UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
SANDOZ, INC. ,
Civil Action No. 06-1134 (RCL)
FOOD AND DRUG
ADMINISTRATION, et. al.,
This matter comes before the Court on the plaintiff’s motion  for a preliminary injunction.
Upon consideration of plaintiff’s motion, the opposition thereto, plaintiff’s reply, the arguments of
counsel, the applicable law, and the record in this case, the Court finds that plaintiff’s motion for
preliminary injunction should be DENIED.
Congress established the Hatch-Waxman Act of 1984 to lower the regulatory barriers
facing generic drug companies and to encourage those companies to challenge the patents
blocking generic entry to the market. See, e.g., Andrx Pharms., Inc. v. Biovail Corp., 276 F.3d
1368, 1371 (Fed. Cir. 2002). In order to encourage generic drug companies to undertake the
substantial cost of identifying patents to challenge and bearing the accompanying risks of
potential patent litigation, Congress created a critical incentive to reward the first generic
manufacturer to file a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a “Paragraph
Case 1:06-cv-01134-RCL Document 27 Filed 07/12/2006 Page 1 of 10
SANDOZ, INC. v. FOOD AND DRUG ADMINISTRATION et al
A Paragraph IV certification must contain a “statement with respect to each patent which claims the listed
drug . . . that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which
the application is submitted.” 21 U.S.C. § 355(j)(2)(A)(vii)(IV).
IV certification”) challenging a pharmaceutical patent—namely, a 180 day period of exclusivity
during which no other generic version of the drug can be approved. See 21 U.S.C.
§ 355(j)(5)(B)(iv) (2002); 21 C.F.R. § 314.107(c)(1). As this Court has explained:
In order to encourage generic drug makers t