JUST like physical objects such as household goods or land are the property of an individual, similarly, a country has its own property. The property ownership and rights of an individual are protected by certain laws operating in a country. On the other hand, transformed microbes, plants, animals and technologies for the production of commercial products are exclusive property of an individual or organization.
However, such long-term projects are not initiated without knowing that the results of its research efforts can be legally protected from competitors. The inventor or creator has complete property rights and should not be neglected by others without legal permission.
For biotechnological innovations, patents are the most important form of Intellectual Property Right (IPR). It is a legal document that gives the patent holder exclusive rights to implement desirable inventions commercially. The patent holder can develop more products that are directly derived from original inventions, while the competitor has the license an invention in order to develop a product based on it. Patents are special rights given to inventors granted by the government. It is personal property that can be licensed or sold by the person or organization.
Patent decisions and laws vary from country to country. The duration of exclusive rights of a patent is 20 years from the date of filing an application. Generally, for a product or a process to be patentable one must satisfy some fundamental requirements. For starters, the invention must be novel. Secondly, a patent cannot be granted for something that was previously unknown.
Thirdly, the invention must be useful in some way, whether it is a process, an instrument, a compound, a microorganism etc. Finally, every patent application must contain a description of the invention so that it can be implemented.
In general, natural raw products are not patentable. Inventions and discoveries that are not patentable include: scientific theories, mathematical methods, aesthetic creations etc. There is no simple immediate system for granting patents. If an examiner agrees that an invention meets the criteria for patentability, then a patent is awarded. If a patent application is rejected by the examiner, then the applicant can appeal to a patent appeals board. If, for instance, the appeal is turned down then the appellent prosecute the board. In USA the applicant who was first awarded the patent has the right for 20 years (first-to-invent principle). In almost all other countries, patents are given to applicants who filed first (first-to-fill principle). Usually it takes two-five years, following the filling of an initial patent application before a patent is granted.
Biotechnology has played a significant role in providing, processing, designing and producing valuable commercial products used in many parts of the world. Currently over three million genome-related patent applications have been filed. USPTO has issued a few patents for gene fragments, a controversial subject.
Some say that patenting such discoveries is inappropriate because the effort to find a gene fragment is small compared to the work of isolating and characterizing a gene and gene product. Not only do the researchers have to inform/ask every patent holder, they also have to pay their staff to conduct research on different patents and determine which are applicable to the area of genome that he/she wants to study.
Single Nucleotide Polymorphism sequences (SNPs) are sequence variations that occur when a single nucleotide (A, T, C or G) in the genome sequence is altered. In April 1999, 10 major pharmaceutical companies and the UK Wellcome Trust Philanthropy announced the establishment of a non-profit foundation to find and map 300,000 common SNPs. They have patented, all SNPs that have been found to date.
Gene tests have also been patented and licensed by the owner of the disease gene patent. All living organisms are largely composed of proteins which are important to researchers because they are the links between genes and pharmaceutical development. Protein has a unique structure and diverse functions. Understanding them is the key to drug designing. Cell lines and genetically modified organisms are considered patentable materials. One such case involving the patentability of single-cell organisms is that of A. Chakrabarty in 1980, in which the Supreme court ruled that genetically modified organisms were patentable.
As a result of this landmark decision US patents have been granted for genetically modified plants and animals. Moreover, after considerable debate, transgenic plants and animals are also patented in many countries.
Pakistan being a member of Bern convention for the Protection of Literacy and Artistic works, Geneva convention, World Intellectual Property Organization(WIPO), the Universal copyright convention of 1952, World Trade Organization (WTO) and Trade Related Intellectual Property Right (TRIPS). However the country needs to follow and implement IPRs.
New laws and regulations have been made in order to address IP rights. In order to bring Pakistan laws related to patents and designs in conformity with the TRIPS agreement, Pakistan Patent and Design Act was amended and Patent Ordinance 2000 was promulgated. According to Patent Ordinance 2000, an application for registration must be filed as a prescribed form by the first inventor. Complete specification is required to describe the invention and the method by which it is to be performed. The application must be accepted within 18 months.
In case of rejection the applicant has the right to appeal to the high court within 90 days. Accepted applications are published in official gazette and remain open for objection for 120 days. If there are no objections, the patent letter is issued. With respect to foreign applicants, section 20 of Ordinance 2000 empowers the controller to ask for the date and number of applications filed abroad, which are related to similar inventions as that claimed in the application filed in Pakistan. The applicant is required to furnished documents related to acceptance or rejection on the basis of the foreign application.
It is important to mention a news item that appeared in the Daily Times (Nov 17). “Federal Science and Technology Minister Professor Dr Attaur Rehman has said that Pakistan had a weak patenting system and stood nowhere in the innovation scene. Mr Rehman said this while inaugurating a seminar on ‘Understanding Patentability issues of Scientific Research.’”
Mr Rehman feels that “inventions and patents were a means for technological progress and patents were awarded to encourage investment in technology. The Pakistani patent...had poor reviews and low budgets.” One cannot help but point out that Pakistani patents need to be revised and an inability to do so will be highly demotivating for scientists and inventors alike.
With the development of molecular biotechnology, the question of whether private industries should be allowed to patent genetically-engineered organisms has been raised. Some argue strongly that IPRs are necessary to stimulate economic growth, which in turn contributes to poverty reduction.
By stimulating invention and technologies the change in the country’s economic and social scenario is likely to manifest itself by an increase in agricultural and industrial production, domestic and foreign investment, facilitation of technology transfer and improvement in the availability of medicines necessary to combat diseases.
An improvement in the standard of living in the developed world is largely based on innovation that depends on financial investment in research. Such investment comes mostly from private investors rather than public funds or charity. Intellectual property rights such as patents allow investors to recover their costs, and protect it from competitors. Without this protection, research into developing new products, would be less likely to be done.
It is feared that biotechnological innovations that require huge financial resources and a very high degree of skill, sophistication, motivation and commitment would further increase the gap in patent holdings of developed and developing nations. Holding a patent and benefitting from it are two entirely different issues. Therefore, the officials concerned need to completely overhaul the patenting system in order to withstand economic burdens imposed by the changing IPR scenario.
The writer is a biotechnologist at the centre of biotechnology, Peshawar University