If national legislation aims to provide no specific restriction on the patentability of substances existing in nature - as is currently the case in the USA and Europe - there is no need for a special provision on the matter. If, on the other hand, a country wants to avoid providing patents for substances as found in nature, a provision excluding the patentability of mere “discoveries” may suffice (Option 1). If a more explicit and restrictive approach is preferred, national laws may provide for specific exclusion (Option 2).

Under Option 1, a substance which existed in nature but which has not yet been identified in its characteristics and in its utility may become patentable, depending on the interpretation given to the concept of “discovery”. Option 2 would exclude such a possibility. Under Option 2, patentability would require making changes in the structure of the material. In the case of genetic materials, in particular, patentability would require modification of their genetic structure in a manner that leads to a new and inventive product.

Neither of these Options would prevent an interested party from patenting the processes employed to isolate, purify or produce a biological material, if the process met the patentability requirements.

Countries should recognize that choosing among the options presented here will determine key aspects of their biotechnology legislative policy.