Second use patents in the Andean Community

In the following article I will express some considerations about the patenting of second uses in the Andean Community (Bolivia, Colombia, Ecuador, Peru and Venezuela), currently expressly prohibited under Article 21, Decision 486, 2000, of the Andean Community Commission (Decision 486).

Article 21:

?Patented products and processes included in the state of the art pursuant to Article 16 of this Decision shall not be the subject matter of a new patent for the simple reason of their being attributed a use other than the one originally contemplated by the original patent. ?

This is the legal ground for the Andean authorities to reject patent applications directed to second uses. However, this article has also generated controversy because of its debated legality in the light of the Trade Related Aspects of Intellectual Property Rights agreement (TRIPS).

The discussion on the legality of this provision focuses on the fact that it expressly excludes the patentability of a certain subject matter, without taking into consideration that TRIPS, in its Article 27, clearly establishes the patentable subject matter and the exceptions to patentability.

TRIPS provides for a general patentability rule for all areas of technology as well as the possibility for member countries to propose restrictions to said patentability in its own legislations. It is evident that this provision is of a restrictive nature, hence, any extension or extraordinary considerations in terms of prohibitions, exceeds the established limits in the agreement. Article 21 of Decision 486 includes an exception to patentability that is additional to those contemplated and allowed by TRIPS, because Article 27 does not consider the prohibition of second or new uses of patented or known matter in the state of the art.

Under most world legislations, second uses are considered as methods or processes, given that they constitute a practical aspect related to the industrial application of the subject matter of the invention. Thus, if it were considered that product and process patents constitute the two major patent categories, then it should be considered that these two categories include the other kinds of inventions among which second use inventions classify.

The European Patent Convention allows the patentability of new uses provided they meet the criteria of novelty, inventive step and industrial application. Therefore, in the European Community the use of a compound for the preparation of medicaments for the treatment of specific diseases is allowable even when the compound is known for having another medical use. The novelty of a second use claim is based on the new purpose or new medical indication.

In the United Kingdom the approach to second uses is essentially the same. The only difference is that when assessing the novelty of a second use, the general disclosure of a first use of the compound in a drug does not affect the novelty of said second use.

In Israel the use of a compound for the preparation of a composition is basically a process claim, thus, it meets the criteria established under this country?s Patent Act. Second use claims, though, must define the aspect that constitutes the inventive step of the new use. Likewise, the US Patent Act establishes that all new uses may and should be included in the concept of process.

Latin-American countries such as Mexico allow the patentability of second uses, provided that the second use is not obvious for a person normally skilled in the field, regardless if the compound related to said second use is novel or not. In this context, a second use patent does not seek protection for a known product or compound, but only for a novel use of said compound.

The indicated position of the international community that considers new uses as inventions of methods or processes constitutes an acknowledgement of the intellectual efforts and intense research work of the inventors as well as an appropriate mechanism to guarantee the return of investment.

Consequently, a new use of known product or process can be patented if said use constitutes a technical solution and meets the patentability requirements.

Although the Article 21 of Decision 486 might violate the TRIPS because it exceeds the limits established by this agreement to member countries ? and for this reason the Andean Community countries are left exposed to the consequences of this non-fulfillment ? it is also true that said Article 21 is part of the industrial property legislation currently in force in the Andean countries. Accordingly, it constitutes the legal support for competent authorities to reject patent protection for second uses, and for users it implies their submission to said norm.

We should then look for the possibility of eliminating Article 21 from the supranational legislation based on arguments such as its unlawfulness vis-à-vis international agreements like the TRIPS and/or its negative effects for those investing in this type of research.