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The patent truth

The US Supreme Court’s judgment on gene patents is fair to patients

Written by Ritu Kamal |
June 20, 2013 4:56:02 am

The US Supreme Court’s judgment on gene patents is fair to patients

Last week,the US Supreme Court ruled that naturally occurring genes cannot be patented,reversing a trend that has allowed over 20 per cent of the human genome to be patented by biotech companies. The case was brought by the American Association for Molecular Pathology and other interested parties against Myriad Genetics,a company that owns patents on two human genes,BRCA1 and BRCA2. Mutations in these genes can cause an increased risk for a woman to develop breast or ovarian cancer.

Over the last two decades,advances in genetics have made it possible to pinpoint the stretches of DNA in a human cell that are responsible for proclivity to certain diseases. Detecting mutations in these DNA segments,which signify higher risk of a particular disease,allows for preventive therapies to be offered to the patient. Recently,the Hollywood actress Angelina Jolie underwent a preventive mastectomy,or removal of breast tissue,in order to prevent the future occurrence of breast cancer. She tested positive for mutations in the BRCA1 gene,which increased her risk for breast cancer from about 12 per cent to about 87 per cent. It is this same BRCA1 gene that was under the scanner of the US Supreme Court in the recent case as well.

Myriad Genetics,a molecular diagnostics company based in Utah,patented the BRCA1 and BRCA2 genes in 1995. According to the laws of intellectual property protection in the US,this granted Myriad monopoly rights to develop and sell diagnostic tests that determine the presence of a mutation in BRCA1 or BRCA2. No other company could develop such diagnostic tests. The price of the Myriad diagnostic test for BRCA1 and BRCA2 ranges between $3000-$4000 per test,which puts it beyond the reach of most patients even in the US,let alone the rest of the world.

In the case before the US Supreme Court,the complainants argued that genes should not be patented by companies,as they are naturally occurring substances in the human body. The court concurred with this viewpoint,against the claim of Myriad Genetics that isolating these genes for use in laboratory conditions made them a patentable product. The court did concede to part of Myriad’s claim by allowing certain types of DNA to be patented: synthetic genes,which are segments of DNA invented by scientists in the lab,and cDNA,an artificially created form of DNA used in genetic engineering. The court further stated that invented methods of isolating DNA were patentable as well. To put it another way,tea leaves are natural products and hence cannot be patented,but the method of converting them into tea bags is an invention,and can be patented.

The implications of this ruling are critically important for biotech companies,medical research,doctors and patients. Several more companies will now enter the field of diagnostic testing for breast and ovarian cancer,which will bring down the cost of the test and increase access for patients. This is great news for Indian patients,as reported rates of breast cancer have doubled in India in the last decade. Further,the high profile nature of this case has brought increased attention to the issue of over-patenting by for-profit companies. Zealous patenting and patent protection via litigation has allowed inflated pricing and has blocked innovation by other companies,much to the detriment of patients in need.

Recently,the Indian government and judiciary have taken up several major cases around patent protection of life-saving cancer drugs. Most recently,Novartis’s drug,Glivec,was denied patent protection by the Indian Supreme Court as it was found to be materially similar to an earlier version of the drug,whose patent protection had expired. This move was hailed by patient advocates as it allows cheaper,generic versions of the drug to be sold in India. It also enables lifesaving inventions to come into the public domain for the benefit of patients,without being held hostage to over-patenting and litigation by companies.

The US is often seen as being held captive to the interests of patent owners with vast resources,leading to patent proliferation and decreased competition,which in turn drives costs skyward. Emerging economies like India and Brazil have challenged the patent proliferation that exists in advanced economies in the interest of having affordable healthcare products for their citizens. A reassessment of patent monopolies,especially in the case of lifesaving products,is essential if access is to be broadened beyond wealthy patients. The Myriad Genetics case in the US Supreme Court is a welcome shift in the direction of honouring only real inventions with patent protection,and allowing other products to remain in the public domain.

The writer is a medical technology professional focusing on medical technology innovation for emerging markets and a former Stanford-India Biodesign Fellow. Views expressed are personal.

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