Eli Lilly criticizes India's patent regime

Some selected excerpts from "India's patent policy is discouraging innovations that can be of help", Q&A: Sandeep Gupta, CMD, Eli Lilly India, in: Business Standard, 31.03.2010

What is your perception of India's product patent regime?

By introducing a product patent regime in 2005, India signalled to the world that it was ready to value and protect innovation. However, this has not been fully implemented in the true letter and spirit. For instance, India’s move of not recognising patents on incremental innovations, unless a significant improvement in ‘efficacy’ is demonstrated, is actually discouraging innovations that can be of great help.

A related issue is data protection. How critical is that for innovation-driven companies like Lilly?
World-over, innovator companies spend millions of dollars to generate extensive clinical trial data to prove safety and efficacy of a drug and obtain marketing approvals from regulators. India doesn’t allow protection to such data and proprietary scientific data of innovator companies are used for granting approvals for generic/second applicants. If this is not unfair commercial use, then what is?

Further, in the absence of a patent linkage mechanism, regulatory authorities continue to grant marketing approvals for a certain product, regardless of its patent status.

Lilly’s global plans include doubling its revenues from emerging markets, including India. Do you have a country-specific strategy to achieve this?
India is one among the top seven countries that constitute the emerging markets for Lilly. Strategy wise, Lilly has its road map clearly laid out. Having excellent in-house talent and resources is one of the pillars of our R&D success, but at the same time, we're excited about the opportunities to collaborate with other companies. That's why we are continuing to transform Lilly from a fully integrated pharmaceutical company (FIPCo) to a fully integrated pharmaceutical network (FIPNet) model. Within this more networked structure, we're teaming with other companies to access innovation and capabilities, reduce costs, share risks, and accelerate productivity.

To illustrate, we already have six-seven research tie-ups in place in India. The tie-up with Zydus Cadila was announced just a few months earlier. Suven, Piramal, Jubilant are some of our other research collaborators.

Source: "India's patent policy is discouraging innovations that can be of help", Q&A: Sandeep Gupta, CMD, Eli Lilly India, in: Business Standard, 31.03.2010