exclusive license agreement (close)
A legal document licensing intellectual property to another party for its exclusive use. Exclusively licensed patent rights cannot, within the scope or field of the exclusive license, be subsequently or simultaneously licensed to any other party.
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.
Mihr/Pipra. 2007. A Better Tuberculosis Vaccine: Aeras and Vanderbilt University. In Executive Guide to Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.
Editors’ Note: This case study was prepared by MIHR members of the Technology Managers for Global Health (TMGH), a special interest group of the Association of University Technology Managers (AUTM) (see www.tmgh.org) and adapted for this Executive Guide. The original version was published as part of a collection of case studies: MIHR/TMGH. 2007.Academic Licensing to Global Health Product Development Partnerships (ed. U Balakrishnan). MIHR: Oxford, U.K.
© 2007. Mihr/Pipra. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.
A Better Tuberculosis Vaccine: Aeras and Vanderbilt University
Tuberculosis (TB) is a contagious disease caused by the bacterium Mycobacterium tuberculosis. Approximately two billion people (one-third of the world’s population) are infected. A TB infection causes active disease in only about five to ten percent of these individuals. The remaining individuals have latent disease that causes no obvious symptoms and cannot be passed on to others. The disease can become active when the immune system is weakened (most commonly when individuals contract HIV/AIDS). TB caused an estimated 1.7 million deaths in 2004 with the highest number of deaths occurring in Africa.
In 1921, BCG (Bacille Calmette-Guerin), the current TB vaccine, was developed using Mycobacterium bovis, a bacterium related to M. tuberculosis.1 However, epidemiological evidence indicates that the effectiveness of BCG diminishes over a person’s lifetime. In addition, the current TB treatment regimen is complicated. It requires patients to take as many as four different drugs for at least six months. Of even greater concern, a multi-drug-resistant strain of the bacterium is emerging. Therefore, an improved TB vaccine would be highly valuable in the effort to stop TB.
The Aeras Global Vaccine Foundation (Aeras)2 was founded in 1997 with the mission to develop and to ensure access to new, effective TB vaccines. Aeras adheres to an industrial model of vaccine development, having created a pipeline of lead and back-up TB vaccine candidates. These include vaccines for initial vaccination and boosters for infants and adolescents. Aeras is also developing vaccines to protect against the activation of latent infections and second-generation technologies with improved product profiles. Aeras has established infrastructure for both preclinical development and clinical trials. They have recently opened a manufacturing facility in Maryland that is capable of providing 150 million annual vaccine doses by 2010. The Bill and Melinda Gates Foundation3 recently awarded Aeras a grant of US$82.9 million to develop a new TB vaccine. Aeras’s goal is to obtain regulatory approval for a new vaccine regimen in seven to ten years.
On May 4, 2006, Aeras and Vanderbilt University4 announced an exclusive license agreement for a TB vaccine based on technology developed at Vanderbilt. The technology enhances the ability of the BCG vaccine to trigger immune system responses. Under the agreement, Aeras will use the technology to modify the BCG vaccine and will guide the new vaccine through clinical trials. The license agreement grants Aeras exclusive rights for developing a TB vaccine. If a successful vaccine results from the use of this technology, then Aeras will manufacture the new vaccine at its facility in Rockville, Maryland. Vanderbilt retains rights to the technology as a delivery system for other uses. This could potentially include new vaccines or immunotherapies against other diseases from HIV and malaria to cancer.
The Vanderbilt technology, called pro-apoptotic BCG, is designed to weaken the BCG virus. It is a version of BCG with genetic modifications designed to inhibit the bacterium’s ability to stop the programmed cell death of a patient’s immune cells. These modifications are likely to result in a vaccine that provides better, longer-lasting protection against TB and may prevent progression to active TB among people with compromised immune systems.
The Gates Foundation awarded funding to Aeras Global TB Vaccine Foundation, a product development partnership, to develop the TB vaccine. Vanderbilt University developed the technology upon which the new vaccine will be based.
Progress, Current Status, and Goals
The goal of the project is to develop a new TB vaccine and conduct clinical trials to secure regulatory approval. Aeras has established test sites for the vaccine near Bangalore, India, and Cape Town, South Africa. Aeras’s goal is to obtain regulatory approval for a new vaccine regimen in seven to ten years (with either the pro-apoptotic BCG or another candidate).
Vanderbilt University granted Aeras an exclusive license in the TB field of use. Vanderbilt retains rights in other fields. The license is royalty bearing (including stacking terms) and stipulates milestone payments. Patent costs are paid by Aeras.
All referenced Web sites were last accessed between 1 and 10 October 2007.