Friulchem S.p.A., a Vivaro, Italy-based contract development, and manufacturing organization for innovator and generic pharmaceutical products for human and veterinary use, reports on a recent ruling in Mexico regarding intellectual property regarding polymorphic forms of rifaximin, an active pharmaceutical ingredient used to treat travelers’ diarrhea in adults and hepatic encephalopathy.

Rifaximin is a semi-synthetic product derived from fermentation and that shows many polymorphs, most of them are covered by patent (alpha-, beta-, gamma-, and delta-forms). Friulchem has patented another polymorph, a pseudo-crystalline solid form, FC rifaximin, derived from rifamycin O. The FC patent was filed in 2011 in Europe, Mexico, and the US, and the patent was granted in Europe, the US, and Mexico.

The company reports that the Mexican Institute of Industrial Property (IMPI), the patent and trademark administration body of Mexico, recently dismissed a patent-infringement and unfair competition case filed against Interquim, S.A. de C.V., a company that develops, manufactures and sells active ingredients and generic pharmaceutical products, by  Alfa Wasserman S.p.A, a provider of pharmaceuticals products. In August 2017 Alfa Wassermann S.p.A., Biofutura Pharma S.p.A. and Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. merged to form Alfasigma S.p.A. The case involved the new polymorph form of FC-rifaximin. 

The resolution was published in the Industrial Property Gazette, the official publication of IMPI,  on November 24, 2017. Alfa Wasserman did not appeal this decision or request reconsideration within the time provided by law, according to information from Friulchem. Accordingly, IMPI’s dismissal of the case is final, and the matter is terminated, according to information from Friulchem.

Source: Friulchem S.p.A