Effect of ever greening on Pharmaceutical Patents: A Hurdle on Emergence of Generic Drugs

Shrashank Tripathi and Shashank Diwakar
Dr. Shakuntala Misra National Rehabilitation University, Lucknow
Uttar Pradesh, India

Volume I, Issue III, 2018

Evergreening generally refers to layering of same product with the help of various patents which is helpful for a company to obtain monopoly for a long period of time. Patent plays an very important role in pharmaceutical industry since innovation in this sector are quite costly, development of drugs is very lengthy and expensive process but patent provide full opportunity to the company to gain profit. But if company layers his same medicine with various patents it will lead to ‘evergreening’, which ultimately exclude the medicine for a long period of time from public domain and also restrict generic manufactures to come into play. A generic drug is a drug which is produced and distributed without patent protection. Brand names companies use various kinds of strategies such as ‘next   generation drugs’, ‘strategic patenting’, ‘over the counter switch’ and continues application practice. Patenting system also build some kind of defence wall for tackling immoral situation in patent layering such as Section 3(d), judicial precedent, Bolar provision and scheme like orange book in U.S.A. Additional layer should only be granted if the proposed medicine had some additional therapeutic efficacy mere minor modification in the medicine should not be qualified for additional patent

This paper will discuss about the patent ‘evergreening’ in pharmaceutical sector and its effect on production of generic drugs, and discuss various techniques and strategies practiced by the brand name company for expanding their patent, measures taken by government for restricting such practices for the emergence of generic drug manufactures. Basic question in this paper is to evaluate that how the libertarian approach in patent system will exploit the interest of poor customers of country where most of the person are not able to afford high cost medicine and various any kind of remedies are available against such kind of exploitation.


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