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Request for wavier of IP rights relating to COVID-19
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India and South Africa in a historical move, on October 2, 2020 have asked the World Trade Organization (WTO) to waive any IP rights (patents, industrial designs, copyrights and trade secrets) relating to COVID-19 drugs, vaccines, diagnostics and other technologies for a limited period. The limited period could extend for a duration of the pandemic or until a fair proportion of the world population develop herd immunity. WTO is an intergovernmental organization with 164 members. The waiver, if granted, would allow the member countries of the WTO to neither grant nor enforce patents or other IP rights relating to COVID-19 for that specified duration. The wavier is not permanent and is valid only for a specific duration. The wavier, if allowed, would be applicable to all the WTO members which include developed, developing and least-developed countries.
The World Health Organization (WHO) has supported India and South Africa’s step. WHO chief Tedros Ghebreyesus in one of his tweets said, “WHO welcomes South Africa’s and India’s recent proposal to WTO to ease international and intellectual property agreements on COVID-19 vaccines, treatments & tests in order to make the tools available to all who need them at an affordable cost”. The Indian domestic pharma industry has backed its government’s move.
The proposal is first submitted to the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Council and then decided at the Ministerial Conference or the General Council. The TRIPS Council is expected to consider the proposal within 90 days and submit a report to the Ministerial Conference for the decision making. The grant of the proposal is based on the general agreement of the WTO members.
India and South Africa’s move gains significance after Gilead, the patent holder of Remdesivir, the only approved drug for the treatment of COVID-19, has its patent licensed in a way that excludes most of the countries and thereby excluding more than half of the world population from benefiting from the lower price generic competition of the drug. The company continues to hold the license after having received over $70 million of public funding to develop the drug. With the exclusive rights, Gilead has priced the Remdesivir drug at a higher price, depriving access to the drug for majority of the population. Therefore, depending on private companies for a solution to the COVID-19 crises is not a solution. The concern extends as vaccines and treatments needed to fight the pandemic could be limited by patents and other IP barriers.
Furthermore, a quantum of patents for COVID-19 vaccines that are in development stages and patents relating to instruments required for treating COVID-19 are being filed. Companies that have received public funding for the development of the vaccine may get exclusive rights for their patents and therefore end up having monopoly over the drug or vaccine which would create barriers to timely access to affordable medical products.
The wavier may allow governments to stand up for public health in solidarity at international level. The wavier may be important for the developing and the least developed countries as these countries may now have an opportunity to procure the basic treatment required for their public health. The wavier would also provide an opportunity for the countries to collaborate in the R&D of COVID-19 vaccine and in scaling up the manufacture and supply of COVID-19 supplies.
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India becomes part of WIPO’s Digital Access Service
WIPO’s Digital Access Service (DAS) is an electronic system that allows easy transfer of certified copies of documents, which are typically required during filing patent applications in multiple countries. WIPO’s DAS allows applicant(s) to request a first patent office/office of first filing to make the certified copies available to other patent office’s/accessing offices where applicant(s) wishes to file the patent application. This certified copies exchange happens electronically between the patent offices. At present, there are nearly 20 patent offices that are using the WIPO DAS.
Considering recent events, a WIPO-India cooperation agreement was established between WIPO and IPO on 31 March 2018, stating that the IPO will now start using the WIPO’s DAS. IPO is now a depositing office, where the certified copies of documents are uploaded using the WIPO DAS.
The applicant(s) must make a request to the patent pffice stating that they require certified copies of documents to be submitted to the WIPO DAS. The request is made along with an applicable fee as per entry no. 49 in the First Schedule of the Patents Rules 2003. In case of Design Patents, the applicant(s) should submit Form 16 along with the applicable fee as per The First Schedule of The Designs Rules, 2001. Once the request is submitted to the depositing office, DAS sends an access code for authorization through email to the applicant(s). A separate access code is received for each certified document that the applicant(s) has requested from the depositing office. The applicant then sends a letter mentioning the patent application number along with the access code received through email from DAS to the receiving patent office(s). The certified copies are then successfully provided to the receiving patent office(s).
WIPO DAS is easy and quick as the system provides a mechanism for the office of first filing to add the certified copies of documents, and the accessing offices to receive the documents. The process is paperless, as the exchange between the patent offices happens electronically. DAS is secure as it’s hosted and administered by WIPO authorities. DAS is also reasonable in terms of cost as the applicant(s) need not pay for multiple sheets/copies of paper certified copies of documents. Also, WIPO does not charge the applicant(s) for using the system. Since all the exchange is done online, applicant(s) also save money on courier/postal charges. According to recent statistics, IPO ranks among top 20 countries for yearly numbers of PCT application filings. Hence, based on the above-mentioned details and statistics, IPO has definitely taken a wise decision in opting for WIPO DAS.
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