IP News

Federal Circuit Invalidates Fosamax Patent

In Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005), the Federal Circuit reversed a lower court's ruling, and found that claims 23 and 37 of U.S. Patent 5,994,329 (the '329 patent) were invalid for obviousness. The '329 patent discloses a method of treating and preventing osteoporosis through less-than-daily administration of bisphosphonate compounds. This patent is listed in the Orange Book as covering Merck's Fosamax drug, which had sales of $3.2 billion in 2004.

In 2000, Teva amended an existing ANDA and sought FDA approval to market a generic version of Fosamax in 35 mg and 70 mg quantities. The '329 patent claims a method for treating and preventing osteoporosis by orally administering “about” 35 mg or 70 mg of alendronate monosodium trihydrate once-weekly. The district court found that Merck had acted as its own lexicographer and had redefined the ordinary meaning of “about” 35/70 mg to mean the equivalent of 35/70 mg.

Teva had argued that the '329 patent was anticipated by a July 1996 publication or rendered obvious by combining the July 1996 publication with an April 1996 publication. (The April 1996 article discloses a weekly treatment program for alendronate, while the July 1996 article discloses a weekly treatment of 40 mg or 80 mg of alendronate.) Based on its narrow construction of the term “about,” the district court rejected Teva's arguments and held that the patent was not invalid for obviousness.

On appeal, the Federal Circuit reversed the district court's claim construction, holding that since the patentee had not clearly redefined the term “about” in the specification, the term should be given its ordinary meaning. Once it determined that “about” meant “approximately,” the Federal Circuit found that the '329 patent was obvious in view of the two 1996 publications.

In addition, the Federal Circuit found that the district court erred by considering evidence that Fosamax was commercially successful as probative of obviousness. Instead, the court found that Fosamax's commercial success was irrelevant in this case because others were legally barred from testing the invention disclosed in the '329 patent as a result of other patents held by Merck.

Second Circuit Finds That Cuban Company Is Prohibited from Acquiring U.S. Trademark Rights

The U.S. Court of Appeals for the Second Circuit, in Empresa Cubana del Tabaco v. Culbro Corp., Nos. 04-2527 and 04-3005, 2005 U.S. App. LEXIS 3242 (2d Cir. Feb. 24, 2005), ruled that Cubatabaco, a Cuban company, was barred from acquiring U.S. trademark rights via the “famous marks” doctrine because of the Cuban trade embargo. The Second Circuit's decision reversed a ruling by the Southern District of New York.

The dispute centered on the use of the COHIBA mark on premium cigars. In 1969, plaintiff Cubatabaco filed a registration for the COHIBA mark in Cuba. By 1978, Cubatabaco had registered this mark in 17 countries around the world, not including the United States. Starting in 1982, Cubatabaco began selling COHIBA cigars outside of Cuba, but never sold COHIBA cigars in the United States because of the trade embargo that has been in place since 1963.

Defendant General Cigar obtained a U.S. trademark registration for the COHIBA mark in 1981 and sold COHIBA cigars from 1978 until 1987. In 1992, General Cigar reintroduced cigars with the COHIBA mark in the United States and has sold these cigars continuously to the present day.

In the district court, Cubatabaco argued that it owned the COHIBA mark because General Cigar abandoned its COHIBA registration in 1987, and by that time, Cubatabaco's COHIBA mark was sufficiently well known so as to be protectable under the “famous marks doctrine.” This doctrine provides that a party with a famous mark at the time another party starts to use the mark has priority over the party using the mark. The district court agreed with Cubatabaco, even though Cubatabaco had never used its mark in the United States.

On appeal, the Second Circuit held that Cubatabaco could not obtain U.S. trademark rights because of the trade embargo. First, the court noted that the Embargo Regulations prohibit a “broad range of transactions involving property in which a Cuban entity has an interest.” The regulations broadly define “property” to include trademark rights. As such, the court found that Cubatabaco's acquisition of the COHIBA mark through the famous marks doctrine would constitute a prohibited transfer. Finally, the court found that Cubatabaco was not authorized to acquire the COHIBA mark by either a general or a specific license. Therefore, the court reversed the district court's finding of trademark infringement.

House of Representatives Committee Approves Trademark Dilution Bill

The House of Representatives Judiciary Committee passed a bill that would enable owners of famous trademarks to prevent use of a junior mark based on a “likelihood of dilution.” H.R. 683, known as the “Trademark Dilution Improvement Act of 2005,” is a direct response to the U.S. Supreme Court's recent decision in Moseley v. V Secret Catalogue, Inc., 537 U.S. 418 (2003), which held that the Federal Trademark Dilution Act (“FTDA”) required proof of “actual dilution” of the distinctive quality of the mark. In addition, H.R. 683 provides that famous marks that are not inherently distinctive are potentially protectable against dilution, so long as they have acquired distinctiveness. Moreover, the amendment would clarify that “tarnishment” is actionable under the dilution act. Finally, the amendment would restrict the types of marks eligible for protection to those “widely recognized by the general consuming public.”

Research in Motion Settles Patent Suit with NTP, Inc.

Research in Motion (“RIM”), the maker of the BlackBerry messaging device, has agreed to pay $450 million to settle its 3-year patent dispute with NTP, Inc. In accordance with the terms of the agreement, NTP will grant RIM the unfettered right to continue its BlackBerry-related wireless business without further interference from NTP or its patents. The settlement follows the Dec. 2004 decision of the Federal Circuit affirming the U.S. District Court for the Eastern District of Virginia's ruling that RIM infringed five of NTP's patents. See NTP, Inc. v. Research in Motion, Ltd., 392 F.3d 1335 (Fed. Cir. 2004). The lower court initially granted an injunction against the sale of all BlackBerry devices in the United States, but immediately stayed the injunction pending the appeal.

Federal Circuit Invalidates Fosamax Patent

In Merck & Co. v. Teva Pharms. USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005), the Federal Circuit reversed a lower court's ruling, and found that claims 23 and 37 of U.S. Patent 5,994,329 (the '329 patent) were invalid for obviousness. The '329 patent discloses a method of treating and preventing osteoporosis through less-than-daily administration of bisphosphonate compounds. This patent is listed in the Orange Book as covering Merck's Fosamax drug, which had sales of $3.2 billion in 2004.

In 2000, Teva amended an existing ANDA and sought FDA approval to market a generic version of Fosamax in 35 mg and 70 mg quantities. The '329 patent claims a method for treating and preventing osteoporosis by orally administering “about” 35 mg or 70 mg of alendronate monosodium trihydrate once-weekly. The district court found that Merck had acted as its own lexicographer and had redefined the ordinary meaning of “about” 35/70 mg to mean the equivalent of 35/70 mg.

Teva had argued that the '329 patent was anticipated by a July 1996 publication or rendered obvious by combining the July 1996 publication with an April 1996 publication. (The April 1996 article discloses a weekly treatment program for alendronate, while the July 1996 article discloses a weekly treatment of 40 mg or 80 mg of alendronate.) Based on its narrow construction of the term “about,” the district court rejected Teva's arguments and held that the patent was not invalid for obviousness.

On appeal, the Federal Circuit reversed the district court's claim construction, holding that since the patentee had not clearly redefined the term “about” in the specification, the term should be given its ordinary meaning. Once it determined that “about” meant “approximately,” the Federal Circuit found that the '329 patent was obvious in view of the two 1996 publications.

In addition, the Federal Circuit found that the district court erred by considering evidence that Fosamax was commercially successful as probative of obviousness. Instead, the court found that Fosamax's commercial success was irrelevant in this case because others were legally barred from testing the invention disclosed in the '329 patent as a result of other patents held by Merck.

Second Circuit Finds That Cuban Company Is Prohibited from Acquiring U.S. Trademark Rights

The U.S. Court of Appeals for the Second Circuit, in Empresa Cubana del Tabaco v. Culbro Corp., Nos. 04-2527 and 04-3005, 2005 U.S. App. LEXIS 3242 (2d Cir. Feb. 24, 2005), ruled that Cubatabaco, a Cuban company, was barred from acquiring U.S. trademark rights via the “famous marks” doctrine because of the Cuban trade embargo. The Second Circuit's decision reversed a ruling by the Southern District of New York.

The dispute centered on the use of the COHIBA mark on premium cigars. In 1969, plaintiff Cubatabaco filed a registration for the COHIBA mark in Cuba. By 1978, Cubatabaco had registered this mark in 17 countries around the world, not including the United States. Starting in 1982, Cubatabaco began selling COHIBA cigars outside of Cuba, but never sold COHIBA cigars in the United States because of the trade embargo that has been in place since 1963.

Defendant General Cigar obtained a U.S. trademark registration for the COHIBA mark in 1981 and sold COHIBA cigars from 1978 until 1987. In 1992, General Cigar reintroduced cigars with the COHIBA mark in the United States and has sold these cigars continuously to the present day.

In the district court, Cubatabaco argued that it owned the COHIBA mark because General Cigar abandoned its COHIBA registration in 1987, and by that time, Cubatabaco's COHIBA mark was sufficiently well known so as to be protectable under the “famous marks doctrine.” This doctrine provides that a party with a famous mark at the time another party starts to use the mark has priority over the party using the mark. The district court agreed with Cubatabaco, even though Cubatabaco had never used its mark in the United States.

On appeal, the Second Circuit held that Cubatabaco could not obtain U.S. trademark rights because of the trade embargo. First, the court noted that the Embargo Regulations prohibit a “broad range of transactions involving property in which a Cuban entity has an interest.” The regulations broadly define “property” to include trademark rights. As such, the court found that Cubatabaco's acquisition of the COHIBA mark through the famous marks doctrine would constitute a prohibited transfer. Finally, the court found that Cubatabaco was not authorized to acquire the COHIBA mark by either a general or a specific license. Therefore, the court reversed the district court's finding of trademark infringement.

House of Representatives Committee Approves Trademark Dilution Bill

The House of Representatives Judiciary Committee passed a bill that would enable owners of famous trademarks to prevent use of a junior mark based on a “likelihood of dilution.” H.R. 683, known as the “Trademark Dilution Improvement Act of 2005,” is a direct response to the U.S. Supreme Court's recent decision in Moseley v. V Secret Catalogue, Inc., 537 U.S. 418 (2003), which held that the Federal Trademark Dilution Act (“FTDA”) required proof of “actual dilution” of the distinctive quality of the mark. In addition, H.R. 683 provides that famous marks that are not inherently distinctive are potentially protectable against dilution, so long as they have acquired distinctiveness. Moreover, the amendment would clarify that “tarnishment” is actionable under the dilution act. Finally, the amendment would restrict the types of marks eligible for protection to those “widely recognized by the general consuming public.”

Research in Motion Settles Patent Suit with NTP, Inc.

Research in Motion (“RIM”), the maker of the BlackBerry messaging device, has agreed to pay $450 million to settle its 3-year patent dispute with NTP, Inc. In accordance with the terms of the agreement, NTP will grant RIM the unfettered right to continue its BlackBerry-related wireless business without further interference from NTP or its patents. The settlement follows the Dec. 2004 decision of the Federal Circuit affirming the U.S. District Court for the Eastern District of Virginia's ruling that RIM infringed five of NTP's patents. See NTP, Inc. v. Research in Motion, Ltd., 392 F.3d 1335 (Fed. Cir. 2004). The lower court initially granted an injunction against the sale of all BlackBerry devices in the United States, but immediately stayed the injunction pending the appeal.