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TRIPS transition for pharmaceutical patents

The TRIPS Council decision of 2013 to extend the transition period until July 1, 2021, has created an opportunity for Bangladesh to reconstruct its policy of patenting in pharmaceuticals.

Mohammad Towhidul Islam
THE dilemma of the least developed countries (LDGs), in dealing with the WTO TO I PS Agreement is associated with the possibilities of exploiting the TRI PS flexibilities. Amongst such flexibilities, the provision for "the period of transition to compliance" that allows the LDCs not to offer patent protection to pharmaceuticals until January 1, 2016, constitutes the major leeway for them. It is believed that the rationale for such exemption period lies generally in the need for promoting the creation of viable technological bases by preserving policy spaces for the LDCs.
However, this transition period can provide some strategic advantages: it may enable those LDCs which have vibrant manufacturing capacity in pharmaceuticals to freely copy medicines which are not patented in the LDCs and to use them for domestic consumption needs and export purposes. In an LDC like Bangladesh, the issue of patenting pharmaceuticals becomes crucial, because of its potentials of exploiting such strategic advantages.
Indeed, the above is a challenge for Bangladesh in implicating the TRIPS regime of patent so that it is not confined to public health concerns only - it also animates the concern of economic development at the same time, especially in facilitating the promotion of its vibrant domestic pharmaceutical industries. The existing legal framework of Bangladesh in relation to patent is, however, less than favourable to face up to such challenge in the way of exploiting the benefits of the transition period. The main reason of this fact is rooted in the Patents and Designs Act 1911, which historically incorporates a liberal approach of providing patent protection to cover a wide range of inventions -trivially modified ones that fall within the definition of "invention."
The century old patent legislation deals with the protection of both the "product and process patent." According to the provisions of this Act, Bangladesh is bound to provide patent protection to pharmaceuticals as "product or process patent." Therefore, Bangladesh can-not refuse to provide patent protection to pharmaceuticals based on the exemption period provided for in the TRIPS since it is a country with an already existing patent regime.
The second problem in this respect relates to the relevancy of the "no rollback clause" of the present patent regime of Bangladesh. This is because Paragraph 5 of the TRIPS Council Decision of November 29, 2005, contains "the no rollback clause" by providing that "least-developed country Members will ensure that any changes in their laws, regulations, and practice made during the ... transition period do not result in a lesser degree of consistency with the provisions of the TRIPS." The plain reading of this clause reveals that the country providing patent protection under the existing intellectual property regime is impeded from getting the benefits of the TRIPS transition period. From this perspective, Bangladesh is also thus barred from taking the benefits of the exemption period.
There is no denying that this fact puts Bangladesh in a seriously disadvantageous position in respect of voicing its concerns regarding protecting public health in general and promoting domestic pharmaceutical industries in particular. Indeed, Bangladesh is in this unenviable situation mainly due to the fact that it was too late for Bangladesh to enact new legislation. The government of Bangladesh, however, took a somewhat "extra-legal" initiative to evade the implications of this disadvantages position. Surprisingly, an executive order (DPDT/P&D Law/2007/74129) was issued by the Department of Patents, Designs and Trademarks (DPDT) on January 7, 2008, which provided for the establishment of a mailbox in the DPDT with the purpose of storing patent applications in the areas of pharmaceutical products and related processes and conferring exclusive marketing rights (EMRs) to the applicants.
The legality of this initiative is questionable for a number of reasons: firstly, any rule related to the TRIPS cannot be implemented by such an executive order, for a treaty provision does not have any direct efficacy in Bangladesh unless such provisions are converted into domestic
legislation through an Ordinance or an Act of Parliament. Secondly and most importantly, the implication of such executive order is in conflict with the existing regime, and thus in conflict with the TRIPS Council Decision of 2005.
Apart from the question of its legality, another problem of this order was that it did not provisionally allow generic manufacturers in Bangladesh to receive any help from the DPDT in legally utilising the clinical test data for generics approval. It, therefore, appears that the issuance of this executive order has created confusion and further complexities in respect of implicating the TRIPS transition for pharmaceutical patents.
However, the TRIPS Council decision of 2013 (June 11, 2013) to extend the transition period until July 1, 2021, has created an opportunity for Bangladesh to reconstruct its policy of patenting in pharmaceuticals. One of the most important aspects of this decision is that it has relaxed the condition of no rollback for the LDCs. In other words, the decision of 2013 allows the possibilities of refusing patents even by those members of the LDCs who already have an existing regime of intellectual property rights.
There is, however, a debate on whether this decision to extend is a plenary one, and applies equally to pharmaceutical patents. Professor Frederick Abbott argues in favour of its generality and says that the decision of 2013 includes pharmaceutical patents. If this argument sustains, then Bangladesh will be able to take the benefit of the TRIPS transition period in not patenting pharmaceuticals. In doing so, the major argument for Bangladesh will come from the fact that it is not bound to provide patent in pharmaceuticals until July 1, 2021, or whenever it ceases to be in the least developed category if that happens before 2021. In line with this argument, Bangladesh may thus come up with a fresh legislation to allow the postponement of patent protection, thereby resolving the public health concerns in general, and promoting the domestic pharmaceutical industry in particular.
The writer is Associate Professor, Department of Law,