Patent Office revokes the patent of Roche's osteoporosis drug Bonviva
Decision comes in a post-grant opposition filed by Cipla, and following an order from IPAB
The dispute was on patent number 208718, for an oral drug used to treat osteoporosis, in which the active medicine is released uniformly and almost completely within 30 minutes, controlling its dissolution rate. The patent application was filed on April 3, 2001 and patent was granted by the Patent Office on August 7, 2007.
Cipla filed its post-grant opposition on September 2008 and the Patent Office dismissed the opposition on August 26, 2010, upholding the patent. Cipla moved an appeal in the IPAB, seeking a relief.
IPAB set aside the order, stating: “The Controller has not at all considered, discussed and appreciated the expert evidence of Cipla and the expert of Roche and the Controller has also miserably failed to assign the reasons for deviating the opinion of the opposition Board.” It also directed the Assistant Controller of Patents to consider the matter afresh by considering the contentions put forward by both sides in respect of the expert evidence provided by Cipla and Roche.
Following the IPAB order, the Assistant Controller of Patents and Designs considered the matter afresh and issued an order on December 19, 2014.
The order said: "...Considering all the relevant documents and pleadings of both the parties, expert evidences, opposition board recommendations and in view of my findings above, the opponent has succeeded on the grounds under section 25(2)(e) and 25(2)(f) of the Patents Act, 1970, and hence the granted Patent 208718 is hereby revoked. There is no order to costs."
Section 25(2)(e) of the Indian Patent Act, 1970, deals with post-grant opposition on the ground that the invention does not involve an inventive step and Section 25(2)(f) is on the ground that the invention under challenge is not an invention within the meaning of the Act, or is not patentable under the Act.
Earlier, the Opposition Board also was of the opinion that inventive step in Roche's claim cannot be acknowledged. However, in its latest order, the Patent Office said there were no findings in the recommendation of the Opposition Board regarding the expert evidences and it was necessary to get the Board's opinion on the expert evidence.
The Patent Office constituted a supplementary Opposition Board to look at the expert evidence and give recommendation, as the members of the main Opposition Board were promoted to higher level or transferred to other branch offices. The supplementary Opposition Board also concluded that the claims lack in inventive step.
Cipla was represented by S Majumdar & Co, while Roche was represented by De Penning & De Penning.
Boniva is used for the treatment and prevention of osteoporosis in postmenopausal women. According to earlier reports, the company had entered into a tie-up with Mumbai-based Elder Pharmaceuticals to sell the drug under the brand Bonviva in India, in 2006, with 35 per cent cheaper price compared to the western market.