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