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21 July 2021
Inventions in biotechnology are subject to the same requirements as any other invention, i.e. they must be novel, inventive and industrially applicable. However due to the ethical implications of technology in this field there are some specific exclusions to patentability that apply.
Plant or animal varieties or essentially biological processes for the production of plants or animals cannot be patented in Europe (see Article 53(b) EPC). An “essentially biological process” is one which consists entirely of natural events such as crossing or selection.
However, this does not completely exclude plants and animals from patentability.
A patent may be granted for a plant or animal produced by a technical process which modifies the genetic characteristics of the plant or animal, i.e. if the heritable trait that is introduced is not a result of crossing or selection. However this technical process cannot be one that merely enables or assists the performance of essentially biological process steps. For example, transgenic plants and technically-induced mutants are patentable, but the products of conventional breeding are not, according to EPO case law.
Products originating from plants, such as flour or sugars, do not fall under this exclusion. In this case it is not relevant whether the products are derived from an essentially biological process or produced artificially, as the patentability of such products is considered on their chemical properties only.
For living matter to be patentable, it must be possible to reproduce it with exactly the same technical features. Examples of how to fulfil this requirement include disclosing the genetic sequence responsible for a claimed trait in the patent application, or by the deposit of samples of the living matter (e.g. seeds, cell cultures).
Depositing multiple samples for multiple patent applications in different countries may be impractical. Therefore a single deposit can be made in accordance with the Budapest Treaty at an International Depository Authority (IDA).
The human body, at the various stages of its formation and development, does not constitute a patentable invention. According to The Biotech Directive (98/44/EC), the following are also unpatentable for moral and ethical reasons:
The patentability in Europe of inventions relating to human embryos has been a point of discussion for many years. G2/06, a decision of the EPO Enlarged Board of Appeal in 2008, precluded the patenting of products which, at the filing date, could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the products were derived, even if the method is not part of the claims. Following this, in T1441/13, an EPO Technical Board of Appeal found that the first disclosure of a method for producing human embryonic stem cell lines without destroying a human embryo in any production step was on 10 January 2008 (Chung et al. Cell Stem Cell, 2008, vol. 2, pages 113-117). This meant that inventions relating to human embryonic stem cells (hESCs) with a priority date before 10 January 2008 were excluded from patentability as they would likely require the destruction of a human embryo.
In this context the term “human embryo” included cells that are capable of subsequent development into a human being, such as totipotent stem cells. However this definition was challenged as to whether it also included a non-fertilised ovum stimulated by parthenogenesis.
In a subsequent opinion (C-364/13), the CJEU decided that parthenotes, and the pluripotent stem cells that form them, should not be excluded from patentability since they do not have the inherent capability of developing into a human being.
Presently, the EPO are of the opinion that WO 2003/046141 (published on 5 June 2003) was the first disclosure of methods for deriving hESCs from parthenotes. It is considered that based on this document, the skilled person would have been able to generate parthenotes and derive hESCs from them. This means that patent applications relating to hESCs filed after 5 June 2003 are not considered to fall within the exclusions of the Biotech Directive and so are not excluded from patentability.
Microbiological processes and the resultant products are patentable in Europe providing the usual requirements of patentability are met.
“Microbiological process” refers to any process that involves, is performed on or results in microbiological material. Therefore in this context a microbiological process also includes a process which involves both microbiological and non-microbiological steps.
A microorganism itself may also be patented as it results from a microbiological process; this includes biological material that is isolated from its natural environment or produced by means of a technical process. However, merely finding a microorganism occurring freely in nature is a discovery rather than an invention, so cannot be patented. “Microorganisms” include bacteria and other genetically unicellular organisms such as plasmids, viruses, unicellular fungi, algae and protozoa. Isolated plant or animal cells or in vitro plant or animal cell cultures are classed as microorganisms as the cells are comparable to unicellular organisms.
A patent relating to a microorganism must provide enough information to enable a person skilled in the relevant field to put the invention into practice. Since this is generally difficult to achieve in writing alone, a deposit under The Budapest Treaty is usually made.
Life Sciences & Chemistry
This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.
© Withers & Rogers LLP July 2021