India Patent Office denies patent for prostate cancer drug sold under brand name Xtandi, generic name enzalutamide

According to this story, the India Patent Office has denied a patent for the prostate cancer drug sold under the brand name Xtandi (generic name Enzalutamide). Opponents of the patent claimed it was a new form of a known substance, and not eligible in India under Section 3(d) of its patent act.

According to the Times of India, the Astellas price for 112 pills (a 28 day supply) of Xtandi was 335,000 rupees, or about $5014.60 US Dollars. This is $179 per day or $44.77 per pill, much higher than the $26 per pill price Astellas sells the drug for in Japan.

According to the World Bank, the 2015 per capita income in India was $1,590 per year, or $4.36 per day.

BDR Pharma was the company challenging the patent. Earlier BDR introduced a generic version of the Johnson and Johnson prostate cancer drug Zytiga (generic name abiraterone) on the India market for 30,000 rupees for a 30 day supply of four pills per day. This is $448.83 US Dollar per month, or $15.59 per day. The J&J price was 125,000 rupees per month, which was $1869.50 per month, or $62.32 per month.

Zytiga is dosed at four 250-mg tablets per day. Enzalutamide is dosed at four 40-mg tablets per day, or just 16 percent of the API required by Zytia.

The Canadian company Biolyse pharma has offered to sell generic versions of enzalutamide in the U.S. to Medicare for $3 per pill, or $12 per day, if Medicare enters into an agreement involving the US royalty free rights in 3 patents on the drug.

KEI reckons that generic competition for enzalutamide could easily drive the price per pill at well less than $.50 per pill, or $2 per day.

The fact that Astellas was charging $179 per day and J&J was charging $62 per day, in a country where average incomes are just over $4 per day says something about the failure of the Modi government to use its compulsory licensing authority when drugs are not reasonably affordable in India.

Here is the story in the Times of India.

Patent denied, price of prostate cancer drug may go down

Rupali Mukherjee | TNN | Nov 10, 2016

NEW DELHI: The Indian Patent Office has denied a patent to Xtandi (Enzalutamide), a steeply priced wonder drug used in prostate cancer, on the pre-grant opposition filed by a clutch of entities, including Mumbai-based BDR Pharma, drug company Fresenius Kabi and Indian Pharmaceutical Alliance. The refusal to grant a patent paves the way for the entry of drug’s generic version at a fraction of the price -at least 60-70% cheaper. At present, Japan’s Astellas Pharma sells the drug in India at Rs 3.35 lakh for a pack of 112 capsules for a month’s dose.

The blockbuster drug which nets nearly $3 billion in worldwide sales, was acquired in August by Pfizer Inc as part of a deal when it bought Medivation, a biotech company. Medivation and Astellas jointly market Xtandi, with the latter selling the drug outside the US. The patent was opposed on grounds of “lack of inventive step, lack of novelty, and lack of clarity and sufficiency”, according to the order, a copy of which was accessed by TOI. The drug was discovered by University of California, and patent application made in 2007 in the Delhi Patent Office, while it was opposed by Fresenius Kabi in 2012, and by BDR Pharma in 2013.

BDR Pharma had earlier launched an affordable version of prostate cancer drug, Abiraterone, marketed by Johnson & Johnson at Rs 1.25 lakh for 120 tablets for a month’s dose. BDR was the first generic to make an entry at around Rs 30,000 per pack for a month’s dose. Umesh Pandey , assistant controller Patents & Designs, said in the order “in view of above instant application is hereby refused as the claimed invention is lacking inventive step under section 2(1) (ja) and also not patentable under section 3(d) and 3(e)”.

The opponents had argued that the compound is not patentable under Section 3(d) of the Patents Act, 1970 as amended by the Patents (Amendment) Act, 2005 as it is a new form of known substances. “The drug showed no enhanced efficacy over the compound known in prior published document of which it is a derivative,” legal experts say .Opponents argued that the product has not provided enhancement in the known therapeutic efficacy, the court order said.

James Love. Knowledge Ecology International