Drug evergreening strategies in India

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Drug evergreening strategies in India

Genéricos/Investigación | Posted 05/06/2015 0 Post your comment

A study of drug patent evergreening in India found that this is a strategy that has been used by manufacturers of a particular drug to restrict or prevent competition from manufacturers of generic equivalents. It is also a strategy still being used in India despite the efforts of Section 3(d) of the Indian Patent Act to curb such practices [1].

Evergreening extends the patent period of an originator drug, often by making small patentable changes to existing products with soon-to-expire patents. Companies can then switch patients to the new products, grabbing market share from generics and increasing costs for both the healthcare system and patients [2, 3].

Author Shuchi Midha from the SIES College of Management Studies carried out a study into evergreening strategies using secondary research methodology and a case study approach. The results indicated that the evergreening strategies usually used by the pharmaceutical industry in India include:

Redundant extensions and creations of ‘next generation drugs’, which result in superfluous variations to a product and then patenting it as a new application.
Prescription to over-the-counter (OTC) switch.
Exclusive partnerships with generics players in the market prior to drug patent expiry thus significantly enhancing the brand-name drug value and earning royalties on the product in the interim.
Defensive pricing strategies or competitive practices wherein the originator companies ensure healthy competition with generics players.
Establishment of subsidiary units by respective originator companies in the generics domain before rival generics players enter the market.
Brand migration, i.e. transfer to other ‘newer’ patent-protected brand-name products.
Creation of combination products.

Generics are the main stay for the pharmaceutical industry in India and therefore, the government will be under increasing pressure to supply low cost drugs to an ever increasing population. However, with Big Pharma increasingly taking advantage of secondary innovations such as specific salts or enantiomers or specialized delivery systems to improve their overall viability, Dr Midha expects further conflicts between pharmaceutical companies and the Indian patent system in the near future.

Conflict of interest
The author of the research paper [1] did not declare any conflict of interest.

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References
1.   Midha S. Strategies for drug patent ever-greening in the pharmaceutical industry. IJPSBM. 2015;3(3):11-24.
2.   GaBI Online - Generics and Biosimilars Initiative. The cost of evergreening strategies [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 5]. Available from: www.gabionline.net/Generics/Research/The-cost-of-evergreening-strategies
3.   GaBI Online - Generics and Biosimilars Initiative. Evergreening patents may make drugs too costly for patients in Thailand [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 5]. Available from: www.gabionline.net/Policies-Legislation/Evergreening-patents-may-make-drugs-too-costly-for-patients-in-Thailand

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