[Ip-health] Update on the Sorafenib Tosylate compulsory licensing case in India

Jamie Love james.love at keionline.org
Mon Oct 10 13:32:04 PDT 2011


This is from the donttradeourlivesaway blog on the NATCO compulsory
licensing case for the cancer drug Sorafenib Tosylate.

*  Current availability of sorafenib tosylate – India does not provide
expensive cancer treatment under the public health programme. Patients have
to pay themselves but Bayer currently markets the drug at a high price of
approximately Rs. 2,80,000 per patient per month.
*   Cipla launched at risk the medicine in the Indian market at Rs. 28,000
per patient per month – 1/10th the cost of the patented version.  Bayer has
now filed an infringement suit against Cipla  in the High Court of Delhi.

*  In July 2011, NATCO filed a CL application proposing to market the same
drug at Rs. 8,800 per patient per month if the patent office grants it a
compulsory license. This is 31 times cheaper than Bayer’s sorafenib tosylate
or 3% of the price at which Bayer sells the drug in India.


http://donttradeourlivesaway.wordpress.com/2011/10/10/india-prices-of-patented-medicines-and-compulsory-licence-test-case/

India – prices of patented medicines and compulsory licence test case

Posted on October 10, 2011 by donttradeourlivesaway

UPDATE ON APPLICATION U/S 84 OF THE INDIAN PATENT LAW FOR GENERIC PRODUCTION
OF PATENTED CANCER DRUG  -  SORAFENIB TOSYLATE

Background – Changes in price due to the introduction of product patent
regime are starting to be experienced in India. This is because the first
set of drugs under patent monopoly have entered the Indian market. The price
levels of these patented medicines are very high. Peg interferon alphas used
in the treatment of Hepatitis C and some cancers are patented in India –
both versions alpha 2a and alpha 2b are patented by Roche and Schering-
Plough respectively and are excessively high. Click here to see price
information on peg interferon.

 Thirdline AIDS medicines patented in India such as raltegravir are
expensive even at discounted rates, cost a person living with HIV Rs.
1,20,276 ($2672 USD) per year. Patented cancer drugs are equally expensive.
According to data from the Drug Controller General of India’s office,
Dasatinib (IN203937) is Rs. 2761 per 50mg tablet. Sunitinib (IN20251) is Rs.
4357 per 25mg capsule.

As patients and developing countries watch what India will do to reduce
prices, including whether it will support CL applications that open up
generic competition,  an Indian pharmaceutical company, NATCO has applied
for a CL to manufacture a affordable generic version of sorafenib tosylate –
the anti-cancer drug for which Bayer has obtained a patent IN215758 in India
in 2008, which will expire in 2020. Click here to view CL application dated
28th July 2011.

US and EU FDA approval for use in the treatment of advanced renal cancer
2005 – 2006. The recommended dosage for advanced renal cancer is 400 mg
twice daily. Link to see approval letter .

FDA approval for the treatment of for the treatment of unresectable
hepatocellular carcinoma (liver cancer) came in 2007.  See link to approval
letter.

Current availability of sorafenib tosylate – India does not provide
expensive cancer treatment under the public health programme. Patients have
to pay themselves but Bayer currently markets the drug at a high price of
approximately Rs. 2,80,000 per patient per month.

Cipla filed a post grant opposition on the sorafenib tosylate patent and
applied for marketing approval with the Indian FDA. Bayer however delayed
the market registration of the generic version by filing a case against the
Indian FDA to prevent it from registering a generic version of sorafenib
tosylate. The Indian courts rejected Bayer’s attempt to link registration of
medicines to their patent status (patent linkage), following which, Cipla
launched at risk the medicine in the Indian market at Rs. 28,000 per patient
per month – 1/10th the cost of the patented version. See news story – Cipla
launches Nexavar generic at 1/10th of Bayer’s price.

Bayer has now filed an infringement suit against Cipla  in the High Court of
Delhi. The matter is listed as Bayer Corporation ANR vs. Cipla Ltd, CS(OS)
523/2010

In July 2011, NATCO filed a CL application proposing to market the same drug
at Rs. 8,800 per patient per month if the patent office grants it a
compulsory license. This is 31 times cheaper than Bayer’s sorafenib tosylate
or 3% of the price at which Bayer sells the drug in India.

Even the health systems of developed countries have found the drug too
expensive. In the UK, the National Institute for Health and Clinical
Excellence (NICE) the body that provides guidance on the use of new drugs by
the National Health Service, decided that NHS could not pay for the drug as
the price being asked by Bayer was too high. The drug was just too
expensive. See BBC News: Liver drug too expensive.

Perhaps it is time that generic competition was opened up to reduce the
price of the medicine. Bayer has to file a response to the CL application by
12th of October 2011 and then the Patent Office will provide a hearing to
the CL applicant. Bayer is likely to strongly oppose the grant of the CL in
India.
-- 
James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.  Sometimes I am using
my MaxRoam number: +447937390810
twitter.com/jamie_love



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