Extended monopolies on biologic drugs – A warning to developing countries

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IP Watch | 10 September 2018

Extended monopolies on biologic drugs – A warning to developing countries

By Fifa Rahman

It was recently announced that the US government would be seeking to table at least 10 years of market exclusivity for biologic drugs in the renegotiated NAFTA. There are several reasons for this. Biologic drugs have become an important economic commodity: nine of the top ten bestselling pharmaceuticals are biologic, including drugs for cancer and rheumatoid arthritis. It is estimated that the global market potential of biologics will reach $250 billion globally by 2020 (Rickwood and Di Biase 2013: 3).

NAFTA was not the start of the United States’ biologics IP ambitions. It was in the TPP, with 12 Pacific countries of diverse developmental levels, that they sought to establish the norm of 12 years of exclusivity for biologic drugs. Both developing and developed countries were aghast – negotiators knew that even domestically US legislators were reluctant to adopt extensive monopolies for biologics, and there were domestic considerations for biologics exclusivity to be limited to 7 or less years. (Rahman, upcoming research) A number of countries were at loggerheads with the US at what was intended to be the final Chief Negotiators Meeting of the TPP in Atlanta in September 2015, with at least Australia, Chile, and Malaysia having bilateral meetings there that dragged the meeting into the early hours into the morning.

Developing countries would be wise at this point to remind themselves of TRIPS and the evergreened patents and exclusivities that bind their medications today. They would be wise to remind themselves that as they develop and their citizens become richer, they will increasingly deal with more ‘developed country diseases’, such as cancer – and that these drugs are biologic. They would be wise to remember that biologic treatments can go into the hundreds of thousands of dollars per patient per year. They would be wise to remember that IP is not negotiated in a silo, but rather it is negotiated in the context of other factors – promises of FDI or perceived technology transfer gains (Pugatch 2004: 57), and that they would be wise to train their negotiators to be adept to developed country demands, and to insulate their economies from needing to accept biologics exclusivity in future trade agreements.

History has taught us of how in recessionary periods, developing countries have become beholden to developed countries, and it is during these times that developing countries are particularly vulnerable to accepting demands on pharmaceutical IP. (Sell 1998: 32)

The United States has throughout history been the principal demandeur of maximalist intellectual property. Their IP proposals are backed by a powerful pharmaceutical lobby that understands the market and anticipates what legal measures should be harmonised worldwide via enforceable mechanisms to maximise profitability. They tried through the TPP and failed, they are trying via NAFTA, and they will continue to try to establish it as the gold standard in pharmaceutical IP in multiple fora.

A quote attributed to an array of authors states, “Those who cannot remember the past are condemned to repeat it.” And so long as we keep the history of TRIPS and the struggles countries have with medicine prices in recent times, and so long as countries prepare for these biologics machinations (by training negotiators, by insulating their economies, by investing in pharmaceutical delinkage), we can stop biologics exclusivities and the corresponding high costs from being a regular part and parcel of our lives.

Fifa Rahman LLB (Hons) MHL (Health Law) (Sydney) is a PhD Candidate in Law at the University of Leeds. She also represents NGOs on the Board of Unitaid, working on access to innovative health technologies in HIV, tuberculosis, and malaria.


Pugatch, M. P. 2004. The international political economy of intellectual property rights. Cheltenham (UK): Edward Elgar Publishing.

Rickwood, S., Di Biase, S. 2013. Searching for terra firma in the biosimilars and non-original biologics market: insights for the coming decade of change. IMS Health [Online]. [Accessed 13 March 2017]. Available from: http://wenku.baidu.com/view/52791087a58da0116c1749b6.html?re=view###

Sell, S. K. 1998. Power and ideas: North-South politics of intellectual property and antitrust. New York: State University of New York

source: IP Watch