COMPULSORY LICENSING
for working the invention under the terms of the licence, then it clearly implies that importing cannot amount to ‘working’ for the licensee. In other words, if the licensee cannot import the product to work the invention in India neither can the patentee. Te same standards have to apply to both the patentee and the applicant, which in our view is an erroneous finding,
With the above grounds set out, the controller general granted this compulsory licence to Natco at a 6 percent royalty of the net sales, with a condition that the licensee will supply the drug free of cost to at least 600 needy and deserving patients per year. Te price of
the
generic version of Nexavar was fixed by Natco at Rs8,800 ($160) per month. Surprisingly, what seems to have been overlooked was whether Natco will be in a position to manufacture and supply the product for the remaining life of the patent at a nominal cost, while paying a 6 percent royalty and providing the drug free of charge to 600 needy patients.
Beyond the order, it has yet to be seen how aſter the grant of the compulsory licence Natco is
able to meet the reasonable requirements of the public and at the same time sell the drug at a reasonably affordable price.
Tis order of the controller general has been received with great appreciation by the generic industry, but it seems to discourage investment in research and development, which is vital to public health care in developing innovative drugs and compositions.
Bayer has filed an appeal against the order of the controller general before the Intellectual Property Appellate Board (IPAB); it is expected that the IPAB will hear this matter on August 21, 2012.
Researchers and innovators across the world will be closely watching the outcome of the appeal, as it will decide the future strategies for investing in patent protection and enforcement in India for new drugs and molecules.
Archana Shankar is senior partner at Anand & Anand. She can be contacted at:
archana@anandandanand.com
Archana Shanker is a senior partner at Anand and Anand and heads the firm's patent practice. A graduate of Law School, Delhi University, North Campus, she went on to complete her Post Graduate Diploma in bioinformatics and pharmaceutical regulatory affairs. She is an active contributing member of various international bodies, such as the Asian Patent Attorneys Association (APAA), Association Internationale pour la Protection de la Propriété Intellectuelle (AIPPI) and the Federation Internationale des Conseils en Propriete Industrielle (FICPI).
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Life Sciences Intellectual Property Review 2012
www.worldipreview.com
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