Biotechnology, according to the United Nations Convention on Biological Diversity as of 1993, is any technological application that uses biological systems, living organisms or derivatives thereof to make or modify products or processes for specific use. Recently, the fermentation processes have been used in pharmaceutical industry for the manufacture of antibiotics. The milestones for modern biotechnology were set in 1950s and 1970s respectively, when the DNA structure was determined and two basic biotechnological techniques were invented, namely DNA recombination and hybridoma creation.
According to classification proposed by the Europeant Association for Bioindustries (EuropaBio), biotechnology can be divided into the following fields: white field relating to biological systems used in industry and environment protection, red field covering health protection (new medicines, diagnostics, genetherapy and transplantology) and green field connected with agriculture (genetic engineering of plants and animals). There is also a violet field relating to legislation on biotechnology.
Because of fast development in biotechnology and its connections with various areas of science, it is essential to make the public aware of possibilities in relation to patenting biotechnological inventions. However, one must first explain what a biotechnological invention is and what criteria must be fulfilled in order to obtain patent protection.
Possible to patent.
Regardless of the field of technology, shall be granted for inventions which are new, which involve an inventive step (i.e. they do not result in an obvious way from the state of the art) and which are susceptible of industrial application. It is possible to patent the following:
- A biological material, isolated from its natural environment or produced by means of a technical method, even if it already exists in the natural state,
- A technical method by means of which biological material is produced, worked or used, even if it already exists in the natural state,
- Any new application of a biological material or a technical method already patented,
- An invention relating to an element isolated from the human body or otherwise produced, by means of a technical method, even if its structure is identical to that of a natural element, provided that its function and industrial application are concretely indicated, described and specifically claimed. By technical method it means what only a human being is able to execute and which nature in itself is not able to achieve.
- An invention concerning plants or animals, or a plant group, characterized by the expression of a particular gene and not its whole genome, if their application is not limited, from a technical point of view, to obtaining a particular plant variety or animal species and if only essentially biological methods are not used, in order to obtain them.
Cannot be patented
The following are excluded, and therefore cannot be patented:
- The human body, from the moment of conception and in the various stages of its development, and also merely the discovery of one of the elements of the body, including the sequence or partial sequence of a gene, in order to guarantee that the patent right is exerted in full respect of the basic rights to dignity and integrity of the human being and the environment,
- Methods for the surgical or therapeutic treatment of the human body or animal, and methods of diagnosis applied to the human body or animal,
- Inventions the commercial exploitation of which is against human dignity, public order and morality, the protection of health, the environment and the life of persons and animals, the conservation of plants and biodiversity and the prevention of serious environmental damage.
- A simple DNA sequence, a partial sequence of a gene, used to produce a protein or a partial protein, except if an indication and a description of a function used to assess the requisite of industrial application are provided, and the corresponding function is specifically claimed; each sequence is considered autonomous for patent purposes in the event of overlapping sequences only in the parts not essential to the invention,
- Plant varieties and animal species, and also essentially biological methods for the production of animals and plants,
- New plant varieties with respect to which the invention consists exclusively of the genetic modification of another plant variety, even if said modification is the fruit of a method of genetic engineering.
- Inventions whose exploitation would be contrary to public order or morality.
Biotechnological Inventions In Malaysia
The usage of biotechnology to produce new inventions has only come to surface more than a few decades ago. At that time, it caused a direct challenge to patent laws that exclude biological material from the domain of patentability. In Malaysia, the effective provision is subsection (b) of s.13 Patents Act Of Malaysia 1983 that excludes:- “plant or animal varieties or essentially biological processes for the production of plants or animal, other than man-made living micro-organisms, microbiological processes and products of such micro-organism proceses.” S.30A Patents Act Of Malaysia 1983 is prohibition of publication of information which might be prejudicial to the nation and S. 85 Patents Act Of Malaysia 1983 is the Registrar in the exercise of his powers shall have the right to refuse to grant a patent for products or processes scheduled under regulations made by the Minister under this Act where it appears to the Registrar that the granting of such a patent would be prejudicial to the interest or security of the nation.
Biotechnological inventions (genetically modified life forms in particular) continue to present intriguing and difficult challenges for 21st century scientists and ethicists, and education and meaningful, respecful discourse are just the beginning of what is required to tackle such complex ethicalissues.
Until we as a society or, perhaps, as a global entity can agree on what beings-human or otherwise-are worthy of moral and legal status and respect, we can expect intense cross-disciplinary debate and discussion as new life forms are created through science and medicine.
- Patents Act 1983 (Act 291) & Regulation
- TRIPS Agreement.
- Buku Patent Law in Malaysia Casses and Commentary by Dr Ida Madieha Bt Abdul Ghani Azmi