Patent regime and resolving mailbox issues of Bangladesh

Right to health and access to medicine at an affordable cost is one of the vital necessities and primary requirements of life, both developed and developing countries strive to promote the welfare of the people by ensuring public health and optimizing the availability of medicines.

However, protecting pharmaceutical products through patenting rights has raised debates from human rights perspectives. The Trade–Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) entered into force on January 1, 1995, to protect public health, one of the tricky agreements. There is an ideological discourse on the agreement and divided opinions on how it has been framed and whether it would be able to protect the genuine interest of the poor countries specially LDCs.

After the enactment, TRIPS allowed a one year grace period for all members under its article 66.1 and additional ten years for least developed countries to avoid treaty obligations other than those arising from articles 3 (national treatment), 4 (most favoured nation treatment),5 (multilateral agreement on acquisition or maintenance of protection).

However, as per articles 70.8 and 70.9, it spelled out that developing LDCs with no existing patent regime can establish a mailbox with exclusive marketing rights (EMR) for accepting patent applications in the pharmaceuticals and agricultural chemical fields’ products starting from January 1, 1996. It also ensured that no rollback facility would be allowed, even if the case is intended for LDCs.

As a founder member of WTO, Bangladesh must abide by the principles of the TRIPS agreement; however, so far, Bangladesh has been enjoying the TRIPS flexibilities as one of the LDC countries. After graduation, Bangladesh will have to abide by the treaty obligations. Developing countries and LDCs encountered different challenges because of the conditions of flexibilities and transitions as regards pharmaceuticals.

Bangladesh is among the LDCs with capacities to produce pharmaceutical products, especially for domestic needs, while exporting to several countries. As per expert opinions, Bangladesh, as one of the Pharmaceutical product producers, supplies medicines at home and abroad, where about one-fifth of such medicines are patented somewhere.

Since 2006, Bangladesh has received application for pharmaceuticals and agrochemical products and preserved them in the mailbox, which is 1340 till 2021, meaning about 84 applications per year.

Since Bangladesh has a patent regime, it is not supposed to provide a mailbox facility for storing patent applications and offering Exclusive Marketing Rights(EMR). Thus the executive order is a contrast with TRIPS. In different analysis, it is seen that keeping the mailbox open and revoking the mailbox system may bring about challenges in the future. A question was raised if the relevant government department may repeal the mailbox or Supreme Court may declare the established mailbox illegal, and whether it could work as a remedy.

Under TRIPS, patent rights will be given from the date of application if such mailbox applications are successful. It means the application made in 2006 will have the right to be granted patent. In that case, generics are already produced out of some applications that succeeded after the country's transition period ending in 2026 because of LDC graduation, patents right will be due from the filing date, which could come as a challenge for the country.

However, Bangladesh, one of the leading LDC member countries of WTO, carefully played the card. Some changes emerged in the Doha Round on TRIPS and Public Health in 2002; TRIPS Council on June 27, 2002, permitted a delay in implementing patents until January 2, 2016. Or until graduation to a developing country, whichever date is earlier. This decision has given LDCs with no patent regime, a relief as they are waived from patenting pharmaceuticals but were asked to mail the patent and grant them EMR under the clauses of 70.8 and 70.9 for pharmaceutical and agricultural chemicals with its obligation under article 27(patentable subject matter).

On November 29, 2005, TRIPS Council extended the general transitional period by 7.5 years, until July 1, 2013, or until LDC graduation to developing country status, whichever date is earlier. However, the decision not to roll back remained. In each case, the decision was tagged with a clause of until LDC graduation to a developing status, whichever is earlier.

Again on June 11, 2013, the TRIPS Council granted a further general extension until July 1, 2021, or until LDC graduation to the developing country, whichever date is earlier. The decision stated that 'the LDCs shall not require applying the provisions of the TRIPS agreement. It also prevented LDCs from complying with the TRIPS provisions of November 29, 2005 regarding rollback.

Bangladesh took a move on behalf of LDCs and asked for an extension of the transitional period under Article 66.1 of TRIPS concerning pharmaceutical products and waivers from obligations arising from 70.8 and 70.9 of TRIPS on February 20, 2015. On November 6, 2015, the TRIPS Council decided that LDCs only require the patenting of pharmaceutical products and the protection of undisclosed information until January 1, 2033, or until their graduation to developing country status, whichever date is earlier. However, regarding the mailbox's continuity, doubt remains about a general waiver.

In a different decision on November 30, 2015, the general council clarified that LDCs do not have to implement the mailbox mechanism for receiving patent applications and granting EMR. From the wording of the decision, it appeared that from November 30, 2015 LDCs, whether having a patent regime or not, can roll back their laws by excluding themselves from the obligations inserted in articles 70.8 and 70.9.

The deal reached is an improvement over the previous transition period, which was for 14 years and without a mailbox waiver. Still, it is a far cry from the LDC Group's original request to the TRIPS Council for a pharmaceutical patent exemption linked to a country's graduation from LDC status, and what is needed to deal with the public health problems in LDCs.

Several health and development NGOs and workers suggested LDCs actively use the created policy space this renewed transition and accordingly take immediate steps to amend their respective national laws to exclude pharmaceutical products from patent protection with explicit provisions that this would be until January 1, 2033 that the WTO Council may grant for TRIPS.

However, Bangladesh's case is different from other LDCs, as it will graduate from November 2026, and TRIPS flexibilities after January 2033 may not apply to the country. Ministry of Industries has tried to amend its existing patent law and remove the mailbox with retrospective effect. This should be done in a proper way to avoid any further confusion, on the other hand, amended IP law would also need adequate provisions to get rid of the mail box predicament.

The writer is CEO of BUILD a Public Private Dialogue Platform. She can be contacted at [email protected]