What is the scope of rights during the extended patent term under 35 U.S.C. 156?

The scope of rights during the extended patent term under 35 U.S.C. 156 is defined in 35 U.S.C. 156(b). According to the MPEP:

“The rights derived from extension of the patent term under 35 U.S.C. 156(a) are defined in 35 U.S.C. 156(b), but are not limited to a claim-by-claim basis. Rather, subsection(a) of 156 indicates that ‘[t]he term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended.'”

However, there are limitations to these rights:

• If the patent claims other products in addition to the approved product, the exclusive patent rights to the additional products expire with the original expiration date of the patent.
• The scope of rights during the extended period only includes the active ingredient of an approved product, or an ester or salt thereof, and not other versions (e.g., metabolites) of the approved product.

To learn more:

• patent term extension
• scope of rights
• extended term
• 35 U.S.C. 156