Patent certification is required for all generic new animal drug applications to account for patents claiming the drug substance (active ingredient), drug product (formulation or composition), or method(s) of use for the reference listed new animal drug (RLNAD) being copied. For more information about patent certification, refer to section 512(n)(1)(H) of the Federal Food, Drug, and Cosmetic Act (the act) and the Code of Federal Regulations (CFR), 21 CFR 314.94(a)(12).
RLNAD Patents are categorized with respect to their listing as part of the Green Book Reports. Relevant patents are listed online under the Green Book Reports, Section 3.0 Patent Information at animaldrugsatfda.fda.gov. Relevant patents may have expired, or will expire in the future, and are always listed in Section 3.0. If an RLNAD has never had an associated patent or has an expired patent that isn’t listed in Section 3.0, it is appropriate to conclude that the RLNAD has no relevant patents.
There are 5 options to select from in eSubmitter if there are relevant patents for the RLNAD.
- Paragraph I Certification: that an enforceable patent exists for the RLNAD, but such patent information is not present in Section 3.0 of the Green Book Reports.
- Paragraph II Certification: that a relevant patent has expired, and it is listed in Section 3.0.
- Paragraph III Certification: that a relevant patent will expire in the future and it is listed in Section 3.0.
FDA will not accept a request for action on a generic investigational new animal drug (JINAD) or abbreviated new animal drug application (ANADA) that refers to an RLNAD with a relevant patent that is more than 5 years from expiration. The exception to this occurs when the sponsor provides a commitment statement that they will submit a Paragraph IV Certification claiming noninfringement or invalidity of such patent.
- Paragraph IV Certification: that a relevant patent will expire in the future and it is listed in Section 3.0, but the patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the generic new animal drug for which the application is filed per 21 CFR 314.95. This certification is not provided until an ANADA has been filed by the sponsor AND accepted for review by CVM. Until that time, a sponsor planning to use this certification provides only a commitment to doing so when they open their JINAD file, when they submit their Patent and Marketing technical section.
- Method of Use Statement: that a relevant patent will expire in the future and it is listed in Section 3.0, but the labeling of the proposed generic drug product does not include any indication(s) claimed in the patent.
For any applicable selection, you will need to indicate the patent number and expiration date of the relevant patent.
You must select whether the RLNAD has been granted marketing exclusivity as defined under section 512(c)(2)(F) of the act and provide the date on which the exclusivity will expire if one is listed in Section 4.0 of the Green Book Reports.