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A group of 56 civil society organizations, the Union for Affordable Cancer Treatment and academic experts have called upon Janet Napolitano, the president of the University of California, and the Board of Regents to withdraw efforts to obtain a patent on the prostate cancer drug enzalutamide (brand name Xtandi) in India as the grant of a patent on enzalutamide in India would prevent generic competitors from supplying the drug at an affordable price, both in India and in other countries where there is no patent, or where Astellas has abused its patent rights by charging prices that are excessive and create access barriers for this important drug.
Enzalutamide is a treatment for prostate cancer, developed by researchers at University of California at Los Angeles (UCLA) with the support of US taxpayer dollars through grants from the National Cancer Institute at the National Institutes of Health and the U.S. Army Prostate Cancer Research Program. UCLA licensed enzalutamide in 2005 to a small San Francisco-based biopharmaceutical company called Medivation, which then entered into a collaboration agreement with the Japanese drug company Astellas Pharma. Astellas is responsible for the worldwide manufacture and distribution of enzalutamide.
Recently, BDR Pharma and Fresenius Kabi, both Indian drug companies, and the Indian Pharmaceutical Alliance, challenged the University of California’s attempt to obtain a patent on enzalutamide in pre-grant patent opposition proceedings. The Indian Patent Office denied the patent, leading attorneys for the Regents of the University of California to file a petition before the Delhi High Court.
“We request that the University of California withdraw its case and cease its efforts to obtain a patent on enzalutamide in India. The high price of Astellas branded Xtandi in India is shocking to anyone who thinks cancer drugs should be accessible and affordable, regardless of where you live. Generic competition in India has historically driven down prices and significantly improved access to cancer drugs in India and other countries that are currently sourcing from India, and this will also apply to enzalutamide as it goes into production and registration”, the civil society organisations said in its letter to the president of the University of California.
California taxpayers should not foot the bill for or permit this patent litigation, which will benefit a Japanese drug manufacturer and a New York-based pharmaceutical corporation, but harm patients seeking affordable access to an important cancer medicine. We also request that you direct your policy and legal teams to evaluate the University of California’s intellectual property policies to ensure that the University does not aggressively pursue acquisition of intellectual property rights when such acquisition will harm affordable access in low-income countries, the letter said.
Astellas sells enzalutamide at a high price in India that is unaffordable to most cancer patients. According to reports, Astellas sold enzalutamide for an exorbitant Rs.3.35 lakh per 112 pills (a 28-day supply), which was estimated at the time amounted to $5,014.60 USD — around $44.77 USD per pill and $179 USD per day. Astellas sells enzalutamide for $26 USD per pill in its home country of Japan.
The World Bank estimated India’s 2015 per capita income at $1,590 USD per year, or $4.36 USD per day, making the cost of the required four pill daily dose of enzalutamide more than forty times a person’s daily income in India.
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