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‘Evergreening’ of Patented drugs: Issue and the opportunities

‘Evergreening’ of Patented drugs: Issue and the opportunities

Novartis’ loss in the Supreme Court of India on Glivec patent has been one of the top news items for some time. Novartis lost, as Supreme Court of India did not saw the merit of the basis that was submitted for ‘evergreening’ of Glivec (chemical name: Imatinib Mesylate) which they claimed that the new ‘improved’ Glivec was substantially better than the earlier Glivec by adding another ingredient.
Though not sure if that is a good news or not-so-good news from the perspective of manufacturers, patients, governments, trade bodies, lobbyists, social NGOs etc. I hope it will be mix.

Lately we have seen some bans, fines, sanctions or barring of many drug makers of Indian origin. What is the core issue here? What is the quantum of improvement that qualifies an existing patent to be ‘evergreened’? Can there be a universal yardstick? What is the stance of TRIPS or WTO on these? The core issue is, if the patents can be extended through further research by improving the efficacy of the drugs. I think there can be wider ramifications and debates with high emotional outbursts from various countries and respective Governments depending on the stakes the respective bodies have.

We need to look into the Pharma companies’ behaviour as well. Why they are looking for ‘evergreening’ as an option to revitalise and extend the product life cycle? Large MNC Pharma companies spend in billions of USD in R&D to come up with new molecules, compositions, products and brands. They take huge amount of risks in that route as possibly one in hundred researches sees the light of the day at the end which should be able to cover the cost, sustain themselves and also fuel further research to new and better products. While large R&D based pharma companies are trying hard to cut the R&D to product introduction cycle shorter to sustain the opposite pressure is coming from the regulatory authorities; latter’s actions are potentially delaying the introduction by the ways of barriers, checks, audits, reports, compliance etc. This is a pressure point for the pharma R&D based companies to sustain in the short to medium term by augmenting an existing product.

In the light of contradicting interests of various groups what are the alternatives? Frankly it is hard to have a ready solution that will be acceptable by all. ‘Evergreening’ is a good option for R&D based organisations but it may be equally not acceptable by non R&D based companies by stating valid ‘mass’ reasons. Price control could be a good option for the Governments to impose a regulatory pressure but the parties must agree based on the recovery and market potential. India is 15bn USD market and going to be 29bn USD market by 2016 with 30% share of MNC drugs makers. It has immense potential for all the players while Governments can also play a key role in remediation.

Emerging economies have points too. They are generally of low per capita and human development index (HDI). They need to make the drugs at affordable cost for their masses. Patented products are generally highly priced and not affordable by many as we have seen in the case of Glivec in India. The doctors and medical community hails low cost regime. Of course, patients and their relatives like it. So do the local pharma products makers who can easily produce the formulation by reverse engineering and make the product affordable at a lower cost.

Pharma markets in India and emerging economies are experiencing some interesting time which has short term impact but can have long term impacts too. Short term impact may be in the form of change in competition landscape, buying or making the product, switching channels, new pricing structure, maintain product market share etc. Long term impact can be in the form of investment in emerging countries, lobbying, and acquisition of generic producers to create muscle to build off patented products as well.

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