KNOWLEDGE PORTAL
on innovation and access to medicines

SYNTHESIS OF THE LITERATURE

 

FEATURES/CHARACTERISTICS

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Patent pools are mechanisms that aim to facilitate both research and development (R&D) and access to medicines within the context of the existing international intellectual property rights framework. Because R&D can require access to many patents held by different entities, product developers may need to negotiate rights to use IP and pay royalties to different patent owners. To address this complex patent landscape, patent pools were conceived as ‘“one-stop shop[s],”’ wherein different IPR holders license their patents into the pool to be bundled together for licensing out (subject to payment of a corresponding royalty), to the other patent owners and/or to third parties (Hoffman and So 2015).

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Licenses granted by patent pools have been referred to as “‘one-stop licenses’” since it cuts the need to negotiate individual licenses with the various patent holders and instead offers all patents relevant for a particular invention in one license agreement (van Zimmeren et al. 2011). Though they were frequently used in the information technology field, Heller and Eisenberg (1998) expressed skepticism that patent pools would be attractive to drug developers considering that patent exclusivity is deemed particularly valuable and profitable in this field (Heller and Eisenberg 1998).

 

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ADVANTAGES

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The pooling of patents, which can make existing patents on compounds accessible to third parties, is expected to facilitate the development of fixed-dose combinations or paediatric formulations of existing drugs, as well as allow generic drug development to begin before the relevant patent term expires (Satyanarayana and Srivastava 2010). Patent pools, in general, are credited for lowering costs for license negotiations, decreasing the risk of patent litigation and addressing the issue of “blocking patents” (Grassler and Capria 2003).

 

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EXAMPLES

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1.a MPP

 

Most of the literature has focused on one particular initiative, the Medicines Patent Pool (MPP). The MPP was created by UNITAID in 2010 (Wirtz et al. 2017). Bermudez and Hoen (2010); Childs (2010) discuss the considerations in setting up the patent pool (Bermudez and Hoen 2010; Childs 2010). MPP focuses on making priority antiretroviral drugs (ARV) covered by existing patents accessible to patients in low and middle income countries (LMICs) by obtaining voluntary license agreements from various patent owners, then sublicensing the patents on non-exclusive terms to various generic drug manufacturers for the development, manufacture and distribution of generic ARV drugs (Juneja et al. 2017). Wirtz et al. (2017) lists the significant milestones achieved by the Medicines Patent Pool from 2010 to 2015, particularly those relating to the patent licenses granted and their effect on drug supply and cost savings (Wirtz et al. 2017). Another paper estimated the cost savings resulting from MPP’s ARVs licenses at USD 2.3 billion from 2010 to 2028 (Juneja et al. 2017). Analysts have noted that the success of the MPP depends on whether patent-holders are willing to license their patents to the pool and be licensed to third parties (Hoen and Passarelli 2013; Hoen et al. 2011). The provisions of MPP licenses, especially those with the pharmaceutical company Gilead, have been analyzed and discussed in detail in the following papers: The Medicines Patent Pool: Promoting Access and Innovation for Life-Saving Medicines through Voluntary Licenses (Cox 2012), A Sliver of Hope: Analyzing Voluntary Licenses to Accelerate Affordable Access to Medicines (Baker 2018), Medicine Patent Pool – Pharma Philanthropy or PR?  (De Luca 2015). As of 2018, the MPP reported that that its adult formulation licenses cover 87 to 91% of HIV patients in developing countries (Medicines Patent Pool n.d. a). Also, every widely-patented WHO-recommended antiretroviral medicine has been licensed to the MPP (See Medicines Patent Pool n.d. b). 

 

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1.b Criticisms of MPP

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I-MAK (2011) analyzed the benefits projected by the MPP in 2009 to the UNITAID Executive Board. Among others, it argued against the following claims: that the MPP would enable the development of fixed-dose combinations and solid pediatric formulations as well as “widespread voluntary licensing.” With respect to these criticisms, I-MAK (2011) provided recomputed financial savings as opposed to those asserted by the MPP (I-MAK 2011).  A noted limitation of this patent pool is the voluntary nature of its licensing process, mainly relying on pharmaceutical companies granting use of their licenses to the pool and on the generic manufacturers making use of these licenses (Bermudez and Hoen 2010). Baker (2018) observes the increased yet limited geographical reach of MPP licenses, particularly that “[t]he territorial coverage of MPP licenses averages only 90% for adult licenses and 99% for pediatric licenses” in low-and middle-income countries. A number of MICs are excluded from this coverage, which mean that millions are still unable to benefit from the licensed medicines. Contrary to criticism, the MPP licenses preserve the right to use of IP flexibilities allowed under the TRIPS Agreement, e.g. patent oppositions or cancellations and compulsory licenses (Baker 2018). The application of competition law has relevance to patent pools (van Zimmeren et al. 2011; Simon et al. 2005).

 

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2. Others

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The Severe Acute Respiratory Syndrome (SARS) pool was intended to be an initial experiment in the life sciences field to set up a patent pool. However, this was never operationalized and has since been discontinued. It was meant to facilitate research and development of SARS vaccines by pooling relevant patents (van Zimmeren et al. 2011). The World Intellectual Property Office Re:Search (WIPO Re:Search) project is another approach to patent pooling. The following organizations have granted royalty-free access to their patents related to neglected tropical disease drug development: GlaxoSmithKline (GSK), Alnylam, AstraZeneca, Eisai, MSD, Novartis, Pfizer and Sanofi (Ziegler, Gassmann, and Friesike 2014). WIPO Re:Search has its origins in the GSK Pool for Open Innovation against Neglected Tropical Diseases, which was then subsequently housed with BioVentures for Global Health (BVGH) before being moved to WIPO (Eisenberg 2014). Schoen-Angerer (2011) pointed out that WIPO Re:Search patents were only available for use in least-developed countries and therefore had very limited geographical scope; other developing countries would only be able to obtain access to the IP through negotiation (Schoen-Angerer 2011).

 

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SUGGESTIONS FOR EXPANDED MODEL

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Patent pool models have been recommended to facilitate R&D and access to the full WHO list of essential medicines (Wirtz et al. 2017) and drugs for “orphan/rare diseases” (Muthyala 2011). Patent pools have also been suggested to advance R&D in the fields of nanotechnology (Sanhai, Spiegel, and Ferrari 2007), genetics (Verbeure et al. 2006; Van Overwalle et al. 2006; Ebersole, Guthrie and Goldstein 2005) and stem cell (Winickoff, Saha and Graff 2009).

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  → See also the review on Voluntary Licensing

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RESEARCH GAPS

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• Analysis of interaction between patent pools and other policies intended to promote innovation or access to medicines

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CITED PAPERS WITH ABSTRACTS​