On 30 January 2015, the Delhi High Court set aside an order dated 13 January 2015 (Order) of the Indian Patent Office (IPO) rejecting a patent to Gilead Pharmasset Inc for a ‘blockbuster’ Hepatitis C drug ‘Sofosbuvir’ (brand name: Sovaldi).
The IPO had passed the Order rejecting the patent application based on Section 3(d) of the Patents Act (Act). Section 3(d) of the Act provides that no new form of an existing substance shall be patentable unless there is an enhancement of the known efficacy of that substance. The Deputy Controller of Patents and Designs (Controller) observed that though modifications described in the patent application made Sovaldi “novel and inventive”, the application filed by Gilead did not prove its enhanced “therapeutic efficacy” compared to its “closest prior art”, WO2001/92282.
The patent application for Sovaldi had been opposed by 4 different entities, (i) Initiative for Medicines, Access & Knowledge (I-MAK) together with the Delhi Network of Positive People, (ii) Natco Pharma, (iii) BDR Pharmaceuticals and recently, (iv) Sankalp Rehabilitation Trust.
According to the Act, the IPO was required to notify Gilead about the pre-grant oppositions filed against their patent application, which it seems, they had failed to do. Thus, according to sources, procedural irregularity had taken place at the pre-grant opposition stage and therefore, the Delhi High Court had remanded the patent application back to the IPO. The Controller contended that he had not relied on claims made in the pre-grant opposition before passing the Order.
A written order has not yet been issued by the Delhi High Court. Further details/clarifications may emerge once the Order is made available.