Paragraph IV Notice Letter

• Author: Kenneth L. Dorsney
• Pages: 665-686

Paragraph IV Notice Letter

CONFIDENTIAL—NOT TO BE DISCLOSED

OUTSIDE OF ADDRESSEES OR THEIR COUNSEL1

[Date]

VIA FEDERAL EXPRESS

BRAND, Inc.

[Mailing Address]

Re: Generic, Inc. ANDA No. 00-001 for GenX; Notice of Certification of

U.S. Patent Nos. 1, 2, 3 and Offer of Confidential Access to Application

Dear President or Counsel:

As required by Sections 505(j)(2)(B)(i) and (ii) of the Federal Food, Drug and

Cosmetic Act (“Act”) (21 U.S.C. § 355(j)(2)(B)(i) and (ii)), as amended by Title XI of

the Medicare Prescription Drug, Improvement and Modernization Act, Pub. L. No. 108-

173, 117 Stat. 2066 (2003), notice is hereby given to Brand, Inc. (“Brand”) respectively

as the holder of approved New Drug Application (“NDA”) No. 00-001 for BrandX

(GenX Tablets) and the record owner of U.S. Patent Nos. 1 (“the ’001 Patent”); 2 (“the

’002 Patent”); and 3 (“the ’003 Patent”), (collectively, “the Brand Patents”) that the U.S.

Food and Drug Administration (“FDA”) has received an [amended] Abbreviated New

Drug Application (“[amended] ANDA”) No. 00-001, submitted by Generic, Inc.

(“Generic”) for BrandX 15, 30 and 45 mg Oral Tablets.

In accordance with 21 C.F.R. § 314.95, Generic hereby cites Section

505(j)(2)(B)(ii)(II) of the Act and, pursuant thereto, the following information is hereby

provided:

1. Pursuant to 21 U.S.C. § 355(j)(2)(B)(iv)(I) and 21 C.F.R. § 314.95(c)(1),

Generic hereby notifies you that it submitted to the FDA, and the FDA has received, an

amended ANDA that contains data from bioavailability or bioequivalence studies for, and

which seeks approval to engage in the commercial manufacture, use and/or sale of

BrandX 15, 30 and 45 mg Oral Tablets.

1. Although paragraph IV notice letters are sometimes characterized on their face as

“confidential” by the ANDA, the confidential designation has been held improper as

notice letters are deemed a public disclosure. See Nycomed U.S. Inc. v. Tolmar, Civ. No.

10-2635, 2011 WL 1675027 (D.N.J. Apr. 28, 2011).

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2. Pursuant to 21 C.F.R. § 314.95(c)(2), Generic’s amended ANDA has been

designated ANDA No. 00-001 by the FDA.

3. Pursuant to 21 C.F.R. § 314.95(c)(3), the “established name” of the

proposed drug product is GenX Tablets.

4. Pursuant to 21 C.F.R. § 314.95(c)(4), the active ingredient, strength and

dosage form of the drug product are as follows: BrandX 15, 30 and 45 mg Oral Tablets.

5. Pursuant to 21 C.F.R. § 314.95(c)(5), Generic states that it has submitted a

“paragraph IV certification,” pursuant to Sections 505(j)(2)(A)(vii)(IV) of the Act (21

U.S.C. § 355(j)(2)(A)(vii)(IV)), that the ’001, ’002 and ’003 patents, expiring no later

than [Date] or [Date] according to FDA records, contain no claims that would be

infringed by the manufacture, use or sale of Generic’s BrandX 15, 30 and 45 mg Oral

Tablets (“Generic’s Drug Product”) solely due to a license granted by Brand to Generic

with respect to the Brand Patents.

6. On information and belief, NDA 00-001 for BrandX 15, 30 and 45 mg

Oral Tablets, which was apparently submitted to the FDA pursuant to 21 U.S.C. §

355(b)(1) and, according to public FDA records, was approved by the FDA, included a

list (or was amended to include a list) identifying the Brand Patents, apparently because

the NDA holder, Brand, believed the patents “could reasonably be asserted if a person not

licensed by the owner engaged in the manufacture, use or sale of the drug.” In

accordance with 21 U.S.C. § 355(j)(2)(B)(iv)(II), as amended by Title XI of the Medicare

Prescription Drug, Improvement and Modernization Act, Pub. L. No. 108-173, 117 Stat.

2066 (2003), and 21 C.F.R. § 314.95(c)(6)(i)–(ii), the Detailed Factual and Legal Basis of

Paragraph IV Certification Regarding the Brand Patents that the Brand Patents contain no

claims that would be infringed by the manufacture, use or sale of Generic’s Drug Product

is set forth in the attachment to this Notice Letter.

OFFER OF CONFIDENTIAL ACCESS TO APPLICATION

Pursuant to 21 U.S.C. § 355(j)(5)(c), as amended by Title XI of the Medicare

Prescription Drug, Improvement and Modernization Act, Pub. L. No. 108-173, 117 Stat.

2066 (2003), this Notice Letter includes an Offer of Confidential Access to Application.

As required by § 355(j)(5)(c)(i)(III), and pursuant to certain restrictions described below,

Generic offers to provide Brand with confidential access to certain information from its

amended ANDA No. 00-001 for the sole and exclusive purpose of determining whether

an infringement action referred to in § 355(j)(5)(B)(iii) can be brought.

Section 355(j)(5)(c)(i)(III) allows Generic to impose restrictions “as to persons

entitled to access, and on the use and disposition of any information accessed, as would

apply had a protective order been entered for the purpose of protecting trade secrets and

other confidential business information.” That provision also grants Generic the right to

APPENDIX

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