Section 355a(d)(3) further provides “[t]he Secretary’s only responsibility in accepting or rejecting the reports shall be to determine, within the 180-day period, whether the studies fairly respond to the written request, have been conducted in accordance with commonly accepted scientific principles and protocols, and have been reported in accordance with the requirements of the Secretary for filing.” 21 U.S.C. § 355a(d)(3). Noticeably absent from the acceptance criteria is a requirement that the study reports include positive results for the use of the drug in the pediatric population.

Case 1:15-cv-07488-CM Document 69 Filed 02/01/16 Page 19 of 61 10 Defendants seek to have their cake and eat it too. They could have chosen to avoid the requirements of 21 U.S.C. § 355a(c)(1)(B)(II) by requiring the generic ANDA filers to convert their Paragraph IV certifications to Paragraph III certifications, which would have subjected the generics to the pediatric exclusivity provisions of 21 U.S.C. § 355a(c)(1)(B)(i)(II). But they did not do so for their own selfish reasons: to create a 180-day exclusivity bottleneck to generic competition.

By operation of the pediatric exclusivity statute, the only way for the 7 generic companies, each of which maintained their Paragraph IV certifications and received final approval prior to patent expiry, to be barred from marketing generic Namenda IR by Forest’s pediatric exclusivity after receiving FDA final approval was by a court determination that the ’703 patent was valid and would be infringed as to each Paragraph IV filer. 21 U.S.C. § 355a(c)(1)(B)(ii). There was no court determination because Forest prevented such a determination by settling with each of the 7 generic companies in the manner that they settled.

That exclusivity – prohibiting the FDA from approving any generic applications – was initially set to expire in December 2005, but was extended an additional six months (to June 2006) by the pediatric exclusivity designation. See 21 U.S.C. § 355a(c)(2). The FDA also recognized that modafinil, the active ingredient in Provigil®, was a “New Chemical Entity,” AC ¶ 54, which, pursuant to Hatch-Waxman, meant no generic company could submit an ANDA until December 24, 2002, four years after Provigil®’s FDA approval, 21 U.S.C. § 355(j)(5)(F)(ii).

The ’894 patent Case 2:14-cv-05151-HB Document 59 Filed 02/06/15 Page 15 of 44 7 expires on August 30, 2020. AndroGel also was eligible for, and several years later received, an additional six months of regulatory exclusivity for pediatric studies under 21 U.S.C. § 355a(b)(1)(B). B. The ’894 Patent Prosecution History 1.

Mylan Labs, 389 F.3d at 1277. The case involved the interaction between: three separate statutory provisions: (1) 21 U.S.C. § 355(j), a provision of the 1984 Hatch–Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA), which authorizes a drug manufacturer to submit an ANDA to the FDA to obtain approval of a generic version of a previously approved drug; (2) 21 U.S.C. § 355a, a 1997 amendment to the FDCA, which authorizes an extra six-month “pediatric exclusivity” period following expiration of a drug patent for a patent holder that has satisfactorily conducted pediatric testing of its drug upon the FDA's request; and (3) 35 U.S.C. § 271(e)(4), a patent statute, also enacted in the Hatch– Waxman Amendments, which sets out the exclusive remedies available in a patent infringement action. Id.

Barr thus entered a full year before any other generic was authorized to enter. (See 21 U.S.C. §355a(b)(2)(A)(ii).) Since June 2004, numerousother generic versions of Cipro have entered the market.

(2 RA 374-377 [deposition of Barr sales and marketing executive].) Because the FDA had, in the interim, granted Bayer a six-month extension of its exclusivity in light of a study on Cipro’s effectiveness in children (see 21 U.S.C. § 355a; 2 AA 248, § 4), the Cipro settlement enabled Barr to enter the market and sell a lower-priced ciprofloxacin product a full year earlier than the law otherwise would have permitted.2 (2 RA 374-877.) C. Cipro Litigation In 2000, direct and indirect purchasers of Cipro sued defendants in various state and federal courts (including this litigation), alleging that the Cipro settlement violated antitrust and consumerprotection laws.

The '444 patent expired in December 2003, but the United States Food and Drug Administration (FDA) granted Cipro pediatric exclusivity until June 9, 2004. Consequently, no generic ciprofloxacin product could be lawfully marketed before June 9, 2004, under federal law. (21 U.S.C. § 355a.) | B. Hatch-Waxman Act In 1991 Barr sought FDA approvalofa generic version ofCipro underthe federal Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act) (21 U.S.C. § 355).

In addition, another six months is added in cases where the FDA grants “pediatric exclusivity,” infra § B.2. 21 U.S.C. § 355a(c)(1)(A)(i)(I). Case 2:08-cv-02141-MSG Document 43 Filed 08/31/2009 Page 16 of 59 - 5 - 180-Day Generic First-Filer Exclusivity.