The central government should resist any external pressure to go for stricter intellectual property rights regime than what has already been agreed upon in the TRIPS Agreement, feel experts. They want Indian generic companies to play a greater role in educating the government on the adverse effect of such treaties.
Commenting on the recent amendments made to the Indian Patent Act, which is still with the Parliament, experts said that no Act, which gives provision for pre-grant opposition to patents, could be called people-friendly.
“We are being pushed to a similar IPR system that is against availability of affordable medicines and generic industry. Number of patents for new chemical entities approved by US FDA in 1985 was 60. It came down to 27 in 2000. At the same time, the number of patents granted for new drug entities were 6730. Most of them were minor or trivial developments of the drugs that were to go off patent. It is quite evident that the intention of innovator pharma companies is to extend the life time of their patents and thereby prevent the entry of generics, which is essential for the availability of low cost medicines”, DG Shah, secretary general, Indian Pharmaceutical Alliance said.
According to Dr Yehudah Livneh, director, Teva Pharmaceutical Industries Limited, Israel, evergreening of patent is a big casualty for generic industry and a stumbling block that prevents access to medicine. “In markets where there are patent protections, companies are coming out with continuous stream of patents supposedly covering their blockbuster drug. New processes, polymorphs, hydrates, metabolites, formulations, blood levels, ultra-pure forms etc of the blockbuster drug are all getting patented. Even if these fraudulent patents cannot stand the legal scrutiny, they succeed in dragging the generic company into litigation and thereby delay the entry of the drug,” he said.
Dr Livneh also found fault with the most common argument of innovator pharma companies that strong IPR can only bring in R&D investments into the developing countries. “They often say if you give data protection, we will invest in your country. EU has the strongest IP Protection yet brand pharma is leaving the EU. The R&D is moving to the US. During the last four years, Pharmacia, Aventis, Novartis, BASF and Bayer have moved out of EU. Israel has no foreign investment even after 20 years of product patent regime. R&D investment is not solely depended on the IPR protection. There are many other factors as well.”
Commenting on the impact of multilateral treaties, Maria Fabiana Jorge, president, MFJ International feared that trade negotiations can deny access to cheap generic medicines. “Countries should have a balanced approach. They have to be consistent with TRIPS agreement but should not concede anything more than TRIPS. There has to be penal provisions for patent infringement as well as patent abuse. If a case of patent abuse is proved, the government, which had to spend more money for medicines due to the delay caused by the litigation, which prevented the early entry of cheap generics, should be compensated. The generic company should also be paid its expenses. Otherwise, such patent abuses will continue to take place.