The Orange Book lists the following as Patents:
The active substances or compounds are claimed in patents.
Patents on drug products, including formulation-composition patents.
Utilize patents for a certain authorized use or indication of the product.
The Bolar amendment to the Drug Price Competition and Patent Term Restoration Act permits a pharmaceutical manufacturer (sponsor) to request approval from the FDA to market a generic drug prior to the expiration of the patent associated with the brand name drug on which the generic is founded.
As part of the Abbreviated New Drug Application (ANDA), the sponsor is required to evaluate the relevant patents and submit the findings to the FDA. The Act mandates that patent information must be filed with all newly submitted Section 505 drug applications, and that no New Drug Application (NDA) can be approved after September 24, 1984, without the submission of the relevant patent information to the FDA.
The ANDA sponsor is obligated to provide a certification stating that, in the sponsor’s opinion and to the best of their knowledge regarding each patent that claims the listed drug, some or all of the following certifications may be submitted:
- Paragraph I: that such patent information has not been filed
- Paragraph II: that such patent has expired
- Paragraph III: of the date on which such patent will expire, or
- Paragraph IV: that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.
A certification in accordance with Paragraph I or II allows for the immediate approval of the ANDA, provided it meets all other eligibility criteria. A certification under Paragraph III signifies that the ANDA may receive approval upon the expiration of the patent.
If the Orange Book lists one or more unexpired patents, the sponsor of The ANDA who seeks
effective approval prior to the patent’s expiration must either:
- Challenge the listing of the patent (e.g., file a Paragraph IV Certification that the patent is invalid or will not be infringed by the manufacture, use, or sale of the drug product).
- File a statement that the application for use is not claimed in the listed patent.