The Intellectual Property Appellate Board (IPAB) has directed the patent office to consider the patent application of US-based Schering Corporation for a crystalline form of a compound for treatment of heart related disease afresh.
The patent application was on a crystalline polymorph of a bisulfate salt of a thrombin receptor antagonist, filed in 2006. The parent invention of the form itself is yet to be fully developed as a drug, according to the information available.
The Assistant Controller of Patents and Desings rejected the patent application on June 18, 2009, against which the company has approached the IPAB.
IPAB Chairman Justice K N Basha and Technical Member (Patents) DPS Parmar, in an order, said that the Board is setting aside the order as it has found in " the perusal of the impugned order that the learned controller passed is a cryptic and wrong speaking order. "
The counsel appeared for the appellant submitted that the impugned order was passed by the assistant controller on two grounds namely – that the appellant failed to provide data regarding the therapeutic efficacy of claimed crystalline form of compound two and that the claims also lack inventive step under a section of the Patents (Amendment) Act, 2005.
Justice Basha, pronouncing the order, said that the fact remains that the claims raised by the applicant was not considered by discussion in detail and rendered finding in each and every argument. While the Section 15 of the Patent Act gives option to the controller namely either to offer the appellant to amend the application or to refuse the applicantion on failure to submit any amendment.
The controller ought not have refused the application and should have excercised the provision to give opportunity to the appellant by taking the amendment in application, added the order.
Correspondingly the Assistant Controler of Patents and Designs shall consider the matter afresh according sufficient opportunity for the appellant/applicant to substantiate their application, said the order.
The controller shall dispose the matter in three months within the date of receipt of the amended claims.
However, the counsel appeared for the company submitted that there is no data to be provided for the therapeutic efficacy. He added that the invention is still in the development stage.
The IPAB said that the appellant could have given opportunity to make amendment in its submission to say the same and it would have given opportunity to substitute claims through documents.
The learned counsel for the controller contended that the learned controller has assigned reasons for passing the impugned order. He also mentioned the Section 3(d) of the Patents Act, in connection to the case.
It may be noted that the patentability of a crystalline polymorph form of a compound was a matter of dispute in relation with the Section 3(d) of the Indian Patent Act, in the matter of Novartis' Glivec patent application.
