What happens if a product is not approved within the period of interim extension under 35 U.S.C. 156(d)(5)?

If a product does not receive approval within the period of interim extension granted under 35 U.S.C. 156(d)(5), further action is required to maintain the patent’s extended term. According to MPEP 2754.02:

“If the product is not approved within the period of interim extension under 35 U.S.C. 156(d)(5), a new request for interim extension must be filed and another interim extension granted to keep the patent in force.”

This means that patent holders must be vigilant about the expiration of their interim extensions and file new requests as necessary to maintain the patent’s extended term while awaiting product approval.

To learn more:

• interim extension
• product approval
• patent term
• 35 U.S.C. 156(d)(5)