In a recent turn of events, the Supreme Court has set aside the order for revocation of Sugen/Pfizer’s patent (Sunitinib/Sutent) as passed by the Controller of the Indian Patent Office in a recent post grant opposition proceedings brought forth by Cipla on the grounds of obviousness and lack of inventive step.
The revocation of the granted patent was made on the basis of comparative testsas carried out between the compounds of the claimed invention and the compounds of the closest prior art which exhibited close structural similarity and that the invention failed to demonstrate any improved activity over the prior arts.
Thereafter, Sugen filed a writ petition before the hon’ble Delhi High Court praying for the order of the Controller to be set aside on the ground that it violated the principle of natural justice - audi alteram partem - by not providing a copy of the recommendations of the Opposition Board to either of the parties. In response to Sugen’s petition, the Hon’ble Court although did not deliberate on the point of law but proceeded further to restrain Cipla from marketing its generic version of Sunitinib till October 15, 2012 i.e. the next hearing date which eventually was adjourned to December 6, 2012.
Henceforth, Cipla filed a Special Leave Petition (SLP) before the Hon’ble Supreme Court requesting for an early hearing of its case where they were restrained from marketing Sunitinib. While deliberating on the point of natural justice, the Apex Court held that the order of revocation was violative of the principle of natural justice since the fact that the Report of the Opposition Board can be crucial in the decision making process, while passing an order by the Controller under Section 25(4) of the Indian Patents Act, 1970 (hereinafter referred to as the Act), principles of natural justice must be read into those provisions.
Copy of the Report/recommendation of the Board, therefore, should be made available to the parties before the Controller passes orders under Section 25(4) of the Act and thereby the impugned order was set aside.
Eventually, the matter has now been remanded to the Controller in order to dispose off the post grant opposition within a period of one-month from the date of communication of the order of the Apex Court.
Also, Sugen/Pfizer had approached the Delhi High Court petitioning to stay Cipla from selling the generic version of its drug on the grounds that the Apex Court had reinstated its patent. The matter has been adjourned to the beginning of next year awaiting the decision of the Controller in respect of the fresh post grant proceedings.