As, I discussed about Patents in my last post, http://sscprep.blogspot.in/2012/09/patent-vs-copyrights.html a new event took place in Mar 2012 and I presume it would be a hot selling cake in coming exams of FCI, CHSL in the GK section. This event was announcement by NATCO to produce the generic of Nexavar a patented drug of Bayer Pharmaceuticals.
For new guys Generic drugs means the me too drugs produced by the companies that have same components and their composition as in the parent drug but are manufactured by the different companies who had no role in developing it. Since parent drug is formed after nearly 20-25 years of research the companies to extract the cost they incurred and to get profit, get patents which disallows any other company to produce that drug. After the expiry of patent this drug comes in public domain and other manufacturers can produce that drug. Since nearly all raw material is same the generic drugs are a perfect substitute for the patented drugs. Moreover they cost nearly 1/100 times of original drug.
What Happened in this case
In a first-of-its-kind move, a government agency has invoked the compulsory licensing (CL) provision of the Patents Act to allow Hyderabad-based Natco Pharma to sell its generic version of German multinational Bayer’s patent-protected cancer medicine, Nexavar (sorafenib tosylate), at a fraction of the cost of the latter drug in India.
Repercussion
This is likely to prove controversial, since almost 90 per cent of all patent-protected pharmaceutical products are imported. This will thwart the plans of foreign drug giants. although this will prove to be a relief for the poor population of India as they would get the medicine at nearly 120 Rs. for which they had to give nearly 10000
The Controller General of Patents Designs and Trademarks of India ("Controller") recently granted Natco Pharma Limited ("Natco"), an Indian drug manufacturer, a compulsory license for Bayer AG's ("Bayer") Nexavar (sorafenib), an oncology drug that extends the patient's life but does not cure the underlying condition.
ReplyDeleteThe Controller found Nexavar eligible for compulsory licensing under Section 84 of the Indian Patent Act because
(1) the drug was not meeting the reasonable requirements of the public,
(2) the drug was not reasonably affordable and (3) the patent was not being sufficiently "worked" in India because it was not locally manufactured.
The Controller's order is subject to appeal. Unless the standards applied by the Controller in the Nexavar case are reversed, there is a significantly increased risk that a number of other patent-protected drug products would be subject to similar compulsory licensing in India.
The Controller held that:
->Bayer had made the drug available to a small percentage of eligible patients (approximately slightly above 2 percent), which did not meet the requirements of the public
->The price of Rs 280,000 per month (approximately US$5,600) was not "reasonably affordable." The term "reasonably affordable" had to be construed predominantly with reference to the purchasing power of the public
->Natco may sell the drug within India at a price of not more than Rs 8,800 (approximately US$176) for a pack of 120 tablets required for one month's treatment
->Bayer's patent was not being "worked" in India as Nexavar was not being manufactured in India. Importation from manufacturing facilities outside India did not satisfy the mandatory requirement of working the patent in India
->Natco is required to pay a 6% royalty to Bayer
Implications of the Controller's Ruling
Compulsory licenses can be granted within a relatively short time-period following application (as little as seven months in the Nexavar case), and applications can be made three years after sealing of the patent in India. Patentees should review their product portfolios to identify vulnerable drug candidates and institute appropriate protective measures to preserve their patent rights against compulsory licensing applications. Such applications could be filed by even current partners of patentees. Patentees concerned about the requirement that the drug be manufactured in India should discuss with their government whether this requirement is consistent with India's obligations under international trade agreements, including the nondiscrimination provisions of the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. Affected parties may be able to seek relief under applicable bilateral investment treaties with India depending on the residence of the affected parties and the language of the relevant treaties. Patentees should pay particular attention to structuring their activities in India so as to benefit from the protections afforded by numerous bilateral investment treaties that India has entered into.
Generic Altima is used to prevent nausea and vomiting due to cancer treatment.
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