Delhi HC allows Glenmark to make, sell antibiotic drug Linezolid

New Delhi: Delhi High Court today set aside its single judge’s order restraining Mumbai-based generic drug maker Glenmark Pharmaceuticals Ltd from making and selling its antibiotic medicine Linezolid. Linezolid is a synthetic antibiotic used to treat infections of the skin and blood, as also pneumonia. A bench of justices Badar Durrez Ahmed and Sanjeev Sachdeva, while setting aside the single judge’s 19 January interim order, directed Glenmark to maintain accounts of manufacture and sale of its medicine and file the same in the court. It also issued notice to Symed Laboratories Ltd, a Hyderabad-based company, on whose plea the single judge had restrained Glenmark from making Linezolid. Symed had claimed that Glenmark was making its medicine by using the processes patented by it. While setting aside the January 19 order, the court noted “it was incumbent upon the single judge to prima facie come to a finding that the active pharmaceutical ingredient (API) of both Glenmark and Symed were identical”. “This (prima facie finding) does not appear to have been done. In these circumstances, we are vacating the interim order and modifying the same by directing appellant (Glenmark) to maintain accounts and file same in court..,” the bench said and listed the matter for further hearing on 16 March. It also noted that the single judge did not go into the point regarding applicability of section 104A of the Patents Act 1970 as per which in suits alleging infringement of process patents, the defendant has to prove its process is different from that of the plaintiff. Glenmark contended the single judge had not considered their submissions under section 104A that the products of both companies are not identical. It also did not prima facie agree with Symed’s contention that its API is identical to that of Glenmark, saying the court was sitting in appeal over the order of the single judge who had not made any such finding. Symed had approached the high court in 2013 seeking to restrain Glenmark for infringing two of its process patent for Linezolid. The Hyderabad-based firm had claimed that upon testing samples of Glenmark’s products, it had found two compounds (novel intermediates) which indicated that Glenmark was using Symed’s patented process to manufacture its products. Denying Symed’s claims, Glenmark, represented by senior advocate P Chidambaram argued that it was not infringing Symed’s patent. Glenmark also contended its API was different from that of Symed as the process used was different. PTI