Case Study – 01
Let us take example of Bristol-Myer Squibb (BMS) patented drug Dasatinib for which Hetero Drugs filed an application with the DCGI for marketing approval of generic dossier of Dasatinib. Suppose the Delhi High Court judgment goes in favor of Hetero and the DCGI gives Hetero the marketing approval but BMS cannot sue Hetero till the generic version is not launched in the market. Now following Hetero’s approval for generic Dasatinib another generic company Cipla too files an application with the DCGI for marketing approval of generic Dasatinib and subsequently obtains the marketing approval. Following Hetero and Cipla, dozens of other generic companies files applications with the DCGI for marketing approval of their generic versions of Dasatinib and subsequently obtains marketing approval. Interestingly BMS cannot stop or sue any of generic company till they launch their generic product in the market.
Now Cipla launches generic Dasatinib in June 2009 and consequently sued by BMS for patent infringement in the Delhi High Court. Now what should be the minimum time period we can expect judgment from the High Court? Let us be too positive to consider such period be around two years. If Cipla wins case then obviously there will be no issue and all other generic companies will be free to enter market without risk. But let us consider judgment is delivered after two years (June 2011) and goes in favor of BMS. Now Hetero launches its generic Dasatinib in August 2011 soon after BMS-Cipla case and sued by BMS for patent infringement. Again let us consider the judgment is made in favor of BMS after two years of court proceedings (around September 2013) and Hetero is prevented for selling generic Dasatinib. Even after BMS wins case each against Cipla and Hetero it doesn’t mean that other companies may not launch their generic launch. Suppose after few months of BMS-Hetero case another generic company launches its generic Dasatinib then again BMS will file and litigate the patent infringement suit. The question is how many times BMS need to go to the Court to enforce its patent for Dasatinib against the generic manufacturers having marketing approval for generic Dasatinib? Does it make any sense that BMS keep fighting multiple infringement lawsuits to enforce the same patent and keep losing crucial patent term and money in just fighting back to back litigations? Is such situation not creating liability on patentees? We know reading this case study seems to be little absurd but one cannot really ruled out such possibility of events. What can be the possible solution to avoid such unjust and unfair liability on patentee? Is such situation not likely to create burden for the Courts and judiciary?