European Journal of Cancer

Issue 1, 2008

By Helen Saul, News Editor

PODIUM - a Q&A session with Professor Gert Matthijs

Relief as BRCA1 patent remains curtailed

Molecular geneticist Professor Gert Matthijs (Catholic University of Leuven, Gasthuisberg, Belgium) has been challenging patents on the BRCA1 gene since the first was granted to Myriad Genetics in 2001. He successfully fought off an appeal by the company in September 2007, meaning that the patent is now limited in scope and will not affect diagnostics in Europe.

Why you?

I can’t explain. I believe in public healthcare and the principle of mutuality: no-one decides which disease he or she will get, let alone with which mutation he or she is born, so everybody should have the same access to healthcare. The principle is under pressure. Also, the way in which a patent interferes with a genetic service is complex, and thus geneticists had a duty to defend the case on behalf of patients.

How did your involvement start?

When I heard, back in 2001, that the BRCA1 gene was covered by a wide, all-encompassing patent, I felt that we had to do something. I became the reluctant volunteer who took on the case. Dr. Dominique Stoppa-Lyonnet (Institut Curie, Paris) had initiated French opposition to the patents, and I expanded this into European action. We were supported by various genetic organisations; we hired keen patent lawyers and kept each other going.

How significant is the recent judgement?

The judgement – by the Appeal Board at the European Patent Office (EPO), Munich – relates to the most fundamental of 3 patents on BRCA1. Myriad Genetics’ original patent covered the entire gene, sequence and protein, and all possible applications. In January 2005, this patent was reduced to a claim on a probe to detect the gene, and the Appeal Board has now confirmed that decision. The difference between the final and the original patent is enormous.

What if the decision had gone the other way?

It would have prevented us from offering diagnostics. The gene sequence would have belonged to the patent owners and we would not have been able to test for predisposition to familial breast or ovarian cancer without a licence. And we would not have been able to get a licence on reasonable terms. Different labs were previously offered licences with huge conditions attached: an upfront fee of $50,000 with a further fee for each mutation searched for. So, in practice, Myriad Genetics would have had a monopoly on the service.

On what grounds did you win?

The EPO confirmed that DNA or amino acid sequences in patent applications are an essential technical feature and have to be correct. Sequencing errors are not acceptable. The ruling acts against those that rush to the patent office with sloppy sequences, and should improve the quality of patents in general. The decision is definitive; further appeals are not possible.

What do the other 2 patents on BRCA1 cover?

The 3 patents overlap. The first deals more specifically with the diagnostic test for predisposition to familial breast and ovarian cancer; this was revoked entirely in May 2004. The last originally contained claims on a series of individual mutations; this was reduced to a claim on a probe to detect a frequent Ashkenazi mutation in January 2005. Appeals on both are outstanding.

Will the EPO’s decision have any impact in the States?

Not directly. European law does not affect US patents. The same arguments could be used – and many of our American colleagues dispute the monopolisation of the BRCA genes – but the patenting system is different. To change anything there, one would have to go to court, and a small regional lab could never make enough profit to pay off a risky court case. In the US, the patent will stand for 20 years.

Does the judgement reflect a change in the legal climate?

Not really. We may have won the battle but lost the war. The patent claim was quashed on the basis of typing errors. As a result, patents without errors may be more solid than before. On the other hand, because diagnostics is moving towards the use of micro-arrays that include many mutations and genes, the manufacturers of these micro-arrays have to obtain a myriad of licences. I believe that the system will become unworkable, and crash itself.

Patents which promote progress have to be distinguished from those which block it. As long as innovation remains possible, it’s fine. If someone can improve on PCR, that’s wonderful. We need challenge and competition; if we patent a gene, innovation becomes impossible. I’m hopeful that the patent office is considering this.

What is the next step?

I chair the Patenting and Licensing Committee of the European Society of Human Genetics that was created to go beyond this individual patent fight. Early in 2008 we will be issuing recommendations on why it is better for genes not to be patented.