A/HRC/11/12
page 13
respects may present good examples for LDCs to consider in adapting to their own needs and
circumstances. LDCs should also consider seeking further extensions of the transition period, as
provided by article 66, paragraph 1, of TRIPS.
2. Patentable subject matter
32. Article 27, paragraph 1, of TRIPS requires patents to be available for inventions that are
“new, involve an inventive step and are capable of industrial application”. It does not define
these patentability criteria. Therefore, member States have the freedom to define each criteria
according to their needs. Countries apply different standards to each of these criteria, either
statutorily or through judicial development. While countries that apply a low level of
patentability standards allow patents to be granted easily, those that provide higher patentability
standards allow for patents only on genuine inventions.
33. Furthermore, article 27 allows member States to exclude certain categories of inventions
from patentability. Thus, they can exclude from patentability those inventions whose commercial
exploitation is detrimental to human life or health. They can also exclude diagnostic, therapeutic
and surgical methods for treatment of humans from patentability. TRIPS does not provide an
exhaustive list of permissible exclusions allowing countries to exclude certain categories of
inventions in order to protect public health.
34. From a right to health perspective, the “evergreening” of patents by pharmaceutical
companies is of particular concern. Evergreening refers to the practice of obtaining new patents
on a patented medicine by making minor changes to it.38 For example, patents are obtained on
new uses, forms, combinations and formulations of known medicines in a bid to extend the
period of the patentee’s monopoly. Such evergreening delays the entry of competitive generic
medicines into the market.
35. The freedom to set high patentability criteria and exclude certain inventions is an important
tool that countries can use to address evergreening and ensure that patents are granted only to
genuine inventions in the pharmaceutical field. Thus, countries can deny patents on new uses,
forms, formulations or combinations of known medicines. India and the Philippines for example,
exclude from patentability new forms of known substances unless they are significantly more
efficacious and new (or second) uses and combinations of known substances.39 If implemented
properly, this can help limit evergreening tactics. Reducing the number of patents granted on
medicines can limit the impact of patents on access to medicines and facilitate the early entry of
generic competition.
38
39
E/CN.4/Sub.2/2001/13.
Indian Patents Act, 1970, section 3 (d), Intellectual Property Code, Philippines (amended by
section 5 of the Universally Accessible Cheaper and Quality Medicines Act of 2008),
section 22.1.
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