The Pharmaceutical Industry of India plays a very important role around the globe. It is one of the largest generic medicine providers in the world. This is attributed to the fact that the laws and regulations are conducive for the generic manufacturers. However, the Indian government now targets pharmaceutical innovation and R&D as one of their focus areas.

Under Vision Pharma 2047, the government plans to accomplish the following objectives:

1. Enable India to become a global leader in the production of cost-effective, innovative & high-quality pharmaceuticals & medical devices
2. Drive innovation and research to ensure delivery of health care products in a sustainable manner to the generations to come
3. Make patient-focused products affordable and accessible by tying up with private companies, academia, and governments to ensure better health outcomes
4. Streamline regulatory framework to enable faster drug approvals in India
5. Minimize India’s carbon footprint in Pharma-MedTech to align with Hon’ble PM’s vision of Panchamrita

The government also continues to strive to foster innovation by introducing multiple schemes such as Scheme for Strengthening of Pharmaceuticals Industry, Scheme for Promotion of Bulk Drug Parks, Scheme for Human Resource Development in the Medical Device Sector, Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP), Production Linked Incentive (PLI) schemes and more. This also includes identifying Centres of Excellence (COE) to promote innovation.

While initiatives and policies that address the bottlenecks of the pharmaceutical industry are being devised and implemented, there is a strong need to reform the Indian patent law to attract pharmaceutical innovation and R&D. The introduction of patent linkage and regulatory data protection could be beneficial to the innovator pharma companies.

Patent linkage system forms a link between the drug marketing approval process and the patent dispute resolution process. An online patent information registry platform that discloses the key patents protecting an innovator drug may prove beneficial to the innovators and generic applicants. Innovators can use this tool during patent infringement litigations while generic applicants can use it as a source of information, make patent declarations, and also notify the intended launch of generics to the innovators. Generic manufacturers may also use it to challenge the validity of patents. Thus, a patent linkage system may help in striking a positive balance between innovation and generic products manufacturing.

Another way of striking this balance can be by the introduction of the provision of patent term extension (PTE). Currently, patents in India have a term of 20 years from the original filing date. Specifically, if the PTE is granted to a patent with respect to a particular new drug/new product, it ensures that the innovators can recover the R&D investment cost. This gives a boost to the innovators and a sense of security.

Having identified as a cost-effective location, India is now attracting many pharmaceutical companies to conduct clinical trials here. The introduction of regulatory data protection for pharmaceutical products can be a game-changer for innovation in the pharmaceutical space. Like other nations, if India introduces regulatory data protection, it will ensure the increase in R&D in India. All these methods, however, have a downside of postponing generic entry into the market.

Another tool that can substantially benefit the innovation is IP financing. This is a tool which is still under discussion. The Indian government recently announced its decision of creating an action plan and institutionalising IP financing in India.  The idea is to address the challenges of raising funds to scale up and diversify the business by enabling the organisations to monetise their IP. It involves using IP rights to get credit, generate revenue and avail benefits such as using the IPR as collaterals. This is most commonly known as Securitisation. If and when this turns into a substantial law, it can help in enhancing innovation.

Recently, the draft Patents (Amendment) Rules, 2023 was published with some very serious changes that may have a huge impact on public health and pharmaceutical industry. Since then, there have been lot of mixed reactions from public and stakeholders. It would be interesting to see how the government reacts to it and publishes the final amendment.

References:

1. https://www.thehindu.com/news/national/explained-the-indian-patent-regime-and-its-clash-with-the-us-norms/article65464988.ece/amp/
2. https://www.lexology.com/library/detail.aspx?g=1bf2a392-5cfc-4321-8a2b-c988ee6dd0e7
3. https://www.lexology.com/library/detail.aspx?g=d3bcd525-d006-44cc-8a32-ec32b2b6516a
4. https://www.investindia.gov.in/team-india-blogs/pharmaceutical-sector-spotlight-driving-innovation-india