/ Biotechnological inventions: patenting of natural microorganisms

Is it possible to patent microorganisms isolated from nature? This question arises quite a lot in the context of biotechnological inventions, as the legal bodies that regulate this give rise to various interpretations.

Matías Saavedra
Patent Engineer
Alessandri

The question regarding the patentability of microorganisms isolated from nature, without genetic or other human-generated modifications, often arises in the context of biotechnological inventions. The legal bodies that regulate this matter have not been entirely explicit, giving rise to various interpretations.

What does the Industrial Property Law 19.039 and its regulations state?

Article 37, letter b, refers to exclusions from patentability and establishes that the following are not considered inventions and are excluded from patent protection: “plants and animals, except microorganisms that meet the general conditions for patentability” and that “proceedings that are essentially biological for the production of plants and animals are not patentable either, except microbiological processes“.

From the above it can be interpreted that microorganisms, without distinction, and microbiological processes are patentable as they are mentioned as counter-exceptions in the norm. However, letter f of the same article states that are also excluded from patentability “part of living beings as found in nature, natural biological processes, biological material existing in nature or that which can be isolated, including genome or germplasm“.

Regarding the scope of the expression “biological material”, Article 33 of the Regulations of the Industrial Property Law states “When the invention includes a living biological material, including virus, or its obtaining proceeding, in such a way that the invention cannot be fully reproduced in the descriptive memory, the Institute may request that said material be deposited in an internationally recognized organization for such purposes, indicating the institution and respective registration number“. This paragraph suggests that it includes microorganisms, since viruses are commonly classified as microorganisms. When interpreting the content of letter f of Article 37 of the Law, taking into consideration Article 33 of the Regulations, it could be assumed that microorganisms (as biological material) existing in nature, and susceptible of being isolated, are part of the exclusions from patentability.

This “gray zone” that accepts multiple interpretations has been explicitly clarified in the latest version of Inapi’s Patent Examination and Registration Proceeding Guidelines published on November 2, 2022 and which came to replace the previous version of October 2017. The document in question refers to this topic by stating that “microorganisms per se may be patented to the extent that they comply with the patentability requirements established by the IPL. This applies even to microorganisms isolated without genetic modification, where the isolation from their natural environment, cultivation, characterization and its application in the solution to a technical problem, could give the character of invention to such microorganism” and that “the minimum requirements that a microorganism must meet to be eligible for protection is that it must be adequately described and solve a technical problem; in addition, obviously, to the requirements of novelty, inventive level and industrial application“.

Therefore, Inapi establishes the possibility of patenting native microorganisms, isolated from nature, without genetic modifications, as long as the patentability requirements established by law are met, i.e.: novelty, inventive level and industrial application, together with being adequately described and solving a clearly defined technical problem.

Inapi’s guidelines also narrow the scope of the term “microorganisms” indicating that it “includes bacteria and other organisms, generally unicellular, with dimensions below the limits of vision, which can be reproduced and manipulated in a laboratory; including plasmids, viruses, unicellular fungi (including yeasts), algae, protozoa and, additionally, plant and animal cells” and that “cells, plant or animal, isolated or in vitro cultivated, are treated as microorganisms, because the cells are comparable to a single-celled organism“.

Now that the doubt is largely settled, it is important to refer to the requirement of “adequate description” of microorganisms, linked to the scope of “technical sufficiency” that every patent must meet in order to be reproduced. In this regard, the Inapi guidelines state that the description of the characteristics of a microorganism in the descriptive memory may not be sufficient to reproduce it fully, in which case it is necessary to deposit a sample of the microorganism in an institution recognized for this purpose.

In Chile, the international depositary authorities (ADI) established in the Budapest Treaty are recognized as the authorities empowered for this purpose. When a deposit is made in an ADI to comply with the requirement of reproducibility and technical sufficiency with respect to a microorganism, it is necessary, together with providing the corresponding Certificate before Inapi, to incorporate references of this (authority and deposit number) in the descriptive memory, in addition to the claims and eventually the figures, in order to accredit and support such technical sufficiency.