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Humanitarian use licenses are provisions in a license whereby inventors and technology suppliers protect in advance the possibility of sharing their technology with people in need. Thus, humanitarian use licenses set the conditions for the provision of access to innovations for people in need at a royalty free basis or at lower costs. Humanitarian use licenses assure that products of research and development stay publicly available and that at the same time the incentive function of exclusive intellectual property rights are maintained.
Humanitarian use licenses represent a tool to distribute the outcomes of research and development more equally. They relax the exclusive claims of intellectual property rights with more permissive licenses for developing countries. Intellectual property is an umbrella term for various legal entitlements which attach to certain types of information, ideas, or other intangibles in their expressed form. The term intellectual property reflects the idea that this subject matter is the product of the mind or the intellect, and that these rights may be protected by law in the same way as any other form of property.
There are several functions related to these rights that make them work as a catalyst for the market. But there are also fundamental differences between the economic and social conditions of developed countries and developing countries. Hence, conventional licensing practices have caused distortions that make humanitarian use licenses a tool worth considering.
The holder of a legal Intellectual Property Right is generally entitled to exclude others for a period of time. This gives the owner a comparative advantage over others for a limited time. Thus, innovative activity is rewarded, which stimulates research and development.
But many developing countries are characterized by a weak research and development sector. Of the 400,000 inventions for which patent applications are submitted annually, developing countries take part in 1 percent whereas the United States, the USSR, the Federal Republic of Germany, and Japan participate in 73 percent. (Vestry Besarovic[ citation needed ]) This makes the industrial sector of developing countries largely dependent on imitation. Universally imposed minimum standards of patent protection, as the TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights) requires, are not likely to contribute to economic growth unless a particular level of development has been achieved (Thompson and Rushing[ citation needed ]). When developing countries have to purchase expensive technology because of a protective regime to comply with TRIPS, it can lead to the breakup of industries and thus reduce economic growth.
Transaction costs hinder development on whether there is a sufficient resource commitment from industry. This factor influences the relative price of a patent and its relative utility. In economies that have to rely on imitation yet clear laws are unlikely to stimulate innovation. Protection gains importance at higher stages of development when it serves to stimulate. Until this stage is reached, the relative benefits for facilitating transactions will not outweigh the relative costs of hindering technology application.
Patent applications must disclose how the claimed invention functions. This disclosure allows persons skilled in the art to make use of the innovation. As new technologies are applied, further innovations can be built on existing ones.
But rates of secondary and university education are much lower in developing countries than they are in developed countries. Along with the lack of capital flows into research and development, this lowers the potential for adoption of new technology and the development of innovations. Thus, the information disclosed in a patent becomes useless, as the preconditions for taking advantage of the information do not exist in developing countries.
The effects of the globally imbalanced power relations are best illustrated by looking at sectors strongly concerned with IPR, medicine and agriculture. These sectors are also crucial for development as they serve the basic needs of people. They can be harmful as they cover consumer products. For example, patent protection for drugs keeps the price high and inhibits competitors from introducing cheaper generic versions.
In agriculture, the patenting of genes or certain properties of crops can make the use of these crops costly and burdensome. Access to varieties that have long been used by farmers can be restricted, and as a result markets can be destroyed. An illustrative example for this is the case of the Enola bean, where a field bean variety showing a certain colour was patented. Subsequently, the licensor required all importers of Mexican beans to pay royalties, which would have caused a significant drop in export sales of beans from Mexico.
But protection may also hinder development in intermediate stages, as it covers not only final products, but also intermediate products, processes and tools to create those products. Thus, protections covering biotechnology can decrease the development of and access to new technologies in developing countries, thus preventing new crops or drugs from being developed.
Moreover, drugs for tropical diseases and crops adapted to tropical conditions have been developed only to a limited extent. The purchasing power in these countries is low and thus there are no lucrative markets. Although only 10% of the global disease load occurs within industrialised countries, 90 percent of global drug investment goes toward the drugs for industrialized countries. Projects that address diseases of developing countries such as malaria and tuberculosis receive comparatively little funding.
Technologies can be provided that stimulate the development of needed and to local conditions adapted products. Companies and research institutes in the specific countries are able to produce and develop at lower costs and know the local needs and problems best. Technology can benefit the poor farmer or the sick people that are in need of drugs or food as well as the economy as a whole.
Humanitarian Use Licenses have the potential to enhance the supply of important consumer products. When cheap or cost-free licenses are granted to companies in developing countries, it would be possible for them to produce copies of drugs or seeds [1] to provide the population with. Apart from missing royalty payments companies in developing countries will possibly be able to produce and distribute at a much lower price than companies in wealthier countries.
Defining the population that should benefit and the institutions that can serve the needs of this population is required in the humanitarian use licensing scheme. Depending on the different technologies that should be assigned via the Humanitarian Use License, there are different approaches of how to formulate a Humanitarian Use License:
Exclusive claims that are connected with intellectual property rights might cause companies to fear loss of revenues. However, this is not necessarily the case, as mostly non-commercial markets are served. People are provided with royalty free goods that otherwise would not have made the purchase in the first place.
Donating technology and support for developing countries will create positive publicity for companies that do so, especially in the biotechnology and medical sectors. This can be reinforced if also governments take a role in this. Promoting positive publicity by giving prices or tax incentives are possible ways to reward companies that are engaged in underserved sectors.
Many developing countries have a growing potential private market for technologies. The technology supplier may plan to develop these growing markets as part of a long-term market strategy, implying that the supplier expects these currently unprofitable markets to become profitable in the future. Thus, the supplier can create a loyal customer base in the future with a generous donation today (IP strategies 2001)
Humanitarian use licences could be compulsorily assigned by the government or subject to voluntary implementation by the patent holder. However, developing standards in humanitarian licensing that encourages also private companies to technology transfers would rather stimulate the voluntarily engagement of the private sector in development. Thus, resources would be directed into more productive channels than compulsory licensing could do. Building trust of partners can be achieved by careful drafted clauses that a rights holder could choose to include in licensing agreements.
The cost of such a failure depends on how many farmers included in the target would have purchased the technology from the market had they not been granted preferential access (IP strategy 2001). A trade-off between the effort to administer the targeting scheme and the size of leakage is probable – the lower the risk of leakage should be, the higher will be the cost of implementation of these targeting schemes. Of particular concern are countries with a wide income disparity, where for example viable commercial markets may exist in the cities, while rural areas are underserved and require a humanitarian license and a significantly different price-point.
Humanitarian use licenses should be considered in every stage of development as there could be restrictions to the access to materials, processes for product development or final products. Patents can be granted with respect to whole varieties, single genes or procedures that permit the isolation of genes. Humanitarian Use Licenses therefore do not only concern companies that bring products to the market and could via such licenses directly deliver people in need. It has to be considered also by universities, national and international agricultural research centres and public-private partnerships whose work represents the basis for further upstream research.
A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention. In most countries, patent rights fall under private law and the patent holder must sue someone infringing the patent in order to enforce their rights.
A royalty payment is a payment made by one party to another that owns a particular asset, for the right to ongoing use of that asset. Royalties are typically agreed upon as a percentage of gross or net revenues derived from the use of an asset or a fixed price per unit sold of an item of such, but there are also other modes and metrics of compensation. A royalty interest is the right to collect a stream of future royalty payments.
Technology transfer (TT), also called transfer of technology (TOT), is the process of transferring (disseminating) technology from the person or organization that owns or holds it to another person or organization, in an attempt to transform inventions and scientific outcomes into new products and services that benefit society. Technology transfer is closely related to knowledge transfer.
Industrial property is one of two subsets of intellectual property, it takes a range of forms, including patents for inventions, industrial designs, trademarks, service marks, layout-designs of integrated circuits, commercial names and designations, geographical indications and protection against unfair competition. In some cases, aspects of an intellectual creation, although present, are less clearly defined. The object of industrial property consists of signs conveying information, in particular to consumers, regarding products and services offered on the market. Protection is directed against unauthorized use of such signs that could mislead consumers, and against misleading practices in general.
Patents are legal instruments intended to encourage innovation by providing a limited monopoly to the inventor in return for the disclosure of the invention. The underlying assumption is that innovation is encouraged because an inventor can secure exclusive rights and, therefore, a higher probability of financial rewards for their product in the marketplace or the opportunity to profit from licensing the rights to others. The publication of the invention is mandatory to get a patent. Keeping the same invention as a trade secret rather than disclosing it in a patent publication, for some inventions, could prove valuable well beyond the limited time of any patent term but at the risk of unpermitted disclosure or congenial invention by a third party.
The pharmaceutical industry is one of the leading industries in the People's Republic of China, covering synthetic chemicals and drugs, prepared Chinese medicines, medical devices, apparatus and instruments, hygiene materials, packing materials, and pharmaceutical machinery. China has the second-largest pharmaceutical market in the world as of 2017 which is worth US$110 billion. China accounts for 20% of the world's population but only a small fraction of the global drug market. China's changing health-care environment is designed to extend basic health insurance to a larger portion of the population and give individuals greater access to products and services. Following the period of change, the pharmaceutical industry is expected to continue its expansion.
James Packard Love is the director of Knowledge Ecology International, formerly known as the Consumer Project on Technology, a non-governmental organization with offices in Washington, D.C., and Geneva, that works mainly on matters concerning knowledge management and governance, including intellectual property policy and practice and innovation policy, particularly as they relate to health care and access to knowledge.
Intellectual property assets such as patents are the core of many organizations and transactions related to technology. Licenses and assignments of intellectual property rights are common operations in the technology markets, as well as the use of these types of assets as loan security. These uses give rise to the growing importance of financial valuation of intellectual property, since knowing the economic value of patents is a critical factor in order to define their trading conditions.
A non-assertion covenant is an agreement by a party not to seek to enforce patent or other intellectual property rights it may have against another party or parties. Nonasserts are often used as patent-infringement settlement agreements that are designed and drafted with the purpose of preemptively resolving future infringement disputes.
Legal scholars, economists, activists, policymakers, industries, and trade organizations have held differing views on patents and engaged in contentious debates on the subject. Critical perspectives emerged in the nineteenth century that were especially based on the principles of free trade. Contemporary criticisms have echoed those arguments, claiming that patents block innovation and waste resources that could otherwise be used productively, and also block access to an increasingly important "commons" of enabling technologies, apply a "one size fits all" model to industries with differing needs, that is especially unproductive for industries other than chemicals and pharmaceuticals and especially unproductive for the software industry. Enforcement by patent trolls of poor quality patents has led to criticism of the patent office as well as the system itself. Patents on pharmaceuticals have also been a particular focus of criticism, as the high prices they enable puts life-saving drugs out of reach of many people. Alternatives to patents have been proposed, such Joseph Stiglitz's suggestion of providing "prize money" as a substitute for the lost profits associated with abstaining from the monopoly given by a patent.
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the World Trade Organization (WTO). It establishes minimum standards for the regulation by national governments of different forms of intellectual property (IP) as applied to nationals of other WTO member nations. TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) between 1989 and 1990 and is administered by the WTO.
Oxford University Innovation Limited (OUI) is a British technology transfer and consultancy company created to manage the research and development (R&D) of University spin-offs. OUI is a wholly owned subsidiary of the University of Oxford, and is located on Botley Road, Oxford, England. OUI was previously known as Isis Innovation (1988–2016) and Oxford University Research and Development Ltd (1987–1988).
On 29 March 2010, the US District Court for the Southern District of New York found several of the patent claims on the BRCA1 and BRCA2 breast cancer genes held by Myriad Genetics to be invalid. The patents were initially issued on the basis that the genes were isolated and purified to a non-naturally occurring state, however the court found, amongst other things, that the purification was not markedly different from a product of nature and thus was not patentable. The ruling may have implications for holders of other gene patents and the patentability of other naturally occurring substances. It has the potential to directly affect the operation of the healthcare and medical research industries, particularly with regards to cancer treatment and prevention, and may alter the accessibility of such therapies to patients.
Licensed production is the production under license of technology developed elsewhere. The licensee provides the licensor of a specific product with legal production rights, technical information, process technology, and any other proprietary components that cannot be sourced by the licensor.
Some authors advocating patent reform have proposed the use of prizes as an alternative to patents. Critics of the current patent system, such as Joseph E. Stiglitz, say that patents fail to provide incentives for innovations which are not commercially marketable. Stiglitz provides the idea of prizes instead of patents to be awarded in order to further advance solutions to global problems such as AIDS.
The Medicines Patent Pool (MPP) is a Unitaid-backed international organisation founded in July 2010, based in Geneva, Switzerland. Its public health driven business model aims to lower the prices of HIV, tuberculosis and hepatitis C medicines and facilitate the development of better-adapted HIV treatments through voluntary licensing and patent pooling. Its goal is to improve access to affordable and appropriate HIV, hepatitis C and tuberculosis medicines in low- and middle-income countries (LMIC). In May 2020, the MPP become an implementing partner of the WHO's Covid-19 Technology Access Pool (C-TAP).
Access to medicines refers to the reasonable ability for people to get needed medicines required to achieve health. Such access is deemed to be part of the right to health as supported by international law since 1946.
At its essence, intellectual property rights are described as “a legal framework for contractual agreements concerning technologies, which encourage the institution of ‘markets for technology’, making easier the international transfer of technology and its diffusion at the local level.” The discussion that has taken place, concerning intellectual property rights and the following agreements, centers around spreading global knowledge and technologies. Intellectual property has been largely discussed and gone through a series of changes. At the globalized level, a global network for ideas led institutions to put policies in place and key players to form opposing viewpoints. Beyond intellectual property, alternative sources for innovation include forming partnerships and moving business activities abroad.
Proprietary drug are chemicals used for medicinal purposes which are formulated or manufactured under a name protected from competition through trademark or patent. The invented drug is usually still considered proprietary even if the patent expired. When a patent expires, generic drugs may be developed and released legally. Some international and national governmental organizations have set up laws to enforce intellectual property to protect proprietary drugs, but some also highlight the importance of public health disregarding legal regulations. Proprietary drugs affect the world in various aspects including medicine, public health and economy.
Biopiracy is defined as the unauthorized appropriation of knowledge and genetic resources of farming and indigenous communities by individuals or institutions seeking exclusive monopoly control through patents or intellectual property. While bioprospecting is the act of exploring natural resources for undiscovered chemical compounds with medicinal or anti-microbial properties, commercial success from bioprospecting leads to the company's attempt at protecting their intellectual property rights on indigenous medicinal plants, seeds, genetic resources, and traditional medicines.