Unigene v. Apotex: Federal Circuit Discusses Standard for Prima Facie Obviousness of Pharmaceutical Composition Claims Post-KSR


On August 25, 2011, the United States Court of Appeals for the Federal Circuit issued a decision in Unigene v. Apotex, No. 2010-1006,1 affirming the lower court's summary judgment of non-obviousness and addressing what is necessary post-KSR to establish a prima facie case of obviousness for pharmaceutical formulation patents claims. This decision is significant because the Federal Circuit applied a modified form of the structural obviousness analysis typically used for a chemical compound claim to a pharmaceutical formulation claim in a manner that has the potential to make it more difficult to invalidate pharmaceutical formulation claims for obviousness—particularly those that are more narrowly directed to a specific combination of an active drug and/or excipient(s), which are often referred to as "picture" or "fingerprint" claims.


Plaintiff Unigene manufactures Fortical, a nasal spray calcitonin formulation meant to treat post-menopausal osteoporosis. Fortical is an alternative formulation of another calcitonin-based drug, Miacalcin, sold by Novartis. Unigene filed its New Drug Application (NDA) for Fortical under 21 U.S.C. § 505(b)(2), naming Novartis's Miacalcin as the reference listed drug. Unigene also filed a patent application on its formulation, which issued as U.S. Patent No. 6,440,392 and was reissued as RE40,812E. Unigene asserted the '812E patent against Apotex in the District Court for the Southern District of New York in response to Apotex filing an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification that indicated an intent to make, use, offer to sell, sell, and/or import a generic version of Unigene's Fortical product. Only claim 19 was asserted, which reads as:

"A liquid pharmaceutical composition for nasal administration comprising about 2,200 MRC units of salmon calcitonin, about 20 mM citric acid, about 0.2% phenylethyl alcohol, about 0.5% benzyl alcohol, and about 0.1% polyoxyethylene(2) sorbitan monooleate."

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