the first rough draft of the human genome was completed in

the first rough draft of the human genome was completed in 2000 the public has waited patiently for the benefits that were promised breathlessly by researchers. almost as quickly as they are discovered; it is estimated that private corporations have filed more than 20 000 preliminary patent applications for human genes.2 Gene patents cover much more than genetic testing and potential treatments. Many patents cover the genes themselves. The gene may occur naturally in humans but the person who discovers the gene usually holds the patent. As the list of patented genes increases there are growing fears about the impact on everything from research Bioymifi to the practice of medicine itself. The example of human epidermal growth factor receptor-2 (HER2) and trastuzumab (Herceptin) illustrates both the promise and the perils of gene patenting. Trastuzumab is an antibody against the product of a known breast cancer oncogene; it acts on HER2 either to inhibit cancer cell proliferation or to signal the immune system to eliminate the cancer cell. Trastuzumab therapy has been shown to increase survival Bioymifi among women with metastatic as well as localized breast cancer. All innovative drugs are patented so why shouldn’t drugs such as trastuzumab be patented as well? The difference in this case is that the trastuzumab patent holder (Genentech Inc.) also holds multiple patents related to the gene and HER2 ligands.3-5 The implications of this are enormous: any researcher or pharmaceutical company who wants to develop a breast cancer treatment based on the gene must obtain permission from Genentech or risk being sued for patent infringement. Given the above it is not surprising that this drug is as expensive as it is usually. The annual cost of trastuzumab therapy in Canada is as high as $50 000.6 The cost of tamoxifen Bioymifi is much lower. Currently the cost of trastuzumab is usually covered according to eligibility criteria set by provincial cancer care agencies or by individual hospitals that provide cancer care. One can argue that the study by Dendukuri and colleagues7 in this issue of (page 1429) is necessary only because patenting issues Rabbit polyclonal to AADACL3. have made the drug so expensive. For the drug to be effective against breast cancer the cancer must be HER2 positive Bioymifi (overexpress the gene). About 25% of all breast cancers are HER2 positive.8 Given how expensive trastuzumab is and how many women with breast cancer could benefit from this Bioymifi drug it is critical that this provinces find the most cost-effective way of determining HER2 status. There are other cost implications of gene Bioymifi patenting. Myriad Genetics Inc. a US biopharmaceutical company has obtained patents in the United States and Canada around the breast cancer genes and (breast cancer 1 and 2 early onset). and mutations have been found in about 10% of breast cancer cases. In 2001 when the provinces started testing for and mutations at publicly funded Canadian laboratories Myriad Genetics alleged patent infringement and demanded that all testing be performed at its laboratories in the United States. Testing at Myriad Genetics costs 2-3 times more than in Canada. In July 2001 Myriad issued a cease and desist notice in Canada. British Columbia stopped all testing at that time but offered to facilitate testing by Myriad Genetics for patients willing to pay. The province later sidestepped this claim by sending samples to Ontario for testing. 9 In Quebec and mutations were awarded many US laboratories performed testing for the mutations. According to a survey published in 2002 10 30 of respondents reported that they stopped developing a genetic test or stopped testing for mutations altogether after the gene was patented. According to the authors of the survey 10 the result has been that validation of genetic testing for hemochromatosis has not proceeded as quickly as it would have had the mutations not been patented. Currently under Canadian law a gene can be patented if it meets 3 criteria: it is regarded as a new invention; this “invention” works and is of interest to industry; and the discovery is not so obvious that anyone working in the field could have made it. Patents are not awarded for medical and surgical procedures..