- On procedural grounds, the Delhi high court sets aside the recent decision by the Deputy Controller of Patents and Design rejecting Gilead Sciences' (NASDAQ:GILD) patent application for its HCV drug Sovaldi.
- The patent office rejected Gilead's submission on the basis of Section 3(d) of the Patents Act which prevents evergreening of patents and states that a new version of an existing substance cannot be patented unless it is much more effective than the old version. Its position was that sofosbuvir represented a minor change to an existing molecule that did not deliver improved efficacy.
- India legal experts believed that the company's appeal would succeed because the reasoning in the controller's order was slipshod. The procedural misconduct occurred in the pre-grant opposition stage of the application review. This is the point where the reviewer examines information submitted by opposing parties before a final ruling is issued. Under Indian law, the office was required to notify Gilead, which it did not . Also, the controller maintained that he did not rely on claims made in the pre-grant opposition, but certain sections of the order appeared strikingly similar to parts of the opposition application from Indian generic firm Natco Pharma Ltd. Justice Rajiv Shakdher said the it appeared that patent office "generously took assistance from the material" filed by the opponents.
- A written order has not yet been issued by the high court but it stated that an order by the patent office cannot be passed without every opposing party being heard. In Sovaldi's case, there are four oppositions so additional review is required before a final ruling can be made.
- Previously: Gilead to fight ruling from India patent office (Jan. 16)
- Previously: India patent office slaps Gilead in the face (Jan. 14)