Opinion ID: 1367174
Heading Depth: 2
Heading Rank: 2

Heading: Cydectin

Text: Wyeth sought and received FDA approval to market Cydectin for the treatment and control of internal and external parasites in beef and dairy cattle. The regulatory review period for Cydectin spanned nearly eight years. It began on April 5, 1990, when at Wyeth's request, FDA established an INAD file for Cydectin, marking the beginning of the testing phase. Wyeth submitted various investigational information to FDA, including information on drug formulation and protocols for clinical studies. On August 8, 1995, Wyeth opted for phased review and submitted its first technical section, which addressed Residue Chemistry. In 1995 and 1996, Wyeth submitted technical sections concerning Effectiveness, Manufacturing, Public Safety, and Target Animal Safety. By agreement with FDA, Wyeth submitted its final technical section, Environmental Safety, in three modules. Wyeth submitted the first of these modules on August 14, 1996. It is unclear when Wyeth submitted the second and third modules. FDA ultimately approved each section, and by January 13, 1998, Wyeth had received all of its complete letters. Wyeth submitted an administrative NADA that same day. FDA approved Wyeth's NADA 16 days later on January 28, 1998. The active ingredient in Cydectin, moxidectin, is claimed in U.S. Patent No. 4,916,154 (the '154 patent), which issued on April 10, 1990. [1] On March 27, 1998, Wyeth sought a patent term extension for the '154 patent based on the regulatory review period for Cydectin. According to Wyeth, this was the first patent term extension request based on a NADA submitted via phased review. Wyeth attached a memorandum to its request setting forth its position that it initially submitted a NADA for Cydectin on August 8, 1995, when it submitted its first technical section (Residue Chemistry). Wyeth argued in the alternative that it initially submitted a NADA no later than August 14, 1996, when it submitted one component of its last technical section (Environmental Safety). The United States Patent and Trademark Office (PTO) requested FDA's assistance in determining whether Cydectin had been subject to regulatory review within the meaning of 35 U.S.C. § 156(g). FDA informed the PTO that Cydectin had been subject to regulatory review within the meaning of § 156(g). [2] FDA further informed the PTO that Cydectin experienced a regulatory review period of 2,857 days, beginning on April 5, 1990, and ending on January 28, 1998. FDA stated that of this review period, 2,841 days occurred during the testing phase and 16 days occurred during the approval phase. Based on these numbers, the PTO calculated a patent term extension of 1,434 days, representing one half of the testing phase (exclusive of six days occurring prior to the issuance of the '154 patent) plus the entire approval phase (calculated as (2,841 - 6)/2 + 16). Wyeth asked FDA to revise its determination of the regulatory review period. Wyeth reiterated its position that it had initially submitted its NADA on August 8, 1995, when it submitted its first technical section (Residue Chemistry). Wyeth reasoned that at that point, FDA had sufficient information to commence its review. FDA denied Wyeth's request. It set forth its position that the approval phase for purposes of patent term extension begins when the marketing application is complete, including all technical sections and the CVM complete letters. J.A. 232. It explained that [a]lthough this approach can result in a very short approval phase, it is most consistent with the idea that alternative drug development and review approaches are intended to permit the applicant to respond to FDA input as the application is developed, making FDA's review more efficient, and shortening the time required for review of the application. Id. FDA further explained that the technical sections are submitted to the INAD file, not to the NADA file, and thus FDA conducts its review of these components as part of the testing phase. FDA therefore concluded that the approval phase in phased review begins with the submission of an administrative NADA. Id. Wyeth filed a complaint in the United States District Court for the District of Columbia challenging FDA's interpretation of the date that its NADA was initially submitted and seeking injunctive and declaratory relief under the Administrative Procedure Act (APA), 5 U.S.C. §§ 701-706. FDA moved to dismiss or alternatively for summary judgment, and Wyeth cross-moved for summary judgment. The district court granted FDA's motion and entered judgment for FDA. Wyeth appeals that judgment. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).