For which patents is Patent Term extension available?

Patent Term Extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act, is specifically applicable to certain patents that meet criteria established by the United States Patent and Trademark Office (USPTO). The Act allows for the extension of the patent term for drugs and biologics to compensate for time taken in regulatory review processes, with specific parameters based on when the patent was filed and the type of approval received.

Patents filed between June 8, 1995, and May 29, 2000, are eligible for patent term extension if they meet the required conditions. This time frame is particularly significant because it includes changes to the law and types of products that are eligible for extensions, distinguishing them from patents filed prior to this period or after the specified date.

Patents filed before June 8, 1995, do not qualify for the same extension terms under the post-1984 provisions, as those were governed by older regulations. On the other hand, while patents filed after May 29, 2000 might also qualify for patent term extensions, they are subjected to different requirements and conditions that must be adhered to under the American Inventors Protection Act and other later regulations