Xtandi patent battle: Affordable healthcare or commercial allure
“Enzalutamide”, which is marketed under the name ‘Xtandi’, is a prescription medicine [invented at the University of California, Los Angeles (UCLA)] for treating men with metastatic castration-resistant prostate cancer. In October 2009, Medivation and Astellas entered into a mutual global agreement to develop and commercialize the drug. The companies jointly commercialize Xtandi in the United States, and Astellas had been vested with the responsibility of manufacturing and all additional filings globally, as well as commercializing Xtandi outside the United States. In August 2016, Pfizer acquired Medivation and as a result received proprietary rights to Xtandi.
In November 2016, the Indian Patent Office refused to grant a patent to the Regents of University of California, for Enzalutamide on the ground that the invention lacked inventive step and was not patent eligible under Sections 3(d) and 3(e) of the Indian Patents Act. The rejection was a result of pre-grant oppositions that were filed by the Indian Pharmaceutical Alliance of Fresenius Kabi, and BDR Pharmaceuticals Limited who vociferously claimed that it was a new form of a known substance, and not eligible in India under Section 3(d) of the patent act. At present, enzalutamide is being sold by Astellas at Rs 3.35 lakh for 112 pills the dosage of which is 4 pills per day — an exorbitant price for most cancer patients in India.
UCLA has been fighting a legal battle in the Delhi High Court. They are being represented by former Union Minister Mr. P Chidambram along with a panel of leading attorneys. The Delhi High Court passed a pertinent order on 20th July 2017, stating that the pleadings must be completed before the next hearing. The latest development in this regard was on 7th December 2017 in which a next date of 24th July 2018 was assigned.
The World Bank estimated India’s 2016 per capita income at $1709 per year (or $4.74 per day), making the cost of the required four pill daily dosage of Xtandi well over 40 times a person’s daily income in India. For India, the cost is estimated around $45 per pill ($179 per day).
This case, whether Xtandi obtains it’s patent or not, will have a sizeable impact on the Indian Pharmaceutical sphere in terms of the availability, or rather the affordable availability, of the drug for the cancer patients in India. The grant of the patent will prevent generic drug manufacturers from providing the said drug at a fraction of the price estimated at around $0.50 per pill, or $2 per day.
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