What type of Patent classification in an ANDA (Abbreviated New Drug Application)
Patent classification in an ANDA (Full form of ANDA is Abbreviated New Drug Application) for the USFDA (U.S. Food and Drug Administration).
In the context of an ANDA, the issue of patent classification is related to the identification and analysis of patents that cover the reference listed drug (RLD) or innovator drug. An ANDA is a regulatory submission made by a generic drug manufacturer seeking approval for a generic version of an already approved innovator drug.
During the ANDA review process, the generic drug applicant is required to certify to the USFDA regarding any patents that cover the RLD. The certifications are classified into four categories under the Hatch-Waxman Act:
1. Paragraph I Certification (No Patent):
The applicant certifies that there are no patents listed for the RLD in the Orange Book (FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations), or that all listed patents have expired.
2. Paragraph II Certification (Expired Patents):
The applicant certifies that the patent for the RLD is expired.
3. Paragraph III Certification (Invalid or Not Infringed):
The applicant certifies that the listed patent is invalid or will not be infringed by the generic drug’s manufacture, use, or sale.
4. Paragraph IV Certification (Challenging Patent):
The applicant certifies that the listed patent is invalid, unenforceable, or will be infringed, and provides detailed reasons for challenging the patent’s validity or non-infringement.
A Paragraph IV Certification is considered a legal challenge by the generic applicant, as it triggers a patent infringement lawsuit by the innovator company (the patent holder). The outcome of the lawsuit will determine whether the generic drug can be approved before the expiration of the challenged patent.
Paragraph in ANDA application in USFDA
More Details on Paragraph III (Para III) and Paragraph IV (Para IV)
Paragraph III (Para III) and Paragraph IV (Para IV) certifications in an Abbreviated New Drug Application (ANDA):
1. Paragraph III (Para III) Certification:
– Purpose: A Para III Certification is made by a generic drug applicant when seeking FDA approval for a generic version of an already approved innovator drug (Reference Listed Drug or RLD).
– What it certifies: It certifies that the patents listed for the RLD in the FDA’s Orange Book will not be infringed by the manufacture, use, or sale of the generic drug.
– Market entry: By submitting a Para III Certification, the generic applicant acknowledges that they will not market or launch their generic product until all the relevant patents listed in the Orange Book have expired.
– No patent challenge: Para III Certifications do not involve a challenge to the validity or enforceability of the patents. Instead, the generic drug applicant waits for the patents to expire naturally before entering the market.
2. Paragraph IV (Para IV) Certification:
– Purpose: A Para IV Certification is a more complex and legally significant certification made by the generic drug applicant in an ANDA.
– What it certifies: It certifies that one or more patents listed for the RLD in the FDA’s Orange Book are invalid, unenforceable, or will not be infringed by the generic drug.
– Market entry and patent challenge: By submitting a Para IV Certification, the generic drug applicant is essentially challenging the validity or enforceability of the listed patents. They are asserting that their generic drug can be marketed before the expiration of the challenged patent(s).
– Patent infringement lawsuit: Upon receiving notification of a Para IV Certification, the innovator company (patent holder) has 45 days to initiate a patent infringement lawsuit against the generic drug applicant.
What is 180 Days exclusivity in ANDA application in US?
– 180-day exclusivity: The first generic drug applicant to submit an ANDA with a valid Para IV Certification and successfully challenge a patent may be granted a period of 180 days of marketing exclusivity. During this period, no other generic competitor can market their product based on the same ANDA.
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