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Wyeth Holdings Corp. v. United States Dep't of Health and Human Services

March 23, 2009

WYETH HOLDINGS CORP., ET AL., PLAINTIFFS,
v.
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Henry H. Kennedy, Jr. United States District Judge

MEMORANDUM OPINION

Wyeth Holdings Corporation and Wyeth ("Wyeth") bring this action against defendants U.S. Department of Health and Human Services, U.S. Food and Drug Administration, and others (together, "FDA") under the Administrative Procedure Act, 5 U.S.C. § 551 et seq. ("APA") seeking a longer patent term extension for their animal drug product ("Cydectin") than that which the FDA has provided. Before the court are the FDA's motion to dismiss or alternatively for summary judgment [#22], and Wyeth's cross-motion for summary judgment [#32]. Upon consideration of the cross-motions, the oppositions thereto, and the record of this case, the court concludes that the FDA's motion to dismiss or alternatively for summary judgment must be granted and that Wyeth's motion for summary judgment must be denied.

I. BACKGROUND

Before a new animal drug may be marketed its sponsor must submit, and the FDA must approve, a New Animal Drug Application ("NADA"). The NADA process proceeds in two phases. First, the applicant must conduct testing and an investigation concerning the drug ("Testing Phase") with respect to seven "technical sections" and submit its findings to the FDA.*fn1

Second, the FDA must evaluate and approve the technical sections ("Approval Phase"), and thereby approve the drug. The sponsor may submit the technical sections together (triggering "Traditional Review") or in stages (triggering "Phased Review"). In Traditional Review, the Testing Phase ends and the Approval Phase begins when the sponsor completes its investigation and submits all of the technical sections as its final NADA. In Phased Review, the sponsor submits the technical sections on a rolling basis into an Investigational New Animal Drug file ("INAD File"). The FDA then evaluates the sections on a rolling basis, issuing a "Complete Letter" as to each one. Once the FDA has approved all the technical sections, the sponsor may submit the final NADA, known as the Administrative NADA.*fn2 In a Phased Review, it is less clear when the Testing Phase ends and the Approval Phase begins. It is this uncertainty that presents the question that underlies this action. It is a pivotal question because certain animal drug patents, such as the one in this case, are eligible for a patent term extension if patent life was lost while the drug was under regulatory review. The extension length is half of the Testing Phase, 35 U.S.C. §§ 156(c)(2) and (g)(4)(B)(i), plus all of the Approval Phase, not exceeding five years, see 35 U.S.C. § 156(g)(4)(B)(ii).

In March 1990, Wyeth asked the FDA to establish an INAD File for Cydectin, a drug designed to treat and control parasites in beef and dairy cattle. In April 1990, the FDA established the INAD File, which initiated the Administrative NADA process for Cydectin as a Phased Review. Wyeth submitted the first technical section (Chemistry) for Cydectin in August 1995. The FDA issued a Complete Letter for this section in December 1997. Thereafter, Wyeth submitted each technical section. For the duration of the Phased Review, there was no time when a technical section was not pending; thus, there was no lag in the submission of technical sections. (See Pl. Mot. for Summ. J. [#32], at 15.) In August 1996, Wyeth submitted the final technical section (Environmental Impact), and the FDA issued a Complete Letter for it in December 1997. At that time, however, at least one other section (Public Safety) was still pending, and the FDA requested supplemental information from Wyeth. By January 1998, Wyeth had submitted all the necessary technical information, and the FDA issued the final Complete Letter on January 13, 1998. Wyeth submitted the Administrative NADA for Cydectin that same day. On or about January 28, 1998, the FDA issued the marketing approval letter for Cydectin.

The dispute in this case arises in connection with Wyeth's application for a patent term extension based on the regulatory review process for Cydectin. The FDA determined that the Testing Phase began on April 5, 1990, (the date the FDA established the INAD file), and that the Approval Phase began on January 13, 1998, (the date Wyeth submitted the Administrative NADA). The FDA thus determined the Testing Phase was 2,841 days, and the Approval Phase was 16 days. Based on these determinations, the U.S. Patent and Trademark Office ("PTO") extended the Cydectin patent from April 10, 2007, to March 14, 2011 - an extension of nearly four years. Wyeth disputed the FDA's determinations and thus the length of its patent term extension. Accordingly, Wyeth filed a Request for Revision of the Regulatory Review Period with the FDA. Specifically, Wyeth contended that the Approval Phase began upon submission of the first technical section in August 1995, and that the Cydectin patent should be extended from April 10, 2007, until January 28, 2012 - approximately ten months longer than Wyeth's current extension. Alternatively, Wyeth contended that the Approval Phase began no later than upon submission of its final technical section in August 1996, which would extend the patent until November 26, 2011 - approximately eight months longer than Wyeth's current extension. The FDA denied Wyeth's request. Wyeth now seeks a court order that would set aside the FDA's final determination of the regulatory review period for Cydectin.

II. ANALYSIS

The sole question before the court is the following question of law: whether the FDA rightly decided that the Approval Phase began upon submission of the Administrative NADA for Cydectin. Because the court must review this question under the APA, the court only will set aside the FDA's decision if it finds that decision to be "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law." 5 U.S.C. § 706(2)(A). Applying this standard, the court turns to the following statutory provisions, which establish when the Approval Phase for Cydectin began, and thus determine the appropriate length of the patent term extension for Cydectin:

(g) For the purposes of this section, the term regulatory review period has the following meanings:

***

(4)(A) In the case of a product which is a new animal drug, the term means the period described in subparagraph (B) to which the limitation in paragraph (6) applies:

(B) The regulatory review period for a new animal drug product is the sum of --

(i) [Testing Phase] the period beginning on the earlier of the date a major health or environmental effects test on the drug was initiated or the date an exemption under subsection (j) of section 512 became effective for the approved new animal drug product and ending on the date an application ...


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