The uncertainty sparked by the US ruling that the BRCA1 and BRCA2 breast cancer genes are not patentable is holding back the development of diagnostics and therapies, says patent lawyer Adrian Tombling
Life sciences research involving the use of human DNA has the potential to diagnose and treat many diseases, but concerns about ethics and a lack understanding of the role of patents play in ring-fencing areas of R&D in order to increase attractiveness to investors, are holding back progress.
The position taken by the US Patent and Trade Mark Office is particularly unhelpful and urgently needs to be tackled if global life sciences is to succeed in securing the investment needed to bring new therapies to the market.
Currently, any proteins, gene sequences or chemical compounds that are derived naturally may not be patentable under US law. This is the clear implication of the US Supreme Court ruling in June 2013 that the breast cancer genes BRCA1 and BRCA2 are not patentable because they are naturally-occurring. The judgement in the case Association for Molecular Pathology v Myriad Genetics overturned a previous ruling in a lower court that, as isolated DNA, the genes were patentable because they do not occur naturally in an isolated form.
However, the Supreme Court ruling did appear to uphold the patent eligibility of complementary DNA, which is produced synthetically.
Sufficient modification
While the Myriad ruling was a setback for life sciences research, its impact has been more limited than first feared by the global biotech industry.
Generally, when using a gene sequence in a therapy it is modified by loading it into some sort of delivery system, such as a virus or plasmid. As these combinations are not naturally-occurring, it appears they will be patentable. The additional level of research required to arrive at a therapeutic product, even if based on a naturally-occurring gene sequence, will involve sufficient modification to ensure that the product can be patented.
By contrast, research to identify biomarkers for a disease that could pave the way for early diagnosis and more effective therapies has been severely impacted by US case law.
Diagnostic tests based on the association between certain biomarkers and disease risk may not be patentable in the US currently, because in effect, the diagnostic test is considered to be a law of nature.
The legal position in the US is threatening to undermine research into diagnostic biomarkers, and perhaps reflects a more widespread lack of understanding about how the industry works, and how life-saving drugs and treatments are produced.
There seems to be some reluctance to grant monopoly rights in the form of patent protection to inventions linked to life-threatening human diseases.
Clearly, this is an emotive subject. However, without such intellectual property rights, the research needed to make important breakthroughs – such as the recent discovery by British scientists of a number of protein markers that could form the basis of a blood test for the early diagnosis of Alzheimer’s disease - would be unlikely to go ahead, due to a lack of investment or confidence in being able to have exclusivity in the market for a period of time.
Opposition from the public
The ethical sensitivity faced by life sciences research is not just a US phenomenon. Benoît Battistelli, President of the European Patent Office, recently commented that it is not easy to obtain patent protection in Europe.
Acknowledging that biotech innovation, “sometimes faces opposition from the public,” he noted that, “only 27 per cent of applications [in the biotech sector] lead to granted patents.’
There certainly seems to be a higher hurdle in terms of the patentability of biotech inventions compared to those in other industry sectors.
Unfortunately, this reluctance to grant patents for biotech inventions could mean that some potentially life-saving treatments and diagnostic methods never make it to market. Investment for biotech research is hard enough to come by without patent offices providing road blocks.
Conducting clinical trials is expensive, and just as in any other area of R&D, investors need confidence they will be able recoup their costs once an invention is approved for use. In the absence of patents covering an invention this is almost impossible.
If we are going to succeed in bringing more potentially life-saving therapies and diagnostic tests to market in the future, the biotech industry must be prepared to speak out with greater confidence about the reasons why monopoly rights are an essential part of the process.
Adrian Tombling is a partner and patent attorney at the law firm Withers & Rogers LLP, and an expert in biopharmaceutical patenting.
The position taken by the US Patent and Trade Mark Office is particularly unhelpful and urgently needs to be tackled if global life sciences is to succeed in securing the investment needed to bring new therapies to the market.
Currently, any proteins, gene sequences or chemical compounds that are derived naturally may not be patentable under US law. This is the clear implication of the US Supreme Court ruling in June 2013 that the breast cancer genes BRCA1 and BRCA2 are not patentable because they are naturally-occurring. The judgement in the case Association for Molecular Pathology v Myriad Genetics overturned a previous ruling in a lower court that, as isolated DNA, the genes were patentable because they do not occur naturally in an isolated form.
However, the Supreme Court ruling did appear to uphold the patent eligibility of complementary DNA, which is produced synthetically.
Sufficient modification
While the Myriad ruling was a setback for life sciences research, its impact has been more limited than first feared by the global biotech industry.
Generally, when using a gene sequence in a therapy it is modified by loading it into some sort of delivery system, such as a virus or plasmid. As these combinations are not naturally-occurring, it appears they will be patentable. The additional level of research required to arrive at a therapeutic product, even if based on a naturally-occurring gene sequence, will involve sufficient modification to ensure that the product can be patented.
By contrast, research to identify biomarkers for a disease that could pave the way for early diagnosis and more effective therapies has been severely impacted by US case law.
Diagnostic tests based on the association between certain biomarkers and disease risk may not be patentable in the US currently, because in effect, the diagnostic test is considered to be a law of nature.
The legal position in the US is threatening to undermine research into diagnostic biomarkers, and perhaps reflects a more widespread lack of understanding about how the industry works, and how life-saving drugs and treatments are produced.
There seems to be some reluctance to grant monopoly rights in the form of patent protection to inventions linked to life-threatening human diseases.
Clearly, this is an emotive subject. However, without such intellectual property rights, the research needed to make important breakthroughs – such as the recent discovery by British scientists of a number of protein markers that could form the basis of a blood test for the early diagnosis of Alzheimer’s disease - would be unlikely to go ahead, due to a lack of investment or confidence in being able to have exclusivity in the market for a period of time.
Opposition from the public
The ethical sensitivity faced by life sciences research is not just a US phenomenon. Benoît Battistelli, President of the European Patent Office, recently commented that it is not easy to obtain patent protection in Europe.
Acknowledging that biotech innovation, “sometimes faces opposition from the public,” he noted that, “only 27 per cent of applications [in the biotech sector] lead to granted patents.’
There certainly seems to be a higher hurdle in terms of the patentability of biotech inventions compared to those in other industry sectors.
Unfortunately, this reluctance to grant patents for biotech inventions could mean that some potentially life-saving treatments and diagnostic methods never make it to market. Investment for biotech research is hard enough to come by without patent offices providing road blocks.
Conducting clinical trials is expensive, and just as in any other area of R&D, investors need confidence they will be able recoup their costs once an invention is approved for use. In the absence of patents covering an invention this is almost impossible.
If we are going to succeed in bringing more potentially life-saving therapies and diagnostic tests to market in the future, the biotech industry must be prepared to speak out with greater confidence about the reasons why monopoly rights are an essential part of the process.
Adrian Tombling is a partner and patent attorney at the law firm Withers & Rogers LLP, and an expert in biopharmaceutical patenting.
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