Merck, Pfizer infectious news
The U.S. Court of Appeals for the Federal Circuit upheld a district court decision that Merck’s antibiotic Cubicin daptomycin has patent exclusivity until June 15, 2016. CAFC upheld the validity of one Orange Book patent, but invalidated four others. Last December, the U.S. District Court for the District of Delaware ruled that Patent No. RE39,071 is not invalid and that an ANDA submission from Hospira Inc. to FDA for a generic version of Cubicin infringes the patent. The ‘071 patent covers Cubicin’s formulation and expires June 15, 2016. The district court invalidated four others covering the cyclic lipopeptide antibiotic -- U.S. Patent Nos. 6,468,967; 6,852,689; 8,058,238 and 8,129,342 -- due to obviousness. The ‘967 and ‘689 patents, which cover dosing methods, expire on Sept. 24, 2019. The ‘238 and ‘342 composition patents expire on Nov. 28, 2020. ...