Surprise! Much Work Being Done On Transparency Of Patents On Medicines

2016:1 KEI Briefing Note
Transparency of Patent Landscapes
April 25, 2016

At an April 12, 2016 WIPO seminar, Reed F. Beall and Amir Attaran presented a paper, “Patent-based Analysis of the World Health Organization’s 2013 Model List of Essential Medicines,” which includes the following odd comment:

“Strangely, the public health community has not placed much priority on patent transparency, although it has often expressed concern about the effect of patents on medicine access.” [page 26]

According to a report in IP Watch, Reed Beall criticized the recent United Nations Secretary-General’s High Level Panel on Access to Medicines, saying “amazingly people were more interested in having the ideological debate than simply focusing and asking for the data that can tell us exactly where there might be medicines access problems so that action can be taken.” [Ideologies Fly In Discussion Of WIPO Pharma Report Calling For Less Ideology, Catherine Saez, IP-Watch, March 13, 2016]

In the Beall/Attaran paper [KEI’s April 12, 2016 comment here: http://www.keionline.org/node/2467], and in the WIPO seminar discussions about the paper, the authors have held themselves out as more or less lonely voices calling for transparency of patent landscapes on essential medicines. This surprised and offended the many people who have not only been concerned about the lack of transparency on patent landscapes, but have been doing most of the work in digging out the facts, and/or proposing remedies.

The Beall/Attaran paper deals specifically with the WHO Essential Medicines List (EML), and the authors might make the argument that not much is known about the patent landscape of the entire EML, per se, but that really misses the point. There are many studies and commentaries on the patent landscape for medicines that are essential, including both those on and off the WHO EML. Much of the work in publishing patent landscapes in recent years has been done by MSF, I-Mak, and the Medicines Patent Pool, as well as several academics and health NGOs. NGOs, including but not limited to KEI, have also addressed policy issues related to the transparency of patent landscapes, not only for medicines, but also in other areas, including clean energy, climate change, and standards essential patents on mobile computing devices, for example.

Below are just a few of the many data points regarding transparency of patents, most of them on medicines. Few of these deal only with the WHO EML, for two well-known reasons.

1. First, from a historical perspective, the EML has generally avoided patented medicines. This includes the outdated version (2013, 18th Edition) that Beall and Attaran studied in their recent report.KEI published an analysis by Paul Miano in 2011 which found that the WHO EML excluded all cancer drugs new enough to be patented. [2011:1. KEI Research Note: Paul Miano. Cancer: Approval, ownership, market structure, and placement on WHO Model Essential Medicines List, for 100 new molecular entities (NMEs) on the NCI alpha list of cancer drugs and vaccines.]Until the EML began to change its policies on patented medicines, continually looking to find patents on the EML was mostly about proving the obvious — a list that avoided patented medicines had few patents.
2. Second, for those drugs that were likely to be patented, such as the drugs on the EML for HIV/AIDS, or more recently drugs for TB, HCV, and other illnesses where treatment efforts were being ramped up for medical reasons, studies have generally offered a deeper analysis focused on specific products, and the specific challenges of overcoming those patents, including patent evergreening on new formulations and new uses. There were also proposals to remedy the lack of transparency of patent landscapes.

This note addresses an exaggeration that seemed intended to portray groups concerned about patents and health as driven by ideological concerns, rather than an empirical approach. There have been extensive efforts for several years to improve the transparency of patent landscapes, involving many players. The work that Beall and Attaran dismiss as scattershot includes projects that have been the most important in overcoming patent barriers in places where they are consequential.

The following Annex provides a number of data points to illustrate how much is being done on this topic, though it is certainly not complete (See WIPO’s http://www.wipo.int/patentscope/en/programs/patent_landscapes/ for many others not mentioned here). Apologies for the inconsistent approach to citations.

Annex: Some data points on the efforts to expand transparency of patent landscape

For the extensive Annexes, please see the original KEI blog post here.