Milan District Court Confirms the Validity of Alfa Wassermann’s Rifaximin-alpha Patents
BOLOGNA, Italy, June 12, 2014 /PRNewswire/ —
Normix® is the only authorized Gastrointestinal antibiotic based on Rifaximin-alpha. No generic version is allowed.
With the judgment entered last April 18, the district court of Milan, Italy – the court having original jurisdiction on the matter -denied a request from generic manufacturers to declare Alfa Wassermann’s patents on Rifaximin polymorphs invalid. Instead, the court upheld Alfa Wassermann’s claim, asserting the Rifaximin-alpha patent and prohibiting any further counterfeit production, advertising and marketing. The announcement is made by Alfa Wassermann, the Bologna-based Italian pharmaceutical multinational that developed Rifaximin-alpha, marketed under the trade name Normix® in Italy, Xifaxan®, Flonorm®, Rifacol®, Spiraxin® and other trade names in other countries. Approved in 34 countries including the US, Rifaximin-alpha is an oral gut-selective antibiotic indicated for most bacterial diarrheas, including travelers’ diarrhea, and other gastrointestinal (GI) disorders. Recently, Rifaximin-alpha was also approved for Hepatic Encephalopathy (HE) in the US and in Europe.
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"We welcome the court decision that has confirmed the uniqueness of Rifaximin-alpha, which is Alfa Wassermann R&D’s most prestigious product and one of the top selling Italian medicines in the US," said Andrea Golinelli, Chief Strategy Officer, Alfa Wassermann. "The court ruling is a landmark decision for the protection of intellectual property (IP) and the recognition of its crucial value for pharmaceutical R&D and innovation. Without IP protection no scientific innovation nor progress to improve people’s health is possible." concluded Golinelli.
Alfa Wassermann is an international Italian pharmaceutical Group with a sixty-year tradition in R&D, production and distribution of medicines of primary importance for people’s health. Its medicines have taken Alfa Wassermann to a leading position in a number of medical areas including Gastroenterology, Vascular medicine, Orthopedics, Rheumatology and Gynecology.
The Group is headquartered in Bologna, Italy, which is also the location of its long-standing R&D facilities. The Group’s international division is in Milan. The Group’s production facilities in Alanno (Pescara, Italy) are some of Europe’s most technologically advanced and make 50 million packaged items annually.
Alfa Wassermann operates globally through 12 subsidiaries in as many world markets. The Group employs 1,400 people and markets products in over 60 countries. In 2013 Alfa Wassermann consolidated sales aggregated to some 400 million euro.
Alfa Wassermann R&D’s most successful product is Rifaximin-alpha, an oral antibiotic for gastrointestinal disorders that is the market leader in Italy, but is also available in many other world countries, including the US. Rifaximin-alpha approval by the US Food and Drug Administration (FDA) has been a highly prestigious recognition for a medicine that is the fruit of Italian R&D.
For further information please visit http://www.alfawassermann.com
Angela Del Giudice