Courts being used to stifle generic challengers

Patent fights are becoming more difficult for domestic pharmaceutical companies, as multinational drug giants, which obtain patent protection for medicines that are vulnerable to post-grant oppositions, are increasingly approaching Indian courts to stall competition from low-cost local manufacturers.

The multinational strategies are different, and in most cases, the litigation process begins even before the local drug manufacturers move a post-grant opposition in the patent office.

One such case was dismissed by the High Court here today. German multinational Bayer had taken the drug regulator and the country’s leading drug manufacturer, Cipla, to court for allowing Cipla to market a low cost version of Bayer’s patented cancer medicine, Nexavar. The HC dismissed Bayer’s petition with costs, as it felt the drug regulator was not legally bound to link patent status to drug marketing approval.

Four months earlier, Cipla got another favourable ruling from the Delhi HC. The court told Swiss multinational Roche to pay Rs 5 lakh towards the cost of litigation aimed at preventing Cipla from marketing a low cost version of Erlotinib, a lung cancer drug over which Roche has an Indian patent. In this case, Cipla had launched the generic version of Roche’s medicine as it felt that the decision of the patent office to grant patent protection for the medicine was incorrect. Cipla also filed a post-grant opposition in the patent office.

The third case was that of B Braun, the German medical device major, and Delhi-based medical equipment maker, Poly Medicure Ltd. Braun filed a patent infringement case against Poly Medicure for coming out with a “safety IV catheter” that was similar to its patented product. Here again, Poly had questioned the patent’s validity and the court has, prima facie, found merit in the argument. Poly alleged that Braun had revised its patent claims after grant of patent (which is not permitted under Indian rules) and before it filed the patent infringement case. In an interim order in April, the HC had rejected Braun’s plea to issue an injunction against the marketing of Poly Medicure’s product.

It is known that there are over a dozen such cases pending with various courts across the country. Patent experts see such aggressive litigation as a major headache for generic companies. “The fault is with the patent offices. Patent grants given by patent offices for applications that do not merit protection are the reason for such litigations. It also shows that post-grant opposition is not always a solution to address such issues”, a Delhi-based patent attorney said. “The patent offices are clearing applications fast, as they feel the aggrieved parties have an option for post-grant opposition. However, it is causing a great deal of inconvenience to the local drug makers.”