The United States Court of Appeals has upheld a patent for Fortical calcitonin nasal spray held by Unigene Laboratories. Fortical, a bioequivalent of Novartis’s Miacalcin, is marketed in the US by Unigene subsidiary Upsher-Smith for the treatment of postmenopausal osteoporosis. The court denied an appeal by Apotex of a summary judgment by the New York federal court that the disputed patent claim was not obvious at the time of invention as Apotex claimed.
Apotex filed an ANDA for a generic calcitonin nasal spray in June 2006, and Unigene quickly sued for infringement. In September 2007, Apotex asked the court to breach attorney-client privilege for Unigene under the crime-fraud exception, alleging, among other things, that Unigene had failed to disclose a patent for an oral formulation of salmon calcitonin. The district court found the patent for the oral formulation irrelevant to the patent for the nasal formulation.
The court also found that the nasal formulation would not have been obvious to “a person of ordinary skill in the art,” defining a person of ordinary skill as “an individual with a masters degree in chemistry, pharmaceutical chemistry, biochemistry, or a similar field with at least eight years of practical experience in pharmaceutical liquid dosage form development, or an individual with a Ph.D. in the same fields with at least four years of practical experience in pharmaceutical liquid dosage form development.”
The appeals court agreed that development of the nasal formulation was not obvious from the oral formulation: “The ‘014 patent claims a solid oral dosage of salmon calcitonin, not a liquid formulation. While the experiments discussed in the ‘014 patent found that ‘the bioavailability of salmon calcitonin increased nearly 10 fold when the amount of citric acid in the formulation was increased only 5 fold,’ . . ., a person of ordinary skill (not Dr. Stern, a co-inventor of the ‘014 patent) would not glean from the ‘014 results a reason to use about 20 mM citric acid in a nasal calcitonin formulation.”
Read the court ruling.
