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PATENTED DRUGS- NO MARKETING APPROVALS TO GENERIC COMPANIES

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TheGovernment of India is finalising a system that will prevent genericmanufactures from getting marketing approval to sell patented drugs in India.As a result the generic companies may no longer get market approval forlaunching generic versions of drugs in respect of which a Patent Grant is inforce in India. Drug Controller General of India will seek list of patenteddrugs from the pharma companies about the valid patents rights in India andshall prepare a data base of such patents, after which no marketing approvalshall be given to their generic versions till such patent right is in force inIndia.

Sucha move will avoid infringement and counter claim litigation in respect ofpharma companies in Indian Courts and will require that generic manufacturesfile Post Grant/ revocation proceedings before the Patent Office etc. and onlyafter their claim is declared successful, they can claim for marketing approvalfor generic versions. Further, to delay grant of Patent rights thegeneric companies will file number of Pre grant oppositions so that no patentis granted or at least grant of Patent is delayed. This system will beineffective where a marketing approval has already be granted by IndianAuthority, in such a case the effective remedy will be to initiate infringementproceedings against the infringer.

Now,the Pharma companies entering India have to be more careful as they can beassure that all possible measures shall be taken by the generic companies todelay their Patent Grant in India. Moreover, no pharma company would like thattheir Patent application is successfully opposed because of inefficientAttorneys that failed to plug the loop holes. In India, there are a number ofIPR firms doing Patent works, which are not proficient with the legalinterpretation of statue as they lack Attorneys with effective courtexperiences and fail to legally safeguard all interest of client. Most glaringexample being the way the Pre grant opposition in respect of Novartis and LGLife Science were handled by the famous IPR firms in India.

Apartfrom above, the innovative pharma companies round the globe require that thetime for filing and disposing pre grant opposition be reduced or at least fixedin India, so that the application can proceed towards grant at the earliest andthis proposed system can be used efficiently by thecompanies.

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Aswal has sinced written about articles on various topics from Legal Matters, Travel and Leisure and Patent and Trademark. Author is an Advocate and Patent and Trademark Attorney with Aswal Associates, Attorneys at law & Intellectual property, New Delhi, India and can be reached at sudhir@aswal.com. Author is a member of APAA, Delhi Bar Council, Delhi High Court Bar Associati. Aswal's top article generates over 1000 views. to your Favourites.

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