The Curious Case of Roche v. Cipla: A Win- Win?
Another IP battle that made headlines this year was the case of Roche v. Cipla. The Delhi High Court in a mixed judgement of sorts held Roche’s patent on Erlotinib to be valid while at the same time acquitted Cipla of the charge of infringement.
Cipla was unable to prove obviousness in the chemical compounds due to lack of evidence and deposition and hence could not bring forth a strong case of invalidation against Roche. The court observed that if the chemical compounds were held to be obvious on the basis of mere perusal and appearance of the structures and assuming that the slight change here and there is inconsequential without a positive evidence medically and clinically as to how the said reaction is immaterial, then several novel compounds can be declared obvious by such exercise and the same shall affect the research process adversely.
Furthermore, Cipla also challenged the validity of Roche’s patent under Section 3(d) as well as under section 8 of the Indian Patents Act, 1970. But these contentions were rejected, since Cipla was unable to discharge the onus of proof on the count of violation of Section 3(d).
On count of infringement, Roche too failed to discharge the onus of proof to establish the infringement of the suit patent. Accordingly, Hon’ble Court held that since Roche was marketing a particular manifestation of the compound (polymorph A and B) and Cipla was merely selling Polymorph B, it would not amount to an act of infringement.