[DOWNLOAD] "Mova Pharmaceutical Corp. v. Shalala" by District of Columbia Circuit U.S. Court of Appeals * Book PDF Kindle ePub Free
eBook details
- Title: Mova Pharmaceutical Corp. v. Shalala
- Author : District of Columbia Circuit U.S. Court of Appeals
- Release Date : January 14, 1998
- Genre: Law,Books,Professional & Technical,
- Pages : * pages
- Size : 87 KB
Description
Wald, Circuit Judge: On December 19, 1996, the Food and Drug Administration (""FDA"") approved an application by a drug manufacturer, Mylan Pharmaceuticals, Inc. (""Mylan"") to market a generic version of micronized glyburide, a drug used to treat diabetes. Another drug manufacturer, Mova Pharmaceutical Corp. (""Mova""), had filed an earlier application to market a generic version of the same drug; however, Mova's application had not yet been approved, because of a patent infringement suit brought by Pharmacia & Upjohn Company (""Upjohn""), in which Upjohn claimed that Mova's product infringed a patent belonging to Upjohn. When Mova learned that the FDA had approved Mylan's application, it brought suit in the United States District Court for the District of Columbia, relying on 21 U.S.C. § 355(j)(5)(B)(iv) (1994),1 to compel the FDA to delay the effective date of this approval until 180 days after the earlier of the dates that Mova won its suit or began to market its product. Because the statutory scheme governing the approval of successive generic drug applications is quite complex, we will, for purposes of the introduction, describe the parties' contentions only in general terms. Mova argued that, because it had filed a previous application to market a generic version of micronized glyburide, the applicable statutory provision, 21 U.S.C. § 355(j)(5)(B)(iv), granted a 180-day market exclusivity period to Mova running from the date Mova won its suit or began marketing its product, and the FDA was barred from approving Mylan's similar application until after the end of that 180-day period. In response, the FDA cited a regulation that permitted the agency to approve Mylan's application immediately, because at the time Mylan submitted its application Mova had not yet ""successfully defended"" against (that is, prevailed in) Upjohn's patent infringement suit. See 21 C.F.R. § 314.107(c)(1). Mova in turn challenged the FDA's regulation as inconsistent with the plain language of § 355(j)(5)(B)(iv). The district court agreed with Mova, and entered a preliminary injunction requiring the FDA to delay its approval of Mylan's application until 180 days after Mova won its suit or began to market its product (whichever came first). The FDA and Mylan have appealed this decision.