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ARTICLE · 27 JANUARY 2005

Patents Ordinance 2004: "Generically" Speaking

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Should generic drug manufacturers, who have a substantial market share of the Indian drug industry, have any immediate worries arising from the new patent regime for pharmaceutical products, introduced by the Patents (Amendment) Ordinance 2004, effective from January 1, 2005?

IndiaLitigation, Mediation & Arbitration
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By Mustafa Safiyuddin and Ajay Shaw, DSK Legal

Should generic drug manufacturers, who have a substantial market share of the Indian drug industry, have any immediate worries arising from the new patent regime for pharmaceutical products, introduced by the Patents (Amendment) Ordinance 2004, effective from January 1, 2005?

The answer appears to be in the negative - the generic drug manufacturers are here to stay. There are three reasons for this: Firstly, majority of the drugs manufactured in India are off patents or are not patentable in India for lack of novelty. Secondly, several ‘mail box’ applications have been filed prior to January 1, 2005 for the grant of pharmaceutical product patents. Examination or processing thereof is to commence only now, i.e., from the beginning of 2005. However, the Indian Patent Office lacks sufficient resources to process them expeditiously. The problem of a huge backlog of pending mailbox applications is likely to multiply with the

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