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Patenting of Living organisms under the European Patent Convention

sangam tiwari

Introduction

Patenting was created for machines, apparatus, and other items. However, as the biotechnological industry progresses, it is being pushed onto living beings. We now have the ability to control genes, proteins, and organisms thanks to biotechnology. It has the potential to revolutionize the way diseases are diagnosed and treated, as well as how we harvest crops, create energy, and dispose of garbage.

Biotechnology is concerned with both living and non-living species, such as plants, animals, and microorganisms. Biological inventions are usually divided into three groups. They are the procedures for creating or modifying live beings and biological materials, as well as the outcomes of such procedures and the applications of such outcomes.

Biotechnological inventions, for even the most part, are considered in the same way as any other invention: they must be innovative, non-obvious, and capable of industrial application, while some specific technologies in this field are banned from patentability in certain countries. Furthermore, regulations, other than patent law may regulate the commercialization of certain biotechnological breakthroughs.

Patenting life forms under TRIPS

The TRIPS Agreement mandates that Member countries grant patents to any innovations, whether products or processes, in all disciplines of technology, without prejudice, subject to the usual requirements of novelty, creativity, and industrial application. Patents must also be accessible and patent rights must be enjoyed without any regard to the site of invention or whether items are imported or produced locally.

The basic criterion of patentability is subject to three exceptions. One is for innovations that are against public order or morals; this clearly covers innovations that are harmful to human, animal, or plant life or health, or that have a significant negative impact on the environment. The application of this exception is contingent on the invention’s commercial exploitation being blocked, and this prevention being essential for the protection of public order or morals.

Members may also prohibit diagnostic, medicinal, and surgical methods for the treating  humans and animals from patentability. This is the second exception.

The last exception is that Members may prohibit nonbiological and microbiological activities from the production of plants and animals other than microorganisms and essentially biological processes.

Any government that excludes plant types from patent protection, on the other hand, must establish a robust sui generis framework for the protection. Furthermore, four years following the Agreement’s entrance into effect, the entire provision will be reviewed. This includes biological forms, which is a contentious topic. WTO member nations are required to grant patent protection for microorganisms and microbiological processes, such as those utilized in biotechnology, under Article 27.3(b) of the TRIPs. Plants and animals are exempt from patent restrictions in most countries. All countries, however, must grant intellectual property rights to plant types, either through patents or a “competent sui generis regime”.

Europe on patenting life forms

The laws are a little different in the European Patent system. “European patents shall be awarded for any inventions that are susceptible of industrial application, are new, and include an innovative step,” according to Article 52 (1). As a result, all innovations that are novel, not obvious, and have industrial, utility is patentable in Europe, subject to the specific restrictions and exclusions. Patents are not granted for inventions that would be in violation of “public order” or “morality.” Plant and animal types, as well as fundamental biological processes used to produce plants and animals, are not patentable. Techniques for surgical or therapeutic treatment of the human or animal body, as well as diagnostic methods, are not patentable. Scientific theories, mathematical procedures, aesthetic works, information presentation, computer programs, plans, rules, and methods for executing mental activities, playing games, and conducting business is not deemed innovations and so are not patentable.

By passing the EC Directive 98/44/EC on patenting of biotechnological inventions in 1998, the European Union standardized its patenting system for transgenic plant and animal types. Rules 23b to 23e have been introduced by the EPO.

  • Commercialization of inventions that would be against the public order or morality

The following are four examples of such inventions: Replicating human beings, modifying human germ line genetic identity; using human embryos for industrial or commercial purposes, and modifying the genetic identity of animals that are prone to causing them suffering without providing a significant medical benefit to man or animal, as well as animals tends to result from such procedures.  Although human embryos are not patentable for industrial or commercial objectives, induced pluripotent stem cells (IPSC) may be. Furthermore, the human body at various phases of development and construction, as well as the simple finding  one of its elements, such as the sequence or partial sequence of a gene, cannot be patented.

  • Varieties of plants or animals

Plant and animal varieties really aren’t patentable, but if the technical feasibility of an invention involving a plant or animal is not limited to a specific plant or animal variety, the invention is patentable. As a result, even though it may encompass plant variations, a claim in which specific plant kinds are not separately asserted is not precluded from patentability. Courts in various cases like NovartisII and Harvard Onco-Mouse have held that genetic alteration of test animals for reasons other than medical research, such as the development of novel cosmetics, is not patentable if the engineering causes the animal pain. The exemption covers not just the animal, but also the technique of alteration, preventing the animal from being patented through method claims.

  • Innovations relating to the human body and its constituent parts

Natural and isolated kinds of inventions are the two types of inventions. On the one hand, the human body at various phases of development and construction, as well as the mere finding  one of its elements, such as the sequence or partial sequence of a gene, cannot be patented. An element separated from the human body or otherwise Inventions developed using a technical, technique, such as the sequence or partial sequence of a gene, may, on the other hand, constitute a patentable invention, even if its structure is identical to that of a natural element.

Plant and animal variations are not patentable, according to the EC Directive.

  • If the Biological process is essential

Patentability is restricted to biological processes for the production of plants and animals that are neither microbiological or technical in nature. The determination of whether or not a (non-microbiological) process is “basically biological” must be made on the basis of the invention’s essence, taking into consideration the entirety of human intervention and its impact on the end outcome. However, the requirement for human intervention is not a sufficient criterion for determining whether or not an invention is “basically biological.” Human intervention could simply indicate that the process isn’t fully organic, without adding anything to the equation. Furthermore, it makes no difference whether the intervention is quantitative or qualitative in nature.

  • Micro-organism

As per A 53(b) of the European Patent Convention (EPC), the European patents shall not be granted in respect of ‘plant or animal varieties or essentially biological processes for the production of plants or animals”, however this provision is not applicable to microbiological processes or the products thereof’.

On the basis that microorganisms are products of microbiological processes, claims to them as such have been allowed. Even if they are only removed from their natural surroundings, their isolation, culture, characterization, and the discovery of a utility can turn a discovery into an invention.

Contributed by:– Nidhi Jha, Legal intern at LLL

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