Patents give protection to technological inventions and design rights to the appearance of mass-produced goods for limited time periods. Patents are granted for inventiveness and for being different from the works done previously. The focus of this article will be on patents and pharmaceuticals. The TRIPS agreement regulates patent requirements for its signatories, specifically within its Articles 27-34. Patent holders also have a "qualified" exclusive right to imports, explained below.
In essence, I argue that the TRIPS agreement strikes a balance of promoting creativity and innovation of the right holder, yet, on the other and provides supply and access of pharmaceutical products to the General public in LDC’s for a much lower price through the exceptions within the TRIPS agreement. Some would state that there exists a loophole within the TRIPS [1] as these exact developing countries; in order to dodge the strict rules on TRIPS now rely on the exceptions to the main rules mentioned above. Transition rule explains the present lack of patent protection for pharmaceuticals in India that was noted in the introduction to this essay. Developing nations must look for generally applicable exceptions to the patent rules of TRIPS if they are to avoid full patent protection for pharmaceuticals in the future without violating WTO law. However, others would state that the aforementioned rationale of there being a gap strikes a good balance for the public in these countries to have access to medicines, for example through compulsory licensing.
According to Geiger [2]the limited role the objectives and principles of the TRIPS Agreement (Articles 7 and 8) have played so far in the interpretation and implementation of its substantive provisions has often been criticised as, when and if uplifted they would be more fair in practice as towards LDC’s. According to Yu[3] pharmaceuticals is a typical example of the foregoing opportunity, as some may call it or challenge. Vaccines and medicines, which are essential for the prevention and treatment of diseases, are products manufactured by pharmaceutical companies. People who need them must purchase them from pharmaceutical companies. It is desirable that all people would have access to necessary medicine, but such access is not guaranteed by the market if one follows the strict interpretations of patentability under TRIPS, however though the use of the exceptions this may be possible. Other examples would be illustrationof developing nations successfully using the exceptions as a loophole (or opportunity?) would be in their claims of compulsory licensing; enacted domestic legislation limiting patents, such as domestic working requirements and setting limits to secondary patents; and launched agendas on development issues, such as access to medicines, promoting the linkage between human rights and health, protection of traditional knowledge, and access to biological resources (Kapczynski 2008).
Moving towards the structure of the TRIPS agreement which bestows upon countries “opportunities” (in relation to LDC’s) or drawbacks (the latter is applicable to industrialised nations).
Article 33, states that patents must be made available for all "inventions, whether products or processes," for at least twenty years from the date of the filing of a patent application. Specifically, new drugs can be covered by patents on their chemical composition (so-called "composition of matter" patents), or by patents on the process used to make the drug.
Article 28 provides that the patent holder must be given the exclusive right to make, use, offer for sale, or sell the patented product (in the case of a product patent) or the product made from the patented process (in the case of a process patent). The additional 5 years[4] (transitional period ending January 2006) was granted to developing countries, as per art 65.2-3 of the agreement as supplementary period to comply with the provisions of the TRIPS agreement.[5]
One of these exceptions to the main rule in article 33 is Article 27.2, which provides: "Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public... including to protect human ... health.., provided that such exclusion is not made merely because the exploitation is prohibited by their law." The wording “Ordre Public” is interpreted as a public health exception to the requirement of patentability. To be clear, this is understood to mean that “ordre public” encompasses patents or inventions that are in themselves harmful for the public, in that they cannot be exploited under national law. [6] The example that Sykes[7] gives is of “for example, the United States might deny a patent on a new type of water pipe designed to enhance the pleasures of opium smoking.”[8]
Article 27 cross-references Article 6 of TRIPS, which provides that "nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights." This provision concerns the question of whether a patent holder retains any rights over the resale of a product once it has been introduced into the market or whether the initial sale or “first sale” by the right holder "exhausts" its rights. For example, a pharmaceutical patent holder sells a drug into country A's market for $10 per unit. In country B's market, by contrast, the patent holder prefers to charge $20 per unit. If the patent holder's rights are "exhausted" following the first sale in country A, then the patent holder has no right to prevent buyers in country B from importing the drug from country A and destabilizing the patent holder's desired price in country B. In such an event, the ability of the patent holder to price discriminate across markets will be destroyed. Likewise, developing countries that face relatively high prices for a particular drug when it is sold directly into its market by a patent holder may be able to amend the problem by importing the drug from another country where a lower price is charged. Such imports are termed "parallel imports", and the perseverance of the "exhaustion" issue thereby determines whether a patent holder has a legal right to require nations in which it holds a valid patent to prevent parallel imports. This issue can be further analysed, yet due to the limits of the answer, I will refrain from doing so.
Article 30, is another exception which reduces protections of pharmaceuticals, stating: "Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner."
Article 31, is another exception limiting the protection of a patent stating "use without authorization of the right holder" or, in other words “compulsory licensing” which is a license to manufacture the patented product that is granted over the objection of the patent holder. Domestic laws that authorize compulsory licensing are permissible under Article 31. India and Brazil have enacted many, as it comes to show, Compulsory licensing must be monitored before an effort over a "reasonable period of time" to negotiate a license from the right holder on "reasonable commercial terms." Article 31(b) provides that this limitation may be waived by a Member in the event of a "national emergency."
In addition, under Article 31(f), any such use must be "predominantly for the supply of the domestic market." Further, "the right holder shall be paid adequate remuneration... taking into account the economic value of the authorization," as provided for by Article 31(h).
Accordingly, these provisions raise a number of interpretive issues. How long must a Member attempt to negotiate a license from the right holder in the face of apparent standoff? When does a "national emergency" exist that allows the prior negotiation to be avoided? What is "adequate remuneration" to the right holder? The developing nations sought favourable "clarification" on these and related issues at the Doha ministerial meeting.
In conclusion, Pharmaceutical prices in the developing world are of growing concern. Pharmaceuticals are patentable subject matter on one hand which seeks to protect the right holders invention and on the other they supply much needed vaccines a more affordable price. HIV/AIDS epidemic affects many developing countries acutely, but due to the patentable pharmaceuticals manufactured in developed countries the affected are unable to obtain effective therapies because of their prohibitive cost, especially in the case of LDC’s.
LDC’s or developing countries now, in their claim use the exception of misappropriation of traditional knowledge, genetic resources, and traditional plant varieties. For example, India has challenged foreign companies’ patents on the grounds that they may be based on pre-existing traditional knowledge and biological material to pre-empt foreign patenting on the grounds of lack of novelty and ensure that the TRIPS provisions on the protection of plant varieties do not affect farmers’ rights to keep and trade seeds (so-called farmers’ rights as opposed to breeders’ rights). Many more exceptions can be used from the TRIPS legislative design and structure.
[1] Alan O Sykes, 'TRIPS, Pharmaceuticals, Developing Countries, and the Doha Solution' (2002) 3 Chi J Int'l L 47 [2] Geiger & Desaunettes-Barbero, The Revitalisation of the Object and Purpose of the TRIPS Agreement (2020) [3] Yu, The Objectives and Principles of the TRIPS Agreement (2009) [4] Article 65.4 TRIPS [5] Article 66.1 TRIPS [6] World Trade Organization, Overview: The TRIPS Agreement 8, available online at (visited Mar 24, 2002). [7] Alan O Sykes, 'TRIPS, Pharmaceuticals, Developing Countries, and the Doha Solution' (2002) 3 Chi J Int'l L 51 [8] Alan O Sykes, 'TRIPS, Pharmaceuticals, Developing Countries, and the Doha Solution' (2002) 3 Chi J Int'l L 47
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