Compulsory Licensing of Patents

Compulsory Licensing of Patents

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.

Introduction

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 in the under developed countries. All of these opinions substantiate the fact that by transforming their patent systems and changing their economic systems into market-oriented economies along with free trade structures to back the financial and monetary system, the under developed world will promote the flight of the desperate foreign capital it needs for its technological growth and development in the pharmaceutical sector as well as other sectors that are vital for growth and development (David, 1999).

The intellectual copyright of biotechnology and pharmaceutical products has been accelerating at a rapid pace. This is because of numerous legal verdicts passed by the international courts, multilateral and bilateral treaties and agreements. In order to gain unmatched profits and make the most of the legal, technological and economic climate of America, several European corporations have been either considering relocating or have already transferred their biotechnology corporations to the United States of America. This move can be attributed to that fact that the United States of America exploited the Uruguay Round of the GATT as an opportunity for the protection of Intellectual Property Rights laws to incline heavily in its favor. This can be observed from the fact that the protection and safeguard of biotechnological discoveries had been brought up in the GATT discussions within a limited framework, which was of the trade-associated features of intellectual property rights agreements (David, 1999).

In order to seize the unmatched profits that lie within the domain of biotechnology and the production and sale of pharmaceutical products, the developed world constantly positions the safeguard and protection of intellectual property rights of pharmaceutical products at the top of its personal international business agenda. Within the legal structure of the GATT as well as the WTO system, the developed world, and United States of America in particular, has effectively attached the gratification of its WTO membership -- along with its helper-benefit of unbiased and equal trade in merchandise as well as services -- as well as -- along with Member States' accord to stand by international system of the patent laws of pharmaceutical products along with other products. Furthermore, the member states are required to allow the patented pharmaceutical products superior safeguard and protection against piracy by fulfilling the obligatory accord on the subject of "Trade-Related Aspects of Intellectual Property Rights" also known as "TRIPS (Reichman, 2004)."

Trade-Related Aspects of Intellectual Property Rights" or "TRIPS" had been intended to reinforce and synchronize international patent laws, in particular the pharmaceutical products and other biotechnology products, with the declared principle of the contract being to decrease misrepresentations and obstructions to global trading system, in view of the requirement to endorse effectual and sufficient safeguard and protection of intellectual property rights (Reichman, 2004).

The rightful Position of the underdeveloped world on the subject of compulsory licensing of Pharmaceutical Patents

Several under developed countries have objected to what they rightly consider the developed world's unfair misappropriation and exploiting from microplasm obtained in the underdeveloped world. The underdeveloped world has been worried by the customary procedures of pharmaceutical corporations, located in the developed world, taking advantage of the remedial medicines generated by customary curers in underdeveloped world, to gain global profits in billions of dollars. The underdeveloped world makes its case that the pharmaceutical companies of the developed world have been making substantial profits from capital investments founded on the misuse of the undeveloped world's germplasm, devoid of any responsibility to give back anything to the custodians of the information (Kevin, 2002).

To energize the process of claiming their rights, as well as, to create more awareness and eventually deprive the western pharmaceutical companies to steal their wealth, the third world has labeled this practice as "bio-piracy," as well as, "bio-colonialism." Quite a few developing countries have started claiming that their natural resources of healing medicines are being stolen by the pharmaceutical companies of the west. The process adopted by the pharmaceutical corporations located in the west has been that first the intellectual resources of the underdeveloped world are obtained free of charge, as "raw materials," then these "raw materials" are converted and purified in the laboratories of the developed world, and subsequently become protected by patent laws under the established international trade systems. The western pharmaceutical merchandises generated from the natural assets of the "side-lined underdeveloped world" are then exported with much higher costs to these very underdeveloped countries. This is where these pharmaceutical products greatly help only the wealthy and influential for their proposed medical objective or price. Consequently, the under developed countries have been unwilling to expand the compulsory licensing of Pharmaceutical patent protection to these resources and other products exported from the developed world (Kevin, 2002).

Critics in the underdeveloped world have been inquiring about the drift of the reimbursements of global intellectual property protection, which have been a major faction of the complete "free trade" package. They fear that all the benefits might be tilted to the advantage of the nations, civilizations, and states of the developed world. Furthermore, the co-conversion of conventional medicinal information gives the impression to be determined by reduced profit that fears to be the loss of the underdeveloped world. For case in point, the Eli Lilly Corporation employed Madagascar's wild rosy periwinkle to grow "wonder drugs" like vinblastine, as well as, vincristine for the cure of pediatric lymphatic leukemia, as well as, Hodgkin's ailment. These pharmaceutical products produce millions of dollars in profits each year for the Eli Lilly Corporation; Madagascar allegedly receives nothing from them. Simultaneously, the underdeveloped countries, import germplasm in the form of extremely costly pharmaceutical products. The underdeveloped has been offended by the fact that the genetically reproduced pharmaceutical products from the developed world have been protected and safe guarded by international patent laws, at the same time the germplasm of the underdeveloped world is being obtained free of charge. To illustrate a case in point, the Indian government has formally challenged the patent, on three different occasions claiming that the ability of the western corporations to patent many indigenous plants produced in India is unlawful; for example, one patent that has produced anger has been a cure for diabetes comprising bitter gourd, eggplants, as well as, jamun, the fruit of the rose apple tree. It has been in the public domain in India for several centuries; however, once again there has been an effort to patent this medicine. However, the direction of the international court inclined heavily in favor of the west, in particular the United Sates of America and the appeal on all the three occasions had been overturned (Kevin, 2002).

The under developed world has been extremely receptive of the moves of the developed world relating to the intellectual property rights of the pharmaceutical products. In fact the underdeveloped world has often been extremely antagonistic towards the developed world's Intellectual Property Regimes, for the reason that they consider their objective is to strengthen the economic authority of the developed world, as well as, to relocate the wealth and the riches from the underdeveloped countries to the developed ones. In line with the views of the underdeveloped world, the patent system of the developed world assists in protecting their technological advantage and, concurrently, dispossesses the underdeveloped world of the much-required technological transfers. Since the developing countries have not the major producers of intellectual property, they have little inducement to forcefully preserve it. The developing countries assert their case that the weak protection is reasonable on the rationale that the underdeveloped world requires utmost exposure to Western intellectual goods for its domestic growth and development and that severe standards of safeguarding and protection can be incapacitating. Therefore, several scholars believe and strongly assert that the worth of the intellectual property system to underdeveloped countries is still contentious, and that the under developed countries could undergo extreme hardship for the reason of rising reliance on foreign copyrights with extremely little countervailing profits (Keith, 2003).

The intellectual property system is operated under enormous costs that are beyond the reach of many underdeveloped nations. Therefore, several underdeveloped countries have also taken this subject of the gigantic expenses connected with generating and then upholding a complicated patent system. Since the underdeveloped world has been overwhelmed by insufficient capital, majority of the governments in the undeveloped states maintain that they are unable to sustain the costs of intellectual property protection, together with the secure drafting, as well as, the loss of inexpensive options to lawful pharmaceutical products. In any case, the instant temporary consequence of a strong patent law system will be advanced royalty expenditure from the underdeveloped world to developed countries. The comparative price of this royalty expenditure is prone to be aggravated by fluctuations in the exchange rates of the foreign currency of the respective undeveloped countries (Keith, 2003).

Even though the developed world believes that illegal reproduction of pharmaceutical products offers no genuine economic advantages, the developing countries have been inclined to believe that illegal reproduction of the intellectual property of pharmaceutical products increases economic growth and development. In several instances, illegal reproduction of the intellectual property of pharmaceutical products has benefited an underdeveloped country by offering patented technology devoid of the extra prices of royalty expenditure to obtain it. The economy of the country acquires a bonus from the savings, as well as, from selling the duplicate goods overseas to other underdeveloped countries that have weak or nonexistent Intellectual Property Rights Protection systems (Mark, 1996).

The up-and-coming global legal regime protecting and safeguarding the intellectual property influences the health in the underdeveloped countries; above all, this influence goes to the degree that it restricts the means of healthcare. The influence of TRIPS on the means of the health care system as well as the life-saving pharmaceutical products is particularly severe when taking into account that approximately one-third of the world's inhabitants have been unable to use the necessary drugs (Keith, 2003). All over the world, health experts have shown their concern on the subject of the TRIPS-enhanced protection of pharmaceutical patents as well as associated property rights. Especially, they have been alarmed that the accords that aspire to synchronize protection and safeguarding of patent laws amid WTO associates employing standards manufactured and engineered in the industrialized world will unfavorably influence the use of patented medicines in underdeveloped countries by escalating the costs (Keith, 2003).

To illustrate this point one should look at the ample court cases that have been filed against the pharmaceutical corporation in the developed world. All these appeals claim the expensive cost of pharmaceutical products, particularly the life-saving drugs. In one instance South Africa decided to challenge the drug prices set by the corporations. The South African government unilaterally decided to trim down the prices of the drug that is used for curing the AIDS ailment. After hue and cry for several months, the western governments and South Africa eventually came to a mutual agreement. In another instance, an appeal by Thailand was put down because the Court reaffirmed the position of the United States of America and rejected the complete-bar method of the principle of equivalents challenged by the government of Thailand. In another case the Brazil government with the sole intention to protect its tropical forestry challenged an American company in the international court. The appeal had been tried in the court devoid of a jury. In took several weeks for the judiciary to give its verdict. After contemplating all the evidence, the Court found that the appeal was invalid. The decision cleared the way for the pharmaceutical company to sell the genetic variety of the plant. All these cases are evident facts that point towards the reality that the western pharmaceutical companies continue to promote "bio-piracy" and deprive the underdeveloped world of its true right and hide under the umbrella of that controversial banner namely, "free trade (David, 1999)."

Fidler asserts that this nexus amid the trade advantages and the contribution in the western-minded patents regimes have been persuading several underdeveloped countries to alter their strategies on protections of intellectual property and the patent laws. Keith Aoki asserts that the TRIPS accord accomplishes, from the possible danger of financial banishment, what could not be achieved during discussions sovereign of the global economic structure. Beneath the "ideological sign" of free trade, policies and regulations that ostensibly had been intended to support and care for imaginative manifestation and scientific modernization have now been established, providing the holders the legal resources to access move-territorially into underdeveloped world to avert illegal utilization of pharmaceutical products. This long-drawn-out contact of the patent regimes of the developed countries takes place at the expense of the underdeveloped world, predominantly the African nations, which are at the edge of the global economy (David, 1999).