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Patenting of Micro-organisms in Europe

The European Union has defined “'biological material" instead of "micro-organism", as under [Article 2.1 (a)]

“Biological material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system"

In Plant Genetic Systems application (T356/93) European Board of Appeal was seized with the question as to what is meant by the term 'micro-organism' The Board held that a micro-organism would include bacteria, yeast, fungi, algae, protozoa, plasmids and viruses, but also animal or plant cells and generally all unicellular entities with dimensions beneath the limits of human vision.

Article 53(b) of the European Patent Convention (EPC) provides that European patents shall not be granted in respect of ‘plant or animal varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof’.

In its decision of 16 June 1999 the Administrative Council inserted a new Chapter VI entitled ‘Biotechnological inventions’ in Part II of the EPC Implementing Regulations. The new provisions entered into force on 1 September 1999 and implemented the requirements of the EU Biotechnology Directive in European patent law. The EPO has introduced four new rules, Rules 23b to 23e. Rule 23b sets out general matters and defines the meaning of biotechnological inventions, biological material, plant variety, and microbiological process. Rule 23c states patentable biotechnological inventions, including:

·                  material isolated from their environment, even if known in nature. This particularly applies to genes that are isolated from their natural environment by means of technical processes and made available for industrial production.

·                   Plants or animals if the invention is not confined to a single variety

The provision clarifies the scope of Article 53(b) of EPC. It indicates that a plant grouping characterized only by a particular gene, but not by its whole genome, is not covered by the protection of new varieties and therefore is in principle patentable. This also applies if such plant grouping comprises plant varieties.

Rule 23d sets out what is not patentable. This includes processes for cloning human beings, processes for modifying the genetic identity of human beings, using human embryos for commercial purposes and modifying the genetic identity of animals such as may cause them suffering without substantial medical benefit. The list is to be seen as giving concrete form to the concepts of ‘ordre public’ and ‘morality’.

Rule 23e indicates what is and is not patentable with respect to the human body. The human body and its elements cannot be patented. However, elements of the body, when isolated from the body, may be patented.  

Patenting of Micro-organisms in Japan

In 1997, the Japanese Patent Office (JPO) published its ‘Implementing Guidelines for Inventions in Specific Fields’. Inventions in the biotechnology field in the Guidelines are divided into four types: genetic engineering, micro-organisms, plants and animals.  Inventions relating to genetic engineering include those of a gene, a vector, a recombinant vector, a transformant, a fused cell, a recombinant protein, and a monoclonal antibody. Inventions relating to micro-organisms include micro-organisms per se as well as those relating to the use of micro-organisms.

In Japan, micro-organism means yeast, molds, mushrooms, bacteria, actinomycetes, unicellular algae, viruses, protozoa, etc. and further includes undifferentiated animal or plant cells as well as animal or plant tissue cultures.

Patenting of New Chemical Entity in US:

According to the United States (US) Food and Drug Administration (FDA), a new molecular entity (NME) or new chemical entity (NCE) means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.

Patenting of Micro-organisms in USA

Art. 35 USC Sec 101 of the US patent law states: whoever invents or discovers any new and useful process, machine, manufactures, or composition of matter, or any new and useful improvement thereof, may obtain a patent thereof…”

In USA, utility requirement in respect of biotech inventions are very strict. A discovery that is not a creation does not meet the requirement of utility. A newly discovered micro-organism existing in nature, a newly discovered plant per se are discoveries because they do not involve creativity. Inventions that are incapable of industrial application do not meet the requirement of utility. Inventions of a gene, a vector, a recombinant vector, a transformant, a fused cell, a recombinant protein and a monoclonal antibody whose utility is not described in a specification or cannot be inferred, do not meet the requirement of utility. An invention of a micro-organism per se, a plant per se or an animal per se whose utility is not described or cannot be inferred does not meet the requirement of utility.

According to the new ‘Utility Examination Guidelines’ of the USPTO, if an isolated DNA fragment has a specific, substantial, and credible utility, the DNA fragment invention satisfies the requirement of utility and a patent can be granted for the DNA fragment. Where a new use is discovered for the patented DNA fragment, that new use may qualify for its own process patent. Of course, the later patent is a dependent patent of the DNA fragment patent. 

Patenting of Micro-organisms in Australia

The Australian patent law defines invention as "any new manner of manufacture." 

The question of patents for living organisms was considered at length in Ranks Hovis McDougall Ltd.'s Application [1976 A OJP 3915] and the Court held that:

a)                No objection can be taken to a claim to a new organism on the ground that it is something living;

b)                Any new variants claimed must have improved or altered useful properties and not merely have changed morphological characteristics which have no effect on the working of the organism; and

c)                Naturally occurring micro-organisms per se are not patentable as they represent a discovery and not an invention, but a claim to a pure culture in the presence of some specified ingredients would satisfy the requirement of a technical intervention.

The guidelines for a micro-organism in Australian Patent Law states, “what is discovered in nature without any practical application, is a mere chemical curiosity”' and is not patentable [Part 8.2.5.3 Australian Manual of Patent Practice]. However, isolated micro-organisms are considered patentable.