A novel look at inventionin inventory

Is the decoding of genetic material something that should be patented? Margaret Llewelyn examines intellectual rights and the human genome.

The completion of the draft of the human genome has focused attention on the extent to which patents should be available over genetic material.

There is concern that bioscience companies are acquiring patents over basic genetic information that does not meet the ordinary concept of an "invention". Patents are granted over inventions that are novel, not obvious to others in the field and capable of industrial application.

The term "invention" is not fully defined in European patent law. Discoveries, however, are not regarded as inventions, and certain inventions that could fulfil the granting criteria are not regarded as patentable for reasons of public policy, eg if they are regarded as being morally unsound. Human genetic material is not expressly excluded.

Questions arise over the way in which the categories of excluded material have been interpreted. Patent offices have adopted a very restrictive approach to their application with the apparent rationale that where the granting criteria have been met, a patent should be granted unless there are exceptional circumstances.

Discoveries are taken to be basic information for which a use has yet to be found. But once a use has been identified and provided, a patent will be forthcoming if the "inventor" can show that what he has done is both novel and non-obvious.

Morality appears to be determined by a two-part test: whether the public would find the invention "abhorrent" and even if it does, whether the invention has beneficial uses. If convinced of the latter, even if this is a speculative benefit, the patent office has proved reluctant to deny a patent on the grounds of the former.

On this basis, arguments relating to the morality of patenting inventions involving human genetic material have been rejected on the grounds that the public in general would not regard the provision of new drugs, albeit derived from a human source, as abhorrent per se, but rather as ultimately for the public benefit. Once again, the definition is biased in favour of permitting, rather than rejecting, patent protection.

Current patent practice raises four key issues. First, is it correct for patent offices to treat products involving genetic material as indistinct from other types of inventions for the purposes of determining patentability?

Second, if there is public consensus that patents should be granted over genetic material, are the granting criteria, and categories of excluded material, being appropriately applied?

The threshold of patentability is determined by the criteria of novelty, non-obviousness and industrial application. But is genetic material novel or its use in the production of medicinal products non-obvious?

Is the threshold of patentability being eroded to permit patents over material that is not truly novel, the identification of the use of which is obvious, but which nonetheless is of considerable commercial value?

If this is the case, where does the responsibility for determining the threshold lie? It would be wrong to lay responsibility solely at the patent office door as offices will apply the standard according to what is permissible within the confines of the law.

Nor should we blame scientists and patent lawyers for seeking protection for material that lies at the borderline between what is and is not patentable.

Many scientists are resistant to the notion of acquiring patent rights over bioscience inventions. But until issues such as the use of protected material for research purposes are clarified, even the most patent-resistant companies will defensively patent genetic material to ensure they have continued access.

Equally, given that the primary obligation of patent lawyers is to their clients, it is understandable that they will exploit any uncertainty over the patentability of genetic material if it is in the interests of their clients.

Those involved in obtaining or granting such patents point out that questions of validity will be determined by the courts.

Third, is it correct that patents are a necessary adjunct to medical research and the development of drugs?

A statement commonly heard in intellectual property circles is that the success of the pharmaceutical, industry is due to the use of, and reliance on, the patent system - take away the rights and the industry would collapse. But there is no evidence to support this.

The final issue is whether the patent system is serving its primary function of providing a framework of protection within which scientists can carry out research and development for the benefit of the public.

A line has to be drawn between allowing too much to be protected and failing to provide the bioscience industry with the support mechanism it needs to produce beneficial new products.

In the same week as the Tony Blair and Bill Clinton statement that free access to the basic results of the Human Genome Project was desirable, Sir Aaron Klug and Bruce Alberts (presidents of the Royal Society and of the United States National Academy of Sciences respectively) also published a joint statement.

In asking what type of patent protection makes sense in order to realise the potential public benefits of the project they stated that it is "critical that the benefits to the public be at least reasonably commensurate" to the reward the inventor obtains via a patent and that the grant of patents "to any portion (of the human genome) should be regarded as extraordinary - and should occur only when new inventions are understood to confer benefits of comparable significance for humankind".

Sadly this does not appear to be current patent practice, and it is doubtful whether the term extraordinary could be applied to either the grant or the invention.

Instead, commercial interests appear to be driving the extension of patent protection to bioscience. The European Union directive on the Legal Protection of Biotechnological Inventions being implemented in the United Kingdom, which permits patents over human genetic material provided the invention constitutes more than the simple discovery of genetic information, has been established to encourage investment in the biotechnology industry.

The question that remains is whether we are prepared to accept commercial diktat as sufficient justification for the extension of patent law on the basis that the material protected may, or may not, ultimately provide a public benefit.

I would argue that we should not and that governments should look beyond the economic interests of an industry that wants to sell back to us that which could be regarded as common property, before engaging in a course of action that should ensure that the interests of all are served.

Margaret Llewelyn is senior lecturer in law at the University of Sheffield and deputy director of the Sheffield Institute for Biotechnology Law and Ethics.