An Indian division bench headed by Justice AP Shah and Justice Muralidhar (Delhi high court) dismissed the plea of the Swiss Pharma giant Roche on temporary injunction against Indian generic player Cipla w.r.t manufacturing and selling the generic drug Erlotinib [N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine] 25 mg, 100 mg and 150 mg tablets till the issue of patent rights was decided through litigation. Also, court imposed 5 lakh rupees cost on innovator Roche for suppressing the material facts.
Earlier, In January, 2008, innovator Roche filed a patent infringement suit against Cipla in the Delhi high court for the infringement of Indian patent IN196774 ('which is equivalent patent of orange book listed patent US5747498), following Cipla’s launch of the generic version of Tarceva in December, 2007. Subsequently, Delhi High Court in March, 2008 allowed Indian firm Cipla to manufacture and sell a generic version of the patented drug, Tarceva, in India (link to opinion of court Here).
Also, innovator Roche may appeal against said decision in Supreme court.
The above litigation is one of the most famous patent litigation in India. Two famous indian politician cum attorney's Mr. Arun Jaitley represented Cipla, while Roche was represented by Mr. Abhishek Manu Shanghvi.
Generic player Cipla has alleged that disputed patent is invalid as obvious and is an attempt by innovator Roche on patent evergreening w.r.t already known and patented quinazoline derivative Gefatinib (further, the patent application on Gefetinib was rejected in India due to strong prior art disclosure in EP0566266). Also, generic player alleged that the Erlotinib can not be patented as per indian patent section 3 (d) as it is derivative of Gefetinib.
Furthermore, generic palyers counsel argued that API in their formulation (cipla's Erlocip formulation) contains crystalline Polymorph form B, whereas, innovator's disputed patent IN196774 discloses Erlotinib as mixture of two crystalline polymorphic forms A and B (thermodynamically unstable polymorph mixture, not suitable for formulation development), accordingly, their formulation is non-infringing.
Additionally, patent application on Polymorph Form B (equivalent of Orange Book listed patent US6900221) was already rejected in India due to obviousness and section 3 (d) during prosecution by patent examiner.
Importantly, court in it's decision observed that innovator's marketed product contains crystalline polymorph form B (as confirmed from XRD analysis), which is not covered by '774 patent.
Further, court considered "Public interest" element w.r.t price diffrence, availability and affordability of this product in India.
Link to review by Spicy IP team Here
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