The Assistant Controller of Patents and Designs on 7 November 2016 allowed two applications of Pfizer Ireland covering their commercial method for production of Etanercept, dismissing four pre-grant oppositions. The claims were for a method of producing a polypeptide in a large-scale production cell culture over several stages.
The controller determined the claims to be novel, noting that the opponents’ calculations were incorrect. Further oppositions against the claims on the ground of obviousness under 25(1(e) Indian Patents Act 1970 were also dismissed. The controller concluded inventive step and non-obviousness in the method as none of the prior art documents either alone or in combination disclosed or taught the method. She opined that “all the discussions of the opponent have been made in hindsight which is impermissible in law”.
Contentions that Pfizer’s two claims were not patentably distinct were also dismissed, with the determination that the two did not involve any issue of ever greening or double patenting.
Gitika Suri discusses the decisions on Patents Rewind.