The section of the patent that defines an invention (the technology that is the exclusive property of the patentee for the duration of the patent) and is legally enforceable; that is, the claims set the metes and bounds of the patent rights. The patent specification must conclude with a claim, particularly pointing out and distinctly claiming the subject matter that the applicant regards as the invention or discovery. The claim or claims are interpreted as set forth in the specification: the terms and phrases used in the claims must be sufficiently described in the specification, that is, patent claims must read in the light of the specification. The specification discloses and the claims define the invention.
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.
traditional knowledge (close)
Tradition-based creations, innovations, literary, artistic or scientific works, performances and designs originating from or associated with a particular people or territory.
Your source for expert commentary on IP management issues.
Bunn AE. 2007. Gastrointestinal Medicines from African Aloe: Baylabs (Pty) Ltd. 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. AE Bunn. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.
Gastrointestinal Medicines from African Aloe: Baylabs (Pty) Ltd.
The plant species Aloe ferox, indigenous to the eastern and southeastern Cape regions of South Africa, has sustained an aloe tapping industry for more than 250 years. However, the industry has failed to substantially improve the economic conditions of communities in the region. Between 1,600 and 3,000 aloe tappers earn, on average, $150 per month.
In 1998, a method for producing a novel fiber in powder form from the discarded leaves of the plant was patented by South Cape Aloe (SCA). A virtual startup company with a strong emphasis on technology and intellectual property (IP) was subsequently formed in South Africa to develop a product to treat irritable bowel syndrome (IBS) and AIDS-related diarrhea (ARD).
The company, Baylabs, aims to form local partnerships to develop, manufacture, and distribute the product to both developed and developing countries. Baylabs’ strategy is to focus on R&D to generate and protect intellectual property and products, while outsourcing noncore functions such as manufacturing, sales, and distribution.
SCA granted the manufacturer African Aloe exclusive rights to make the powder and gained a share hold in Baylabs in exchange for exclusive, royalty-free, worldwide rights to exploit the powder. Baylabs filed a Patent Cooperation Treaty application for the novel powder formulation, with national filings in 13 European countries and prosecutions in the United States, Japan, Australia, and China.
Baylabs has developed four over-the-counter natural remedies from A. ferox that are distributed to pharmacies. The revenue generated is used to file patents and obtain scientific evidence of efficacy for gastrointestinal (GI) problems. The products will continue to be marketed and regulated as a dietary supplement while scientific evidence is being gathered and until the product is registered as a medicine.
The company’s value has grown through its intellectual property and clinical trials of IBS and infantile diarrhea disease (IDD). Discussions are underway with international strategic partners regarding exclusive license agreements; efforts to secure government or venture capital funding are in progress. Baylabs plans to build preprocessing field plants and a facility to manufacture the powder, with the aloe tapper community as an equity partner, which could lead to increased salaries (almost double) for aloe tappers.
There is no traditional knowledge (TK) involved in using the waste leaf but TK exists in using the A. ferox. A key feature of this case study is the potential for other treatments; the formulation can be used for IBS in developed countries and ARD in developing countries. Once clinical trials have been completed, Baylabs plans to register the product as a medicine. However, the advantages of registering the product as a drug rather than as a food supplement have been questioned. Such registration would require, among other things, strict manufacturing quality standards and could be fraught with regulatory difficulties. Many intended herbal remedies, if subjected to full clinical trials and toxicity (as required by regulation), would not meet these standards.
In natural products a key issue is long-term planning and supply. If the product were to become a blockbuster, arrangements would have to be made for the community to benefit, such as through a trust fund. It is important to recognize traditional harvesters and traditional plant users and their stake in bioprospecting. Baylabs is set to give the aloe tapping community a stake in the project.
The Baylabs example illustrates how the development of a technology can have positive commercial and positive moral outcomes. Through the creation of strategic alliances and partnerships, there can arise opportunities for securing and developing intellectual property for the benefit of underserved communities in both developed and developing countries.
Types of Agreements
As part of the GI medicines from African aloe project, Baylabs has entered into the following types of agreements:
IP Rights Decisions and IP Management
Baylabs has faced key areas of IP rights decision making and strategic IP management issues including:
The SA Medicines Control Council (MCC) is presently formulating policy on traditional and herbal medicines. Companies are therefore able to place over-the-counter products in the market without clinical trials. These may not make any medicinal claims. This enabled Baylabs to place four elementary products (aloe gel, a high fiber tablet, a laxative tablet, and an antiarthritic tablet containing aloin as the active ingredient) on the market and to secure income from their sale. These products had to be submitted to the traditional medicines registry at the MCC to enable continued manufacturing and sales.
External Factors That Affected Decision Making
A number of considerations influenced Baylabs’ strategies and decision making. These include:
Key Lessons Learned
The following items represent key lessons from the Baylabs GI Medicines/Aloe project, which may be applicable to other companies that aim to utilize intellectual property: