ITC Issues General Exclusion Order for Certain Sildenafil (Counterfeit Viagra)
The International Trade Commission (ITC) has issued a general exclusion order in its Section 337 investigation of certain sildenafil or any pharmaceutically acceptable salt thereof, such as sildenafil citrate, and products containing same1 (Inv. No. 337-TA-489) and announcing that it has terminated the investigation.
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This general exclusion order prohibits the unlicensed entry for consumption of sildenafil or any pharmaceutically acceptable salt thereof, such as sildenafil citrate, and products containing same that infringe a specified patent owned by Pfizer, Inc.
The ITC also states that it has determined not to review an initial determination (Order No. 22) issued by the presiding administrative law judge (ALJ) terminating the investigation as to respondent Biovea on the basis of a settlement agreement.
1 ITC sources have previously explained that this investigation essentially concerns the importation of certain counterfeit, "knock-off" forms of the prescription drug, Viagra.
Bond Required During Presidential Review Period
The ITC states that during the 60-day Presidential review period for this general exclusion order, excluded goods may only be imported into the U.S. under an entry bond in the amount of 100% of the entered value of the articles in question.
(U.S. government sources have previously stated that in accordance with 19 CFR 12.39(b)(3), if the President accepts this general exclusion order (which is expected), importers or consignees of infringing articles entered under bond during the Presidential review period would be required to export or destroy such articles under U.S. Customs and Border Protection (CBP) supervision within 30 days after being notified to do so by the applicable port director or face liquidated damages in the full amount of the bond.)
(See ITT's Online Archives or 12/05/03 news, 03120535, for BP summary of the ITC's request for comments in connection with the remedy phase of this investigation.)
ITC contact - Wayne Herrington (202) 205-3090
ITC notice (Inv. No. 337-TA-489, FR Pub 02/17/04) available at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-3306.pdf