Under Article 27.1, TRIPS Agreement, you as a legislator are obligated to make available patent protection for "inventions". The TRIPS Agreement, however, does not define this term, but only specifies the requirements that an invention should meet in order to be patentable. You are therefore free to insert in your patent law your own definition of "invention".

Traditionally, many national patent laws have defined an invention as resulting from a technical contribution to the art, or as being of a technical character, solving technical problems, or having a technical effect, as opposed to mere discoveries. The protectable subject matter must result from someone's ingenuity and creativity. Innovations that lack such a technical contribution, are no inventions and do therefore not merit patent protection.

Against this background, substances existing in nature are deemed to be non-patentable subject matter as they do not result from human ingenuity.

Other possible exclusions from patentable subject matter, that are particularly relevant in the public health context, are abstract scientific theories, principles and ideas, as well as methods of treatment. As opposed to naturally occurring substances, these are deemed to be inventions but they may nevertheless be excluded from patent protection for practical reasons. Abstract scientific theories, principles, and ideas are essential for follow-on innovations. Would they be patentable and thus not publicly available, other inventors could not use them for continued research & development (R&D) and thus technological progress. The rationale behind the exclusion of methods of treatment is that medical doctors' every day work, such as administering drugs, should not be hampered by patents. In this context, the patentability of new uses of known substances will be discussed in the course of this module.

Finally, you will also learn about legal means to exclude pharmaceutical product derivatives from patentability that do not show any significantly enhanced efficacy.