Saturday, December 10, 2011

Compulsory licensing: some thoughts!

For some time now, we have been reporting on compulsory licensing case filed by Natco Pharma with respect to IN215758 for anti-cancer drug Nexavar marketed by Bayer. Natco mainly relied upon on the issues of (1) excessive pricing, (2) non-working of patent, (3) limited circulation of patented product, and (4) public requirements not reasonably satisfied. However, Natco provided no factual evidence/data to support most of its argument but merely relied on secondary sources that suggested statistical data about cases and deaths reported in India for Hepatocellular carcinoma (primary liver cancer) and renal cell carcinoma (kidney cancer), particularly in the year 2008.

In this post, we are not to discuss the merit of compulsory licensing case made by Natco but will discuss whether mere presumptive data or mere statistical data taken from secondary sources are sufficient to make prima facie case for compulsory license. 

In its application for compulsory licensing, Natco categorically highlighted that – 

  • 18043 reported cases of death in India due to Hepatocellular carcinoma (numbers taken from secondary sources).
  • 5733 reported cases of death in India due to kidney cancer (numbers taken from secondary sources).
  • Over 24000 patients die in India every year due to different types and forms of renal cell carcinoma and hepatic cell carcinoma (numbers seem to be presumptive based on Natco’s business presence in the treatment of cancer for over 20 years).

None of the above statistical data was supported by any factual data collected from the field study/research. In India, it is more than a customary practice that drugs are prescribed by practicing doctors and that also prescribed using brand names (unlike US or Europe where drugs are prescribed using generic names). Also, in many cases, doctors have privilege to choose from various choices of prescription drugs depending on patient’s affordability quotient. For example, a doctor while prescribing medication for a diabetic patient in India does consider financial affordability of a patient and accordingly prescribe a drug to the patient. Not all patients in India are prescribed comparative expensive Vildagliptin for treating diabetes, most doctors prefer and still continue to prescribe cheaper alternatives like metformin and glipizide. 

Now let us suppose that a generic company files an application for compulsory license for Vildagliptin by mere highlighting alarming number of diabetic patients in India or high pricing of Vildagliptin, does that mean that all diabetic patients are prescribed and/or in need of Vildagliptin? Whether high pricing of Vildagliptin prevent diabetic patients from treatment of diabetes or from taking any cheaper alternatives? 

In short, mere presumptive or statistical data lacking factual evidence cannot be relied to make a prima facie case for compulsory license. Now coming back to Nexavar, it is not that all patients suffering from hepatocellular carcinoma and renal cell carcinoma go for drug medication. In many cases, patients are treated with surgery and radiotherapy. A mere presumptive or statistical data cannot differentiate the numbers where patients have undergone or likely to undergo for surgery/radiotherapy and patients are in need of or being prescribed Nexavar. 

The Controller of Patents probably must take into account some of these facets before examining the case of compulsory license or else it would be no surprise that the compulsory license may often be misused by providing presumptive and possibly deceiving numbers.