The world is in the midst of Scientific & Technological Revolution once again, but this time apart from transforming industry, business, trade even the life forms are at stake. It is indeed a great challenge to our ingenuity how these developments are chanellised and put for the benefit of humanity.
If we look back to the past century it was the century of inventions & revolutions. The greatest revolutions can be termed as IT (Information Technology), MT (Management Technology) & BT (Biotechnology), which have transformed the industry from material based knowledge based of today.
The 21st Century belongs definitely more to such knowledge-based industries and services than ever. The emergence of biotechnology in late 70s in the form of r-DNA technology has brought real revolution definitely in the drug and pharmaceutical industry. It has become a force majore'' for future human betterment and existence.
Looking the immense potential it offers and billions of dollars investments made in it the need for the protection of Biotechnological Intellectual property has become inevitable.
Biotechnology: International Definitions
European federation of Biotechnology: "Biotechnology is the integrated use of biochemistry, microbiology and engineering sciences in order to achieve technological & Industrial application of the capabilities of microorganisms, cultured tissue cells and parts there of".
US National Science Foundation: "Biotechnology is the controlled application of biological agents, such as micro organisms or cellular components, for beneficial use".
Scope & Importance
Some of the biotechnological research programs undertaken by several biotech-based drug and pharmaceutical industries as well as purely biotech companies worldwide are on the following lines.
- Automated bioscree-ning
- General improvement of pharmaceutical micro organisms.
- Engineering of a series of Organisms for specific industrial uses.
- Developing immobilized cell and enzyme systems for chemical process industries.
- Improved production of vitamin B12.
- Upgrading hydrocarbons microbiologically.
- Production of human interferons, insulin, hormones etc.
- Production of monoclonal antibodies for organ transplant tissue typing.
- Production of plants resistant to herbicides, viruses, insects and other pests.
- Production of Photosynthetically efficient plants.
- Production of biopesticides and biofertillizers.
- Human gene therapy.
As far the Drug & Pharma Industry is concerned New Drug Discovery research has assumed wide significance in the modern competitive world of Globalisation. Biotechnology in its armoury has a wide array of discovery tools for the discovering new drugs of Biotech, as well as traditional synthetic origin. These are as follows;
Patenting of life Forms
- The TRIPS Text demands that protection be extended to plant varieties microorganisms, non-biological and microbiological processes.
- The floodgates for patenting of life forms opened with the 1980 historic decision of the US Supreme Court in Dr. Chakrabarty case.
- Patents on microorganisms were followed by patents on plants in 1985 and on animals in 1988.
- In 1990 John Moore, was treated for leukemia and his cell line patented.
- On 14th March 1995, the genetic material of an indigenous man of Hagahai tribe in New Guinea was patented.
Patenting of Genes and DNA Sequences
The genes that are synthesised artificially can be patented. If the protein that the artificial gene makes, and the organism into which the gene is inserted are also novel, such a patent may extend to the protein and the organism.
Is Patenting DNA is Patenting Life? ---- No.
Human cannot be patented. It is impossible to patent a gene in vivo because that would contravene a fundamental criteria of patentability namely novelty. A gene can only be patented in an isolated form, cut free from human DNA of which it normally forma a part. (Genomic DNA).
Whether a natural molecule can be patented?
The answer is YES and NO
It is not possible to patent a molecule in exactly the same form in which it is known in nature. It is possible to patent a product originating from natural sources in a form in which it does not occur naturally. For example in a highly purified form. Thus an antibiotic isolated from a microorganism present in a soil sample is regarded as novel.
Non patentable inventions
- Techniques for surgery as bypass heart surgery, organ transplant, implant of heart valves, artificial limbs, dialysis, plastic surgery and other surgical methods used in cancer.
- Artificial insemination
- In vitro fertilization and embryo transfer
- Live plants, naturally occurring microorganisms, micro propagation, tissue and organ culture techniques.
- Microorganisms selected for production of antibiotics, aminoacids, enzymes, alcohol etc. However, protection for microorganisms modified for commercial use may be allowed.
Patenting of Products from Natural Origin (Plant Origin):
The Sui Generis System/ UPOV (International Union for the protection of new varieties of plants)
- Article 27 of the Trips Agreement mandates that every member state shall provide protection to plant varieties either by patenting or by an effective Sui Generis system
- According to 1991 UPOV treaty, breeders exemption and farmers exemption have been curtailed.
- UPOV 1991 demands all plants genera and species to be covered and the period of protection ranges from 20-25 years.
- The authors are with Modern College of Pharmacy, Sinhgad College of Pharmacy, & DRA Scholer, Pune