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No generic version of Taraceva holds Madras High Court


Courts have to be exceptionally careful while deciding a patent infringement suit unlike a copyright or a trademark issue where evidence and existence of validity of the intellectual property holds lesser importance. When the product is pharmaceutical patentt, a higher degree of caution is required since it has to cater to the interests of the public also. In a recent order passed by the Madras High Court, that too ex-parte, Hyderabad based Matrix Laboratories was restrained from making or selling generic version of Roche’s cancer drug erlotinib hydrochloride popularly know as Tarceva. The order comes in such a crucial time when the question of validity of the said drug is being adjudicated upon before the Delhi High Court in the high profile case of Roche vs Cipla. The issue there was the launch of generic version by Cipla, which costs around 4 times lesser than that of Roche’s patented drug. By way of this order, generic drugmaker Matrix is being temporarily injuncted for 2 months from launching the drug. It is unsure whether Matrix intended to make the product available to the Indian pubic or US as they are in possession of 180-day market exclusivity since they are first to file application for Tarceva in US. But the pertinent question is, while the Honble Supreme Court reserved its judgement regarding the validity of the patented drug and has asked the Delhi High Court to ascertain the matter, how can such a callous judgement be made assuming patent validity and that too ex-parte order. The order states, “The respondent (Matrix), without any authority has proposed to launch similar compound, which affects the interests of the plaintiff’s (Roche) and it is prima facie clear that there is an infringement of the patent.” Prima facie infringement can be a good standard in case of non-pharma patents, but its uniform application with regard to pharmaceutical patents can lead to extreme consequences.

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