On revocation of mailbox for pharmaceutical patents
Nobel laureate Joseph Stiglitz in his book Making Globalization Work showed that the international pharmaceutical patents law, the WTO Agreement on the Trade related aspects of Intellectual Property Rights (TRIPS) 1994,was framed against the interest of the developing and least developed countries (LDC). However, a few flexibilities were consciously inserted in the Agreement to ensure that ideological dissenters of the agreement would not otherwise lose out in the negotiations in the deeply divided world. Notably, Bangladesh is seemingly unaware of (or at least less concerned about) these flexibilities in international law in order to protect public health by ensuring access to medicine.
The TRIPS Agreement requires the member states to provide patent protection for both pharmaceutical products and processes while the Least Developed Countries are waived of such obligation. It was initially required of the LDCs to have a mailbox for storing patent applications with Exclusive Marketing Rights (EMR) for pharmaceutical products starting from 1 January 1996. Later, through several decisions from the TRIPS Council, the obligations of the LDCs were waived in phases at different stages. Prime Minister Sheikh Hasina played a crucial role in propounding the latest grant of waiver. In the 64th World Health Assembly she advocated for another waiver period for the LDCs. Her bold stand was subsequently followed by a successful formal request to the TRIPS Council on behalf of the LDC group. As the TRIPS currently stands, the obligation of the LDCs to protect pharmaceutical patents including the 'no roll-back' clause have been waived until 1 January 2033 or the graduation of the LDCs to Developing Country status, whichever is earlier. It means that even countries with existing patent regimes are not only waived of their obligations to grant patent protection but also that they could provide for lesser to no protection than they previously had provided.
Due to its colonial legacy, Bangladesh had been granting product and process patent since 1911 until when the National Drug Policy 1982 disallowed product patent. In the post TRIPS era, the waiver for the LDCs was followed by a prohibition of process patent in 2002 by a notification in the Official Gazette of Bangladesh. In 2007, the Government of Bangladesh issued a questionable executive Order establishing a mailbox which is still storing applications in the mailbox. Professor Mohammad Towhidul Islam in his book TRIPS Agreement of the WTO: Implications and Challenges for Bangladesh shows that the establishment of a mailbox by a mere executive notification was beyond the limits of the then government in 2007. Such an opinion is justified on the ground that the Patents and Designs Act 1911 did not give the government power to establish a mailbox. To establish a mailbox, it would have required a legislative enactment. Thus, the mailbox provision goes beyond the tenets of the law. However, the 2015 waiver in international pharmaceutical patent law permits Bangladesh to entirely revoke its mailbox making the submitted applications null and void.
The rationale of an anti-mailbox campaign in Bangladesh is that under the TRIPS Agreement, in cases of mailbox applications, if patents rights are granted after the transition period, they shall come to effect from the date of filing of the application. Very recently in July 2019, Brazil Federal Court of Appeals ruled that Mailbox Patents shall be granted with the validity date of 20 years from the date of filing, resulting in a retrospective effect given to the operation of patent rights facilitating infringement suits for past production of generic drugs. Bangladesh is one of the largest generic medicine producers of the world fulfilling 98% of its own needs and the only LDC in the world that has pharmaceutical manufacturing capacity. Around a fifth of drugs produced in the country is patented in other countries and rest of the manufactured medicines are those the patent protection of which have been expired. All the received applications in the mailbox shall be burdensome for Bangladesh in the long run if proper steps are not taken immediately. Because the day Bangladesh graduates from LDC status, all the generic medicine manufacturer companies shall be sued for their past infringement of patent rights and they will be required to immediately suspend such production.Being forcefully stopped to manufacture generic medicines and being sued for past production thereof shall bring a disastrous impact on the public health and economyin general of Bangladesh.
Moreover, the increase of medicine price due to such legal proceedings shall result in losing out export business of these pharmaceuticals.The revocation of the mailbox in its entirety would result into no suits for infringement of patent rights during the pre-graduation days.
For long Bangladesh seems to have been unaware about its approach to international law with regard to the protection of public health and pharmaceutical industry. As a result, the country seems to have taken additional international obligation on itself without being required to do so. In the context of Bangladesh's booming economy till Covid 19 outbreak, the rapid progress of Bangladesh towards attaining a developing country status, Bangladesh now needs to use all the impending flexibilities of international law at hand to safeguard its citizens' public health and to ensure smooth growth of the pharmaceutical industry of the country.
The writer is a law graduate from the University of Dhaka.