Genes for sale: barely used

Arguably, what the debate boils down to is a fundamental question of ‘what exactly should a patent give ownership of?’ The textbook answer to this question is simple: Firstly you’ve got to produce something ‘original’, something that’s never been produced anywhere else in the world. Secondly you have to show that it involved something called an ‘inventive step’, meaning that you’ve done something that wouldn’t be obvious to someone in the same field. The third criterion, the US calls ‘utility’ and the UK calls ‘industrial applicability’, however the underlying principal is the same – you have to know why your innovation is useful: in terms of genes, the applicant for a patent must know what a particular gene sequence does (why it is useful) to be issued a patent on that knowledge.

Advocates of gene patenting argue that the process of sequencing a section of DNA, and determining its meaning, fulfils all three of these criteria, primarily because it gives utility to a sequence of genetic code that would otherwise have been useless.

Perhaps it is not the patent system itself that is flawed, proposes Graeme Laurie, Professor of Medical Jurisprudence at Edinburgh University of Law. “This situation is not exactly unique to biotechnology,” he says. “Anytime you have a new technology… very often what you see happening is the patent office awarding patents that are too broad... The fundamental principle of the patent system is that you should only receive a reward, which is a monopoly, to the extent that you contributed to human knowledge.”

Professor Laurie reflects on the company BioGen’s dispute over a patent they held relating to the Hepatitis B Virus. “They basically found a way of crudely isolating the sequence for hepatitis B, when they didn’t know what that sequence was,” he describes. “But when they put an application in for a patent, they claimed basically all forms of the sequences, produced by any means and applicable to any circumstances. So that’s claiming an awful lot more than you actually contributed,” asserts Professor Laurie.

The UK’s House of Lords ruling on BioGen vs. Medeva (1997) took the same viewpoint; that the patent was invalid on the grounds of insufficiency. “So that’s a mechanism that the patent offices and the courts have used to review the impact of patenting. They look at the breadth of the claim and what that mean is either they can strike it out, or they can say we have to narrow it,” says Professor Laurie.

So, as technology advances it becomes harder and harder to fulfil the necessary criteria for patenting, leaving overly broad patents open to appeal. Does this mean that the self-regulating patent system is actually doing a pretty good job of driving innovation in the genetics revolution? “Probably,” thinks Professor Laurie. “I think… the patent offices have learned an awful lot about not granting very broad patents… We’re much clearer about what is and what isn’t inventive.

Yet the system is far from perfect, warns Professor Laurie. “America has a much more liberal attitude to patenting and they let things through that in Europe would not be allowed,” he says, blaming the “commercial environment”. “They have a presumption almost in favour of patentability, where as in Europe we say, you have to prove that this is patentable,” he adds.

For more information

Professor Grame Laurie's page - University of Edninburgh School of Law
http://www.law.ed.ac.uk/staff/graemelaurie_49.aspx

Biogen vs. Medeva - a synopsis
http://www.law.washington.edu/CASRIP/newsletter/Vol4/newsv4i2eu2.html