Ethics and gene patents
Should genetic material be patentable?
This question stems from the nature of biotechnology itself, based as it is on the manipulation of natural, biological processes. This gives rise to continuing ethical and legal concerns over the patenting of genetic material which we outline below.
Some ethical concerns can best be summarised as an unease at associating property rights with biological materials, especially human biological materials which are arguably part of the common heritage of humanity. In 2002, The Nuffield Council tried to address these ethical issues and expressed unease at what they regarded as in essence patenting of information, but preferred to see the way ahead as looking at the proper operation of the patent system .
To a certain extent this view is probably borne out of practicality. The views in this area are entrenched and not capable of easy resolution. There is also little realistic prospect of bringing about any required change in law – which requires international co-operation – in the near term, and some consider that change to the law may harm the delivery of products downstream – though others consider that it would be beneficial. In the short term, HGC agrees with the Nuffield Council and the Royal Society that the way forward is to ensure that the balances built into the patent system are applied properly and to focus on issues of access – see below. In this way, in effect the issue of ethics can be addressed.
Some have questioned the appropriateness of patent examiners being required under patent law to apply moral criteria considering that this should be the province of government by way of regulation of the foregoing research and/or exploitation of the invention, and for society at large to determine what is ethical. The criteria on which morality may be judged may vary from country to country. How it is being currently applied needs to be considered further by the relevant bodies. The elaboration of the grounds for exclusion under the Directive provides more certainty but is not an exhaustive list and the possibility remains of adding further grounds.
Legal concerns – the proper application of the law
The Nuffield Council and Royal Society reports emphasize the need to ensure an over-arching balance between public and private interests in applying the law such that:
- the scope of patent protection is commensurate with the contribution that the invention makes to the advancement of knowledge; and
- the return to society is as great as the benefit enjoyed by the patentee from the monopoly.
In regards to DNA sequences, debate has centred on whether these claims can meet the legal requirements for patentability. For example, many consider that the identification of genes and their function are discoveries (and thereby excluded from patentability) and that many claimed DNA sequences result from mere routine use of the technology particularly computerised techniques, making it more difficult to demonstrate any inventive step by the researcher.
The Nuffield report concludes that proper application of the criteria for inventive step (obviousness) would result in fewer gene patents being granted – they would become the exception rather than the norm. In the long term this would happen in any event as the technology moves on and it becomes increasingly difficult to demonstrate an inventive step for sequences.
A further concern is that claims may be granted which are not justified by the contribution to the invention – overly broad patents. For example the rule that the first person to patent a substance is entitled to a patent over all its uses, even if they were not foreseen by the patentee. The Nuffield report recommends limiting patents to uses sufficiently described by the inventor. Industry claims that such a limitation would hamper drug development, as it provides less effective protection. The recent tightening of the rules regarding disclosure of uses may limit the granting of overly broad claims. Attention to competition and access issues can probably also overcome these concerns.
In summary therefore, it is increasingly important to analyse how the law is actually being applied and this is the focus of current research by the Department for Trade and Industry and of HGC.
Competition and access to information
There is concern over whether access to information or material by researchers and/ commercial concerns may be impeded either by too broad patents (which have a wide area of protection) or the unavailability of licences, or licences on terms that are prohibitive either individually or together if several licences are needed from third parties to be able to exploit the patent. (“royalty stacking” or “patent thickets”). There is little evidence available which shows whether the patent system has had a negative, positive or broadly neutral impact on research or whether commercial development is impeded. The Department of Trade and Industry (DTI) commissioned a report which was published in May 2004. The report, Patents for Genetic Sequences: The competitiveness of current UK law and practice, concluded that the UK patent system appears to be working satisfactorily at least at present, but recommended future research.
Perhaps of most public concern is the potential limit of access in a clinical setting particularly for genetic tests. The most high profile example of this is the Myriad [1] case. This case raises the issue of cost and terms of access, as well as broad claims and differing countries approaches to state funding of healthcare. The OECD is currently carrying out a study to see whether policies such as Myriad’s are widespread in companies offering genetic tests and their effect as there is currently little available evidence to determine whether Myriad is an isolated case. However, even if it is currently an isolated case, if it succeeds in its aims the concern is that others may follow. The scope of the exemption from infringement allowing researchers to use a patent varies in interpretation worldwide. Several bodies are studying this issue.
Informed Consent, donor identification and confidentiality
Recital 26 of the Directive states that a donor must have had an opportunity to express informed consent for an application for a patent to be filed arising out of the donated material. This has not been incorporated into national legislation and there are no current plans to do so. Informed consent and this issue are discussed in “Inside Information”, an HGC report. The European group on Ethics was of the view that any application involving human stem cells should specify their origin. Personal Information derived from genetic data can be confidential and is protected in law. The adequacy of the protection remains a concern and is considered in the HGC “Inside Information” report.
Endnotes
1.Myriad/BRCA1 and BRCA2
When the BRCA1 and BRCA2 genes mutate, they are involved in approximately 5% of cases of breast cancer. Women with these mutations are 7 times more likely to develop breast cancer than females without the mutation. Myriad have obtained exclusive rights to the BRCA1 and BRCA2 genes in many countries. Its licensing terms stated that all tests should be done in its own laboratory and the tests cost in the order of USD 2500. The company sent cease and desist letters to several laboratories offering the test. Institute Curie and several other bodies lodged oppositions to the European patents.
The case raises 2 broad issues. The first is breadth of claim, although as the Myriad patents were applied for several years ago and practice and technology has moved on, this will become less of an issue over time. The Nuffield report recommended that the criteria for patentability be applied strictly, particularly inventiveness. If this is implemented, Nuffield believe that the granting of product patents which assert rights over DNA sequences for use in diagnostics would become the rare exception rather than the norm.
The second issue is the alleged abuse of monopoly in the way the tests are offered and sold. Competition policy provides a check to the way that a patent monopoly can be exercised, in the form of compulsory licences and competition legislation. The question here is whether the checks are working sufficiently to provide the correct balance of reward to the patentee and access by the public particularly in the area of public health.
However the issues raised remain matters of debate and the Myriad patents are being opposed.
For more recent developments in this area, see:
European Patent Office press release
European Society of Human Genetics press release