The purpose of this paper is to highlight the causes and affects of the compulsory licensing of pharmaceutical products. Initially, the paper highlights the fundamental positions, attitude, inclination and concerns of the developed world and the under developed world with regard to the intellectual property rights of the pharmaceutical products. The paper also concentrates on the subject of the intellectual property rights of the biotechnology products (plants); this is because plants are the major source of almost all pharmaceutical products being used today. Furthermore, it is a matter of fact that the patentability of plants has been given a lot of attention by the developed world, in particular United States of America, as well as, the developing World. The paper also exposes the priorities of both the developed world and the under developed world, priorities that have been a major hurdle in all previous negotiations on Intellectual Property Rights (IPR) protection. Subsequently, the paper gives practical recommendations that ought to be followed in all future negotiations so that both parties can derive maximum benefits from patentability of pharmaceutical products.
The debate on the subject of Compulsory licensing of Pharmaceutical Patents
This part of the paper highlights the different postures of the developed world and the under developed world on the subject of intellectual property rights of pharmaceutical products. The paper concentrates on the conflicting views on the spirit, function and degree of Intellectual Property Rights in the sphere of biotechnology. The manner in which the developed world and the under developed world have confronted this issue has led to a complete failure of the negotiation process. This failure, of both the developed world and the under developed world, to pleasingly settle outstanding disparities on the subject of patentability of pharmaceutical products sustains to ignite the various disputes over affordability, as well as, accessibility.
Brief Background to Biotechnology
Over the years, it has become a general belief that biodiversity will pave the way for a solution to almost all the diseases that exist today and continue to negatively influence our lives. This belief has led scientists to take further steps in the Research and development (R&D) of biotechnology. These steps comprise of various compounds, compounds that are biologically active, compounds that are natural resources, for example microbes, insects, fungi, marine organisms, and plants. However, laboratories are not capable of producing these complex biologically active and complex compounds. This is because the key places of genetic biodiversity are situated in the tropical and the subtropical regions of the world (Tara, 1994). Therefore, it is imperative for biotech scientists to go into the tropical forests with the purpose of locating these biologically active compounds.
These places have been gifted with fertile, productive, biodiversity resources. This is because these regions had maintained their genetic biodiversity all through the Ice age, at the same time as, when the plants in these regions had been buried into an extreme chill. Scientists have predicted that more than fifty percent (50%) of all the plant species have been located in these tropical regions, together with almost fifty percent (50%) of the 250000 superior plant varieties discovered on earth (Phillip 1993).
While almost all of the productive places of genetic biodiversity have been located in the tropical areas of the under developed world, it is a matter of fact that all the copyright holders, plant producers, advertisers and sellers of genetically modified plants or "Plant Genetic Resource (PGR)" are located in the developed world, in mostly the United States Of America. Biotechnology corporations located in developed world make use microplasm obtained from the tropical forestry of the under developed world. They do this to generate new kind of patent plants, microbes, medicines, drugs so as to diversify the biologically active compounds (Michael, 1986). In order to find out the possible value and saleable feasibility of the plants, biotechnology scientists monitor plant varieties obtained from the forests of the under developed world. Therefore, once a biotech firm located in the developed world determines a complex compound possessing the power to heal in the conventional medical customs; it purifies its chemical composition and acquires a copyright for the purified compound so as to increase their profits. Scientists predict that more than sixty five percent (65%) of all the pharmaceutical products being manufactured and marketed in the United States and else where have been obtained from or acquired from plants located in the tropical and subtropical regions of the under developed world. Also, it is a matter of fact that the corporations selling these pharmaceutical products have been profiting in excess of billions of dollars every year (Mark, 1995).
Patent Laws and International Trade Organizations
The developed states have been extremely defensive on the subject of the copyright and patent laws relating to pharmaceutical products. The developed world, in particular the United States of America, makes tremendous efforts and goes to great extents in order to guarantee that the multilateral trade pacts relating to copyright laws of the pharmaceutical products do not diverge from their vested interests. Previously, in the developed world, inventions in the fields of biology, along with discovery in new plant types, had not been considered as suitable products for copyright laws. However, the dawn of the twentieth century brought about a change in the attitude of the developed world. This was because the hurdles allied with acquiring copyright for the farming of plants and the growing insight that newly discovered plant types had incredible saleable prospective provoked quite a few developed countries to pass laws for safeguarding the newly discovered plant types. At the same time the developed countries have banned the copyrighting of naturally growing material, they have, however, made patent laws when substance that had been formerly unidentified in its filtered and remote structure becomes purified into a distinct creation that reveals unforeseen and unpredicted properties (Bernard, 1999).
Over the years, the developed world, in particular The United States of America has been offering sizable and important patent rights to genetic plant producers. For case in point, the 1930 "U.S. Plant Patent Act" generated immunities in copyright laws to offer copyright protection for a number of plants -- providing producers who generated new types of plants, the entitlement to completely breed the patented plants by androgynous breeding for a period of seventeen years. In addition to that right, "Plant Variety Protection Act" of the 1970 passed by the congress broadens the range of patent laws to comprise plants that are regenerated by sexual means (Bernard, 1999).
Furthermore, in the middle of the twentieth century, a new development took place that changed the face of patent laws of plants' varieties. In 1961, "International Convention for the Protection of New Varieties of Plants" (UPOV Convention) recognized a new international standard of patent laws for newly discovered plant types, in that way, establishing the professed plant producers' rights. The convention standardized the patent law of plants by emphasizing that only those plant varieties will come under the patent protection that are evidently distinct by no less than one significant feature from all the others. To make a long story short, under the UPOV convention, plant producers' patent rights have been protected devoid of taking into account the source of the plant -- whether it is synthetic or completely natural -- of the original distinction from which the new plant type was produced (Michael 1986).
In the observation of the developed world the revelation necessities of the patent classification promote Research and Development (R&D) for the reason that they offer safety measures and security to the fund givers of the Research and Development (R&D). On top of that, the developed world asserts that through augmenting the market price of Plant Genetic Resources (PGR), biotechnology copyright assists in increasing the scientific advancements acquired from diversification of biological resources (David, 1999).
Furthermore, the developed world also makes a case that the underdeveloped world are the major gainers of this system providing they strengthen their patent protection structures, predominantly for the reason that they do not have the technological capability to participate in thriving piracy. For case in point, whereas piracy may offer an under developed country with cheaper duplicates of a number of pharmaceutical products, it is extremely complicated to duplicate newly produced pharmaceutical products for the reason that highly developed and pioneering technology are essential more often than not. On top of that, the under developed world is in need of gigantic sums of capital investments to grow a technological foundation. In addition to that, a country's rejection to act in accordance with the established Intellectual Protection association jeopardizes its people to the degree that the drug producers (who supposedly consume as much as $400 to $500 million developing one single drug) might decline to vend their pharmaceutical products in under developed countries, which are giving absolutely no protection what so ever to the drug producer. Lastly, it is argued that an embargo on compulsory licensing assists in encouraging scientific research and development (R&D) of industries…