Patent Term Extensions And Adjustments

This report surveys the law on extensions and adjustments of patents in nine jurisdictions: Australia, Canada, the European Union, France, Germany, Israel, Japan, South Korea, and the United Kingdom. All of the surveyed jurisdictions provide for a standard patent term of twenty years, and all of them except Canada provide for extensions of protection for certain products that are subject to regulatory approval before they can be marketed. For the European Union and France, Germany, and the United Kingdom, supplementary protection certificates (SPCs) are available that extend the protections of patents for medicinal and plant protection products to cover the period needed for regulatory approval of the product, typically to a maximum of five years. Australia similarly provides for extensions of patent protections for pharmaceutical substances to account for the period needed for regulatory approval up to five years. Israel permits the term of basic pharmaceutical patents to be extended for a period equal to the time between submission and granting of the marketing license application, up to five years. Israel also permits extension of related patents held in the United States, Italy, Britain, Germany, Spain, and France where there is patent extension or SPC in the country of origin. Japan allows an extension of the duration of a patent right by up to five years when the patented invention is subject to certain regulatory approval processes that take a considerable time to complete, including those for agrochemicals and pharmaceuticals. South Korea likewise allows for the extension of patent terms for up to five years with respect to medicines and agricultural chemicals to account for the period of product registration.