For more than 20 years, the patentability of genes and genetic material has been controversial.
For more than 20 years, the patentability of genes and genetic material has been a controversial issue, which is now coming to a head in a case before the Federal Court and with the introduction of a Private Member’s Bill which seeks to exclude the patenting of human genes and biological materials existing in nature.
The patentability of genes and genetic material has been a controversial issue since at least 1990, when the Bill which introduced the Patents Act 1990 (Act) was considered before Parliament. At that time, an exclusion directed specifically to genetic inventions was proposed, but was rejected by the Senate Standing Committee on Industry, Science and Technology. A similar amendment to the Act was proposed in 1996 and 2001 by Senator Stott Despoja, and re-tabled in 2002 without subsequent consideration. The proposed amendment provided that naturally occurring genes, gene sequences, or descriptions of the base sequence of a naturally occurring gene or gene sequence, would not be regarded as novel or inventive for the purposes of s 18 of the Act.
More recently, on 8 June 2010, proceedings were commenced in the Federal Court of Australia by Cancer Voices Australia and breast cancer patient Yvonne D’Arcy. The case centres on patents relating to the BRCA1 gene, which is linked to an increased risk of breast and ovarian cancer. The basis of the case is that the patent on the BRCA1 gene held by US-based Myriad Genetics Inc and Melbourne-based Genetic Technologies Ltd is invalid. It follows a decision in March 2010 in the US, where the Federal District Court in New York found that certain claims of the patents relating to the BRCA1 and BRCA2 genes had been improperly granted to Myriad Genetics.
For more than two years, the issue of gene patenting has been the subject of a Senate Inquiry. On 26 November 2010, the Senate Community Affairs Committee tabled a report in relation to its inquiry into the “impact of the granting of patents in Australia over human and microbial genes and non-coding sequences, proteins, and their derivatives, including those materials in an isolated form”. The report took into account more than 80 submissions from interested stakeholders.
Coinciding with the Senate’s report, on 24 November 2010, the Patent Amendment (Human Genes and Biological Materials) Bill 2010 (Bill) was introduced into the Senate by Senators Coonan, Heffernan, Siewert and Xenophon as a Private Member’s Bill “to amend the Patents Act 1990 to prevent the patenting of human genes and biological materials existing in nature”.
On 26 November 2010, the Senate’s Selection of Bills Committee referred the Bill to the Legal and Constitutional Affairs Legislation Committee for inquiry and report, to allow for submissions and evidence to be received from interested parties by 25 February 2011, and to provide a report by 16 June 2011. It is anticipated that the issues which were explored in the previous inquiry will be considered in the context of the proposed Bill.
The Proposed Bill
According to the Explanatory Memorandum to the Bill, the purpose of the Bill is “to advance medical and scientific research and the diagnosis, treatment and cure of human illness and disease by enabling doctors, clinicians and medical and scientific researchers to gain free and unfettered access to biological medicines, however made that are identical or substantially identical to such materials as they exist in nature”.
The Bill proposes to insert a provision into section 18(2) of the Patents Act 1990 (Act) that “biological materials 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” are not patentable inventions. The term “biological materials” is defined in a proposed new section 18(5) and includes “DNA, RNA, proteins, cells and fluids”. However, the terms “components and their derivatives” and “substantially identical” are not defined.
The Explanatory Memorandum states that the Bill is intended to reinforce the applicability of the distinction between a discovery and an invention, and applies that distinction by expressly excluding from patentability biological materials which are identical or substantially identical to such materials as they exist in nature. It thereby gives effect, according to the Explanatory Memorandum, to the proposition that biological materials which are found in nature are not inventions, even if they are isolated, purified or synthetically made.
Does the Bill contravene international trade agreements?
Australia is a signatory to the World Trade Organisation Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and the Australia-United States Free Trade Agreement (AUSFTA). Both the TRIPS Agreement and the USFTA set out minimum standards of intellectual property protection which signatories must adhere to, and provide that patents may be granted only for inventions, which are novel, inventive and have a practical application. Relevantly, Article 27(1) of the TRIPS Agreement provides that “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided they are new, involve an inventive step and are capable of industrial application.” Article 17.9 of the AUSFTA is couched in essentially similar terms.
The introduction of legislation which specifically seeks to restrict the patentability of biotechnological inventions would appear to be contrary to the TRIPS Agreement and AUSFTA, both of which provide that patents should be available “in all fields of technology”.
In this regard, processes or methods involved in the isolation, purification and synthesis of biological materials should be patentable as long as they meet the threshold patentability criteria of novelty, inventive step and have a practical application. Inventions which make use of biological materials to derive new and inventive diagnostics, medicines and treatments should continue to be afforded patent protection, just as they are now.
What is the international position?
In the US, it was ruled in March 2010 that 15 claims of seven US patents granted to Myriad relating to the BRCA1 and BRCA2 genes were invalid because they were not inventions. In October 2010, this view found support from the US Government when the US Department of Justice filed an amicus curiae brief in the appeal to that case, adopting a position against the patenting of isolated genomic DNA, which it acknowledged was “contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA”. It remains to be seen, of course, how the appeal to the Myriad case proceeds in the US courts. On the other hand, EU laws currently provide that isolated biological materials are patentable. Directive 98/44 EC provides for the legal protection of biotechnological inventions. Article 3 of the Directive provides:
- For the purposes of this Directive, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.
- Biological material which is 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.”1
A distinction has to be drawn between a discovery of something that is naturallyoccurring and an invention which results subsequent to that discovery. The inclusion of the word “may” in the second paragraph makes it clear that not all biological material which is isolated from its natural environment will, as a matter of course, be patentable, and that patentability will depend (as it does for all types of inventions) on whether the threshold tests of novelty, inventive step and industrial application are satisfied.
Article 5 of the Directive sets out the EU position with respect to patentability of genetic material:
- The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.
- An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.
- The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.”
Article 5 thus provides that, as long as an “element” of the human body (eg DNA) is in its natural environment, it is not patentable. However, once it has been isolated from that environment or otherwise produced by means of a technical process, it becomes potentially patentable subject matter. Further, paragraph 3 of Article 5 makes it clear that, in order for a patent to be granted in respect of a gene sequence, the patent application must disclose the specific industrial application of that gene sequence. It is not enough that the gene sequence has been merely isolated or produced by a means of a technical process.
What is the position under Australian law?
Under current Australian law, an invention is patentable if it is “a manner of manufacture” within the meaning of section 6 of the Statute of Monopolies, is novel and inventive, and is useful. The High Court considered the term “manner of manufacture” in the case of National Research Development Corporation v Commissioner of Patents2 and held that for an invention to be patentable, it “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.”
More specifically, the patentability of gene sequences was considered in Kirin- Amgen Incorporated v Board of Regents or the University of Washington and Genetics Institute, Inc3. In this case, the Commissioner of Patents considered the distinction between a discovery and an invention, and held that the “purified and isolated” DNA sequences were patentable because they claimed “an artificially created state of affairs”. The Commissioner further held that “a claim directed to naturally occurring DNA characterised by specifying the DNA coding for a portion of that molecule would likely be claiming no more than a discovery per se and not be a manner of manufacture”.
In essence, the case law in Australia makes it clear that genes or gene sequences in the form in which they exist in nature are not patentable because they will not satisfy the “manner of manufacture” requirement. For genetic material to be patentable, there must be an “artificially created state of affairs”, such that genetic material which has been isolated or synthetically produced is capable of being patented, provided the tests of novelty, inventive step and utility are also satisfied.
For example, isolated DNA is not in the same form as DNA as it exists in the human body. An isolated DNA molecule must be chemically changed to break the covalent bonds that link it to other nucleotides in the human body, which results in an “artificially created state of affairs”.
Thus, the mere discovery or isolation of a new gene, without knowledge of its function and practical application, will not satisfy the requirements for patentability. To be patentable, the gene or gene sequence must:
- be isolated from its naturally occurring environment (or synthetically produced), AND
- its function must not have been previously known and must be described in detail in the patent claim, AND
- the requirements of novelty, inventiveness and utility must be satisfied.
Protecting the public interest
That then leaves the question of the possible social, ethical and moral issues raised by the patenting of inventions such as a diagnostic test which detects increased susceptibility to cancer.
Fundamentally, inventors should have the right to benefit from and exploit inventions in which they have invested considerable resources to create. In this regard, the right to exploit an invention which detects increased susceptibility to cancer is no less significant than, say, the right to exploit an invention which is used to treat cancer. A public interest element arises in relation to both inventions, and yet there have been many therapies in the treatment of cancer which have been patented, without the same public controversy which has arisen in the case of the BRCA genes.
If there is a real need to safeguard the public interest, there are a number of other options already available under the Act. The Act provides for Crown use and acquisition of a patented invention.4 In addition, the Act provides that the Federal Court may grant a compulsory licence to a patent if “the reasonable requirements of the public with respect to the patented invention have not been satisfied”.5
Whilst there is little precedence for either of these provisions having been invoked, if there is perceived a need to protect the public interest, they could potentially be applied in circumstances in which the patentee has not provided reasonable access to the patented invention.
Does the current law stifle research?
There is no empirical evidence which demonstrates that the current law is stifling research. In relation to the BRCA genes, for example, which are currently patent-protected but are the subject of validity proceedings in the US and Australia, there have been more than 5,500 scientific papers published from independent researchers, despite the existence of patents in respect of the genes.
However, one of the proposals to address the specific concerns expressed by the research community is to introduce a research exemption into the Act, which would provide an exemption to infringement if a patented invention was used for certain specified research or experimental purposes. There appears to be broad support for such an exemption from researchers, patent owners and IP Australia, which would ensure that the public interest in advancing scientific and medical research is safeguarded.
Where to now?
An express prohibition on the patenting of biological material would appear to be unwarranted. There is a real danger that legislation which expressly prohibits the patentability of “human genes and biological materials existing in nature” will be improperly applied to prevent the patenting of important diagnostics, medicines and therapies based on antibodies, antibiotics, hormones, metabolites and proteins which have been essentially “isolated from nature”. The proposed legislation would have arguably prevented the patenting of inventions relating to insulin, erythropoietin, human growth hormone and other “natural” therapies which have been of great importance to the community.
The Australian patent system is designed to ensure that only patents which properly satisfy the threshold tests for patentability are granted, through tight examination of patent applications to ensure the threshold tests of novelty, inventive step and utility are satisfied before a patent is granted. Provided this occurs, the current system already contains appropriate safeguards which address the concerns raised during the Senate Inquiry.
However, to alleviate concerns with respect to the application of the current legal system, a research exemption introduced into the legislation would provide an exemption to infringement for certain research or experimental use, and would thereby safeguard the interests of advancing medical and scientific research. Infringement would only arise if a patented invention was exploited for commercial benefit.
Organisations and individuals with an interest in making submissions to the Legal and Constitutional Affairs Legislation Committee should note that submissions must be made by 25 February 2011. Piper Alderman would be pleased to assist any organisation or individual wishing to make such a submission.