Mumbai: The Indian Pharmaceutical Alliance, or IPA, has sought an investigation into several delayed orders in patent opposition cases.
The alliance, which represents India’s top pharmaceutical companies, including Ranbaxy Laboratories Ltd, Dr Reddys Laboratories Ltd and Sun Pharmaceutical Industries Ltd, has said in a statement that patent offices should initiate a “quality audit check for all such cases and ascertain reasons for the inordinate delays in issuing the final orders with a view to take appropriate action to create deterrent to unhealthy practices”.
The statement was sent last Tuesday to P.H. Kurian, controller general of patents, designs and trademarks, and T.C. James, director, department of industrial policies and promotion, the Union government body that oversees the country’s patent enforcement regulations. IPA had contested several patent grants using these provisions, and final orders are still awaited.
Referring to a Mint story, “Patent offices asked to clear opposition cases by 31 March”, IPA has also asked the patent office to make public a list of cases where the orders were kept pending for at least six months after the final hearing. Mint reported on 17 March that the new controller general of patents, after taking charge in January, had issued an internal circular urging the heads of the four regional patent offices in Kolkata, New Delhi, Mumbai and Chennai to issue final orders by 31 March in some 600 patent and trademark opposition cases. Some of these have been pending for three years.
Several companies have taken advantage of the delays in deciding on pre- or post-grant opposition by either keeping genuine patent holders from commercializing their products or by selling their own generic versions till a final decision is made. A delay in deciding on a post-grant opposition case results in a patent holder enjoying a continued monopoly in the market even if its patent rights are under question.
Dilip G. Shah, secretary general of IPA, said the association has requested the controller general to find out if there is any corruption behind such delays. “The provisions in the patent law for opposing patents before and after the grant are given in the interest of the public, and these are provided to prevent frivolous and unsubstantiated patent grants in the country. So, attempts to block the ultimate benefit of such provisions by department officials are sheer misuse of power and they have to be penalized,” Shah said.
Kurian and James could not be reached for comments.
Earlier this month, IPA had asked the Union government to re-examine 86 drug patents granted between 2006 and 2008, the first three years of India’s new product patent regime for the drugs and agriculture sector. The body said 67 of these 86 patents were in violation of section 3(D) of the 2005 amended Indian patent law, and the remaining 19 were against section 3(E) of the new law.
Data compiled by the Centre for Monitoring Indian Economy (CMIE), an independent economic think tank headquartered in Mumbai, shows that 81 such doubtful patents were granted to foreign drug makers during this period, and five to Indian firms.
Section 3(D) of the Indian patent law doesn’t permit patent grants for mere modifications of known drugs unless they can claim a significant enhancement of therapeutic efficacy compared with the previously known base product. And as per section 3(E), mere combinations of two or more known drugs don’t qualify for patent rights in India.