By examining individual firm behaviour, comparing patenting practices of small and large firms, and the issuance of patents, we can demonstrate that the way we have looked at patents so far has been fundamentally flawed.
In the UK, the Patents Regulations 2000 confirmed and clarified that inventions concerning biological material, including gene sequences, may be legitimately the subject of patent applications. In other words, these Regulations have established beyond doubt the legitimacy of biotechnology patents in the UK.
"An invention shall not be considered unpatentable solely on the grounds that it concerns (a) a product consisting of or containing biological material; or (b) a process by which biological material is produced, processed or used" - [Paragraph 1, Schedule A2 to the Patents Act 1977].
Universally, it is an established practice that a natural substance which has been isolated for the first time and which had no previously recognized existence, does not lack novelty because it has always been present in nature.
It is generally agreed, and it is particularly relevant in the field of biotechnology, that a patent should not be granted merely because the applicant had been involved in laborious and costly effort. If the goal is known and sufficient of the theory and practice is known for the applicant to predict where he is going, without there being an original step, then an obviousness objection would be well founded.
Patenting of Micro-organisms in China
Claims for micro-organisms per se are allowed in China. DNA sequences are considered to be large chemical compounds, and may be patented as compositions of matter. Although patent claims to naturally occurring DNA sequences might be expected to trigger the products of nature rule, courts have upheld patent claims covering purified and isolated DNA sequences as new compositions of matter resulting from human intervention. An excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature; or synthetic DNA preparations are eligible for patents because their purified state is different from the naturally occurring compound.
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.
Biological 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 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 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.
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:
No objection can be taken to a claim to a new organism on the ground that it is something living; 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 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 184.108.40.206 Australian Manual of Patent Practice]. However, isolated micro-organisms are considered patentable.
Patenting Practices of Micro-organism in Brazil
Article 10 states that the following shall not be considered inventions or utility models:
"all or part of natural living beings and biological materials found in nature or isolated there from, including the genome or the germ plasm of any natural living being and any natural biological process."
Article 18 states that the following should not be patentable:
"living beings, in whole or in part, except for transgenic micro-organisms meeting the three requirements of patentability - novelty, inventive step and industrial application - in accordance with Article 8 and which are not mere discoveries."
For the purposes of this law, transgenic micro-organisms mean organisms, except for plants or animals in whole or in part, that due to direct human intervention in their genetic composition express a characteristic that cannot normally be achieved by the species under natural conditions.