Friday, July 22, 2011

Corporate Self-Interest And Strategic Choices: Gilead Licenses To Medicines Patent Pool

Intellectual Property rights and Public Health constitute two increasingly overlapping areas, most specially since 1994 with the creation of the World Trade Organization (WTO) based upon a diverse set of international treaties regulating different aspects of trade and commerce, among them the Trade Related Aspects of Intellectual Property (TRIPS), which for the first time aims to establish a global common ground on regulating (through such instruments as patents) production, trade and stockpiling of pharmaceutical products.  Its implications in terms of access are a matter for concern, and a legitimate human rights issue which we will be following closely. 

Unfair trade is one of the driving forces behind entrenched poverty and widening health disparities.Trade policies impact health through their effects on the social determinants of health as shown in this chart prepared by the Economic Governance for Health
In this occasion we would like to highlight a good piece by Northeastern University School of Law professor (affiliate to its Program on Human Rights and the Global Economy)  and Health Gap Policy Analyst (Global Access Project) Brook K. Baker in IP-Watch on recent developments in the IP and Public Health area, most specially the recent licensing agreement between Gilead and the Patent Pool for medicines.  

Here is the summary with some hyperlinks for further reference. You can read the whole thing   in IP-Watch 

Despite some important advances to the scope of its previous purely voluntary licenses on key antiretroviral medicines, Gilead’s licenses with the UNITAID-sponsored Medicines Patent Pool (MPP) contain unfortunate restrictions that undermine the potential impact of the MPP on access to more affordable generic ARVs of assured quality throughout the developing world. Major defects in Gilead’s licenses include their geographical exclusions of many low- and middle-income countries in North Africa, Asia, and Latin America and the bizarre provisions restricting licenses to Indian generics only and requiring that all licenses source Active Pharmaceutical Ingredients only from Gilead or from licensed Indian suppliers. 

A careful review of available information on Gilead’s patent landscape reveals that it is relying on weak tenofovir patent claims in India as the basis for collecting royalties on sales in 109 of 111 countries where it has no patent claim whatsoever. Generics companies may wisely choose to delink Gilead’s tenofovir API license from the licenses for its pipeline medicines so that they can supply not only those 109 countries (plus India), but also many other middle-income countries where Gilead holds no blocking patent, such as Brazil. In addition, countries should closely analyze Gilead’s patent claims domestically and in India to ascertain whether they need to issue compulsory licenses on Gilead products. If so, sec. 92A of the Indian Patents Act is easily used to permit export of needed quantities to countries with insufficient local manufacturing capacity. Indeed, excluded countries should act quickly and decisively to signal both to Gilead and other ARV right-holders that refusal to cooperate fully with the Patent Pool will result in self-protective measures to access affordable medicines.

Whole article available here 

More on the issue  In the blog