Case studies
These are only brief discussions of complex cases, intended to illustrate how some of the facts and ideas laid out in our summary of patents and international agreements play out in practice.
India: the effect of adopting TRIPS
In 1995, India's patent laws did not meet TRIPS requirements. At that time, medicines were not patentable per se in India, but the process by which a medicine was manufactured was. Thus, if any company could simply think of a new way to manufacture a medicine, they could manufacture and sell that medicine legally. Thus, many drugs have been produced generically in India for a long time, so that India has often been called the "pharmacy of the developing world". Doctors Without Borders/Médecins Sans Frontières, for example, relies on Indian-supplied drugs to treat 70% of their HIV patients.
As discussed above, India was given 10 years to revise its patent laws. As of 2005, India's patent law conforms to TRIPS. Any medicine invented prior to 1995 will remain non-patentable in India, and any company that was already legally manufacturing a drug prior to 2005 will be allowed to continue to do so. However, newer drugs will likely not be available generically from India.
Brazil and Thailand: use of TRIPS flexibilities
The Brazilian government, as part of a program aiming to deliver universal HIV treatment for Brazilians, has successfully used simply the threat of compulsory licensing to bargain for lower prices on patented HIV medicines, and has gone on to issue a compulsory license on one drug.
Thailand also issued compulsory licenses for several drugs in 2007, including drugs for HIV and heart disease. The US Trade Representative subsequently placed Thailand on its 'Watch List' of countries that do not sufficiently protect IP, despite the fact that compulsory licenses are legal. More disturbingly, Abbott Pharmaceuticals, the patent-holder on three of those drugs, responded by cutting off the supply of all its other drugs. This was also a legal move on Abbott's part, but it illustrates the fact that the freedom of a government to act is not determined solely by law: political and economic pressures can play a major role as well.
Read more about the use of TRIPS flexibilities by Brazil and Thailand.
Canada and Rwanda: implementing the August 30 2003 decision
In 2004, Canada became the first country to amend its patent law to take advantage of the new TRIPS flexibility to allow compulsory licensing for export to poor countries, discussed above. (The amendment was originally known as the Jean Chrétien Pledge to Africa Act, but has since been renamed to Canada's Access to Medicines Regime, or CAMR.) Canadian drug manufacturers, in theory, are now free to sell generic versions of patented drugs, to poor countries that request it. Global public health advocates hailed Canada's leadership.
However, it took 4 years for CAMR to actually be used: in 2008, Canadian pharmaceutical manufacturer Apotex at last began shipping an HIV drug to Rwanda. Apotex has said that it will not use the law again unless it is reformed, citing excessive bureaucratic requirements and unnecessary economic disincentives. However, if CAMR is reformed, Apotex has indicated its willingness to manufacture a pediatric HIV drug for Rwanda. As of September 2009, the Canadian HIV/AIDS Legal Network is leading an advocacy campaign to reform the law.
The limited use of the August 30 2003 decision to date may be due to the fact that the least expensive medicines continue to be produced in India. However, now that medicines are patentable in India, this source will not be as comprehensive in the future, and useable implementations of the August 30 2003 decision will likely become an increasingly important mechanism to provide poor countries with low-cost access to new drugs.
