The Argentine Patents Office of Argentina (I.N.P.I) has recently passed Resolution No. 283/2015, which amends the “Patent Guidelines” in relation to amino acid sequences, genetically modified organelle claims and claims of transformation events.
The resolution entails a more restrictive interpretation and application regarding the prohibition of patentability of every living matter preexisting in nature set forth in section 6 of the Argentine Patents Law. The Guidelines provide that plants, animals and essentially biological procedures for reproduction or production (obtention) thereof shall not be deemed inventions. Specifically, it excludes plants, parts and components thereof that may lead to a full individual whether or not modified and the essentially biological procedures for reproduction or production (obtention) of plants. The justification of such restriction lies on preventing the monopoly of the natural reproduction procedures or non-technical procedures.
The Guidelines define that, for the purposes of the Argentine Patents Law, by essentially biological processes it is meant the series of phases ending in the obtention or reproduction of plants fulfilled mainly or significantly by action of the phenomena proper or existing in nature. Therefore, in order to determine whether a procedure for the production or reproduction of plants and animals is essentially biological, the technical aspect of the process is relevant: if the technical involvement of the human being plays a significant role in the determination of the result or if its influence is decisive, then the process shall be deemed to have a technical nature and shall therefore be patentable.
Resolution 283/2015 in question specifies that by parts and components of plants it is meant, merely as an example, the sprouts, seeds, stems, cells, fruits, bulbs, tubers, buds, pegs, flowers, etc.; as well as its cell components such as organelles, membranes, DNA molecules, etc.
The Resolution further includes a new requirement for claims with modified parts and components: these must specify their isolated status, and that they are capable of leading to a complete organism, to avoid falling in the prohibition of patentability indirectly. Moreover, the Resolution amends item 2.1.7.9 and provides that claims of plants or animals shall not be allowed even when obtained through a biotechnological procedure; the previous wording only makes reference to microbiological procedures. To avoid the disparity of interpretations, the item concludes providing that the prohibition to patentability is maintained “even though the technical involvement of man is significant”.
As a result of the above, only the patentability of biotechnological procedures shall be possible (i.e., not those essentially biological) for the obtention of transgenic plants and animals, provided they meet the patentability requirements.
In addition, the prohibition of claims of products referred to plants and animals set forth in section 6 of the Patents Law shall be independent of its form of production.
By way of example, an application claiming a genetically modified animal expressing a certain gene and susceptible to a disease used as lab sample, would be dismissed. Likewise, it shall not be deemed an invention under the Argentine Patents Law an invention consisting on a “Non-human bitransgenic mammal that produces humanized milk, milk, vectors and methods…”, as described in patent application AR087557.
This invention, created by Argentine scientists, financed with State funds and resulting from an interdisciplinary work that took many years, would not be patentable in the same country where it originated.