04-12-2013, 06:11 AM
The Human Genome Project, a large collaboration of scientists to sequence all of the base pairs of DNA in the human genome, was launched with the hope that the information gathered could revolutionize medicine. Scientists promised novel therapies and cures to many genetic disorders and other diseases. The promise of personalized medicine for patients was also touted as the Human Genome Project began. Indeed, the data obtained from sequencing the human genome has resulted in correlations being found between a person’s genetic content and many medical issues. Genetics components have so far been linked to a variety of human conditions and problems, including reactions to medications, susceptibility to certain types of cancer, and predilection to Alzheimer’s disease, among others.
Patents on new research advancements, technologies, and discoveries are important to help protect the work of both industry and academic scientists. Patents on methodology, therapeutics, and even organisms are common in all areas of biotechnology research. While the ultimate goal of patents is to protect the intellectual property and ensure due credit to the inventor, while preventing other parties from making money off of the inventor’s work, patents can sometimes cause difficulties for other researchers, companies, and clinicians using the technology. Other academic investigators, as well as biotechnology companies, must ensure that they are paying licensing fees to patent holders to conduct valuable medical research.
With the sequencing of the human genome complete, many companies have even begun to patent the sequence of individual genes, or variations in the sequence of individual genes. Estimates suggest that 20-40% of all known human genes have been patented. This has caused a great deal of concern among scientists. For example, in an upcoming case to be heard by the Supreme Court, medical diagnostics company Myriad Diagnostics will be defending their patents on the sequences of BRCA1 and BRCA 2 mutations that are associated with breast cancer. The suit does not involve any patents on techniques or methodologies involved in sequencing; it only concerns the patents of the DNA sequences for the specific genes. Myriad Diagnostics applied for the patents in order to protect their research and investments, as any biotechnology company would do for their advancements. Opponents to the patents on genes argue that this could potentially hamper research on these genes, and make medical diagnostics involving these genes legally complex.
One of the greatest concerns brought up by opponents involves relating information obtained from whole genome sequencing to patients. For example, if the entire genome is sequenced for a patient, and mutations are found in either the BRCA1 or BRCA2 genes, clinicians fear they would not legally be allowed to share that information with the patient, as those specific sequences are patented. This could negate any potential benefits to individual whole genome sequencing, and make personalized medicine more difficult. This concern has been likened to taking an x-ray of a patient, but being unable to share information about a specific area with the patient.
Proponents of patents on specific DNA sequences argue that the patents will not have such a drastic effect on clinical matters. Various analyses of patents have suggested that there would be little effect on clinical or research oriented studies. Because the patents are only for specific sequences, when an entire genome is sequenced, the patent would not apply. As far as researching the effects of the mutations in BRCA1 and BRCA2, many argue that the patents do not indeed hurt researchers. Many companies that hold patents on DNA sequences are more concerned with stopping others from making money off the sequence, as opposed to stopping scientists involved in basic scientific research. Still, many scientists and clinicians may be reluctant to take the risk of being sued in either of the above circumstances. In addition, some argue that overturning patents on human DNA sequences would not have large effects on the availability of detecting individual gene variants. For example, even if the Supreme Court does overturn the patents Myriad owns on BRCA1 and BRCA2 sequences, genetic testing for these specific sequences would not become more readily available, as Myriad also owns patents on diagnostic techniques to detect these sequences. Regardless of the Supreme Court’s decision, Myriad would still have patent rights to protect the detection of those specific DNA sequences.
References:
http://www.nature.com/news/gene-patents-...ck-1.12767
http://www.genome.gov/10001772
http://www.bing.com/news/search?q=genetic&FORM=HDRSC6
http://www.nature.com/news/the-great-gen...te-1.11044
Patents on new research advancements, technologies, and discoveries are important to help protect the work of both industry and academic scientists. Patents on methodology, therapeutics, and even organisms are common in all areas of biotechnology research. While the ultimate goal of patents is to protect the intellectual property and ensure due credit to the inventor, while preventing other parties from making money off of the inventor’s work, patents can sometimes cause difficulties for other researchers, companies, and clinicians using the technology. Other academic investigators, as well as biotechnology companies, must ensure that they are paying licensing fees to patent holders to conduct valuable medical research.
With the sequencing of the human genome complete, many companies have even begun to patent the sequence of individual genes, or variations in the sequence of individual genes. Estimates suggest that 20-40% of all known human genes have been patented. This has caused a great deal of concern among scientists. For example, in an upcoming case to be heard by the Supreme Court, medical diagnostics company Myriad Diagnostics will be defending their patents on the sequences of BRCA1 and BRCA 2 mutations that are associated with breast cancer. The suit does not involve any patents on techniques or methodologies involved in sequencing; it only concerns the patents of the DNA sequences for the specific genes. Myriad Diagnostics applied for the patents in order to protect their research and investments, as any biotechnology company would do for their advancements. Opponents to the patents on genes argue that this could potentially hamper research on these genes, and make medical diagnostics involving these genes legally complex.
One of the greatest concerns brought up by opponents involves relating information obtained from whole genome sequencing to patients. For example, if the entire genome is sequenced for a patient, and mutations are found in either the BRCA1 or BRCA2 genes, clinicians fear they would not legally be allowed to share that information with the patient, as those specific sequences are patented. This could negate any potential benefits to individual whole genome sequencing, and make personalized medicine more difficult. This concern has been likened to taking an x-ray of a patient, but being unable to share information about a specific area with the patient.
Proponents of patents on specific DNA sequences argue that the patents will not have such a drastic effect on clinical matters. Various analyses of patents have suggested that there would be little effect on clinical or research oriented studies. Because the patents are only for specific sequences, when an entire genome is sequenced, the patent would not apply. As far as researching the effects of the mutations in BRCA1 and BRCA2, many argue that the patents do not indeed hurt researchers. Many companies that hold patents on DNA sequences are more concerned with stopping others from making money off the sequence, as opposed to stopping scientists involved in basic scientific research. Still, many scientists and clinicians may be reluctant to take the risk of being sued in either of the above circumstances. In addition, some argue that overturning patents on human DNA sequences would not have large effects on the availability of detecting individual gene variants. For example, even if the Supreme Court does overturn the patents Myriad owns on BRCA1 and BRCA2 sequences, genetic testing for these specific sequences would not become more readily available, as Myriad also owns patents on diagnostic techniques to detect these sequences. Regardless of the Supreme Court’s decision, Myriad would still have patent rights to protect the detection of those specific DNA sequences.
References:
http://www.nature.com/news/gene-patents-...ck-1.12767
http://www.genome.gov/10001772
http://www.bing.com/news/search?q=genetic&FORM=HDRSC6
http://www.nature.com/news/the-great-gen...te-1.11044
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