SINGAPORE--As soon as the Delhi High Court revived Gilead Sciences' patent hopes for Sovaldi, a new actor has come on the scene: Sankalp Rehabilitation Trust, which has joined three other plaintiffs in opposing the new patent.
After weighing Gilead's ($GILD) appeal of a patent rejection last month, the high court has ordered the Delhi Patent Office to reconsider. Justice Rajiv Shakdher said officials there had relied too much on evidence from the patent's challengers, Natco Pharma, BDR Pharmaceuticals International and Delhi Network of Positive People.
Now, the office has to hold new hearings on the company's application.
While all that is going on, Gilead still retains market approval for the drug and plans to launch it in India in April. The company has been widely criticized in India and abroad for the high price it charges for Sovaldi while keeping generics off the market.
Gilead has sought to smooth feathers by licensing the drug to 8 Indian drugmakers, allowing them to market lower-cost versions in 91 emerging markets.
Gilead's patent application, if approved, would add to other patents it holds for the drug in India. New applications seek protection for drug combinations with Sovaldi. The Sankalp trust argues that the Gilead application in dispute "has no merit." The patent request clearly falls short of India's intellectual-property law, which requires a product to be new or inventive, the trust says.
In sending the appeal back to the patent office, Shakdher said the office appeared to rely too much on material supplied by the three opponents. He said the patent office's intentions may have been good, but its denial of the patent was improper.
Special Report: Top 10 Drugmakers in Emerging Markets