It was indeed stimulating to read Dr. Mary Henry's recent article on Gene Patenting and there is no doubt that few issues in biological research have produced as much concern and debate as this issue. When I first discussed the issue informally over dinner with Mary a few weeks ago, I was somewhat unsure whether genes per se themselves could be patented or just gene fragments (ESTs) which can be used as scientific probes to help find a gene or help map a chromosome. Nevertheless, despite this arbitrary distinction, we both agreed that allowing holders of such "gatekeeper" patents to exercise undue control over the commercial fruits of genome research is ethically unfair. The focus of attention was the right to patency of the BRCA2 gene, which is presently being challenged in the European Court by the Institut Curie in Paris and other researchers. The story that led the patenting of the BRCA2 gene is itself quite fascinating. It also involves the philanthropic basis of British research and the initial decision of the Cancer Research Campaign to patent the gene because they felt that to do so, was the only possible way to transfer a new discovery into the healthcare system for the ultimate good of the patient.
The story started in 1988, when the UK breast cancer study group initiated the establishment of a syndicate to search for the genetic basis of breast cancer. It was known at that time that approximately 10% of all breast cancer cases could be ascribed to a hereditary association. Within a few years this syndicate evolved into the Breast Cancer Linkage Consortium (BCLC), a European wide consortium of researchers who had an interest in breast cancer. Some additional researchers in the US were also incorporated into the consortium but the funding for the BCLC came principally from the European Union and each member group within the consortium obtained funding from their respective national governments. In 1990, a US research group lead by Mary-Clare King in California reported the identification of a genetic locus on the long arm of chromosome 17, which was linked to a familial predisposition to breast cancer. In 1993, these findings were confirmed by the BCLC and reported in the American Journal of Human Genetics. All of the research performed in discovering the locus was done with funding that was received from public funding agencies. During the period BCLC was researching the BRCA1 gene, a newly established Salt Lake Genomics company, called Myriad Genetics started performing its own search using the information published by the BCLC. In 1994, a group from the University of Utah in association with Myriad genetics announced in Science that they had identified the BRCA1 gene.
It became evident around this time that a second gene was playing a critical role in causing hereditary breast cancer and consequently BCLC commenced studies into identifying the BRCA2 gene. Consequently, a race between Myriad Genetics and researchers led by Dr Mike Stratton at the Institute of Cancer Research, Sutton, Surrey was initiated to find this gene. Most people felt that the superior funds of the Genomics company would allow them to discover this second breast cancer gene but against the odds, the group of researchers led by Mike Stratton stunned everybody by announcing that they had discovered the BRCA2 gene. Even before BRCA2 was fully identified, the pioneering research of Prof. Peter Daly of St. James Hospital and discovery of the first mutation in a large Irish family should be remembered and totally respected. The problem unfortunately existed that the discoverers of BRCA2 had opposed the patenting of genes, and had specifically not joined the Myriad consortium because of disagreements with the way the company was proposing to use the BRCA1 discovery. The discoverers immediately discussed the implications of the discovery with lawyers and directors at the Institute of Cancer Research and the charity, which funded the research, the Cancer Research Campaign (CRC). After much 'soul searching' it was decided to take a pragmatic approach and to file for patent application to prevent other less altruistic organisations securing an advantageous position. This decision was compounded by the fact that the Sanger Centre in Cambridge were sequencing the BRCA2 interval, containing the gene, and were due to publish this interval sequence, hence damaging the potential of obtaining a strong patent.
On December 22nd, 1995, the day before Nature published the paper, the team announced the discovery of the BRCA2 gene and the filing of patent application. The same day Myriad announced to the US press that they had discovered the BRCA2 gene and had filed their own patent application. By the strict interpretation of patent law, genes are and always have been patentable, as the recent directive of the European parliament has clearly stated. In the simplest terms, the owner of a granted has the exclusive right to practice the 'invention' or to license that right to anyone else. It is important to realise that in the case of a gene patent, that the 'invention' is really the industrial use of the gene, not the actual gene 'per se'and hence it is the use of the genetic information encoded by a gene that is really the basis of a patent. There are some difference in US and European patent law, including the fact that the US has a concept of 'first to invent' while the rest of the world use a 'first to file' system. Another important concept in the UK is the difference between 'inventorship' and ownership. A British scientist who makes an intellectual contribution to the invention, (such as the finding of a gene linked to a disease), is an inventor but rarely the owner of the invention. The owner is usually the employer of the scientist, in most cases the host University. The decision whether to file a patent application covering the BRCA2 discovery was a joint decision between the scientists involved, the host institution, in this case the Institute of Cancer Research, and CRC Technology.
By filing this application, they were effectively saying that they wanted to be in the best position to decide how to use this discovery to obtain maximum benefit for the cancer patient. Thus, early in 1996, after the chaos surrounding the discovery had died away, a group of experts from the Institute, CRC sat down to decide how best to use their patent position, especially defend the patent and the distribution of the BRCA2 genetic test. In 2001, the Cancer Research Campaign decided it would give Britain's National Health Service free access to the gene, BRCA2. Because of the CRC position, the NHS were granted a free license chose to on the diagnostic test for BRCA2 and a patency battle presently ensues between the charity and Myriad that will determine whether women should pay thousands of dollars for genetic testing or continue to receive it free. The UK charity says it would also make the gene available at minimal cost for use in Irish and Australian hospitals as well as Britain.
Presently, Myriad charges many thousands of dollars to analyse the two genes and the service is available without prior genetic counselling. We should hence also recognise the philanthropic attitude of The Cancer Research Campaign Technology, who have blocked the Myriad patent in Britain and in Australia on the basis that it mostly funded the initial research that eventually led to BRCA2's identification.
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