Patenting Pharmaceutical Products – Putting IPR & Human Rights on a Weighing Scale
We often get intrigued by the © or ™ signs on the packets of different products we buy and wonder what it means? Well, the © here means copyright, and ™ here means the trademark and these are a part or type of intellectual property. Intellectual Property is a concept of law that came into highlight towards the end of the twentieth century. This concept, however, prevailed in countries like the UK from the 17th century but in many countries, it was in the twentieth century that it became commonplace. A very important facet of intellectual property is patent and patenting of pharmaceutical products is an important part of it, which shall be discussed in this article. Before understanding the meaning of patent and patenting rights, we shall understand the meaning of Intellectual Property.
Understanding the Terms
According to World Intellectual Property Organization (WIPO), a specialized agency of the UN, ‘Intellectual property (IP) refers to creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names, and images used in commerce.’ Some examples are patents, trademarks, copyrights, logos, etc. It is an intangible property and an asset and as are with tangible property there are rights associated with it also called Intellectual Property Rights. The Intellectual Property Rights are necessary to safeguard the interests of the inventor or creator and to protect the material form of Intellectual Property (or idea of the inventor or creator) that is tangible. Now, we will walk through the meaning of patent.
What is a Patent?
According to the Cambridge Dictionary, in plain language, a patent is ‘the official legal right to make or sell an invention for a particular number of years.’
According to the World Intellectual Property Organization (WIPO), a patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem. To get a patent, technical information about the invention must be disclosed to the public in a patent application.’
It could be extracted from the above definitions that –
- The patent is a right.
- It protects the new inventions and ideas of a company or an individual so that no other person or company could steal them and fraudulently name or as their own.
- It is granted for a particular period of time.
Patent Rights – Fundamental or Constitutional?
Now, the term ‘right’ in the context of a patent is ambiguous. Primarily, there are two types of rights granted to a citizen i.e., fundamental rights and constitutional rights. But patent tends to fall under the ambit of neither of them. In the US Constitution, there is an IP (Intellectual Property) Clause or patent clause (Article I, Section 8, Clause 8) under which Congress is empowered to make laws regulating patents and copyrights. But what is the case in India? In India, no special clause has been incorporated for Intellectual Property in the Constitution of India, so rights associated with it are not constitutional rights. So, in such a case, the patent is an intellectual property right.
Patenting of Pharmaceutical Products
Patents are of utmost importance in the pharmaceutical industry. When the Trade-Related (Aspects of) Intellectual Property Rights (TRIPS) Agreement was discussed in Uruguay, “one of the primary reasons for incorporating intellectual property issues into the GATT framework was the pharmaceutical industry”. India is also a signatory to this agreement, it has to follow all its guidelines and provisions. The statute in India which governs patents is the Patents Act, 1970. Furthermore in India, there are certain types of pharmaceutical patents, like drug compound patents, formulation or composition patents, synergistic combination patents, technology patents, polymorph patents, biotechnology patents, and process patents. If any company or institution wants to transfer their patent, it could be done through assignment or granting of a license in writing.
The Conflict between Pharmaceutical Patents and Human Rights
The chairman of the U.S. Senate Subcommittee on Patents, Trademarks, and Copyrights stated in 1958: “The patent system has, from its inception, involved a basic economic inconsistency. In a free-enterprise economy dedicated to competition, we have chosen, not only to tolerate but to encourage individual limited islands of monopoly in the form of patents.” There has been a conflict between Intellectual Property Rights and Human Rights due to the reason that IP rights like patents are not in consonance with human rights however they should be because IP and human rights are intertwined and no other right should violate the basic human rights of humans. The root of this conflict lies in the various international treaties and declarations.
The Universal Declaration of Human Rights (UDHR) provides that “everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he [or she] is the author.” The International Covenant of Economic Social and Cultural Rights also provides for intellectual property rights which clarifies the stance of human rights committees on intellectual property protection but no reference has been made to human rights in any international treaty on intellectual property like Rome, Paris, Berne, or TRIPS, which is one of the reasons underlying the rift between these two rights. The International Covenant on Economic, Social, and Cultural Rights (ESCR Covenant) recognizes every human’s right to ‘enjoyment of the highest attainable standard of physical and mental health’. In its General Comment 14, the committee has also briefed about the circumstances when this right stands infringed and one of these is ‘the policies manifestly incompatible with pre-existing domestic or international legal obligations in relation to the right to health.’
It was after the TRIPS Agreement, that its signatory countries were obliged to patent pharmaceuticals. The critiques of IP protection assert that the patenting of pharmaceutical products leads to an increase in their prices and thus hamper their accessibility to the poorer section of populations of different countries, which ultimately infringes their human right to health as it includes the right to appropriate healthcare and access to medicines. The protection of intellectual property through patents etc. also refrain companies from research and development of new drugs and the technologies that are suitable for manufacturing medicines in smaller markets. Generally in poor countries, the medicines are costly and on the contrary, they are inexpensive in developed countries like Europe and US. Moreover, patenting passes pricing decisions in the hands of patent holders, generally big corporations, who fix high rates for the drugs fulfilling their business interests and these products subsequently become inaccessible for the poor. Even though it is not the only favor for such inaccessibility but is indeed a prominent factor.
The United Nations Development Programme (UNDP)’s Human Development Report, 2000 states that the provisions of the TRIPS Agreement are a restraint to the public policies that aim to provide access to healthcare and medicines on a wider scale. Many developing countries before signing this agreement deliberately had laws that excluded pharmaceuticals from the product patent production to promote manufacturing of generic drugs by local industries of their nations and to ensure that they are available at affordable prices. However, process patents were prevalent in these countries.
So, the shift from process to product patents brought about by the TRIPS Agreement had led to a drastic reduction in the possibility for local manufacturers to produce affordable versions of integral life-saving medicines like those for cancer and HIV/AIDS. In India also the regime before TRIPS was bereft of product patenting and consequently the prices for medicines curing serious diseases were lower in comparison to the neighboring countries. In 1998 the anti-AIDS drug fluconazole cost $55 in India for 100 tablets (150 milligrams) but $697 in Malaysia, $703 in Indonesia, and $817 in the Philippines. The next issue was that The multinational companies (MNCs) holding the patents frequently tried to block and delay the entry of competitive generic medicines into the market through ever-greening. So, in 2005, India added strict patentability criteria for handling the ever-greening of patents, and in 2013, in the ‘Glivec case’ ruled against a pharmaceutical company Novartis AG in Switzerland.
In an attempt to resolve this conflict, in 2005, the Committee on, Economic, Social and Cultural Rights, published General Comment 17, in which it emphasized that “It is therefore important not to equate intellectual property rights with the human right recognized in article 15, paragraph 1 (c). The human right to benefit from the protection of the moral and material interests of the author is recognized in a number of international instruments.” The other points of this comment reflect that the committee aimed to establish the understanding that IP rights are not human rights and the latter has precedence over the former. However, certain people reckon that the committee failed to achieve its aim.
The gist of the whole discussion is that intellectual property rights and human rights are intertwined and conflicting simultaneously. In the contemporary world when innovations and unique creations are being made every day it is imperative to provide the inventors and creators with intellectual property rights to protect their creations. But at the same time the fact that tops every other consideration is that human rights are prime. The debate on this conflict has been going on for many years and scholars have come up with different theories and philosophical points of belief. Humans, as citizens of different nations, have a myriad of rights guaranteed to them but the rights that have precedence over every other right are human rights.
Likewise, intellectual property rights must be also in accordance with human rights. There are a lot of factors that do not let the right balance struck between intellectual and human rights. The treaties like TRIPS inter alia have provisions that make product patenting mandatory and extend the time limit of patents to twenty years etc., these provisions prima facie are conceivable and purposeful but gradually their effects prove to be violative of the right to health. So, the need of the hour is to have an international treaty in which intellectual property rights are guaranteed to maintain sync with human rights. And since we are humans above everything else, human rights must weigh more on the weighing scale.