IPAB snubs Assistant Controller of Patents, sets aside Pre-Grant Opposition Order against Abraxis

The IPAB has recently come up with a decision that calls into question the reasoning behind an order given by the Assistant Controller of Patents & Designs allowing a pre-grant opposition against an application for a pharmaceutical patent. Details of the case are provided below. While the merits of the patent application or the opposition posed thereto had not been discussed in this case, yet given the manner in which and the grounds on which the Assistant Controller’s decision seems to have been criticized by the IPAB, this may very well turn out to be yet another loss of face for the former.

Case Name: Abraxis BioScience LLC v. Union of India and Controller General of Patents, Design, Trademarks & Geographical Indications and Assistant Controller of Patents & Designs and M/S Natco Pharma Ltd. (M.P.NO.57/2010 IN OA/3/2010/PT/DEL AND OA/3/2010/PT/DEL).

Decision Date: January 20, 2014.

Bench Composition: Justice K.N. Basha and D.P.S. Parmar

Facts: Abraxis (appellant), a U.S. based biotechnology company, had filed a patent application before the IPO for its invention titled ‘composition and method for delivery of pharmacological agents’ under the application number 2899/DELNP/2005. It claimed to be the inventor of a proprietary tumor targeting system known as nab Technology platform, based on only protein based nano particles chemotherapeutic for cancer treatment clinically approved by regulatory agencies in several countries. The application also covered the generic version of the medicine Abraxane. Natco, which had launched Albupax, a biosimilar drug, had filed a pre-grant opposition against this application on several grounds.

Based on this opposition, the Assistant Controller had on April 28, 2009, rejected the application filed by Abraxis. The present case had been filed by Abraxis appealing from that decision.

Contentions: The ground on which the appellant argued in the present case was that of gross violation of the principle of natural justice, which stems from the fact that the Assistant Controller failed to accord Abraxis an opportunity to be heard u/s 14 of the Patents Act, 1970 before giving an order u/s 25(1), which was not appealable at that time. Furthermore, the appellant also challenged as erroneous the Assistant Controller’s decision to suo motu take into consideration the additional ground of ‘insufficiency’ u/s 25(1)(g) despite Natco not having raised the ground in its opposition petition. In its support, the appellant cited decisions such as Ferid Allani v. UOI [2008(37) PTC 448 (Del.)], Kalyan Singh Chouhan Vs. C.P. Joshi [2011 (1) UJ SC 0453] and LML Limited vs. Bajaj Auro Limited [IPAB Order No.96 of 2013 in TRA/3/2007/PT/DEL dated 2^nd May, 2013]. Natco, however, contended that the appellant had participated in the proceedings u/s. 25(1) and had been given adequate opportunity to be heard and therefore, cannot at present claim to have been deprived of such opportunity.

Judgment: The IPAB concluded that there existed sufficient evidence to prove that the appellant had been denied of an opportunity to be heard u/s 14 and 15, despite having made specific requests to that effect on January 6, 2009 and vide letter dated April 8, 2009. The Assistant Controller was therefore factually wrong in holding that no such request had been made within the prescribed time limit. Given the mandate of such an opportunity having to be provided to the parties u/s 14, it was therefore clear that the appellant had been wrongly denied of his statutory right in this case. The IPAB made it even clearer that the Assistant Controller was aware of such mandate by referring to portions of his own judgment (paragraph 3.3) rejecting the patent application. In a strongly worded judgment, the IPAB went on to opine that “we have no hesitation to hold that the learned Assistant Controller has passed the impugned order in flagrant violation of the Principle of Natural Justice.”

With respect to appellant’s second contention too, the IPAB considered the cases cited by the appellant and held in the appellant’s favour, stating that the Assistant Controller had wrongly considered an additional ground of opposition that had not been raised by Natco in its opposition petition to begin with!

Decision: The IPAB therefore set aside the order earlier given by the Assistant Controller of rejecting Abraxis’ application and sent the matter back to the Assistant Controller to be decided within three months, after giving both the parties adequate opportunity to be heard.