Patents term extension

The PTE complex law of 1984 (USA) offers an opportunity to extend the effective life of patents for new medical inventions up to five years. 

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It should be noted that applications for a patent term extension must be handed in as early as within 60 days (USA) or 6 months (EPO) from product approval. 

Other countries have followed the U.S. lead regarding patent term extension. Japan enacted a provision effective January 1, 1986, whereby patents covering pharmaceutical products could be extended for up to 5 years. The Japanese provisions differ from the U.S. law in several ways. First, more than one patent can be extended for each product. Also, the Japanese law requires that the patent be granted 2 years before health authority approval of the product. Korea has enacted a patent term extension law very similar to that in the Japanese system. Australia has replaced its lack of renumeration system with a system based on regulatory delay. 

Various strategies are pursued by pharmaceutical companies to extend the product life cycle. Under the Hatch-Waxman Act, patent term extensions are available for patented drug substances, drug products, method of use, and method of manufacturing to compensate for the time lost in the FDA s regulatory approval process. However, the limitations of the statute of the following aspects have to be considered ... 

A listing of drugs for which the patent term had been extended by the US FDA is available at the website mentioned in Ref. 20. The longest patent term extension given by the U.S. FDA to any drug belongs to U.S. Patent 3,737,433 (Trental) for 2494 days. 

Engelberg, A. B., Patent Term Extension An Overreaching Solution to a Nonexistent Problem, Health Affairs l(l) 34-45, 1982. 

The end of the patent term under the 17- or 20-year term can be advanced by failure to pay maintenance fees or by a terminal disclaimer. The end of the patent term can be extended in some cases by the patent term extension provisions. See section 2.4.2. 

Under the current system, an applicant may question whether even to file such divisional applications. If broad and adequate protection can be provided in the parent case, it appears that divisional applications may not be necessary. For example, if broad composition of matter claims can be obtained in the parent application, method of use claims presented in a divisional application may offer little additional protection and offer no additional patent term extension. Little additional protection is provided because the broad composition of matter claims will cover all uses of the compound, including a new use. In the event, however, that the composition of matter claims are later found to be invalid or unenforceable, the method of use claims could prove to be valid and enforceable. Thus, there are strong arguments that such divisional applications should be filed even under the current system. 

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