Influenza Antiviral Drugs and Patent Law Issues (CRS Report for Congress)
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| Release Date |
Revised Aug. 16, 2007 |
| Report Number |
RL33159 |
| Report Type |
Report |
| Authors |
Brian T. Yeh, American Law Division |
| Source Agency |
Congressional Research Service |
| Older Revisions |
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Summary:
The potential for a worldwide influenza pandemic caused by bird flu has generated public interest in the availability and affordability of influenza antiviral medications such as the prescription drug Tamiflu. The possibility of a pandemic flu outbreak has contributed to a surge in orders for Tamiflu, as countries attempt to stockpile sufficient countermeasures. 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 annuallyâan 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. The U.S. government's authority to declare compulsory licenses is Section 1498(a) of Title 28 of the U.S. Code. Other legal avenues to increase the supply of, and lower the price for, a patented drug include voluntary licensing agreements between the drug's patent holder and other companies for manufacturing or distributing the drug. 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.
