Drug patents under the spotlight, sharing practical knowledge about pharmaceutical patents

Patents have been one of the most hotly debated topics on access to essential medicines since the creation of the World Trade Organization (WTO) and the conclusion of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) in 1994. Patents are by no means the only barrier to access to life-saving medicines, but they can play a significant, or even determinant, role in the that they grant the patent holder a monopoly on a drug for a number of years. The patent holder’s freedom to set prices has resulted in drugs being unaffordable to the majority of people living in developed countries.

On the other hand, a functioning patent system is also supposed to guarantee that the public at large benefits from any innovation, including medicines. Countries have deployed various strategies to strike a balance between private and public interests in their intellectual property systems, and they have had various degrees of success. Getting the balance just right is particularly important for governments of developing countries as they work to protect public health while making their patent laws TRIPS compliant.

A full and frank re-appraisal of the role that a patent system plays in public health alongside other public policy tools is now taking place. The WTO 2001 Doha Declaration on TRIPS and Public Health has played a powerful role in this process. Another important development has been the publication of the report of the UK Commission on Intellectual Property Rights, “Integrating Intellectual Property Rights and Development Policy” in September 2002, which strongly advocated for patent systems that support the public health policies of developing countries according to the needs and level of development of each country.

Médecins sans Frontières (MSF) works in many developing countries around the world. Procurement of medicines is part of the organisation’s daily business, which is why we are interested in knowing which medicines are patented in which countries. This information is currently not publicly available in a form that can be easily understood.

Some patent surveys have given only yes or no answers about whether or not a medicine is patented ina given country. But the situation is more complicated than that. For use in its own projects, MSF has had to gather the necessary information for itself. This document has grown out of that process. The table in Annex A shows the patent data we collected regarding 18 pharmaceuticals in 29 countries.

This report hopes to further inform the debate about pharmaceutical patents amongst a wider audience. For those WTO Members that do now provide patent protection for pharmaceutical products, much of the debate surrounding patents and access to essential medicines has so far focused on safeguards in the TRIPS Agreement, such as parallel importation, compulsory licensing and government use, that take effect after a patent has been granted. However, even when fully implemented, the TRIPS Agreement still allows some degree of decision making by WTO Members before a patent has been granted, i.e. about what sort of inventions they will grant patents for. The report focuses on the latter. It draws from MSF’s practical experience and is intended to complement much of the work done so far on overcoming patent barriers.

The TRIPS Agreement sets out the minimum standards for patent protection all WTO Members must abide by. Unlike in the days before the TRIPS Agreement, countries that are Members of the WTO can no longer rule out granting patents in particular fields of technology, such as the pharmaceutical sector. But the TRIPS Agreement also requires that patents are granted for inventions which, among other things, are new and inventive. There is no internationally accepted definition of either of these terms and different WTO Members have taken very different approaches, deciding on definitions that best suit their needs. This document will give some concrete examples of the different choices available and the consequences of those choices.

No patent office is perfect. Many patents issued in, for example, the European Patent Office or the United State Patent Office have turned out to be invalid when tested by a court. No patent office is or ever could be in such a position of perfect knowledge that they grant only valid patents. The fact that patents in, for example, OECD countries get revoked now and again shows that there are checks and balances in place to catch cases where a patent should not have been granted.

But when we studied patent systems in developing countries, it quickly became apparent that in many of these countries, very few if any patents have ever been revoked. This cannot be right. The lack of feedback demonstrates that the system isn’t functioning properly. Challenging invalid patents is a topic that has received little detailed attention so far. A recent court decision in Thailand gives some that this situation may be changing, as will be discussed below.

This report is aimed at a non-expert, non-legal audience, and it aims to offer new approaches to those seeking to overcome patent barriers. We also hope that those with responsibility for deciding which sorts of patents to grant and which not grant will find some new issues to take into account, so that fewer patent barriers are created in the first place.

MSF is a humanitarian medical aid organisation. We focus on people in need of care. We gathered the information contained in this report as we struggled to find the most appropriate and affordable care for our patients. We grew more familiar with pharmaceutical patents, the TRIPS Agreement and the WTO in the process - not because we wanted to but because we had to.

Although we are happy to share some of what we have learned, others cannot be complacent, For reasons that we will explain in this report, the information presented can never be regarded as complete. We call on organisations such as the World Health Organization and the World Intellectual Property Organization to use their expertise, resources and mandate to take the work of this report further and produce the public, easily understood and transparent database on pharmaceutical patents status that Is so necessary.