Opinion ID: 210471
Heading Depth: 2
Heading Rank: 1

Heading: The challenged legislation

Text: The D.C. City Council has adopted specific legislation which prohibits any patented drug from being sold in the District for an excessive price. The operative section of the Excessive Pricing Act reads: It shall be unlawful for any drug manufacturer or licensee thereof, excluding a point of sale retail seller, to sell or supply for sale or impose minimum resale requirements for a patented prescription drug that results in the prescription drug being sold in the District for an excessive price. D.C. Code § 28-4553. The legislation was adopted after the Council determined that: The excessive prices of prescription drugs in the District of Columbia is threatening the health and welfare of the residents of the District as well as the District government’s ability to ensure that all residents receive the health care they need, and these excessive prices directly and indirectly cause economic harm to the District and damage the health and safety of its residents. . . . [I]t is incumbent on the government of the District of Columbia to take action to restrain the excessive prices of prescription drugs. Id. § 28-4551. The Council’s response to that finding was passage of the challenged legislation. Following signature by the Mayor and the expiration of the statutorily prescribed period for Congress to review D.C. statutes, see D.C. Code § 1-206.02(c)(1), the Act took effect on December 10, 2005. The statutory term “excessive price” is not specifically defined. The statute states that “[a] prima facie case of excessive pricing shall be established where the wholesale price of a patented prescription drug in the District is over 30% higher than the comparable price in any high income country in 2006-1593 2 which the product is protected by patents or other exclusive marketing rights.” Id. § 28-4554(a). If such prima facie excessive pricing is shown, the burden shifts to the defendant to prove: that a given prescription drug is not excessively priced given demonstrated costs of invention, development and production of the prescription drug, global sales and profits to date, consideration of any government funded research that supported the development of the drug, and the impact of price on access to the prescription drug by residents and the government of the District of Columbia. Id. § 28-4554(b). A “high income countr[y]” is defined as one of “the United Kingdom, Germany, Canada, or Australia.” Id. § 28-4552(2). The Act provides for both public and private enforcement: “Any affected party, including the District of Columbia, shall have standing to file a civil suit in a court of competent jurisdiction for a violation of this chapter and to seek a remedy, including declaratory and injunctive relief.” Id. § 28-4555(a). The term “affected party” is itself broadly defined as “any person directly or indirectly affected by excessive prices of patented prescription drugs, including any organization representing such persons or any person or organization representing the public interest.” Id. § 28-4552(1). The Act provides for a wide array of remedies: (1) Temporary, preliminary, or permanent injunctions to enjoin the sales of prescription drugs in the District at excessive prices; (2) Appropriate fines for each violation; (3) Damages, including treble damages; (4) Reasonable attorney’s fees; (5) The cost of litigation; or (6) Any other relief the court deems proper. Id. § 28-4555(b). 2006-1593 3