The Delhi High Court has dismissed Bayer's plea to restrain the Drug Controller General of India from granting a licence to Cipla for the manufacture, sale and distribution of the drug 'soranib'. Further, the Court has imposed a cost of Rupees 6,75,000 on Bayer, as it felt that the petition was based on a desire to delay the examination of Cipla's generic alternative. Arun Jaitley, Senior Counsel appeared for Cipla and was assisted by Pratibha Singh.

Bayer's plea was that, by virtue of its patent over the drug, Sorafenib Tosylate, the Drug Patent Controller must refrain from granting a licence to Cipla to manufacture a close imitation. Mr. Shanti Bhushan, Senior Counsel appearing on behalf of Bayer, contended that the grant of such licence is impermissible under the Drugs Act, as it would contradict the Patents Act. Mr. Shanti Bhushan was briefed by the offices of Remfry & Sagar, Gurgaon led by Partner Sanjay Kumar and assisted by Ms. Arpita, Vineet Rohilla and Peeyoosh Kalra.

Justice Ravindra Bhat [left], disagreeing with the contention, stated that the Drugs Act and the Patents Act possess disparate objectives, and a plain joint reading is not possible. The Court opined that the role of the Drug Controller is to ensure the observance of safety and good manufacturing practices at the time of manufacturing a drug, and held that the drug agencies are not competent to adjudicate on a possible patent infringement that could arise from the manufacture of a drug.

Mr. Shanti Bhushan said, "I disagree with the judgement of Justice Bhat", and added that the question of appealing against the order is one that Bayer must decide.

The Court's separation of the adjudication of a possible patent infringement from the process of approving manufacture allows generic manufacturers to obtain a licence to manufacture a drug prior to the expiry of its patent term. This judgement permits the speedy entry of generic alternatives of a particular drug on the expiry of its patent term.

Pratibha Singh, one of the Counsels for Cipla, commented, "It is an erudite judgement. Given that there are no precedents in India, this is a milestone." She adds, "This judgement illustrates the maturing of the Indian Patent system."

Reference Points

WP(C) No. 7833/2008; Bayer Corporation and Others Vs. Union of India and Others.