PATENTS, TRIPS AND ACCESS TO MEDICINES – a legal perspective Tapiwanashe Kujinga Civil society briefing 21 January 2014

INTELLECTUAL PROPERTY Intellectual property (IP), very broadly, means the legal rights which result from intellectual activity in the industrial, scientific, literary and artistic fields. IP is protected at law and it safeguards the creators from infringement and gives them a specific time period to exploit their inventions. The rights of inventors do not apply to the physical object in which the creation may be embodied but instead to the intellectual creation as such.

PATENTS A patent is a document, issued, upon application, by a government office (or a regional office acting for several countries), which describes an invention and creates a legal situation in which the patented invention can normally only be exploited (manufactured, used, sold, imported) with the authorization of the owner of the patent. The protection conferred by the patent is generally 20 years.

HOW DO PATENTS WORK? The effects of the grant of a patent are that the patented invention may not be exploited in the country by persons other than the owner of the patent unless the owner agrees to such exploitation. In the event that any other person starts producing products covered by a patent, the patent holder has the right to sue for infringement. This right therefore allows the patent holder to enjoy exclusive benefit from his invention.

INTELLECTUAL PROPERTY AND DEVELOPMENT Rich countries have basically used intellectual property to enhance development. For instance, Apple holds the right to the iPhone, among other products. In 2013, the iPhone earned Apple a total of US$88 billion. Think about other electronic conglomerates such as Microsoft, Hewlett-Packard, AT&T and Dell.

INTELLECTUAL PROPERTY AND DEVELOPMENT South Korea was poorer than Zimbabwe (then Southern Rhodesia) in 1959, but its current manufacturing capacity is now much larger. Chaebols (manufacturing conglomerates) such as Hyundai, Samsung, LG and Daewoo have boosted the national economy.

PATENTS AND MEDICINES All ARV medicines are protected by patent, and a few have now gone off patent as the 20-year limit has expired. These include Stavudine, older forms of Lamivudine, Emtricitabine, Didanosine and Efavirenz. Once an ARV medicine is discovered, a patent is applied for, and this means that the patent holder, normally a branded pharmaceutical manufacturer, has exclusive rights over that medicine. That exclusive right almost always translates into the right to charge an exorbitant amount as newer and more effective ARVs are always in demand.

TRIPS TRIPS is an acronym for “Trade-Related Aspects of Intellectual Property Rights.” In 1994, all countries which were members of the World Trade Organisation signed to the TRIPS Agreement. Basically, the Agreement required enforcement of patent protection for pharmaceutical products, including medicines and diagnostics. The Agreement was driven by rich countries which wanted to ensure protection for their products.

THE EFFECT OF TRIPS The HIV pandemic had already to affect many sub- Saharan countries by 1994, and research and development in effective antiretrovirals was under way. When triple therapy was discovered in 1996, the cost was between US$10,000 – 15,000 per patient per year, the reason being that all the medicines were patented, and the TRIPS Agreement protected the patent holders from infringement. Patents therefore became a barrier to access to treatment.

THE DOHA DECLARATION After realising the detrimental effects of the TRIPS Agreement, developing countries, led by Zimbabwe (Ambassador Boniface Chidyausiku), lobbied for the inclusions of “flexibilities” in the Agreement on the basis of the HIV and AIDS pandemic. The Doha Declaration on the TRIPS Agreement and Public Health was adopted in November 2001 at the Fourth World Trade Organization (WTO) Ministerial Conference.

EFFECTS OF DOHA The Doha Declaration clarified the scope of, and provided interpretive guidance for, the policy flexibilities embodied in the TRIPS Agreement that could be used to ameliorate the impact of patents on access to medicines. It also extended until 2016 the transition period before least-developed countries (LDC) must provide patent protection to pharmaceuticals.

EFFECTS OF DOHA (cont) Of importance was the confirmation provided by the Doha Declaration that public health considerations can and should condition the extent to which patents on pharmaceuticals are enforced and that flexibilities in the TRIPS Agreement could be used to improve access to medicines.

TRIPS FLEXIBILITIES Compulsory licencing allows a country to issue a licence for the manufacture or importation of a medicine for HIV under certain circumstances. Where a compulsory licence is issued, the patent holder is entitled to payment of royalties, which are a percentage of the sales of the medicine. The company or companies that manufacture under a CL do not have research & development expenses, hence their prices are cheaper than the branded medicines.

COMPULSORY LICENCING IN ZIMBABWE In 2002, the Patents Act was amended to incorporate provisions allowing for the issuing of compulsory licences. In the same year, Government issued a notice of a state of emergency effectively allowing for the issuing of compulsory licences for HIV and AIDS medicines. Compulsory licences were issued to Varichem and CAPS which produced some ARV medicines, including Stalanev.

TRANSITION PERIODS Countries that signed to the TRIPS Agreement were given specific time periods within which to fully comply with the provisions of the Agreement. Developing countries, such as Zimbabwe, were given up to 2005, and least developed countries up to 2016 (now extended to 2021). India made full use of this transition period by producing generic medicines, but cannot produce generics for newer medicines patented after 2005.

PARALLEL IMPORTATION This flexibility is also known as international exhaustion, and it allows countries to opt for medicines in other countries where it would be cheaper. Where a patent holder sells or releases medicines into the market, its rights of control are lost, and any buyer can purchase the medicines regardless of where that purchaser is based. Such a purchase is allowed even where the medicines are being sold subject to a bilateral agreement.

BOLAR EXCEPTION This exception allows a potential competitor to use an invention to undertake acts necessary for obtaining regulatory approval and registration of a generic product before the expiry of the patent term without the authorization of the patent holder. This flexibility allows generic medicines to be on the market as soon as the patent on the branded medicines expires.

PATENTABLE SUBJECT MATTER For an invention to be patentable, and subsequently protected, it must have some novelty (new) and must be capable of industrial application. Countries have the right to decide on what criteria to use in patenting innovations. This means that some inventions can be deemed not worthy of protection, and this means that such inventions can be exploited by countries.

PATENTABLE SUBJECT MATTER Some patent holders will add a little value to their inventions and seek to patent the “new” invention before the original patent expires. Some patent holders can also seek to patent old innovation on the basis that they have found a new use for it, e.g. aspirin was originally a painkiller and now is also used for blood thinning. Such practices, called “evergreening”, can be stopped if countries restrict patentability criteria.

ZIMBABWE DOMESTICATION OF FLEXIBILITIES Zimbabwe has domesticated a number of TRIPS flexibilities, such as: Government use licence Compulsory licences Patentable subject matter Parallel importation Bolar exception Anti-competitive behaviour

WHERE ARE THE GAPS? The legislative framework has never been fully exploited besides the Government use licences that were issued out in the early 2000s. A number of policy inconsistencies have hampered full utilisation of the flexibilities. For instance, internal policies within the Medicines Control Authority of Zimbabwe (MCAZ) do not allow for parallel importation. Other challenges include lack of knowledge and lack of political will.

WAY FORWARD The current meetings with lawyers, civil society, Government officials, pharmaceutical companies, development partners, commerce and bilateral partners has given an opportunity for reflection on our IP policy and legislative framework. There is need to fully exploit the TRIPS flexibilities for access to medicines in Zimbabwe, especially on other critical health issues such as cancer.

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