confidentiality agreement (nondisclosure agreement, confidential disclosure agreement) (close)
A legal document through which intellectual property can be disclosed by one party to another wherein the latter party is permitted to use the information for certain purposes, and only those purposes, that are stated in the agreement and agrees not to disclose the information to others.
intellectual property (IP) (close)
Creative ideas and expressions of the human mind that have commercial value and are entitled to the legal protection of a property right. The major legal mechanisms for protecting intellectual property are copyrights, patents, and trademarks. IP rights enable owners to select who may access and use their intellectual property and to protect it from unauthorized use.
A grant of permission to use an IP right within a defined time, context, market line, or territory. There are important distinctions between exclusive licenses and nonexclusive licenses. An exclusive license is “exclusive” as to a defined scope, that is, the license might not be the only license granted for a particular IP asset, as there might be many possible fields and scopes of use that can also be subject to exclusive licensing. In giving an exclusive license, the licensor promises that he or she will not grant other licenses of the same rights within the same scope or field covered by the exclusive license. The owner of IP rights may also grant any number of nonexclusive licenses covering rights within a defined scope. A patent license is a transfer of rights that does not amount to an assignment of the patent. A trademark or service mark can be validly licensed only if the licensor controls the nature and quality of the goods or services sold by the licensee under the licensed mark. Under copyright law, an exclusive licensee is the owner of a particular right of copyright, and he or she may sue for infringement of the licensed right. There is never more than a single copyright in a work regardless of the owner’s exclusive license of various rights to different persons.
patent (U.S.) (close)
A grant by the federal government to an inventor of the right to exclude others from making, using, or selling his or her invention. There are three kinds of patents in the United States: a standard utility patent on the functional aspects of products and processes; a design patent on the ornamental design of useful objects; and a plant patent on a new variety of a living plant. Patents do not protect ideas, only structures and methods that apply technological concepts. Each type of patent confers the right to exclude others from a precisely defined scope of technology, industrial design, or plant variety. In return for the right to exclude, an inventor must fully disclose the details of the invention to the public so that others can understand it and use it to further develop the technology. Once the patent expires, the public is entitled to make and use the invention and is entitled to a full and complete disclosure of how to do so.
Your source for expert commentary on IP management issues.
Satyanarayana, K. 2007. HIV/AIDS Vaccine: Indian Council of Medical Research. In Executive Guide to Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (Krattiger A, RT Mahoney, L Nelsen et al.). MIHR (Oxford, UK), PIPRA (Davis, USA), Oswaldo Cruz Foundation (Fiocruz, Rio de Janeiro, Brazil), and bioDevelopments-International Institute (Ithaca, USA). Available online at www.ipHandbook.org.
Editors’ Note: An earlier version of this case study was presented at the MIHR conference Using Intellectual Property for Improved Health in Developing Countries: An Evidence Based Approach to Good Practice, Bellagio, Italy, June 14–18, 2004.
© 2007. K Satyanarayana. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.
HIV/AIDS Vaccine: Indian Council of Medical Research
This HIV/AIDS initiative is a collaborative venture between the Indian Council of Medical Research (ICMR), New Delhi, the International AIDS Vaccine Initiative (IAVI), New York, National AIDS Control Organization (NACO/Indian Ministry of Health), New Delhi and Therion Biologics, Cambridge, Mass. The project aims to develop a safe and effective HIV/AIDS vaccine—such development has been mandated by the Indian government—for India and other developing countries. The vaccine has now been developed by ICMR in collaboration with Therion and is undergoing clinical trials.
Under the terms of this public-private partnership (PPP), ICMR will provide technical expertise, obtain all necessary permissions and permits, conduct R&D to develop the vaccine in collaboration with Therion, prepare the community (in India) for clinical trials, and conduct the trials. ICMR will select an Indian partner for the manufacture of vaccine and has overall responsibility for ensuring that the project is executed according to its objectives. NACO will facilitate the execution of the project. IAVI will support the project, facilitate development of an appropriate vaccine through transfer of technology from Therion, engage in capacity building and advocacy, and facilitate technology transfer for the local manufacture of the vaccine. Therion will assist ICMR with the vaccine development and help transfer technology to the selected Indian manufacturer.
The project involved an overall agreement between ICMR and IAVI, a patent and technology transfer agreement between ICMR and IAVI, and an IP (intellectual property) rights and confidentiality agreement between ICMR and Therion Biologics. A project management committee was set up, comprising representatives from ICMR and IAVI, to coordinate and monitor all activities and assessments of the R&D programs. The committee is also responsible for strategic IP management.
All new intellectual property generated will be jointly held by IAVI and ICMR, and the Indian government shall have the exclusive right to use all patent and other new IP rights to inventions arising out of the program to benefit India and its neighboring countries. The ICMR will grant nonexclusive royalty-free and sublicensable licenses to all new intellectual property arising out of the project to selected third parties in order to make, use, sell, and import the HIV/AIDS vaccine in countries other than those indicated in the agreement (to the extent ICMR has the right to permit this use). The IAVI shall have IP rights for rest of the world.
Initially, the program was to be implemented only in India, but the Government of India, realizing that the program could benefit other developing countries as well, asked for licensing rights. In arriving at this realization, policymakers (bureaucrats) of the government needed to be educated about intellectual property and its role in technology transfer. This case has highlighted the importance of keeping government officials involved in order for an international PPP to be successful.
Although no patents were filed in India, a significant amount of clinical trial data was generated. From an IP perspective, it was crucial to recognize private sector interests. Therion has global rights for the technology needed for the vaccine construct, but India will have rights to improvements made to the vaccine. Therion’s stringent IP regulations meant confidentiality agreements were imposed on collaborating scientists, which the Government of India appreciated.
The recruitment process for the vaccine trials envisages serious ethical concerns as well as potential liability issues, as the vaccine is for HIV/AIDS. It was recognized that clinical trials must be conducted in a fair and transparent manner and the interests of participants protected through informed consent as per the ICMR’s Ethical Guidelines and that all necessary safeguards to protect subjects of the study had to be built into the system.
The case study recognizes (1) the role of “honest broker” that international nongovernmental organizations like IAVI can play in a PPP, providing funding and access to high technology from a private company; (2) the need to educate policymakers (bureaucrats) from the beginning of a project to ensure smooth progress; and (3) the equally crucial need to involve policymakers, lawmakers, politicians, women’s associations, and other civil society organizations in the execution of such projects that envisage clinical trials. This project is offered as an example of productive North–South collaboration and broad capacity building and a partnership in which the strengths of the partners complement each other.
Types of Agreements
As part of the HIV/AIDS project, ICMR entered into the following types of agreements:
IP Rights Decisions and IP Management
The project has resulted in the following arrangements with respect to IP rights and strategic IP management issues:
Policy is implemented through a project management committee comprising representatives from the IAVI, ICMR and NACO, and jointly chaired by members appointed by ICMR and IAVI. The committee is responsible for the coordination and monitoring of all activities, periodic assessments and updates, and refinements and revisions of the R&D program.
External Factors That Affected Decision Making
A number of external considerations influenced ICMR’s strategies and decision making. These include:
Key Lessons Learned and Health-Access Issues
The following items represent key lessons from ICMR’s HIV/AIDS vaccine project, which may be applicable to other entities that aim to utilize intellectual property: