The process of taking an invention or discovery to the marketplace. It involves working the idea into a business plan, consideration of protection options, and determining how to market and distribute the finished product.
The term, or length of time that an IP right lasts. A U.S. utility patent on an invention, for example, has a duration of 20 years from the date on which the patent application was filed, as does a plant patent. The duration of a U.S. copyright is usually the life of the author plus 70 years (for works created after January 1, 1978). Protection of information as a trade secret lasts as long as the information remains secret. Duration of a trademark continues as long as it is used (as a source indicator) and properly maintained/protected.
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.
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. Reduced-Duration Tuberculosis Treatment: TB Alliance and Bayer HealthCare. 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.
Reduced-Duration Tuberculosis Treatment: TB Alliance and Bayer HealthCare
Tuberculosis (TB) is caused by Mycobacterium tuberculosis, slow-growing bacteria that thrive in areas of the body that are rich in blood and oxygen. TB in the lungs is easily spread to other people through coughing or laughing. M. tuberculosis infects one-third of the world’s population, resulting each year in nine million new cases of active TB and two million deaths, 90 percent of them in developing countries. China and India alone account for 35 percent of all estimated new TB cases each year. An estimated one billion people will be newly infected between 2000 and 2020; 200 million will fall ill and 35 million will die. TB is a leading cause of death among people living with HIV/AIDS, and multi-drug resistant strains are spreading at a rate of 300,000 newly diagnosed cases a year.
The R&D Challenge
The TB drug market will require sufficient incentives to support the research needed to develop a pipeline of continually improving drugs. Even with the market potentially reaching US$700 million by 2010, it is concentrated in poor countries, and no single industry player has been able to pursue the full development of an anti-TB drug. The Global Alliance for TB Drug Development (TB Alliance)1 was designed by the international community as the primary instrument to fill this vacuum and to ensure that new anti-TB drugs are affordable and accessible in endemic countries.
Current TB therapy is based on four drugs for preventing multi-drug-resistant TB. These drugs were discovered 40 or more years ago and must be administered for six to eight months, often under the direct observation of a health-care provider. The four-drug regimen consists of isoniazid, rifampin, pyrazin-amide, and ethambutol. There is a real need for new treatments that are less expensive, of shorter duration, and easier to manage.
Moxifloxacin is an antibiotic that was first approved in 1999 and is currently used in 104 countries to treat certain bacterial respiratory, skin and intra-abdominal infections. The antibiotic has been used by more than 47 million patients worldwide. It is generally well tolerated but treatment may result in certain usually mild side effects, including nausea, diarrhea, and dizziness. In vitro and in vivo studies have demonstrated moxifloxacin activity against M. tuberculosis. Investigators at Johns Hopkins discovered that substitution of moxifloxacin for isoniazid in the TB treatment regimen reduced treatment time by two months in mice. The treatment regimen included rifampin, pyrazinimide, and either moxifloxin or isoniazid.2
In October 2005, the TB Alliance and Bayer Healthcare AG3 announced a partnership to coordinate a global clinical development program to study the potential of moxifloxacin to shorten the standard six-month treatment of TB by two to three months. The trials will evaluate whether the substitution of moxifloxacin for one of the standard TB drugs (ethambutol or isoniazid) eliminates TB infection faster than the current standard therapy. If successful and approved by the respective regulatory agencies, a new, shorter regimen could be available within the five years.
The Phase II and III clinical trial program involves countries in four continents and will enroll close to 2,500 patients with TB. The trials will be carried out in Brazil, Canada, South Africa, Spain, Tanzania, Uganda, the United States, and Zambia. If the trials are successful, the partnership aims to register moxifloxacin for a TB indication. Upon regulatory approval, the partnership is committed to making it affordable and accessible in developing countries, where the disease is most prevalent and deadly.
For this project, Bayer will donate moxifloxacin for each trial site and will cover the costs of regulatory filings, and the TB Alliance will coordinate and help cover the costs of the trials, seeking to leverage support from the U.S. Centers for Disease Control and Prevention (CDC), the Orphan Products Development Center of the U.S. Food and Drug Administration (FDA) and the European and Developing Countries Clinical Trials Partnership (EDCTP). In May 2006, the TB Alliance received a US$104 million grant from the Bill and Melinda Gates Foundation. The grant will be used in part to fund Phase II and III trials of moxifloxacin with the goal of showing the efficacy of moxifloxacin in reducing TB treatment times by two months by 2010.
Public health experts note that a shorter TB regimen would help ease the economic burden of the disease, estimated at US$16 billion a year, and enable health-care workers to treat more patients. A shorter treatment protocol may improve patient adherence to therapy and, thereby, help save lives. When patients complete treatment successfully, there is less chance of relapse or of the emergence of drug resistance.
Major partners in the TB treatment project are:
Clinical studies would be carried out by the following entities:
No commercialization plan for the improved treatment has been announced. Funding has been provided to the TB Alliance by:
Progress, Current Status, and Goals
Goals of the TB Alliance are:
Clinical trials are underway:
Licensing deals include the following terms:
All referenced Web sites were last accessed between 1 and 10 October 2007.
2 Nuermberger EL, T Yoshimatsu, S Tyagi, K Williams, I Rosenthal, RJ O’Brien, AA Vernon, RE Chaisson, WR Bishai and JH Grosset. 2004. Moxifloxacin-Containing Regimens of Reduced Duration Produce a Stable Cure in Murine Tuberculosis. Am J Respir Crit Care Med. 170(10): 1131-1134.