The Intellectual Property Appellate Board (IPAB) by its recent orders [see end note 1] dated 20th January, 2014 and 23rd January, 2014, set aside the orders of Assistant Controller rejecting the patent applications for a "sterile pharmaceutical composition" [see end note 2] and a "crystalline polymorph of a bisulfate salt of a thrombin receptor antagonist" [see end note 3] on grounds of lack of compliance with Section 14 and Section 15 of the Patents Act, 1970 (the Act) respectively.
IPAB on Section 14 compliance - Factual background
The application of Abraxis BioScience LLC (appellant) pertained to a proprietary tumor targeting system known as nab technology platform for treating cancer and other critical illness. Natco Pharma, which had launched a biosimilar drug called Albupax, filed a pre-grant opposition. The Assistant Controller, based on Natco's opposition rejected the application under Section 25(1) of the Act without providing the Appellant an opportunity of hearing under Section 14 of the Act. The appellant filed an appeal to the IPAB mainly on ground of violation of principles of natural justice.
The appellant contended that denial of an opportunity of hearing under Section 14 of the Act in spite of a specific request for the same was a gross violation of the principles of natural justice. The appellant also highlighted that lack of a hearing and a consequential order under Section 14 of the Act, deprived the appellant an opportunity to appeal against said order since an order under Section 25(1) of the Act at the pre-grant stage was not an appealable one at the relevant time. Such orders became appealable only subsequently after the ruling by the Delhi High Court in a batch of writ petitions. Further, the appellant contended that the Assistant Controller took suo-motu consideration of an additional ground of ‘insufficiency’ under Section 25(1)(g) of the Act to reject the appellant's application despite the fact that Natco Pharma did not raise such ground in its opposition petition. Natco Pharma raised the contention that the appellant was afforded an opportunity to be heard as part of the proceeding under Section 25(1) of the Act and thus there was no violation of the principles of natural justice.
The IPAB took into consideration the appellant's reply to the first examination report on 6th Jan, 2009, prior to the deadline mentioned in the examination report and the appellant's letter dated 8th April, 2009 seeking a hearing under Sections 14 and 15 of the Act and held that the Controller's finding that the reply to the first examination report was not filed in time was factually wrong. The IPAB clarified that the opportunity of hearing under Section 14 of the Act is a mandatory provision and that the Assistant Controller failed to fulfill this mandatory requirement. Further, referring to the judgment of the Delhi High Court in Ferid Allani v. Union of India [(2008 (37) PTC 448], the IPAB reiterated that Section 14 of the Act, read with Rule 129 of the Patent Rules, 2003 casts a duty on the Controller to give a hearing to an applicant before exercising any discretionary power that is likely to affect an applicant adversely. The IPAB also held that the law does not mandate suo-motu consideration of grounds of opposition in the absence of any specific plea taken by the petitioner of an opposition petition.
IPAB on Section 15 compliance - Factual background
Schering Corporation (appellant) filed an application pertaining to a crystalline polymorph of a bisulfate salt of a thrombin receptor antagonist. The Assistant Controller rejected the appellant's application on the ground that it had to provide data regarding therapeutic efficacy of the claimed crystalline form of the compound and that the claims lacked inventive step under Section 2(1)(ja) of the Act. On appeal it was argued that the Controller did not take into consideration the claims and contentions raised by the appellant and that the order of the Controller failed to mention any cogent reasons for rejecting the application.
The IPAB held that the Controller failed to adequately consider the claims raised by the appellant and also failed to render a finding on each aspect. Under Section 15 of the Act the Controller ought not to mechanically refuse applications and the provision mandates discretion to give opportunity to the applicant to make amendments in the application so as to comply with the provisions of the Act. Also, the IPAB held that the finding of lack of inventive step by the Controller was a bald one with vague reasoning and remanded the matter for fresh consideration.
It is interesting to note that this is not the first time that the IPAB has set aside Controllers' orders for non-compliance of Section 14 or 15 of the Act. In spite of repeated attempts by the IPAB to ensure adherence to principles of natural justice, there have been numerous orders which are either non-speaking or mechanical rejection of application without affording the applicant an opportunity to amend the application.
In NTT DoCoMo Inc v. The Controller of Patents and Design (Order No. 252 of 2013, dated 28th Oct, 2013) the IPAB set aside the Controller’s order and permitted the applicant an opportunity to submit an amended application under Section 15 of the Act with required documents to establish proof of right to apply. The IPAB clarified that in the case of procedural defects in an application, the Controller must not refuse the application without allowing the applicant to amend the application by furnishing the relevant documents. It is pertinent to note that unreasoned orders and findings contrary to principles of natural justice are an unnecessary burden on the applicants and thus it is time the Indian Patent Office took notice of this issue and train the Examiners and Controllers accordingly.
[ The author is an Associate, IPR Practice, Lakshmikumaran & Sridharan, New Delhi ]
- Order No. 9 of 2014 and Order No. 8 of 2014
- Application No. 2899/DELNP/2005; Controller's Order dated 28th April, 2009
- Application No. 2491/CHENP/2006; Controller's Order dated 18th June, 2009