells and other bodily products have been fought out in courts. One court has suggested that patients can relinquish control over body tissues by signing consents, whereas other Judges have asserted that human beings may not ever hold any proprietary interest even prior to the point at which biological material is extracted from the human body.

  4. pacelegal says:

    Hi Rudolf,
    In Australia a person has to be a registered Patent Attorney to give any advice at all on patents. I would imagine there are similar requirements in other jurisdictions.
    Based on my understanding it is almost impossible to give a general cost estimate in the area of patents. It depends very much on the type of patent you are seeking, eg whether or not it is an innovation patent or a standard patent. (the US name is utility patent?), what your filing strategy is (eg globally under one of the treaties). The drafting of the patent specification is important and legal costs will vary according to the firm and the amount of searching which needs to be done. There are so many variables.

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