IP News

Patent Term Extension Denied for Combination Drug

In The Arnold Partnership v. Dudas, 2004 WL 574480, CV-03-1339 (Fed. Cir. March 24, 2004), the Federal Circuit affirmed the district court's denial of a term extension for the drug marketed under the name Vicoprofen. Vicoprofen, an analgesic and anti-inflammatory drug, is a combination of hydrocodone bitrate and ibuprofen, both of which had been previously marketed either alone or in conjunction with other active ingredients.

The plaintiff received patent protection for the Vicoprofen and filed a New Drug Application (NDA) as required by the FDA. After receiving FDA approval, the plaintiff applied for a patent term extension under 35 U.S.C. '156 to restore the time spent for the approval of the NDA. The Federal Circuit affirmed the district court's denial because the drug did not meet the “first commercial marketing” requirement of 35 U.S.C '156(a)(5)(A). Plaintiff argued that the statute did not intend to determine the whether each ingredient was newly commercialized, but rather if the whole drug was new. The Federal Circuit disagreed. Pointing to the language of the statute, the court held that in order to be eligible for patent extension under 35 U.S.C. '156, at least one of the active ingredients in the drug must be new to the marketplace. The court noted that its reading of 35 U.S.C. '156 did not perfectly overlap the FDA's requirement of filing a NDA for a combination drug such as Vicoprofen, and suggested the lapse in protection was an issue best suited for Congress.

Cuban Cigar Company Triumphs in Trademark Suit

In Empresa Cubana Del Tabaco v. Culbro Corp, 2004 U.S. Dist. LEXIS 4935 (S.D.N.Y. March 26, 2004), a Cuban cigar company, which had been using the name “COHIBA” for a brand of cigars, won a trademark infringement suit against a U.S. company that had registered a trademark for the same brand name of cigars. The decision dealt with trademark issues in connection with the U.S. trade embargo against Cuba.

The court found that even though the Cuban corporation could not sell its products in the United States due to the trade embargo, nor did it register the trademark, nor did it protest when the defendant registered the mark, the defendant's conduct constituted willful trademark infringement. While the defendant was the first to use the mark in the United States, the Cuban company had a legally protectable mark because the mark was already “well-known” when the defendant began to use the mark. The court held that the Cuban COHIBA brand was famous and known as a premier brand by cigar smokers as evidenced by more than 46 unsolicited articles that referred to the COHIBA brand as the best of the Cuban cigars. Further, the court found that the defendant's decision to brand U.S. cigars with the COHIBA mark was made to capitalize on the success of the Cuban COHIBA brand, and that likelihood of confusion existed between the two brands. As a basis for finding trademark infringement and canceling the defendant's trademark registration, the court pointed to evidence that the defendant knew of the strength of the Cuban COHIBA brand and advertisements from the defendant describing its product in terms to evoke an association with Cuba.

Judge Dismisses Suit Over Rights to Winnie the Pooh Due to Plaintiff Misconduct

A California Superior Court judge dismissed, with prejudice, a suit brought by the owner of the rights to Winnie the Pooh against Disney. Steven Slesinger bought the U.S. merchandising rights to the character from the author A.A. Milne in the 1930s and partnered with Disney to create merchandise that accounts for sales of more than $5 billion a year. Steven Slesinger, Inc. (SSI)'s suit began 13 years ago when it accused Disney of withholding royalties from merchandising and videotapes. Disney moved to dismiss the suit, alleging that SSI had hired a private investigator to steal more than 6000 pages of documents from garbage bins over a period of 4 years, doctored those documents, and refused to provide the documents to Disney's lawyers. SSI argued that the documents had not been obtained improperly due to their retrieval from publicly accessible trash bins. The court found that SSI could not properly explain how it came to posses the documents and that SSI was likely to conceal any evidence of how the investigator discovered them. In a strongly worded opinion, the court dismissed the case and terminated sanctions that SSI previously won, stating that “SSI's misconduct is so egregious that no remedy short of terminating sanctions can effectively remove the threat and adequately protect both the institution of justice and (Disney) … from further SSI abuse.”

Patent Term Extension Denied for Combination Drug

In The Arnold Partnership v. Dudas, 2004 WL 574480, CV-03-1339 (Fed. Cir. March 24, 2004), the Federal Circuit affirmed the district court's denial of a term extension for the drug marketed under the name Vicoprofen. Vicoprofen, an analgesic and anti-inflammatory drug, is a combination of hydrocodone bitrate and ibuprofen, both of which had been previously marketed either alone or in conjunction with other active ingredients.

The plaintiff received patent protection for the Vicoprofen and filed a New Drug Application (NDA) as required by the FDA. After receiving FDA approval, the plaintiff applied for a patent term extension under 35 U.S.C. '156 to restore the time spent for the approval of the NDA. The Federal Circuit affirmed the district court's denial because the drug did not meet the “first commercial marketing” requirement of 35 U.S.C '156(a)(5)(A). Plaintiff argued that the statute did not intend to determine the whether each ingredient was newly commercialized, but rather if the whole drug was new. The Federal Circuit disagreed. Pointing to the language of the statute, the court held that in order to be eligible for patent extension under 35 U.S.C. '156, at least one of the active ingredients in the drug must be new to the marketplace. The court noted that its reading of 35 U.S.C. '156 did not perfectly overlap the FDA's requirement of filing a NDA for a combination drug such as Vicoprofen, and suggested the lapse in protection was an issue best suited for Congress.

Cuban Cigar Company Triumphs in Trademark Suit

In Empresa Cubana Del Tabaco v. Culbro Corp, 2004 U.S. Dist. LEXIS 4935 (S.D.N.Y. March 26, 2004), a Cuban cigar company, which had been using the name “COHIBA” for a brand of cigars, won a trademark infringement suit against a U.S. company that had registered a trademark for the same brand name of cigars. The decision dealt with trademark issues in connection with the U.S. trade embargo against Cuba.

The court found that even though the Cuban corporation could not sell its products in the United States due to the trade embargo, nor did it register the trademark, nor did it protest when the defendant registered the mark, the defendant's conduct constituted willful trademark infringement. While the defendant was the first to use the mark in the United States, the Cuban company had a legally protectable mark because the mark was already “well-known” when the defendant began to use the mark. The court held that the Cuban COHIBA brand was famous and known as a premier brand by cigar smokers as evidenced by more than 46 unsolicited articles that referred to the COHIBA brand as the best of the Cuban cigars. Further, the court found that the defendant's decision to brand U.S. cigars with the COHIBA mark was made to capitalize on the success of the Cuban COHIBA brand, and that likelihood of confusion existed between the two brands. As a basis for finding trademark infringement and canceling the defendant's trademark registration, the court pointed to evidence that the defendant knew of the strength of the Cuban COHIBA brand and advertisements from the defendant describing its product in terms to evoke an association with Cuba.

Judge Dismisses Suit Over Rights to Winnie the Pooh Due to Plaintiff Misconduct

A California Superior Court judge dismissed, with prejudice, a suit brought by the owner of the rights to Winnie the Pooh against Disney. Steven Slesinger bought the U.S. merchandising rights to the character from the author A.A. Milne in the 1930s and partnered with Disney to create merchandise that accounts for sales of more than $5 billion a year. Steven Slesinger, Inc. (SSI)'s suit began 13 years ago when it accused Disney of withholding royalties from merchandising and videotapes. Disney moved to dismiss the suit, alleging that SSI had hired a private investigator to steal more than 6000 pages of documents from garbage bins over a period of 4 years, doctored those documents, and refused to provide the documents to Disney's lawyers. SSI argued that the documents had not been obtained improperly due to their retrieval from publicly accessible trash bins. The court found that SSI could not properly explain how it came to posses the documents and that SSI was likely to conceal any evidence of how the investigator discovered them. In a strongly worded opinion, the court dismissed the case and terminated sanctions that SSI previously won, stating that “SSI's misconduct is so egregious that no remedy short of terminating sanctions can effectively remove the threat and adequately protect both the institution of justice and (Disney) … from further SSI abuse.”