NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

“Patent term extension (PTE) is available under the 1984 Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act (The Act). The Act allows the extension of the term of a patent claiming a product that requires regulatory approval prior to being sold, or a method of using or manufacturing the product. Such products include human and veterinary pharmaceuticals, food additives, color additives and medical devices. PTE aims to restore a portion of the patent term that is lost while the patent holder is awaiting regulatory approval of the product.

The determination as to whether PTE should be granted is made by the U.S. Patent and Trademark Office (PTO), in consultation with the regulatory agency responsible for approval of the product.”

https://www.sternekessler.com/news-insights/publications/patent-term-extension