Professor Brook K. Baker
Senior Policy Analyst Health GAP
June 6, 2021
The complications and limitations of compulsory license-dependent measures to respond to the COVID-19 pandemic need to be better explained. The European Union and several other countries that rely on TRIPS-compliant compulsory licenses to overcome patent obstacles have opposed temporary intellectual property (IP) from India and South Africa. exemption proposal on COVID-19 Health Technologies at the World Trade Organization. Although compulsory licensing (CL) on patents alone may be sufficient to enable generic production of small molecule drugs, CLs are unlikely to suffice when it comes to vaccines, biological drugs, including antibodies. monoclonal, and more complex diagnostic tests, medical devices and respirators. Compulsory TRIPS-compliant licenses do not affect the additional intellectual property rights covered by the disclaimer – confidential information / trade secrets, regulatory data, copyright and industrial designs, each of which plays a critical role in preventing producers alternatives to manufacture health technologies protected by intellectual property. Even with patents alone, compulsory country-by-country and product-by-product licenses are ill-suited to bringing together the components needed to manufacture vaccines. The explanation below highlights the shortcomings of the EU’s proposals to rely on LGs even to override patents.
Complex supply chains require dozens of CLs to access key components
Patent rights give rights holders the power to exclude competition – to bring private infringement action against alternative manufacturers to prevent them from “making, using, offering for sale, selling or importing” the infringing product. or the product produced by a counterfeit process (TRIPS Art 28). Countries can also impose border measures to prevent the export, transshipment or import of patent infringing products (TRIPS Art. 51-60).
The International Federal of Pharmaceutical Manufacturers and Associations (IFRMA) likes to Explain the complexities of the supply chain for messenger RNA (mRNA) and viral vector vaccines: âVaccine supply chains are international. The BioNTech / Pfizer vaccine contains 280 ingredients from 19 countries. Moderna’s AstraZeneca and Johnson & Johnson are equally complex. This great complexity is part of what makes compulsory licensing the wrong tool to meet the need to increase production of COVID-19 vaccines.
Basically, for each component or patented process for which the patentee was not willing or able to sell sufficient quantities and was not willing to grant a voluntary license, the importing country of final destination who wishes to rely on LCs should find another producer willing to apply for an LC for this component (in the case of a commercial all-sector LC) or to accept a non-commercial / government license for this component. The country of final destination would have to convince the country where the component licensee was manufacturing to issue the LC required for export.
To make the process even more complex, if the next step in the vaccine manufacturing process is to take place in a country other than the importing country of final destination – let’s call this the country of ‘formulation’, the country of final destination will have to convince the country of final destination. formulation country to issue both an import license for each component for which the patent is blocked and for the vaccine itself and an export license for the formulated vaccine. At the formulation stage of mRNA vaccines, for example, licensed manufacturers need complex machinery and processes to combine patent-protected mRNA, protein caps and lipid nanoparticles, as well as various stabilizers. After issuing several import LCs to allow the formulator to amass the necessary inputs, the country where the formulation was undertaken should also issue an export license so that the formulation can proceed to the next step, e.g. filling out and finish. If the filling and finishing step also cannot be accomplished locally in the final destination country, another set of import and export licenses must be granted by the filling and finishing country.
As a final step, the country of final destination and use should itself issue a LC for import.
If the countries involved in this complex chain of events relied on Article 31bis, appropriate notifications to the WTO would be required by all exporting and importing countries in the chain.
In summary, at least for the manufacture of LC-compliant vaccines that is not âvertically integratedâ (all phases in one plant), an impressive number of LCs must be coordinated and tuned in multiple countries.
The COVID-19 patent landscape is vast and complex
The scenario described above assumes that the components and products are all patented in the country of manufacture / export and import / use. That may or may not be true, but we’re still finding out how well companies have filed for patents. Early reports indicate that there is a complex web of patents on COVID-19 vaccine technologies and that they have been filed in many countries capable of producing components and vaccines (additional source).
Large nodes represent relevant entities while edges represent agreements or patents between two entities. The smaller nodes around the entities represent the patents that have been identified as being relevant to the underlying vaccine technology
Complications of CL are on the rise
Even what is described above could be further complicated by the fact that the countries in the chain described have not yet adopted the rules of Article 31bis of the export / import CL. TRIPS Article 31bis is not self-applicable in countries, and the clarifications proposed by the EU on CL would not be self-applicable. Even if all countries in the supply chain adopted Article 31bis rules, each supplier / exporter country should cooperate. A break in the chain of necessary LCs could derail the entire effort.
As pointed out in the introduction, LCs on patents would not suffice. To enable the production of bioidentical vaccines, each country needing confidential information protected by intellectual property, trade secrets, regulatory data, software, plans and copyrighted documents and designs manufacturers should adopt a sui generis set of rules going beyond these multiple IP protections. They should also know how to force the transfer of technology for confidential information, trade secrets and biological resources that are held in other countries.
The complexities of CL described above apply to every country that needs vaccines. As low- and middle-income countries are currently lagging behind given the collusion of business and rich countries to prioritize the Global North, a large number of countries might need to navigate this same labyrinth of elaborate LC and confusing. All this bureaucracy could be removed if the WTO adopted the TRIPS waiver and countries quickly followed suit at the national level.
Europe claims that these problems of notification, cooperation and coordination do not exist and that the existing TRIPS flexibilities are sufficient. This is not the case and the four clarifications proposed by the EU on CL offer nothing substantial. LCs for patents are clearly insufficient to allow large-scale production of COVID-19 vaccines to save lives, prevent further social and economic chaos, and prevent the emergence of new variants that can undermine existing immunity. It is time to put the misconception that TRIPS flexibilities alone are up to the task. The EU and other countries blocking waivers must face the fact that barriers to intellectual property must be removed if we are to survive this viral scourge.