Benefits of Substantive Examination for Pharmaceutical Patent Claims

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Compulsory licensing Indian Patent tAct Specific Provisions: Sec. 84 – On application by generic companies Sec. 92 – notification by central govt for public noncommercial use/national emergency/extreme urgency Sec. 92A – for export Sec. 100 – govt use
First CL in India Cancer Drug-Sorafenib Tosylate 200 mg 300,000 Rs. 2,80,428 250,000 Natco Pharma requested for a CL for the anti‐cancer drug Nexavar (Sorafenib Tosylate), patented by Bayer Rs./pe er patient per ye ear 200,000 150,000 100,000 50,000 Originator Company Generic Companies 8,880 6,840 0 Bayer Natco Pharma * The graph highlights the generic price of the cancer drug sorafenib tosylate. The drug is patented in India and Bayer's price is unaffordable. Natco has applied for a compulsory license to the Indian patent office in July 2011 and has committed to substantially reduce the prices by 97%(31 times) for cancer patients in India who need the drug if the compulsory license to produce the generic version is granted to the company by the Indian patent office. Not for drug supplied to the Public sector but actually sold in The private sector Granted in March 2012: o Bayer’s import was grossly inadequate to the needs (hardly 2%) o No import in certain years o Price not reasonably affordable to the public. Bayer price 5210 USD for 120 tabs for a month; Natco 164 USD
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Page 8 and 9: SOUTH AFRICA - TRIPS FLEXIBILITIES?
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Page 12 and 13: A number of countries have already
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Page 21 and 22: India High prices of patented drugs
Page 23 and 24: 200 150 Indian Patent Office 130.24
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Benefits of Substantive Examination for Pharmaceutical Patent Claims

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