NATCO recently filed an application with the Indian patent office for Nexavar, Bayer’s blockbuster drug for treating liver and kidney cancer on the grounds of exorbitant pricing and non-availability/limited availability. The application was published on August 12, 2011. The Indian patent rules provide a period of two months from the day of publication within which documented support or objections may be sent to the patent office.
In it’s application, NATCO claims that the drug Nexavar costs (approximately) 50 USD per tablet and the price for a month ‘s course is 6000USD (4 tablets/day*30). An additional argument was that the drug was available only with high end pharmacies in major metros only (Chennai, Delhi, Mumbai, and Kolkata) and hence was not available for patients in small towns and cities. [Section 84 of the Indian Patents Act provides: “[A]t any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely: ….(b) the patented invention is not available to the public at a reasonably affordable price…” ]Incidence of cancer in India: In a 2010 study reported by India Today, cancer (malignant tumors) was among the top 10 causes of death in India. Additionally, according to data from The Indian Cancer Society, in a sample study for a district in Maharashtra, the most common forms of cancer were related to the buccal cavity (mouth).
Lessons from the past-hold or surrender: Brazil and Thailand have effectively negotiated with pharmaceutical giants, like Merck and Bristol Myers Squibb respectively to bring down prices of drugs to support national health programmes. In 2003, after Brazil allowed generic manufacturers to import or produce ARV drugs without the consent of the patent holder, the price of the drug was discounted drastically by 25-75% of the original price. In 2006 Thailand granted a compulsory license on two antiretroviral drugs, efavirenz and clopidogrel.
This move by NATCO has placed the ball in Bayer’s court-Bayer now needs to decide whether to hold its ground or capitulate and reduce the price of Nexavar for India and the policy guidelines that come out as a result of this application would be interesting for both patentees and generic drug manufacturers.
Can you link the application filed by NATCO?
Anon @ 4:11: I will be posting a separate post analyzing NATCOs application in detail and will also provide a link to the application filed.
I sincerely hope that NATCO succeeds in getting the CL for Nexavar and bring relief to those suffering patients. India has to really learn from Thailand’s experience of not only bringing down the prices of the negotiated drugs but also covering those drugs under the public health coverage.
Lalitha
I sincerely hope that NATCO succeeds in this CL application for NEXAVAR and bring relief to those suffering patients. India has to really learn from Thailands experience. Thailand has successfully negotiated to bring down the prices of the negotiated drugs and also provide these drugs through the universal health coverage.
lalitha
why indian pharm companies always act like a bagger.on one hand we say we are a developing country and on other hand why indian companies not investing in R& D and always believe in making copy?