1 May, 2016
Indian Patent Office Rejects Compulsory License Application Filed by Lee Pharma
The Controller General of Patents (‘Controller’) by order dated January 19, 20165 (‘CL Order’) rejected the compulsory license (‘CL’) application filed by Lee Pharmaceuticals Ltd. (‘Lee’) for AstraZeneca’s SAXAGLIPTIN patent. SAXAGLIPTIN is a class of drug used to treat Type II Diabetes Mellitus (DM) and held that Lee failed to establish the following three factors required to grant a CL, as specified under Section 84(1) of the Patents Act, 1970 (‘Patents Act’): (i) the Controller held that Lee had failed to provide evidence of what constitutes reasonable requirements of the public with respect to SAXAGLIPTIN, in the context of (a) total number of patients suffering from Type II DM in India; (b) the number of patients that were unable to procure it due to non-availability; and (c) the comparative requirements of the public, with respect to SAXAGLIPTIN as against other Dipeptidyl Peptidase-4 inhibitors (‘DPP-4 Inhibitors’) for treatment of Type II DM, which are also available in the market; (ii) the Controller observed that the other DDP-4 Inhibitors, which are substitutes of SAXAGLIPTIN, were available at the same price range as SAXAGLIPTIN and Lee failed to provide any evidence that SAXAGLIPTIN was the only option available to the patients in India at a reasonably affordable price; and (iii) the Controller observed that as Lee had failed to provide the exact quantitative demand of SAXAGLIPTIN in India and any factual details regarding the shortage in the Indian market, it was very difficult to conclude whether manufacturing of the drug covered by the SAXAGLIPTIN patent in India was necessary.
The Order of the Controller in respect of Lee’s CL application is critical as it categorically rejects any arguments or claims based on mere assumptions or estimates and requires the applicant to support its claims by providing credible and authentic data and evidence.
Initiation of Rectification Proceedings in a pending Trademarks Infringement Suit
A full bench of the Delhi HC, in the case of Infosys Technologies Ltd. v. Data Infosys6, was approached to address a judicial conflict on the issue of whether prior permission of the Court was necessary for filing a rectification application before the Intellectual Property Appellate Board (‘IPAB’), during the pendency of an infringement suit, as per Section 124(1)(b)(ii) of the Trade Marks Act, 1999 (‘TMA’). By its judgement dated February 5, 2016, the Delhi HC held that, as per Section 124(1)(b)(ii) of the TMA, prior permission of the Court, before which an infringement suit was pending, was not a condition precedent to filing a rectification application before the IPAB. In coming to this conclusion, the Delhi HC observed that the TMA confers exclusive jurisdiction on the Registrar of Trademarks/IPAB for deciding the matters regarding validity of a trademark. Therefore, the IPAB’s jurisdiction is not conditional or subordinate to that of a Civil Court.
5 – Lee Pharma Ltd. v. AstraZeneca AB., C.L.A. No. 1 of 2015.
6 – Infosys Technologies Ltd. v. Data Infosys, FAO (OS) 403/2012, Delhi High Court.
For further information, please contact:
Zia Mody, Partner, AZB & Partners
zia.mody@azbpartners.com
