Mometasone Hydrate (NASONEX) Patent Valid But Not Infringed

On June 15, 2012, the District Court for the District of New Jersey released its redacted opinion in litigation between Schering and Apotex involving mometasone furoate monohydrate (NASONEX) and US. Patent No. 6,127,353.  The '353 patent is generally directed to the monohydrate form of mometasone furoate and aqueous nasal sprays containing the same.

 Non Infringement

In its infringement arguments, Schering did not contend that Apotex used the claimed monohydrate at the time of manufacture, but rather that the anhydrous form of mometasone furoate in Apotex's proposed product converts to the claimed monohydrate within the two year shelf-life of Apotex's product. The primary issue at trial was whether this conversion from the anhydrous form to the patented monohydrate occurred.  Whereas Schering's expert found that conversion begins to occur as soon as the Apotex ANDA product is manufactured, Apotex's expert provided evidence that the "Apotex formulation would be