Pharmaceutical Patent Laws
Pharmaceutical patent laws have changed considerably since the 1980s. Prior to 1990, many countries’ patent laws explicitly prohibited patenting food, medicine, plant and animal varieties and agricultural products. Through pressure from several industries and the U.S. government, many countries have removed some, or all, of these limits from their patent laws. Today, pharmaceuticals are patent-protected in almost every country.
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Patents
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Patents for pharmaceuticals are granted under the “inventions” category of most countries’ patent laws. The standard term of a patent for an invention is 20 years, though in some countries pharmaceutical patents are shorter with the possibility of extension for up to five years. Patents generally grant the holder exclusive, monopoly rights to use, reproduce, manufacture, distribute and import the patented product.
Public Health Emergencies
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Many countries have a clause written into their patent laws that allows the government to break the patent (either through compulsory licensing, government production or importation of generics) in the case of a national public health emergency. This clause is supported by the World Trade Organization, and the action is specifically protected under the Trade Related Aspects of Intellectual Property (TRIPS) agreement, though it is not invoked often.
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Issues
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Despite monopoly rights, protections and criminal penalties for violators on paper, the pharmaceutical industry experiences high levels of piracy. Many small companies and factories all over the world routinely ignore patents and produce generics of patented drugs or use patented drugs to boost their own research and development. India has the largest number of such small companies and factories, but the practice is common around the globe.
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References
- Photo Credit drug addict image by Keith Frith from Fotolia.com