Patented Drugs- No Marketing Approvals to Generic Companies

Patents in the USA

The Government of India is finalising a system that will prevent generic manufactures from getting marketing approval to sell patented drugs in India. As a result the generic companies may no longer get market approval for launching generic versions of drugs in respect of which a Patent Grant is in force in India. Drug Controller General of India will seek list of patented drugs from the pharma companies about the valid patents rights in India and shall prepare a data base of such patents, after which no marketing approval shall be given to their generic versions till such patent right is in force in India.

Such a move will avoid infringement and counter claim litigation in respect of pharma companies in Indian Courts and will require that generic manufactures file Post Grant/ revocation proceedings before the Patent Office etc. and only after their claim is declared successful, they can claim for marketing approval for generic versions.  Further, to delay grant of Patent rights the generic companies will file number of Pre grant oppositions so that no patent is granted or at least grant of Patent is delayed. This system will be ineffective where a marketing approval has already be granted by Indian Authority, in such a case the effective remedy will be to initiate infringement proceedings against the infringer.

Now, the Pharma companies entering India have to be more careful as they can be assure that all possible measures shall be taken by the generic companies to delay their Patent Grant in India. Moreover, no pharma company would like that their Patent application is successfully opposed because of inefficient Attorneys that failed to plug the loop holes. In India, there are a number of IPR firms doing Patent works, which are not proficient with the legal interpretation of statue as they lack Attorneys with effective court experiences and fail to legally safeguard all interest of client. Most glaring example being the way the Pre grant opposition in respect of Novartis and LG Life Science were handled by the famous IPR firms in India.

Apart from above, the innovative pharma companies round the globe require that the time for filing and disposing pre grant opposition be reduced or at least fixed in India, so that the application can proceed towards grant at the earliest and this proposed system can be used efficiently by the companies.  

About the Author:

Author is an Advocate and Registered Patent And Trademark Attorney with Aswal Associates and handles IPR division of the firm and is having the vast experience of having being associated with various premier IPR firms of India in the past. The author is also a member of APAA



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