Wednesday, July 09, 2008

Playing Double Standards?

Often accusing foreign MNCs for ever-greening of patent protection, Cipla has filed fair number of patent applications for new forms of known drug substances such as Alfuzosin, Tolterodine, Perindopril, Citalopram, Fexofenadine, Levosulbutamol, Sibutramine, Topotecan, Clopidogrel, Duloxetine, Montelukast, Olanzapine. Over the years, Cipla has successfully pioneered reverse-engineering of innovator drugs with an ability to launch generic versions within shortest possible time. This business strategy not only made Cipla a preferred choice for cheap generic drugs but also transformed into Billion Dollar Company. Though Cipla lacked any expertise in drug discovery or research but went ahead challenging the validity of Tarceva patent under section 3(d) arguing that Erlotinib is a mere derivative of known drug (Gefitinib). I wonder do reverse-engineering expertise gives sufficient insight to complex drug discovery and make such statement (which essentially requires strong research experience and scientific evidence). It is almost like a chemistry department of third-tier University questioning research ability of premier National Chemical Laboratory (NCL) or Indian Institute of Technology (IIT). Interestingly, Cipla recently got patent for inclusion complex of esomeprazole with cyclodextrin, which technically is a case of frivolous patenting but instead they booked Roche for frivolous patenting of Erlotinib. In India, there seems to be case evolving for ‘differential non-obviousness’ and why not Cipla is not innovator and at their level of expertise any patent application filed by them (though how obvious that is) is non-obvious but when it comes to copying of innovator drugs everything under the sun is obvious.

1 comment:

  1. Thanks varun..
    That was a very interesting piece of write-up

    Chitra Iyer