Future of mailbox patents
— Moeller IP
ALTHOUGH the World Trade Organisation agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS) came into force on January 1, 1995, members — developed, developing, and least developed countries — were initially given one year to implement the treaty obligations. Accordingly, developed countries implemented the agreement by January 1, 1996. However, developing and least developed countries were given a transition period of 10 years until January 1, 2006.
In addition, in LDCs where there is no existing patent regime, patent applications for pharmaceutical and agricultural chemical products are required to follow the mailbox since January 1, 1996 with exclusive marketing rights. This means that patent applications must be stored on offering exclusive marketing rights therein. At the end of the transition period, the applications have to be disposed of and the patents granted thereto have to be given the retrospective effect. In addition, no rollback will apply to countries with an existing patent regime, which means that countries with an existing patent regime will not be able to change their laws to stop issuing patents (Articles 70.8 and 70.9).
Subsequently, on June 27, 2002, the TRIPS Council relaxed further the LDCs’ obligations of patenting medicines till January 1, 2016 or until the countries graduate to the developing country status, whichever comes first, citing paragraph 7 of the Doha Declaration 2001. In addition, the decision of the WTO General Council dated July 8, 2002 waived the LDCs’ obligation to grant exclusive marketing rights to pharmaceutical products as described in Article 70.9 of the TRIPS until January 1, 2016. Further, on November 29, 2005 the TRIPS Council extended the LDCs’ general transition period for not complying with the TRIPS to July 1, 2013. So, it is clear from these decisions of the TRIPS and General Council that in LDCs where there is an existing patent regime for pharmaceuticals, the patenting thereof has to continue. Such countries will not be able to stop the issuance of drug patents by changing their laws. On the other hand, the LDCs that do not have an existing patent system for medicines will store applications and process them at the end of the interim period, giving the patents a retrospective validity. However, they do not have to provide exclusive marketing rights.
Although Bangladesh has an existing patent regime for pharmaceuticals, the country’s Department of Patents, Designs and Trademarks in a notice issued on January 7, 2008 suspended processing patent applications already filed and to be filed for pharmaceutical and agricultural chemical products until January 1, 2016 or such further date as may be extended and required them to be stored in the mailbox during the said period. It also asked for paying off new fees to process the stored applications in the future. As a result, these orders of the department appear to be in complete opposition to the decisions of the TRIPS Council and the WTO General Council for dealing with pharmaceutical patent applications.
Subsequently, on June 11, 2013, the TRIPS Council extended the LDCs’ general transition period to July 1, 2021. In addition, on November 6, 2015, the TRIPS Council in another decision exempted LDCs from implementing patents on pharmaceutical products and protection of undisclosed information until January 1, 2033. However, in the case of Bangladesh, this concession may not last long since it is graduating to the developing country in 2026.
Then, on November 30, 2015, the General Council called on the LDCs to remove the mailboxes with exclusive marketing rights for patent applications arising of pharmaceutical products. As a result, from November 30, 2015, the LDCs will now be able to roll back their laws. This means that an LDC can change its patent laws to stop the pharmaceutical patenting and the mailbox system therefrom with exclusive marketing rights. However, in the notification of the department, the rollback of the patent law has been done in Bangladesh from January 7, 2008. As a result, the patent application for pharmaceutical products has been stored in the mailbox since then instead of patenting them. Nevertheless, the mailbox applies only to countries that do not have an existing patent system.
Therefore, in compliance with the decisions of the TRIPS Council and the WTO General Council, it was the obligation of Bangladesh to continue the existing patent system till June 11, 2013 and not to accept patent applications for pharmaceutical products after the said date. Further, from November 30, 2015, all countries, including Bangladesh, were also supposed to give up the mailbox system with exclusive marketing rights.
In defiance, some unwary situations might arise that while patent applications for many pharmaceutical products have been under consideration since 2008, domestic pharmaceutical companies have been manufacturing generics of such products and supplying them at home and abroad. In the absence of the compulsory licensing issued by the government, it will then be seen that many generic drug companies are facing patent infringement lawsuits when the applications for the same are granted patents at the end of processing. The easiest way to get rid of this is to revoke the department’s 2008 notification with a retrospective effect as per the General Council’s decision of November 30, 2015 regarding the rollback.
Dr M Towhidul Islam is professor of law in the University of Dhaka.