How Do You Patent Living Organisms in Europe?

Introduction

A Patent is a form of Intellectual Property Right, which are rights of ownership on something which you invented, created or innovated using your mind’s intellect. These creations, being unique and of economic value are to be owned exclusively by its creator, to prevent it from getting copied or misappropriated.

It follows, therefore, that anything one creates or invents can get patented, even living organisms. Living organisms such as a new varieties of plants, microbes, or animals, or any new method of creating artificially what exists in nature already, can be patented. These are called biotechnological inventions. In Europe, this is governed by the European Patenting Convention.

Essentials for Patenting Living Organisms

Biotechnological inventions, like any other type of invention, must meet the three essential characteristics to be patentable:

They must be unique;
They must be creative.
They must be industrially applicable.

Additionally, Rule 27 of the EPC Implementing Regulations states that biotechnological innovations are patentable if they relate to:

A biological substance extracted from its natural habitat or created by a technological technique, even if it already occurred in nature;
Plants or animals if the invention’s technological feasibility is not limited to a specific plant or animal kind;
A microbiological or other technological technique, or the result of such a process that is not a plant or animal variation.

Patenting Microbes

Microorganisms, including bacteria, fungi, yeasts, and viruses, are defined as “biotechnological innovations” under Rule 26 EPC, which defines “biological material” as any material with genetic information capable of reproducing itself or being reproduced in a biological system. Furthermore, because microorganisms are not listed in the list of exceptions to patentability (Rule 28 EPC), they are patentable if the remaining patentability standards are met.

The economic advantages of genetically-modified bacteria are nearly limitless. Bacteria can be used as probiotic elements, to clean waste water, to break down petroleum products in the case of environmental contaminations (such as oil spills), and so on.

Patenting Plants

Rule 28 (2) of the EPC states that plants or animals obtained only through an essentially biological method are not patentable.This includes procedures utilizing basic sexual cross-breeding and plant selection, even when human involvement is involved in the cross-breeding process. On the other hand, methods that incorporate a technological phrase which alters the plant’s genome methods are not regarded as truly biological processes.

Some examples of plant-related patents would be those related to transgenic plants with enhanced features, such as insect resistance, and transgenic plants with health-promoting attributes.

Patenting Animals

Animals created using a genetic alteration procedure may be patentable. However, depending on the impact of the genetic alteration on the animal, it may be prohibited from patentability for moral considerations, as innovations with economic exploitation that is opposed to public order or morals are not patentable.

The list of stated biotechnological innovations harmful to morality is provided in Rule 28 (d) EPC, which includes animals originating from techniques for changing the genetic identity that are likely to cause them misery without providing any real medical advantage to man or animal. The cloning procedure that results in such animals is patentable, and the EPO issued a patent on the technology of cloning Dolly, the famous sheep, in 2001.

To patent an animal the following conditions must be met:

The invention is not limited to a single animal species.
The animal was not created by a purely biological method (cross-breeding and selection without any genetic tinkering), and
The animal was not obtained through a genetic alteration method, leading the animal to suffer with no significant medical or veterinary advantage.

Conclusion

As technology moves forwards, we are seeing more and more modifications at the micro-levels. Biological innovations and gene editing might be the answer to quite a few of the impending resource scarcity and environmental problems people are facing today. Allowing patenting of such technology in an effort to encourage such innovations is a logical move, in many cases.

Author: Sejal Chaturvedi, Legal Intern at PA Legal.

In case of any queries, kindly contact us here.