Patent certification

Patent information on any patent that claims the drug, if applicable Patent certifications (not for BLA)... 

In one pending case, the FDA determined that the brand-name company failed to submit the required information for a particular patent in a timely manner. Therefore, the generic applicant was not required to submit a patent certification to address that patent, the 30-month stay was dissolved, and the FDA subsequently approved the ANDA. Commercial patent litigation was still pending as of June 1, 2002, however, and the generic applicant has not yet entered the market. 

Patent certification—a certification regarding any patents that claim the listed drug or that claim any other drugs on which investigations relied on by the applicant for approval of the application were conducted, or that claim a use for the listed or other drug. ... 

Unlike a full NDA for which the sponsor has conducted or obtained a right of reference to all the data essential to approval, the filing or approval of a 505(b)(2) application may be delayed due to patent or exclusivity protections covering an approved product. Section 505(b)(2) applications must include patent certifications described at 21 CFR 314.50(i) and must provide notice of certain patent certifications to the NDA holder and patent owner under 21 CFR 314.52. 

If there is a listed drug that is the pharmaceutical equivalent of the drug proposed in the 505(b)(2) application, the 505(b)(2) applicant should provide patent certifications for the patents listed for the pharmaceutically equivalent drug. Patent certifications should specify the exact patent number(s) and the exact name of the listed drug or other drug even if all relevant patents have expired. 

R. Roque-Malherbe, A. Picart, C. Diaz, and G. Rodriguez, Patent Certificate 21055, ONIITEM, C Street and 15 Avenue, Vedado, Havana, Cuba, (1986). 

R. Sanchez, C. Hernandez, R. Roque-Malherbe, and H. Campana, Cuban Patent Certificate No. 21644 Al, Cuban Office for the Industrial Property, Havana, 1987. 

R. Roque-Malherbe, R. Roque and F. Morales, Patent Certificate No. 21059, ONIITEM, Havana, Cuba (1982). 

The application form, as well as the index and the summary (items 1 and 2), should be bound together in a single volume. Items 3 to 12 should be submitted in separately bound volumes in the order in which they are listed. Patent information on the applicant s drug (item 13) and a patent certification with respect to the drug (item 14) should be submitted on a separate piece of paper attached to the application form itself. 

According to the FDA s Guideline on Formatting, Assembling, and Submitting New Drug and Antibiotic Applications, the patent certification and patent information should be attached to the application form in the submission. 

Applications for a national patent or at the International Patent Office may cost up to an equivalent of US 3,000 per application for a search report and the examination. A similar amount can be assumed for the involvement of a patent attorney as long as only formalities are concerned. Creative work by a patent attorney office (e.g. formulation of the claim or of defending statements) as well as translations result in the extra cost of about US 100-300 equivalent per hour, depending on the qualification of the person who deals with it. Thus, the effective cost of the patent application may rise up to US 8,000-10,000 per country. Annuities for a national patent are raised as a constant rate per year or increase during the life-span of a patent. The figure of US 100-300 per year and country (or per patent certificate from international patent organizations) may serve as a clue for what must be expected. 

Regardless of whether the generic applicant seeks approval via the ANDA route or the paper NDA route, it must provide the patent certification... 

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