Essay: INTELLECTUAL PROPERTY RIGHTS LINKED WITH ACCESS TO MEDICINES

 
Introduction
This chapter examines the intellectual property rights that are linked with access to medicines. Part one looks at the definition of IPR. Part two looks at the different types of intellectual property rights. Part three explores the rationale for IPRs. Part four looks at the IPRs that have an effect on access to medicines. Part five summarizes the findings of the chapter.
Definition of intellectual property rights (IPRs)
Black’s Law Dictionary defines “intellectual property” as ‘a category of intangible rights protecting commercially valuable products of the human intellect.’ Intellect refers to using the mind creatively. IP is a right arising from using the mind in a creative manner.
According to the World Intellectual Property Organization (WIPO), intellectual property refers to ‘creations of the mind; inventions; literary and artistic works; and symbols, names and images used in commerce.’
World Trade Organization (WTO) states that ‘intellectual property rights are the rights given to persons over the creations of their minds. They usually give the creator an exclusive right over the use of his/her creation for a certain period of time.’
The WIPO intellectual property handbook states that IP means ‘the legal rights which result from intellectual activity in the industrial, scientific, literary and artistic fields.’
Provided an individual has created a product from his mind, it is considered as intellectual property. The person becomes an intellectual property holder possessing all the IPR stemming from the creation as provided for in the international and local law.
Types of intellectual property
Intellectual property is divided into two branches, industrial property and copyright. The Convention Establishing the World Intellectual Property Organization (WIPO), concluded in Stockholm on July 14, 1967 provides that ‘intellectual property shall include rights relating to: literary, artistic and scientific works; performances of performing artists, phonograms and broadcasts; inventions in all fields of human endeavor; scientific discoveries; industrial designs; trademarks, service marks and commercial names and designations; protection against unfair competition and all other rights resulting from intellectual activity in the industrial, scientific, literary or artistic fields. ’ Although the convention does not give a list of which right falls under each branch, publications of the WIPO do so. Industrial Property includes patents for inventions, trademarks, industrial designs and geographical indications. Copyright covers literary works (such as novels, poems and plays), films, music, artistic works (e.g., drawings, paintings, photographs and sculptures) and architectural design.
Rationale for IPRs
There are several compelling reasons. First, the progress and well-being of humanity rest on its capacity to create and invent new works in the areas of technology and culture. Second, the legal protection of new creations encourages the commitment of additional resources for further innovation. Third, the promotion and protection of intellectual property spurs economic growth, creates new jobs and industries, and enhances the quality and enjoyment of life. An efficient and equitable intellectual property system can help all countries to realize intellectual property’s potential as a catalyst for economic development and social and cultural well-being. The intellectual property system helps strike a balance between the interests of innovators and the public interest, providing an environment in which creativity and invention can flourish, for the benefit of all.
In general terms IPRs are tools for economic advancement that should contribute to the enrichment of society through:32 1. The widest possible availability of new and useful goods, services and technical information that derive from inventive activity and; 2. The highest possible level of economic activity based on the production, circulation and further development of such goods, services and information. Basically intellectual Property Rights provide incentives towards various creative endeavors of the mind by offering protection; giving such creators official recognition; creating repositories of vital information and facilitate the growth of both domestic industry or culture and international trade. 33 In the pharmaceutical industry, patent protection provides the incentive for the industry to use its skills and resources in the discovery, development, testing, quality control and distribution of new drugs and vaccines. Few, if any companies will start on the long trail of new drug discovery and development, if they cannot be protected from competitors coming in once the drug is successful.
IPRs linked with access to medicines
The main categories of IP that play a significant role in the right to access medicines are patents, trademarks and protection of undisclosed information (trade secrets) .
• Patents
According to Black’s Law Dictionary, a patent is “the right to exclude others from making, selling, offering for sale, or importing an invention for a specified period (20 years from the date of filing), granted by the federal government to the inventor if the device or process is novel, useful, and non-obvious.”
WIPO defines a patent as ‘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.’
A patent is also understood as the legal document providing protection to the ideas of any individual issued by the Patent Office of a country . It is granted to any firm or individual whose application is duly accepted after having the requisite criteria for patents.
Locally patent is not defined in any law. However, the Kenya Industrial Property Act 2001 defines an invention as a solution to a specific problem in the field of technology .
Patents are protected under the following treaties: Paris Convention, Patent Cooperation Treaty (PCT), Strasbourg Agreement Concerning the International Patent Classification, Patent Law Treaty (PLT), the Budapest Treaty and the TRIPS . The treaties also provide the procedures required for obtaining a patent but they do not define what a patent is. Although the documents fail to provide a definition of the term patent, they perform the fundamental function of protecting patents and ensuring they are legally acquired.
For patentability to be achieved, the following conditions must be met: patentable subject matter, industrial applicability (utility), novelty and inventive step (non-obvious) .
 Industrial Applicability (utility). The invention must be of practical use, or capable of some kind of industrial application in industries such as the agriculture, medicine, fishery and other service industries.
 Novelty. The invention must show some new characteristic that is not known in the body of existing knowledge in any part of the world prior to the filing date for the application. Attempts to acquire patent over invention that are already in the public domain always fail. These include things existing in nature as illustrated in the U.S. where, WR Grace Company had a patent for the manufacture of a pesticide revoked as the one of the active ingredients-neem seeds- occurs naturally in nature and Indians had knowledge of its benefits.
 Inventive step (non-obviousness). It must show an inventive step that could not be deduced by a person with knowledge or skill in the technical field that the patent is sought at the time of filing the application.
 Patentable subject-matter. The invention must fall within the scope of patentable subject matter as defined by national law. In Kenya, the IPA 2001 only gives the subject-matter that cannot be patented.
The IPR to patent an invention is the one that many in the pharmaceutical industry fight for. Cases such the United States vs. Brazil illustrate this as shown below:
‘In February 2001, the United States took action against Brazil at the WTO Dispute Settlement Body (DSB) over Article 68 of the Brazilian intellectual property law which requires holders of Brazilian patents to manufacture the product in question within Brazil – a so-called “local working” requirement. If the company does not fulfill this requirement, the patent is subjected to compulsory licensing after three years, unless the patent holder can show that it is not economically feasible to produce in Brazil or can otherwise show that the requirement to produce locally is not reasonable. If the company is allowed to work its patent by importation instead of manufacturing in Brazil, parallel import by others will be permitted. The United States argued that the Brazilian law discriminated against United States owners of Brazilian patents and that it curtailed patent holders’ rights. The United States claimed that the Brazilian law violated Article 27.1 and Article 28.1 of TRIPS. Brazil argued that Article 68 was in line with the text and the spirit of TRIPS, including Article 5.4 of the Paris Convention, which allows for compulsory licensing if there is a failure to work a patent. Article 2.1 of TRIPS incorporates relevant articles of the Paris Convention.’
From the case, it is clear that patents often raise questions especially when the intellectual property holder of the medicine is compelled to give a compulsory license.
• Trademarks
A trademark is a sign capable of distinguishing the goods or services of one enterprise from those of other enterprises. Kenyan law defines trademark as a mark used or proposed to be used in relation to goods or services identifies the provider of the goods or services. These signs individualize the goods or services offered by an enterprise setting them apart from the similar products offered by competing businesses. For example, bathing soap sold by different companies contain different signs. These marks are seen as marketing tools and not just an intellectual property right. They provide exclusive rights to use distinctive signs, such as symbols, colours, letters, shapes or names to identify the producer of a product, and protect its associated reputation e.g. Coca-Cola®, Panadol®. The trade mark owner has the exclusive right to prevent third parties from using identical or similar marks in the sale of identical or similar classes of goods or services that might mislead or confuse customers.
International laws such as TRIPS stipulate a minimum period of protection of 7 years while international organizations such as WIPO provide a minimum of 10 years after which the trademark is renewed. Locally, the Trade Marks Act provides a minimum of 10 years renewable for successive periods of 10 years. Plenty of legislation and case laws exist showing this IPR in action.
In Pharmaceutical Manufacturing Co v Novelty Manufacturing Limited , the plaintiff who was the registered proprietor of the trademark “Trihistamin” registered in class 5 in respect of pharmaceutical and veterinary substances brought an action for trademark infringement against the defendant for manufacturing and selling in Kenya a pharmaceutical product known as “Tri-histina” expectorant. The court in finding that the defendant’s use of its mark was a clear infringement of the plaintiff’s exclusive rights, held that the defendant’s mark was so substantially similar to the plaintiff’s mark as to be likely to deceive or cause confusion in the course of trade in relation to pharmaceutical and medical preparations and substances in respect of which the mark was registered.
Similarly the High Court of Kenya in Beiersdorf AG v Emirchem Products Limited in finding that the defendant’s use of its mark “NIVELIN” on petroleum jelly infringed on the plaintiff’s exclusive rights to its registered marks “NIVEA” and “NIVEA Crème” registered in class 3 and used on petroleum jelly, stated that the similarity and resemblance in the two marks was so striking as to cause confusion to consumers.
• Trade secrets
Trade Secrets or Know-how is commercially valuable information such as production methods, business plans or clientele that may give a person or company a competitive advantage. As long as it is known only to a few people, such information can be legally recognized and protected as a trade secret but, once they are learnt through legitimate means they enter the public domain. A claim for protection of know-how as a trade secret requires that efforts be made to prevent disclosure. Law makes the taking without permission of a trade secret an illegal act, but not the discovery by proper means i.e. by independent discovery, accidental or actual disclosure or by reverse engineering.
In Sunbird Helicopters Ltd v Michael Odongo31, the Plaintiff sought, inter alia, orders to restrain the defendant from taking up employment with its competitor and an injunction for one year, to restrain the defendant who had been in the plaintiff’s employ as a Helicopter Chief Engineer from using and/or disclosing any confidential information and/or any trade secrets acquired by the defendant from it. The court, ruled that it would not enforce any negative covenants that would result in either the defendant remaining idle or being forced to work and dismissed the case.
Conclusion