Certification requires the ANDA applicant to state that: the NDA holder submitted no patent to the FDA (Para

I); any patent submitted has expired (Para II); the date on which the patent (s) covering the approved

LECTURE 42 PATENT CERTIFICATION

1

drug will expires (Para III); or that the patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the drug product for which the abbreviated application is submitted (Para IV).
2

The Paragraph I Certification The paragraph I certification states that patent information for the approved drug on which ANDA is based has not been filed according to the requirement of the state. The Para I certification also applies when the innovator failed to use the patent covering the approved product & the ANDA applicant would establish that he was not aware of any unused patent that claimed the approved drug. An ANDA filed with Para I certification may be approved immediately
3

The Paragraph II Certification Under paragraph II certification, the generic drug manufacturer certifies that the patents covering the approved products have already expired. Typically Para II certification are used only for the other drug products because it is common for the ANDA to be filled before the actual expiry of the innovators patent. An ANDA filed with Para II certification may be 4 approved effective immediately

Shirsat A.E., Department of Pharmaceutics Marathwada Mitra Mandals, College of Pharmacy, Thergaon, Pune-33.

The Paragraph III Certification Under paragraph III certification, the generic drug manufacturer certifies that the innovator patents will expire on certain date & requests marketing approval as of that date. In this case FDA may grant tentative approval of the generic drug manufacturers ANDA before the patent expires but the generic drug manufacturers does not receive full approval.
5

The Paragraph IV Certification Under paragraph IV certification, the generic drug manufacturer certifies that the innovator patents is not infringed by the generic product or that the patent is invalid

Under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based. The first company to submit an Abbreviated New Drug Application (ANDA) with the FDA has the exclusive right to market the generic drug for 180 days.
2) 1)

To begin the FDA approval process, the generic applicant must: certify in its ANDA that the patent in question is invalid or is not infringed by the generic product (known as "paragraph IV certification"); and notify the patent holder of the submission of the ANDA.

Shirsat A.E., Department of Pharmaceutics Marathwada Mitra Mandals, College of Pharmacy, Thergaon, Pune-33.

REFERENCES
If the patent holder files an infringement suit against the generic applicant within 45 days of the ANDA notification, FDA approval to market the generic drug is automatically postponed for 30 months, unless, before that time, the patent expires or is judged to be invalid or not infringed. This 30-month postponement allows the patent holder time to assert its patent rights in court before a generic competitor is permitted to enter.
9 10 3. 4. 5. 2. 1.

Raisch D.W; Felton L.A; The New Drug Approved Process and Clinical trial Design: In Remingtons The Science and Practice of Pharmacy;

Lippincott, William and Wilkins Publication; 21st edition, 965-975. Allen L.V; Popovich N.G; Ansel H.C; Ansels Pharmaceutical Dosage Forms & Drug Delivery Systems; Publication; 8th edition; 2005;43-65. http://www.accessdata.fda.gov http://en.wikipedia.org/ http://leda.law.harvard.edu Lippincott, William and Wilkins

Shirsat A.E., Department of Pharmaceutics Marathwada Mitra Mandals, College of Pharmacy, Thergaon, Pune-33.