Beyond exclusion of pharmaceutical products from patentable subject matter as a solution to limited access to medicines in Africa

In the past few months, the US House of Representatives has held several hearings with pharmaceutical companies on the high prices of prescription drugs and the impact on patients. US Senators have also joined the fray broaching the idea of reforming the US patent system and reducing the exclusivity period for prescription drugs.

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Article 27(3) of the TRIPS Agreement lists specific subject matters that Member States may exclude from patent protection while Article 27(2) offers Member States the leeway to exclude other subject matters from patent protection for the purpose of protecting ordre public or morality or human, animal or plant life or health. The leeway to indicate exclusions from patentable subject matter is not available when the grounds for exclusion is merely that the laws of such Member State prohibits the exploitation of such subject matter. As a result, while the range of patentable subject matter varies across Member States, pharmaceutical products usually escape exclusion from patentable subject matter in most countries.

Exclusion of pharmaceutical products from patentability in Africa
Even though Africa as a region does not have a specific single regional convention or agreement that compel Member States to have similar rules regarding patentable subject matter (like the EU for instance), most African countries do not exclude pharmaceutical products from patentable subject matter. Between the two main IP conventions in Africa: African Regional Intellectual Property Organisation (ARIPO) and African Intellectual Property Organisation (OAPI), excluded patentable subject matters vary. Outside both OAPI and ARIPO, Least Developed Countries like Madagascar, South Sudan, Sudan, Angola, Libya, who are not signatories to either convention, may exclude applications for patents related to pharmaceutical products.

Patents in OAPI Member States can only be issued by OAPI and so, OAPI Member States share harmonised rules on patentable subject matter and only exclude the subject matters specifically permissible under the TRIPS Agreement. By extension, the 17 countries that are signatories to the OAPI Convention do not exclude pharmaceutical products from patentable subject matter. Once a patent application has been examined and granted by OAPI, the patentee will enjoy patent protection in the designated member states.

The situation is different with respect to ARIPO and its Member States. ARIPO Member States can issue national patents. Accordingly, after ARIPO has examined a patent application, Member States may still reject the application where it is incompatible with their national patent laws. However, while most ARIPO Member States do not exclude pharmaceutical products from patentable subject matter, some did and/or still do. Under Section 8(3)(f) of Uganda’s Industrial Property Act 2014, pharmaceutical products are excluded from patentable subject matter until 1 January 2016 or some other extended period as the WTO allows it as a Least Developed Country (LDC). This exclusion now extends to 2033 at least, given the WTO’s decision to continue to exempt Least Developed Countries from the application of the TRIPS Agreement on pharmaceutical products. For Rwanda, while its IP Policy 2009 indicates that it will maintain the exclusion of pharmaceutical products from patentability in accordance with the WTO Decision providing transition period for LDCs until, at least, 2016, the WTO extension allows it to validly retain its Article 18(8) of its Law on the Protection of Intellectual Property 2009, covering the exclusion. Despite these specific exclusions, these countries have usually allowed patent applications once they (the applications) have been accepted by ARIPO. However, there are reports that this approach is changing, and the patent office in Rwanda now refuse ARIPO-accepted patent applications for pharmaceutical products on the grounds of incompatibility with its patent law. This may be connected to the report in 2018 advising patent applicants for pharmaceutical products to amend their applications to exclude claims to the products and retain claims for process patents.

While countries like Malawi, Zambia and Zimbabwe do not specifically exclude pharmaceutical products from patentability, patent application may be refused on the grounds “that it claims as an invention a substance capable of being used as food or medicine”. See Section 18(c) of Malawi’s Patent Act and Section 13(1)(c) of Zimbabwe’s Patent Act. Section 17(e) of Zambia’s Patent Act excludes “new uses of a known product, including the second use of a medicine” from patentability. These provisions may be interpreted to exclude pharmaceutical products from patentable subject matter especially given that most of these countries are designated “least developed” by the United Nations.

What options outside exclusion of pharmaceutical products as an access to medicine policy?
For countries in Africa, millions of people die of poverty-related and infectious diseases, such as tuberculosis, hepatitis C and HIV/AIDS. The required drugs often exist, but the prices are too high and unaffordable, due to the patents on those drugs. While LDCs can validly use the leeway accorded them by the WTO Council to exclude pharmaceutical products from patentability, other African countries must devise other means to provide increased access to medicines while still according patent protection to pharmaceutical products.

Several suggestions have been made. In the case of South Africa, which has been ‘accused’ of granting more patents on pharmaceutical products than even most developed countries, it has been suggested that the patent laws should be reformed to:

(i) introduce patent opposition procedures so third parties can submit evidence as to why some patent applications should not be granted [As discussed on the IPKat, patent opposition, albeit via the courts in Netherlands led to the invalidation of patent on Ethiopian teff]
(ii) limit the granting of patents on new uses of, and minor modifications to existing medicines. [Zambia’s Patent Act excludes “new uses of a known product, including the second use of a medicine” from patentability. India and Argentina also make similar exclusion.]
(iii) adopt an examination system and move from the current registration system that allow ‘weak’ patents to scale through to grant.
(iv) Simplify the process and procedure for issuing compulsory licences.

These suggestions are all about taking advantage of the flexibilities available in the TRIPS Agreement and adapting them to suit the socio-economic realities in Africa particularly with respect to access to medicines. Indeed, the report on Assessing Regional Integration in Africa (ARIA) IX discussed here makes similar suggestions to inform the negotiations on the Protocol on IP, which will form part of the Agreement establishing the African Continental Free Trade Area (AfCFTA).