Indian pharma industry in spite of being one of the fast-growing lacks essential infrastructure and sponsorship, and these factors go about as an impediment for the innovators, said Ajay Bhargava, Partner, Khaitan, and Co.
The industry would only succeed if there is adequate support from the government for research and development regarding infrastructure and if encouraging policies are formulated. This is the place the country’s patent regime is seen to positively encourage innovation, he included.
To encourage R&D in India, the Union government’s draft National Pharmaceutical Policy, 2017 wherein the import of active pharmaceutical ingredient (API) for manufacturing drugs in India are proposed to be taxed at higher rates. The intent is to ensure Indian industry will have the ability to manufacture their drugs at home.
Patent induces an innovator to disclose his innovation. It offers the reward for the labor, skill and monetary investment to bring it to the stage at which it could be commercially practicable. It urges to invest capital in new lines of production which might not seem profitable if many competing manufactures leave on them at the same time, said Bhargava.
India turned into a signatory to Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), in order to fulfill the commitment to World Trade Organization (WTO), Indian Patents (Amendment) Act, 2005 was established to introduce product Patents in India and marked the beginning of a new patent regime went for protecting the Intellectual property rights of patent holders.
As a feature of its WTO-TRIPS regime commitments under Articles 70, India made the ‘mailbox’ to withhold patent applications which had pharmaceutical products as a subject-matter. After the amendments to the India Patent Act, the need to balance protection of patents and maintaining the competition between the pharmaceutical companies emerged.
Before the new product patent regime, it was easy but difficult to get patents for the way toward making a drug but now the regime has made it difficult for the pharmaceutical industry to get patents on products as the criteria for patentable subject matter has turned out to be stringent, said Bhargava.
But the introduction of the concept of product patenting has changed the situation. In a judgment of Novartis v. Union of India (2013) 6 SCC 1 on the issue of whether the former could patent Gleevec in the Supreme Court interpreted Section 3(d) of the Indian Patent Act, 1970.
This is one of the landmark cases where it can be seen that the criteria for getting patents for a drug have turned out to be stringent. One might say that the product alongside the procedure must be novel, non-obvious and inventive for a grant of the patent, said Bhargava.