Whenever a nutraceutical company has an invention that was made in the United States-if one or more inventors were working in the United States-they must obtain a Foreign Filing License before filing a patent application in another country.
This is true even if most of the inventors were not working in the U.S., even if the patent owner is a foreign company (or foreign parent/subsidiary) with no other ties to the U.S., and even if a U.S. patent application is filed on the same day.
The penalties for violating this law are severe.
If a Foreign Filing License is not obtained, the corresponding U.S. patent is "barred" (invalid) and anyone who knowingly and willfully violates the law is subject to fines (up to $10,000) or imprisonment (up to two years), or both.
For most patent applications, a Foreign Filing License is automatically granted six months after the U.S. application is filed, and a license may be granted sooner, as indicated on the application's Filing Receipt.
Moreover, no license is required for a PCT (international) application that is filed with the U.S. Receiving Office.
Nevertheless, nutraceutical companies should be aware of Foreign Filing License issues that can arise from common patent practices: -A license must be obtained (automatically or by request) before filing a patent application in a country that is not encompassed by the PCT (including Argentina, Chile, Peru, Iran, Iraq, Saudi Arabia, Taiwan, Thailand and Pakistan).
-A license must be requested if any foreign filings are made before a license is automatically granted on a corresponding U.S. application, even if the foreign application is identical to the U.S. application.
-A supplemental license may be required if a foreign patent application contains additional subject matter that is not encompassed by the license granted on a related U.S. application, for example, when a U.S. provisional application is supplemented for the non-provisional filings.
The procedures for obtaining a Foreign Filing License are not onerous, and licenses can be obtained on an expedited basis, within a few business days.
Importantly, a "retroactive" license can be obtained for an unlicensed foreign filing, if sought diligently after the unlicensed filing is discovered, and as long as the unlicensed filing was made "through error and without deceptive intent," and the application does not raises national security concerns.
By taking steps to ensure that the U.S. Foreign Filing License requirements are met, nutraceutical companies can secure their positions in the global market by obtaining world-wide patent protection for their inventions without jeopardizing the validity of their U.S. patents.
Courtenay Brinckerhoff is a partner in Foley's Washington, D.C. office.
She is a member of the firm's Biotechnology & Pharmaceutical, Chemical & Pharmaceutical and Appellate Practices, and the Life Sciences Industry Team.
She can be reached at 202.295.4094 or via email at cbrinckerhoff@foley.com.