For which patents is Patent Term extension available?

Patent Term Extension (PTE) is specifically available for patents that are issued for inventions that could not have been commercially exploited in the marketplace due to regulatory delays. This policy was enacted under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act. The valid criteria underpinning the extension are tied to the regulatory review period necessary for getting approval for products such as pharmaceuticals and biologics.

Patents filed between June 8, 1995, and May 29, 2000, fall under the provisions of the American Inventors Protection Act that extended the PTE rules applicable to such patents. This reflects a period where both regulatory procedures and the need to incentivize pharmaceutical development were significant considerations, which represent the correct context for granting extensions.

Patents filed before June 8, 1995, and those filed after May 29, 2000, do not meet the requirements stipulated under the current provisions of the law that govern PTE. Therefore, distinguishing the specified window from the other periods is crucial to understanding the eligibility for patent term extensions.