Author: Alok Samal
Evergreening also known as “stockpiling,” “layering,” “life-cycle management,” or “line-extension” refers to the process of obtaining multiple patents that cover different aspects of the same product commonly observed in the Pharmaceutical Industry. In fact, one of its earliest definitions is that “evergreening refers to attempts by owners of pharmaceutical product patents to effectively extend the term of those patents on modified forms of the same drug, new delivery systems for the drug, new uses of the drug, and the like.”
So how does it come to the picture? Well, on a global scale it has attracted a lot of attention in the 111th US Congress where it was the centre of attraction of the issue of settlements of patents dispute that delay the market entry of generic drugs in the $800 billion dollar Pharma Industry. Its critics believe that through evergreening the patent holders continue their dominance by coming up with derivative patents of the same substance or other aspects of the same product thereby impedes the introduction of generic versions of the same drug. So, for e.g. Say today Corporation A has a patent on a particular substance since 2001, and then again in 2011 they file another patent on an improved version of manufacturing the same substance. So, the earlier patent which was due on 2021 is now effectively moved to 2031 once the patent is approved. Now say Corp B could have started the manufacturing from 2021 for the drugs but because of the extension it may be able to sell those after 2031.
On the other hand its proponents believe that ‘evergreening’ is a misplaced word. Their view is that most of the technological developments occur incrementally. They believe that many of the improvement patents cover advances that are of significance to the patients. They also argue that the developer of improvement or derivative patents is not the original entity always. But, how much of it is supported by empirical evidence in the field of Pharmaceuticals is still a bone of contention.
In the Indian context where India allowed product patents after 2005, Swiss major Novartis was the first major case where it tried to get a patent on Glivec, the blood cancer drug. However the Intellectual Property Appellate Board (IPAB) turned down Novartis’ patent claim stating that it was just a modified form of the original compound and does not meet the criterion of enhanced therapeutic efficacy under the Section 3(d).
In my opinion Section 3(d) is one regulation that contributes significantly to the soundness of derivative innovation and definitely, it will cause many more heartburns for many of the Global firms that are trying to get patents on improved or modified products in India. Anyways, I will conclude with some ‘food for thought’. Do you know that ‘as per the an FDA report out of the 941 approved drugs from 1995-2005 only 311 were new ‘biologics’ or NMEs(new molecular entities) and rest were so called ‘me too drugs’.
References:
http://en.wikipedia.org/wiki/Evergreening
http://en.wikipedia.org/wiki/Me-too_drug
http://donttradeourlivesaway.wordpress.com/2011/12/01/novartis-case-apn-interview/
http://nopr.niscair.res.in/bitstream/123456789/6057/1/JIPR%2014(5)%20385-396.pdf
Innovation and Intellectual Property 