This article throws light upon the two forms of biotechnology inventions. The two forms are: (1) Biotechnology Products and (2) Biotechnology Processes.
Biotechnology involves the production of a large number of commercial products of economic importance. Broadly, biotechnology inventions can be categorized into two forms — products and processes.
1. Living entities:
The various forms of life- existing and life-supporting systems derived from living organisms are regarded as living entities. These include microorganism, animals and plants, cell lines, organelles, plasmids and genes.
2. Naturally occurring products:
The primary and secondary metabolites produced by living systems e.g. alcohol, antibiotics.
Biotechnology involves development of several processes — isolation, purification, cultivation, bioconversion etc. Novel, innovative, simple and cost-effective processes are developed for the isolation and creation of the above products. Some examples are listed:
i. Production of monoclonal antibodies
ii. Bioconversion of sugar to alcohol
iii. Microbial production of antibiotics.
What is a Patent?
A patent is a government (or patent office) — issued document that allows the holder (patentee) the exclusive right to manufacture, use, or sell an invention for a defined period, usually 20 years. The patent may be regarded as a legal document safeguarding the privileges and rights of an invention/inventor. The very purpose of patenting in biotechnology is to ensure the just financial returns for those who have invested heavily — the finances, intellectual abilities, besides the hard work.
Intellectual Property Rights:
Patent is the most important form of intellectual property rights (IPRs) in biotechnology. The other IPRs are trade secrets, copyrights, and trademarks.
The private information pertaining to specific formulations and technical procedures that a company wishes to protect from others are regarded as trade secrets. The best known trade secret is the formula for coca-cola. Only five persons in the world are said to know the formula which has been kept in a bank in Atlanta, Georgia. The trade secret of coca-cola has remained a secret for more than 100 years!
The protection of authorships of published work comes under copyrights of IPRs.
The specific symbols or words to identify a particular product or process of a company constitute trademarks.
The Process of Patenting:
As regards patenting of biotechnology inventions, the products or processes are patentable.
For patenting, the following criteria must be satisfied:
i. The invention must be novel
ii. It must be useful
iii. The patent application must provide the full description of the invention.
In contrast to various other technology inventions, biotechnology inventions most often relate to living materials. For this reason, the patenting of biotechnology inventions is often associated with difficulties. Patenting, in general, is a commercial decision, assisted by legal advice.
The patent application must be prepared by an expert with the assistance of a patent lawyer. It must contain the detailed information about the invention — background, description explaining the nature of the invention with figures and illustrations, its utility etc. The patent office, after a thorough scrutiny of the application, may reject or grant the patent.
If rejected, the applicant may appeal to the Patent Appeals Board. If again rejected, the decision may be challenged legally. Many a times, the process of patenting becomes a frustrating experience. Thomas Edison, probably the only individual in the world with more than 1000 patents to his credit, once said about patenting ‘an invitation to a lawsuit’.
Patenting in different countries:
Patenting laws are very complex and vary between different countries. It is interesting to note that a patent application rejected in one country may be given patent in other country. The best example is the production of recombinant human tissue plasminogen activator (tPA) in E. coli. Genentech Company was awarded patent for tPA production in USA, while it was first rejected in UK. After appeals and legal battles, patent was finally granted in UK also.
A genetically engineered strain of the bacterium Pseudomonas called superbug was the first microorganism to be patented. Superbug is capable of breaking down the multiple impurity of crude oil. It took almost 10 years of procedural delays, and legal battles to get the superbug patented. Now, many microorganisms are patented.
Patenting multicellular organisms:
A genetically manipulated mouse namely the oncomouse was the first and probably, to date the only animal to be patented in both USA and UK. This transgenic mouse carries a gene that makes it susceptible to tumor formation.
The human genome projects (HGPs) have elucidated almost the entire sequence of human genome, besides identifying the genes. Patenting of DNA sequences and genes has become a controversial and debatable issue. Some researchers and institutions in fact have approached the patent offices for grant of patents. So far, patents have not been granted for genes. The most important reason being that the genes are natural, universal and inherent biological functional units of all individuals.
Patenting and cell/tissue donor’s rights:
While dealing with human tissues/cells, the involvement of the donor of source material becomes very important. John Moore was a victim of hairy-cell leukemia, a rare form of cancer. His spleen was removed, and Mo cell lines developed. These cell lines were patented by the researchers and their associated organizations. Moore however was not involved in the patenting. Moore filed a suit in the court on the ground that he should also be a party to the profits derived by using his tissue. The court allowed his claim to share the profits.
Plant Breeders’ Rights:
Agriculture for the first time was included (in 1994) in the trade-related intellectual property rights (TRIPS). TRIPS is a major concern for developing countries. The plant varieties in many countries (not in India) are protected through plant breeders’ rights (PBR) or plant variety rights (PVR).
PVR provides legal protection to the original breeder or owner of the plant variety. It is believed that PBR will encourage innovative research and plant breeding programmes, in view of the expected financial returns.
Plant breeders’ rights are comparable to the patent rights. Under TRIPS agreement, plant breeder possesses the exclusive rights over the plant developed. It prevents the third parties from using the plant without the owner’s consent.
Although PBR will increase competition and development of good plant varieties, the owner’s motto would be profit making. Therefore, PBR will prohibit the free exchange of plant materials, besides threatening the farmer’s rights. It is feared that PBR will benefit rich farmers and developed countries only.
Patenting and Biotechnology Research:
In the earlier years, research used to be mostly for academic interest and worthwhile scientific contributions. And researchers were purely academic-oriented with not much interest in financial gains from what they do. Further, unlike now, the research used to be supported mostly by Governments/Universities.
There used to be no secrecy in research. Academic recognition and outstanding research publications (open to all) were adequate to satisfy the researchers. Watson and Crick who discovered DNA structure never had a thought of patenting!
The situation has now changed. A good proportion of research is either being conducted or financially supported by private companies/ universities. It is quite natural for these companies to expect returns for their investments. There is a lot of change in the attitude of researchers also. For many scientists, financial gains have become more important than academic recognition. Consequently, some people carry out research secretly and opt for patenting of their discoveries rather than publishing.
We have to accept the fact that the progress of research is usually much faster in private companies compared to many government organizations. This may be due to the higher financial returns and efficient administration. Probably, the biotechnological research might not have progressed to the same extent as it is today without the dreams of getting the patents by scientists and research funding organizations.