Tamiflu (generic name: oseltamivir) is an antiviral medication that works against most but not all strains of flu — it is not effective against flu strains that have become resistant to it. Used preventively during an outbreak, Tamiflu significantly reduces the likelihood of illness. Used as a treatment (if taken promptly after the onset of symptoms), it may significantly reduce the duration and severity of illness.
As the world’s health officials prepare for a pandemic of fatal bird flu, the Swiss drug giant Roche may have the most important ingredient of all: the antiviral drug Tamiflu. That is a lot of responsibility considering that bird flu is often fatal and a viable vaccine is not yet available. (1)
The largest, most devastating outbreak of an infectious disease in modern history occurred in 1918, when a highly virulent influenza A (H1N1) virus spread throughout the world and killed between 20 million to 40 million people. Additional epidemics occurred in 1957 (H2N2) and 1968 (H3N2), both originating in Asia and each killing approximately 1 million people. (2)
Picture 1. Countries Reporting Avian Influenza during 2004. (Information is from the World Organization of Animal Health). (3)
In 2005, there was considerable concern that the owner of the exclusive right to manufacture the patented drug, the Swiss pharmaceutical company Roche, Inc., lacked the production capacity to meet the needs of these governments worldwide. In response to the heightened demand for the drug, as well as faced with threatened abrogation of its patent rights by U.S. politicians and government officials in other countries, Roche significantly boosted Tamiflu production in 2006 and 2007 by voluntarily signing licensing agreements with 19 external contractors in 9 different countries to manufacture the drug. This expansion in manufacturing capacity has increased production of the drug to over 400 million treatments annually — an amount that, according to the company, is sufficient to fulfill its existing orders (as of April 2007) for Tamiflu from governments and corporations. In addition, Roche has donated “rapid response” supplies of Tamiflu (more than 5 million treatment courses) to the World Health Organization for establishing regional stockpiles to help contain or slow the spread of a pandemic. Finally, Roche has agreed to arrange for special pricing for government orders and to reduce the price of Tamiflu for low income countries. This report examines the role that intellectual property rights play in affecting the availability of a patented drug such as Tamiflu during public health crises. The report also explains one legal mechanism for increasing a patented drug’s production without the patent holder’s consent: governments may abrogate a pharmaceutical company’s patent rights by issuing compulsory licenses to other drug companies to manufacture generic versions of the drug. Such option is available to countries under the Trade-Related Aspects of Intellectual Property (TRIPS) Agreement, a component of the treaties that created the World Trade Organization (WTO) in 1995. (4) In the case of Tamiflu and the avian influenza antiviral drug supply, Roche’s willingness to sublicense its patent rights to several manufacturing partners has helped to lessen the concern over intellectual property rights hindering efforts to prepare for and respond to an influenza pandemic.
Picture 2. Nature, Vol 427,
5 FEB 2004 www.nature.com/nature
Tamiflu, known generically as oseltamivir, can treat seasonal influenza and has helped some people infected with H5N1. Roche licenses it from Gilead Sciences. Another drug, Relenza or zanamivir, made by under license from Australia's Biota, can also treat and prevent flu. It is an inhaled formulation and a report in The Lancet magazine suggests the efficacy of Relenza, licensed by GlaxoSmithKline, is similar. But governments responsible for...