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existing substance based on finding a new use for it, instead of inventing a new drug.
The aim of evergreening is to restrict the entry of generics on the market42 and it is
capable of increasing the prices of drugs. Some authors describe evergreening as the
most important strategy of pharmaceutical companies to gain profits from “high sell
volume” drugs.43
A great example of evergreening is the patent of a retroviral drug Zidovudine. The
patent was first filed in 1964; it should, therefore, have expired in 1984, 20 years
after the filing. However, the patent holder keeps extending the original patent. As
a result, the patent protection of Zidovudine in the US will not expire before 2021.44
By providing patents for minor variations of old drugs that do not provide any new
therapeutic benefits, evergreening allows pharmaceutical companies to prevent gener-
ics from entering the market, thus depriving costumers of more affordable medicines.
For example: in 2001, the cost of Gleevec, a leukemia drug, rose from 30 000 to
92 000 SUD per year – this was a result of a patent holder obtaining new patent for
the same drug.
The question to ask when considering evergreening is what subject matter is patent-
able. TRIPS is ambiguous with regard to evergreening. In its art. 27, it states that “pat-
ents shall be available for any inventions, whether products or processes, in all fields
of technology, provided that they are new, involve an inventive step and are capable of
industrial application.”45 However, it is not clear what is meant by “invention.”
In the US and EU, invention can be granted for “incremental innovations,” 46 such
as a new use of an already patented substance. On the other hand, for example India,
a country known for its massive generics production, prohibited such patents. In order
to protect its generic production from evergreening, it adopted a restrictive interpre-
tation of what is meant by “invention.” In section 3(d) of Indian Patent Act 2005,
it states that patents are not available for inventions in the meaning of “discovery of
a new form of a known substance (…) or the mere discovery of any new property or
new use for a known substance or of the mere use of a known process.” The substantial
differences in IP protection between US and India are one of the main reasons why an
US-India FTA has not been negotiated so far.47 However, it is possible that by extend-
ing evergreening to a large number of FTAs, including the TPP, India will be forced to
adjust its own regulations.
In its FTAs, the US insist on extensive patent protection and, therefore, protection
of evergreening. Therefore, the US-Australia, US-Morocco and US-Bahrain provide
42 Ibid
43 Rhonda Chesmond, “Patent Evergreening in Australia after the Australia-United States Free Trade
Agreement: Floodgates or Fallacy?”, (2006) 9 Flinders J. L. Reform 51 at 54 [Chesmond].
44 Macmillan, Palgrave, Impact of TRIPS in India, Palgrave Macmillan 2010 at 87.
45 TRIPS art. 27.
46 Evergreening supra note 108.
47 at 91.