The recent COVID-19 pandemic has put a new focus on striking a balance between enforcement of patent rights and access to essential or life-saving drugs. Amidst the pandemic, countries are reviving rarely used legislation and focus on developing new measures to ensure that COVID-19 related medicines are available.
Israel recently invoked an emergency patent-suspension clause for the first time, allowing it to import a generic version of Abbvie’s Inc Kaletra, which could potentially be used against the coronavirus.
Canada, Germany, Chile, and Australia consider lowering the hurdle in the issuing of compulsory licences of patents rights on treatments and vaccines to curb the COVID-19 pandemic. In a recently reported USA patent matter, Labrador Diagnostics LLC filed a complaint for patent infringement of two US patents to stop Biofire Diagnostics, LLC and Biomerieux S.A. for making and distributing COVID-19 tests. With the outcome of this case, the plaintiff agreed to grant the defendants a royalty-free license.
South Africa is no novice in this arena. In 2009 GlaxoSmithKline granted South Africa’s Aspen the right to make its HIV drug Abacavir in a royalty-free licensing deal, as part of the company’s efforts to cut the cost of anti-retroviral medicines for HIV in poorer countries.
Although critics argue that the issue of compulsory licenses would substantially diminish incentives to the R&D firms to conduct research and development, there has always been substantial support from public health advocates to grant compulsory licenses under certain conditions. As a counter-argument, it can be argued that limits on patent protection are unnecessary as market forces are already a positive dynamic due to the fierce competition amongst pharma companies looking for a cure and effective treatment.
South Africa became a member of the World Trade Organisation (WTO) in 1995 and are bound by the general standards of patent protection that all WTO members are required to provide under the TRIPS agreement. TRIPS requires that WTO members provide 20 years of patent monopoly protection on products and processes that are patentable, and also includes essential safeguards that countries can adopt into their national laws to ensure that patents do not block medicine access.
South African legislation does not include many of the safeguards allowed under TRIPS to protect public health. However, current legislation is not without teeth and can be invoked to promote access to affordable medicines. Section 56 of the Patents Act stipulates the provisions for compulsory licencing and anyone, including the Department of Health, may apply to the Commissioner of Patents for a compulsory licence to stop any abuse of patent rights, under certain circumstances.
In the case of a public health crisis, Section 4 of the Patents Act grants the government walk-in-rights for public purposes, under conditions as agreed with the patentee or in default of such agreement and its requirements as determined by the Commissioner of Patents. However, if the above is believed to be inadequate, Sections 4 and 56, as well as other sections of the Patents Act, could be amended to include further TRIPS compliant grounds for a compulsory license thereby extending the flexibility of the Patents Act to that allowed for under the Doha agreement.
Under Section 15C of the Medicines and Related Substances Act, South African law allows parallel importation of medicines, which is the importation of the original product sold by the patent owner or its licensee in another jurisdiction. However, this provision has never been invoked.
It is believed that owners of the patents on test kits and other medicinal requirements would support governments to help to alleviate the public health needs of society. In the case of a public health crisis, patent rights would not be an obstacle in the way to affordable access to existing or new medicines and devices in the battle against the coronavirus.
This pandemic will undoubtedly redefine for what is regarded as an emergency when considering the limiting of patent rights.
For more information, please visit: https://www.sapat.co.za/intellectual-property-services/