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The importance of the deposit of biological material for Biotechnology Patents

Even though initially it was only just about possible to patent products, the patents system has developed to include the processes for obtaining products, the use of the said products, and nowadays also patents for “biological material”. The legislation relating to the patents system worldwide includes certain requirements. One of the most controversial relating to technology innovation patents is that of sufficient description.

Legislation relating to patents has a clear principle: “an invention must be described in sufficient detail to permit a person skilled in the art to repeat the effect of the invention”. Bearing in mind the difficulty in clearly describing some inventions relating to living organisms under the Budapest Treaty (of 28 April 1977), microorganisms may be deposited with international depositary authorities providing the description of this type of invention is insufficient through traditional means.

In countries, for example Brazil, which have not signed the Budapest Treaty, it is necessary to confirm that the depositary centres for genetic material meet national requirements. It is extremely important that when drawing up the description and preparing the claims, if the description is not sufficiently clear to allow realisation or reproduction by a person skilled in the art, the access number of the microorganism published by the depositary centres may be cited. Understanding and analysis by national patents institutes will thus be facilitated, allowing the promotion and development of scientific and technological knowledge. In the event that the material is already known, is available to the general public or may be quickly consulted in a known and available source, it does not need to be stored in a culture collection in order to apply for the patent.

The deposit date of the biological material depends on the legislation applicable in each country where the patents is applied for. Biological material is normally deposited at least on the same date as the patent is filed or on the date of priority. Some countries accept the deposit on any date providing it is before the disclosure of the patent application. The forms and formalities for depositing biological material for patent purposes must be in accordance with the requirements of the culture collection depository under the Budapest Treaty.

The depositary authorities are responsible for collecting, storing, maintaining and supplying samples as required by the patents office. However, these authorities are not responsible for any examination related to the requirements for granting the patents, such as novelty, inventive step and industrial application.

It is important to highlight that the final responsibility for the deposited biological material lies with the applicant.

Carmen Sánchez-Puelles