Equitable Access Licences
What it is
Equitable Access Licences (also called Humanitarian Use Licensing) are one way to promote private sector involvement in the development of a product. These licences can also serve to maintain technology transfer options for developing countries and are therefore highly relevant to public sector research.
Equitable Access Licences (EALs) ensure that inventors and technology suppliers protect the possibility of sharing their IP with people in need, or with people/organisations who work to benefit those in need. - They set the conditions for the provision of access to innovations on a royalty-free basis or at a reduced cost. EALs ensure that R&D products are available as public goods while maintaining the incentive function of exclusive Intellectual Property Rights.
How it works
EALs are subject to negotiation between the parties involved. Both parties should take into account the concerns of the other when entering the negotiations. Public sector research organisations want to ensure wide distribution for their products at low cost; the private sector is concerned with revenue and liability. Depending on the different technologies that should be assigned via a Humanitarian Use Licence, there are different approaches of how to formulate a HUL.
Here are some examples of strategies of how an EAL can be assigned.
Assigning non-exclusive licenses: The public-sector Agricultural Genetic Engineering Institute (AGERI) in Egypt owns patents covering a technology for producing insect-resistant maize via the insect toxin Bacillus thuringiensis (Bt). AGERI allowed the US company Pioneer Hi-Bred to evaluate some of these patented proteins and genes, and in exchange Pioneer Hi-Bred trained AGERI scientists in methods for characterising Bt and maize transformation technologies. The Agricultural Biotechnology Support Project of the US Agency for International Development supported the project. Now, AGERI is commercialising the technology in Egypt while Pioneer Hi-Bred has commercial rights in the US.
Source http://www.cgiar.org/biotech/rep0100/Madkour.pdf
Pricing:The WHO Tropical Disease Research Programme (TDR), the Medicines for Malaria Venture (MMV), and GlaxoSmithKline have formed a partnership to build on the two-drug anti-malarial, called “Lapdap” by adding artesunate to the combination. The new therapy will be called CDA, for its ingredients chlorproguanil, dapsone, and artesunate. The original Lapdap was conceived by scientists from the Welcome Trust Laboratory in Nairobi and the University of Liverpool, then brought to market by a public-private partnership involving MMV, various British universities, the Welcome Trust, GlaxoSmithKline and the UK Department for International Development. It was approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in 2003. Under the agreement for developing the new triple-drug combination, it will be made available at preferential prices to the public sector in malaria endemic countries.
Source: TDR News No. 72. 2004. “Artesunate combinations are coming: partnership develops Lapdap plus artesunate.”
Available at: www.who.int/tdr/publications/tdrnews/news72/lapdap.htm
Assemblers bringing paddy for milling in South Viet Nam
Market segmentation - Golden Rice:One of the most noted examples of humanitarian IP management involves vitamin A-enriched “golden rice.” Although developed mainly with public sector funding and research, around 45 patents associated with golden rice are owned by approximately 30 companies and public institutions in the US, and only a few patents are held in developing countries. The inventors of golden rice licensed their related inventions to “Greenovation”, a biotech spin-off company from the University of Freiburg, which is owned by the inventors themselves. Greenovation then exclusively licenced its golden rice-related patents to AstraZeneca (now Syngenta). Subsequently, Syngenta entered into a licence agreement with the inventors that allowed them, and Syngenta, to licence golden rice technologies to developing countries. Other companies holding golden rice-related patents also agreed to the same arrangement. The arrangement allows both Syngenta and the inventors to grant licences-with the right to sub-license-to any bona fide research organisation for the development of golden rice. The rice can be used royalty-free and allows farmers to earn as much as $10,000 per year from its sale. Higher sales would require farmers to acquire a commercial licence from Syngenta. The example of golden rice illustrates that it is possible to make IP available for research and commercialisation in developing countries.
Source: www.biodevelopments.org/innovation/ist3.pdf
The Generation Challenge Programme “Consortium Agreement”:
This is an illustration of an agreement not to assert rights. Please view the Generation Challenge Programme “Consortium Agreement” - in particular the amendment clause 24.5 “Agreement not to assert right”
24.5 Agreement Not to Assert Rights. Each Consortium Member hereby agrees that during the term of this Agreement and thereafter it will not assert, directly or indirectly, any claim or cause of action based, in whole or in part, upon the purported infringement for the benefit of Subsistence User of any Challenge Program IP that it may now or in the future own or control, worldwide, based on:
(a) the manufacture, use, importation, offer for sale, sale or other transfer of products, compositions or methods claimed in patents or patent applications included in Challenge Program IP;
(b) the production or reproduction, conditioning for the purpose of propagation, offer for sale, sale or other marketing, exporting, importing or stocking of plants protected by breeder’s rights included in Challenge Program IP; or,
(c) the reproduction, display, performance, modification, preparation of derivative works or distribution of works of authorship (excluding trademarks and trade names) included in Challenge Program IP.
For this clause, and information on the entire agreement please visit: http://www.generationcp.org/iphelpdesk.php?da=0634224
For more information
www.biodevelopments.org/innovation/ist3.pdf
http://sippi.aaas.org/SIPPI%20Humanitarian%20Use%20Report%20-%20July%202004.doc
