It is widely recognized that intellectual property (IP) rights can create roadblocks throughout the innovation cycle, limiting the possibility of collaboration, follow-on R&D, production, or equitable access to end-result products.
To address these barriers, DNDi’s Intellectual Property Policy is based on two guiding principles that inform all contract negotiations:
- the need to ensure that drugs are affordable and accessible in an equitable manner to patients who need them; and
- the desire to develop drugs as global public goods whenever possible.
DNDi also publishes model contracts or templates of the collaboration and licensing agreements that it signs with public and private partners, including with pharmaceutical companies.
Research Collaboration and License Agreement Template
Development Collaboration and License Agreement Template
DNDi has managed to secure non-exclusive, permanent, irrevocable rights to the drugs it jointly develops with its partners for neglected diseases, with the aim of making them accessible to all patients and ensuring all knowledge generated through the R&D process is publicly shared. The aim is to provide policy makers and global health experts with useful insights, in light of debates rekindled by the COVID-19 pandemic on ensuring that medicines and vaccines developed with public funding guarantee equitable access. This question is also at the core of the ongoing and difficult global negotiations on a future treaty for pandemic preparedness and response.
‘Including access conditions on publicly funded R&D is a key way of operationalizing equity. DNDi’s publication of its licensing model contracts can provide insights on how terms and conditions can be applied in R&D collaborations.’
Michelle Childs, Policy Advocacy Director, DNDi
Our call for change
DNDi advocates for public and philanthropic research funders to build in strong IP and licensing terms into grant agreements that ensure equitable and affordable access to resulting innovations.
Gold standard terms for equitable, affordable access
Using its negotiating experience with pharmaceutical companies and others, DNDi has defined ‘gold standard’ licensing terms to ensure equitable and affordable access to treatments, including, whenever possible:
- terms such as perpetual royalty-free, non-exclusive, sub-licensable licenses to DNDi in the contractually defined target disease(s);
- worldwide research and manufacturing rights;
- commitment to make the final product available at cost, plus a minimal margin, in all endemic countries, regardless of income level; and
- non-exclusivity, enabling technology transfer and local production to multiply sources of production and decrease price of product.
Research Collaboration and License Agreement Template
Development Collaboration and License Agreement Template
Our call for change
DNDi advocates for countries’ use of flexibilities available under the TRIPS agreement to enable production or importation of affordable medicines.
How do we manage IP and licensing?
Early-stage drug discovery – the NTD Drug Discovery Booster
Initially, DNDi screened large collections of quality compounds through bilateral agreements with several pharmaceutical companies and other institutions, using new, medium- to high-throughput screening assays developed by DNDi.
In 2015, DNDi launched the NTD Drug Discovery Booster with eight pharmaceutical companies to significantly accelerate the discovery of validated hits through a multilateral cooperative mechanism. Under this collaborative framework, participating companies commit to not protecting the resulting hit if the ‘seed’ compound is in the public domain or belongs to DNDi. If it belongs to one of the participating companies, the commitment is to license any resulting hit series to DNDi on a non-exclusive basis for use and affordable distribution in the treatment of Chagas disease or leishmaniasis. Booster consortium partners include AbbVie, Astellas, AstraZeneca, Celgene (now part of Bristol-Myers Squibb), Eisai, Merck, Shionogi, and Takeda Pharmaceutical Company Limited.
Later-stage compounds – hepatitis C
In the case of compounds more advanced in development, DNDi negotiations must consider the partner’s investments prior to DNDi collaboration, and existing IP. In the case of ravidasvir for the treatment of hepatitis C, the compound had been developed up to a Phase III trial when DNDi negotiations started in 2015. DNDi negotiated a non- exclusive licence agreement from the patent owner, Presidio Pharmaceuticals, to further demonstrate the safety and efficacy of ravidasvir as a pan- genotypic treatment, used in combination with sofosbuvir, and make it available at an affordable price in LMICs. Development has been conducted in collaboration with the Egyptian company Pharco Pharmaceuticals and registration obtained in 2021, was undertaken in collaboration with Malaysian company Pharmaniaga, which is the market authorisation holder.
Non-exclusivity was deemed essential to increase competition in the field and drive down the prices of hepatitis C treatments. However, the agreement includes, for the first time in DNDi history, the payment to Presidio Pharmaceuticals of tiered royalties of 4 or 7% of net sales (based on gross national income) – but only in the countries where Presidio Pharmaceuticals holds patents on ravidasvir. Such royalties will be borne by DNDi sub-licensees, namely the companies which will benefit from a technology transfer from DNDi and Pharco Pharmaceuticals to sell ravidasvir.
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