What information is required to demonstrate that a patent claims the approved product?
To demonstrate that a patent claims the approved product in a patent term extension application, 37 CFR 1.740(a)(9) requires the following:
“The application need only explain how one product claim of the patent claims the approved product, if there is a claim to the product. In addition, the application need only explain how one method of use claim of the patent claims the method of use of the approved product, if there is a claim to the method of use of the product. Lastly, the application need only explain how one claim of the patent claims the method of manufacturing the approved product, if there is a claim to the method of manufacturing the approved product.“
The MPEP provides guidance on how to present this information:
- For chemical products, list variables and substituents corresponding to the approved product.
- For claims using “means for” language, reference relevant patent text and describe equivalents.
- For medical devices, consider using a claim chart with an element-by-element approach.
The showing should clearly demonstrate how the claim(s) read on the approved product, method of use, and/or method of manufacture, as applicable.
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