Document Type

Article

Publication Date

6-2020

Abstract

Given the importance of access to medicines to human rights and well-being in Kenya, it is appropriate to analyze whether Kenya has currently incorporated the allowed public health flexibilities to the greatest extent possible in its draft Intellectual Property Bill, 2020. This analysis will focus on the patent, utility model, and enforcement measures only as they are the ones directly relevant to access to medicines and other health technologies. The analysis starts with the premise that Kenya wishes to avoid granting unwarranted patents on unworthy inventions, especially with respect to medicines and other health technologies. In particular, the assumption is that Kenya wishes to avoid granting secondary patents or minor variations to known medicines and medical technologies which have the sole effect of extending patent monopolies and preventing local generic production or importation. It is assumed that Kenya wants to have a patent regime that prevents granting patents on new medical uses of medicines and on new formulation and dosages. In a word, the analysis assumes that Kenya wants to avoid evergreening. It assumes instead that Kenya wants to maximize TRIPS-compliant policy space to minimize unneeded patent barriers and further to bypass patents to advance its public health and public interest needs. Finally it assumes that Kenya further desires to expand policy space that would allow growth of domestic and regional pharmaceutical capacity.

In crafting these recommendations, the author has relied extensively on EAC and COMESA recommendations that adoption and use of TRIPS-flexibilities be maximized, on academic and think-tank commentary, and on best practices from countries that have adopted and successfully used TRIPS flexibilities. The paper also draws on the positive example of India, which has adopted the vast majority of recommended TRIPS-compliant public health flexibilities.

In sum, there are many positives in the proposed Kenyan Intellectual Property Bill, 2020, that have at least partially incorporated desired flexibilities but there are important gaps and omissions as well. On the plus side, the Bill incorporates several important TRIPS public-health flexibilities, including parallel importation and the right to issue government use and compulsory licenses. The Bill also incorporates a research exception and promotes close regulation of anti-competitive provisions in voluntary licenses. Also on the plus side, the Bill has updated the 2001 Act to adopt more rigorous standards of patentability and disclosure, including additional exclusions from patentability for new methods of using and new uses of existing medicines and required disclosures to include the best method for practicing the invention. However, the proposed Bill could still include even higher standards of patentability, more exceptions to exclusive patent rights, and strong pre- and post-grant opposition procedures. It could also make it easier to issue government use and compulsory licenses and broaden even further the grounds for doing. Finally, It should also ensure that utility models do not cover medicines or other medical technologies.

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