Roche Vs Cipla: Valgancyclovir Case

This is the first time an Indian court is reviewing the decision of the patent office, the Madras High Court today called for re-examination of a patent granted to Swiss drug maker F Hoffman-La Roche's valgancyclovir, marketed under the brand name Valcyte in India. Valgancyclovir is a critical drug needed for patients suffering with life threatening illnesses such as AIDS to prevent them from infections.

"Source said that the court wants the patent granted on Valgancyclovir to be re-examined before January 31, 2009. The court's decision is in response to a petition filed by the Indian Network of Positive People and the Tamil Nadu Network of People with HIV/AIDS against the Chennai patent office' decision to grant patent for Valgancyclovir without hearing their pre-grant opposition.

The patent for the valgancyclovir  was granted to Roche in June 2007, without hearing the pre-grant opposition filed by the patient groups alleging that the drug lacks novelty and hence non-patentable. The patient groups has maintained that the drug was first patented in the US in 1994 and as Indian laws provide product patent protection only to those drugs that are patented after 1995, and hence, cannot be considered patentable.

Here patient group erroneously said that valgancyclovir is pre-1995 invention which is non-patentable as a product in India . It is not the case because the  application for valgancyclovir was not available to the public before Jan 01, 1995, it was available only after Jan 01, 1995 so the drug qualifies post 1995 invention which is patentable in India  as a product U/S 5(2) of Indian Patent Act 1970.

Please also note that valgancyclovir product is patented in crystalline form in US. In US, the application claiming basic product and its crystalline form was rejected twice, but due to non-disclosure of the crystalline  form of valgancyclovir in prior art reference, applicant was able to get the claim on crystalline form of valgancyclovir.  But in India it is patented as a basic product and its crystalline form as well. Therefore, In my personal opinion, Cipla/opposition party (ies) has to invalidate the patent on the ground of lack of novelty and obviousness  based on prior art references; not just by saying that the claimed drug is pre1995 invention; thus non-patentable in India. Secondly, Roche may not get the preliminary injunction because of the price difference between two branded drugs (one is by Roche and another is by Cipla); we are expecting this from the outcome of the earlier case between Roche and Cipla for lung cancer drug, Tarceva.