Richter Gedeon, Hungary's largest pharmaceutical firm, has filed a patent infringement suit in the US district court in New York against 10 international drug manufacturers for violating five of Richter Gedeon's registered patents.
The suit alleges that the companies, all of which do business in the United States, unlawfully use Richter Gedeon's patented crystallised polymorph version of famotidine, an ingredient used in antiulcer drugs.
Named in the suit are Andrx Corporation, Andrx Pharmaceuticals, Carlsbad Technology, Cheminor Drugs, Dr Reddy Laboratories, Ercros (ECR), Ercros Industrial, Fermentaciones Y Sintesis Espanolas, Gyma Laboratories of America, and Reddy Cheminor.
Richter Gedeon is seeking a permanent injunction banning the defendants from producing, using, and trading their versions of the ingredient. The company also is asking for an as yet undisclosed amount in damages. No hearing date has been set.
According to Richter Gedeon, famotidine was developed by the Japanese pharmaceutical group Yamanouchi in 1995. Its patent expired in April 2000, but Richter Gedeon had developed two new refined versions in a crystalline form, which are under patent protection until 2007. It manufactures and supplies its version of famotidine in an antiulcer drug called Quamatel.
The 100 year old company is also one of the leading drug manufacturers in central and eastern Europe and is a major exporter to the former Soviet Union, the EU countries, Japan, and the United States.
Famotidine accounts for almost 10% of Richter Gedeon's total sales and as much as 8% of its exports. Turnover from famotidine in the United States last year totalled $750m (£536m), the company reported.
Erik Bogsch, the chief executive officer of Richter Gedeon, said, "Although it pleases me to see the global expansion of Richter's licensed products and manufacturing processes, the company will not tolerate the illegal use of its intellectual property."
International pharmaceutical market analysts said that under the United States's 1984 Patent Term Restoration Act, Richter has a strong chance of winning its case.