A federal appellate court has affirmed a lower court ruling finding a patent for Johnson & Johnson and Merck & Co.’s popular over-the-counter heartburn drug Pepcid Complete invalid. The following patent was at issue
US5817340 (Expiry: June 1, 2013)- which covers A solid oral dosage form for the treatment of gastrointestinal disorders comprising a therapeutically effective amount of impermeably coated famotidine granules for the treatment of gastric disorders and pharmacologically acceptable salts thereof; and a therapeutically effective amount of aluminum hydroxide or magnesium hydroxide wherein the oral dosage form has said coated famotidine granules and the aluminum hydroxide or magnesium hydroxide in contact with each other, but separated by said impermeable coating on the famotidine granules which is impermeable to the aluminum hydroxide or magnesium hydroxide
On June 5, 2007, the Court of southern district of New York issued its opinion, concluding the'340 patent is invalid due to obviousness. The court noted that the patent was obvious which was evident from office actions and patent office repeatedly rejected original claims as evident in prosecution history of 340’ patent. However, innovator got patent in 1998 with amended claims. This decision was based on KSR V/S Teleflex decision. Pepcid has annual sale approximately $90 millions in 2007.
Pepcid
Famotidine (2-[4-[2-(amino-sulfamoyliminomethyl)ethylsulfanylmethyl]-1,3-thiazol-2-yl]guanidine) was developed by Merck and is marketed by a joint venture between Merck and Johnson & Johnson. The imidazole-ring of cimetidine was replaced with a 2-guanidinothiazole ring. Famotidine proved to be 30 times more active than cimetidine.
It was first marketed in 1985. Pepcid RPD orally-disintegrating tablets (that are not swallowed) was released in 1999. Generic preparations became available in 2001, e.g. Fluxid (Schwarz) or Quamatel (Gedeon Richter Ltd.). In the United States, Pepcid Complete is available that combines famotidine with an antacid in a chewable tablet to ameliorate the relatively slow onset of effects.
US5817340 (Expiry: June 1, 2013)- which covers A solid oral dosage form for the treatment of gastrointestinal disorders comprising a therapeutically effective amount of impermeably coated famotidine granules for the treatment of gastric disorders and pharmacologically acceptable salts thereof; and a therapeutically effective amount of aluminum hydroxide or magnesium hydroxide wherein the oral dosage form has said coated famotidine granules and the aluminum hydroxide or magnesium hydroxide in contact with each other, but separated by said impermeable coating on the famotidine granules which is impermeable to the aluminum hydroxide or magnesium hydroxide
On June 5, 2007, the Court of southern district of New York issued its opinion, concluding the'340 patent is invalid due to obviousness. The court noted that the patent was obvious which was evident from office actions and patent office repeatedly rejected original claims as evident in prosecution history of 340’ patent. However, innovator got patent in 1998 with amended claims. This decision was based on KSR V/S Teleflex decision. Pepcid has annual sale approximately $90 millions in 2007.
Pepcid
Famotidine (2-[4-[2-(amino-sulfamoyliminomethyl)ethylsulfanylmethyl]-1,3-thiazol-2-yl]guanidine) was developed by Merck and is marketed by a joint venture between Merck and Johnson & Johnson. The imidazole-ring of cimetidine was replaced with a 2-guanidinothiazole ring. Famotidine proved to be 30 times more active than cimetidine.
It was first marketed in 1985. Pepcid RPD orally-disintegrating tablets (that are not swallowed) was released in 1999. Generic preparations became available in 2001, e.g. Fluxid (Schwarz) or Quamatel (Gedeon Richter Ltd.). In the United States, Pepcid Complete is available that combines famotidine with an antacid in a chewable tablet to ameliorate the relatively slow onset of effects.
