26 May 2020 7:51 AM GMT
The devastating effect of COVID-19 pandemic is indicated by the alarming figures of the infection and related deaths. For an effective response to COVID-19, we should have affordable access to various medical products such as medicines, medical devices including diagnostic kits and personal protective equipment. These products may not be accessible or affordable in the...
The devastating effect of COVID-19 pandemic is indicated by the alarming figures of the infection and related deaths. For an effective response to COVID-19, we should have affordable access to various medical products such as medicines, medical devices including diagnostic kits and personal protective equipment. These products may not be accessible or affordable in the absence of competition. Manufacturers use IP protection as an important tool to eliminate or control competition and it can be a hindrance in containing the pandemic. While patent protection is the main form of IP which is posing a threat to access to affordable medical products it is important to note that, other forms of IP rights such as copyrights, industrial design trade secrets etc. can hinder a country's response to COVID 19. For instance, the European Commission had to threaten Roche to disclose the recipe of a chemical component used for the COVID 19 test. Similarly, 3M the largest manufacturers of N95 masks are proceeding against competitors under the trademark law. Similarly, design protection can create barriers in the manufacturing of ventilators, masks, or PPE.
There is also demand from the civil society organisations to waive the licensing restrictions on copyright works to facilitate remote education, research and "access to culture, including across borders, both to help address the global pandemic, and in order to minimise the disruption caused by it".
Though IP legislations provide public interest flexibilities to give exemptions to IP rights to make use of IP without the permission holder the envisaged public interest context varies from each IP. For instance, patent law provides the public interest flexibility like compulsory license i.e. the permission to use the patent without the consent of the patent holder, in the public health emergency. The same flexibility is not available in the copyrights. In response to COVD 19, there might be a requirement to pirate the software to use in more computers deployed in the public health system or to use in medical equipment. Similarly, a manufacturer may need to copy the design of medical equipment or PPE. Thus the COVID19 requires the use of flexibilities across the IP spectrum. The moot question is whether the TRIPS Agreement allows the suspension of protection and enforcement of all type of IP in an emergency.
In this regard, the letter of Carlos Correa, Executive Director of the South Centre to the Director Generals of WHO and WTO and UN Secretary-General is worth noting. The letter requested the three Director Generals " to support developing and other countries, as they may need, to make use of article 73(b) of the TRIPS Agreement to suspend the enforcement of any intellectual property right (including patents, designs and trade secrets) that may pose an obstacle to the procurement or local manufacturing of the products and devices necessary to protect their populations".
The letter states: "Security exception' contained in Article 73 of the Agreement on Trade-related Intellectual Property Rights (TRIPS Agreement), any WTO member can take the 'actions it considers necessary for the protection of its essential security interests'. The use of this exception will be fully justified to procure medical products and devices or to use the technologies to manufacture them as necessary to address the current health emergency".
The security exception under Article 73 states:
Nothing in this Agreement shall be construed:
(a) to require a Member to furnish any information the disclosure of which it considers contrary to its essential security interests; or
(b)to prevent a Member from taking any action which it considers necessary for the protection of its essential security interests;
(i)relating to fissionable materials or the materials from which they are derived;
(ii)relating to the traffic in arms, ammunition and implements of war and to
such traffic in other goods and materials as is carried on directly or indirectly to supply a military establishment;
(iii)taken in time of war or other emergency in international relations; or
(c)to prevent a Member from taking any action in pursuance of its obligations under the United Nations Charter for the maintenance of international peace and security.
It is worth noting that Article 73 does not set any procedural obligations on the Member States to invoke the security exception. Moreover, the term "other emergency" has not been exhaustively defined, giving countries the liberty to set its scope of " other emergency in international relation " as per their requirements. Though the use of Article 73 to suspend the obligation can be scrutinized by the WTO dispute panel it is an important flexibility to use under a health emergency like COVID19 Pandemic. Legally speaking, WTO Member States can make use of the flexibilities in the TRIPS Agreement to address the IP barriers related to medical products. However, often the TRIPS flexibilities are understood in the context of patents and access to medicines. There was little discussion about the use of flexibilities in the context of copyrights, industrial designs or trade secrets to address a public health emergency. However, the issue is the domestic implementation of the Security exception. Domestic IP laws of many countries do not have Article 73 type security exceptions.
In the Indian context, the central government has the power to make rules for cancellation of the registration under the Designs Act 2000. Section 46 empowers the Controller to cancel the registration of designs specified by the Central Government, in the interest of the security of India. It includes any article used for war or 'other emergency' in international relations. The Section 68(c) of The Semiconductor Integrated Circuits Layout-Design Act, 2000 empowers the Registrar can take any action including the cancellation of registration of the layout-design registered under the said Act necessary for the security of India including other emergencies in international relations.
The Indian Patents Act incorporates all the public health flexibilities in the TRIPS Agreement including the flexibility contained in Article 73 ( b ) iii and 73 ( c). Section 157A allows the central government to take any action including the revocation of patents necessary in the interest of the security of India. The security of India includes emergencies in international relations. However, there is no definition of any action and whether the government can suspend the protection and enforcement citing other emergency international relations. The use of Section 157 allows the Central Government to suspend all patents required for the generic manufacturing of all medical products instead of going by patent to patent approach, which is tedious and time-consuming. Though government use allows the use of patents Government needs to identify the patents and licensee. This is time-consuming. In such a situation the government must enable all the potential manufacturers to make use of them to produce medical products required for the pandemic.
There is no similar provision in the Copyrights Act. Similar provisions should be incorporated in the Copyrights Act.
To facilitate the local production the government should urgently set up a committee to find out the relevant patents, designs, or any other IP protection which is potentially affecting the manufacturing or use of the medical products including medicines, vaccines, diagnostic kits, PPE or other medical devices such as a ventilator, oxygen concentrator etc and invoke security exception to suspend the IP. Similarly, Ministry of Human Resources should waive of the enforcement of Copyrights resections to facilitate remote education, research and "access to culture.