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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