Source: http://www.fdalawblog.net/2017/01/505b2-nda-and-anda-amendments-dont-forget-to-meet-the-new-verification-requirement/
Timestamp: 2019-04-20 14:26:12+00:00

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FDA’s October 6, 2016 Final Rule implementing certain provisions of the December 8, 2003 Medicare Modernization Act (“MMA”), Pub. L. No. 108-173, 117 Stat. 2066, ushered in a lot of changes for NDA and ANDA applicants and sponsors (see our previous post here). The new regulations went into effect on Monday, December 5, 2016, and FDA immediately began to enforce them.
(iv) To change the physical form or crystalline structure of the active ingredient.
(2) If the amendment to the ANDA does not contain a patent certification or statement, the applicant must verify that the proposed change described in the amendment is not one of the types of amendments described in paragraph (d)(1) of this section.
New Subsection (d)(1) codifies FDA’s position, developed over the past decade or so, that certain changes proposed in an ANDA amendment require an applicant to recertify to patent information listed in the Orange Book for the brand-name RLD, and, in the case of a Paragraph IV certification, to provide a new notice of Paragraph IV certification. A patent infringement lawsuit filed in response to such a renotification can result in the imposition of a superseding 30-month litigation stay on ANDA approval. We previously blogged on that issue here, and there are various FDA Citizen Petition Decisions discussing the issue (Docket No. FDA-2012-P-0943; Docket No. FDA-2011-P-0127; Docket No. FDA-2010-P-0223; Docket No. FDA-2010-P-0632), as well as instances in which the issue has been raised in patent infringement litigation because of a product change in an amendment (See, e.g., Alza Corp. et al. v. Impax Laboratories Inc. et al., Case No. 1:10-cv-01024 [here]; Alza Corp. et al. v. Impax Laboratories, Inc. et al., Case No. 1:11-cv-00395 [here]; Teva Branded Pharmaceutical Products R&D Inc. et al. v. Perrigo Pharmaceuticals Co. et al., Case No. 13-cv-01441 [here]).
If an amendment to an unapproved ANDA does not contain a patent certification or section viii statement, or a recertification, the applicant must verify that the proposed change described in the amendment is not one of the types of amendments described above.
Your amendment is deficient under 21 CFR 314.96(d). It currently does not contain (1) a patent certification or section viii statement, (2) a recertification, or (3) a verification statement. As appropriate, please submit a patent certification or section viii statement, a recertification, or a verification statement (referencing your amendment dated [DATE]).
For future reference, to comply with the requirement of 21 CFR 314.96(d), we recommend that a patent certification or section viii statement, or recertification be referenced in the cover letter of an amendment to an unapproved ANDA and included in module 1.3 of such unapproved ANDA. Similarly, we recommend that a verification statement be included in the cover letter of an amendment to an unapproved ANDA. For inquiries related to this requirement please contact the Patent and Exclusivity Team at CDER-OGDPET@fda.hhs.gov.
Avoiding such a deficiency letter is relatively simple: Remember to incorporate the verification in any template correspondence for an ANDA amendment.
We’ll probably see more from FDA and other interested parties on the new verification requirement as new scenarios crop up. (And we’re likely to see a lot of ink spilled on what types of amendment changes might trigger the patent certification/recertification requirement. After all, the phrase “other condition of use” at 21 C.F.R. § 314.96(d)(1)(i) seems pretty ambiguous.) In fact, we’ve already come across one instance that seems to run contrary to the “either/or” choice FDA explains in the preamble to the MMA Final Rule (i.e., “if the amendment to the 505(b)(2) application or ANDA does not contain a patent certification or statement, the applicant must verify. . . .”). In the case of a timely-listed later-listed Orange Book patent, an ANDA applicant must certify to the patent in an amendment; however, the amendment may not be for one of the changes listed at 21 C.F.R. § 314.96(d)(1), and thus requires a verification under 21 C.F.R. § 314.96(d)(2).

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