The Patent Term Extension (PTE) is a legal measure which was first established by the Drug Price Competition and Patent Restoration Act of 1984, in the United States of America. Broadly speaking, under the PTE, the extension of the validity of a patent, claiming a product and a method of manufacturing, can be requested by the patentee due to unreasonable delays that would have occurred within the marketing approval process of its new product before the corresponding health authority. Such product must be directly related to the granted claims.
On the other side, the Patent Term Adjustment (PTA) is a legal measure similar to the PTE, which was first established by the American Inventors Protection Act of 1999, in the United States of America. Under the PTA, the patentee is allowed to request the extension of the validity of a patent due to the unreasonable delays which would have occurred during the substantive examination of an invention.
Although the PTE and PTA were originally established in the United States of America as mentioned above, these statutory provisions have been implemented in other countries, such as Australia, Japan, the European Union member states and Israel. The idea behind these provisions is that unreasonable delays caused by administrative authorities reduce the effective patent term and, thus, the period that patentees have to recover their investment in research and development of new technologies. For example, if a patent prosecution took seven years, the effective patent term would be thirteen years instead of fifteen years.
In the case of Peru, both PTE and PTA were discussed during the negotiations of the Free Trade Agreement between the United States and Peru. However, in the final Agreement, signed in 2006, Peru accepted to introduce only the PTA in its Patent Legislation, but without including patents over pharmaceutical products. The PTE is only mentioned in this Agreement under the following terms: “With respect to any pharmaceutical product that is covered by a patent, each Party may make available a restoration of the patent term or patent rights to compensate the patent owner for unreasonable curtailment of the effective patent term resulting from the marketing approval process related to the first commercial marketing of the product in that Party…”. At the present time, it is known that Peru has not the intention of implementing the PTE.
The PTA has been established in the Peruvian patent legislation to compensate patentees for unreasonable delays caused by the Patent Office, which must be more than: (i) five years from the filing date of an application to the granting date of the patent; or, (ii) three years from the expiration of the period for requesting the substantive examination to the granting date of the patent. If an opposition is filed after the publication, the three-year term will be counted from the date on which the opposition phase is declared closed.
The request of adjustment must be filed within thirty working days from the granting date of the patent. Furthermore, for the calculation of the adjustment, it is considered one day of adjustment for every two days of delay.
Finally, it is important to note that although the Free Trade Agreement between the United States and Peru excluded only the pharmaceutical products from the PTA, the Peruvian patent legislation excludes also patents which claims are referred to both a pharmaceutical product and its manufacturing procedure. Moreover, it is not clear in this legislation if the exclusion is also extended to the patents which refer only to a pharmaceutical procedure.