Patents term adjustment

As a simple example, the life span of a US patent used to be easy to calculate US patents used to last 17 years, calculated from the date of issue. But US patents filed after 7 June 1995 now last 20 years, calculated from the date of filing (which has been typical outside the United States for many years). Also, a form of tax, known as a maintenance fee, is now imposed on US patents. If the patentee does not pay each fee as it becomes due, the patent lapses. Lastly, patents can be extended via two different mechanisms. Under the rules of Patent Term Restoration, certain patents, mostly pharmaceutical patents, can be extended for up to five years. The theory is that the patentee has suffered an injustice because he or she was essentially denied a portion of the patent s life and not allowed to earn potential profit from the patented invention because of the need to first obtain regulatory (e.g. FDA) approval before bringing the product to market. Under the rules of Patent Term Adjustment, extensions can also be obtained for certain procedural delays during the prosecution of a patent application. The actual term extension for each patent is determined by its specific facts. These two calculations are independent of one another. 

Patent Term Adjustment is not limited to pharmaceutical patents. When does this U.S. patent expire used to be, but no longer is, a trivial question to answer. 

Patent law in the area of pharmaceuticals in general has become more complex, both from the government regulation policy side and in terms of the details of patent term adjustment between the Patent Office and the FDA s approval process. A better understanding of drag patent and regulatory issues will help to maximize protection of an approved drag product. 

Adams SR. Information Sources on Postgrant Actions to Pharmaceutical Patents. World Patent Inf. 2001 42 467-472. Where to find information about patent term adjustments, supplementary protection certificates, and other modifications to U.S., Emopean, and other pharmaceutical patents. 

To protect innovation adequately in fields subject to government regulation, a procedure should be est lbllshed providing for an appropriate adjustment in the patent term when commercialization is held up due to regulatory delay. 

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