Santarus, Inc. et al. vs. Par Pharmaceutical, Inc.

Docket No. 2010-1360, -1380

September 4, 2012

Brief summary: Negative claim limitations may be supported where specification describes a reason to exclude the relevant limitation; parent application of CIP may be prior art; teaching away must include “clear discouragement”.

Summary: Santarus appealed DC finding that its licensed patents related to the proton pump inhibitor omeprazole (Zegerid®) were not uneforceable for inequitable conduct (IE) but invalid for inadequate written description and obviousness. Par argued for IE because certain information was only submitted for second patent application in chain and it alleged a declaration was misleading. The DC disagreed, and the FC panel affirmed (citing Therasense, FC 2011) (“no specific intent to deceive the PTO”). The written description issues turned on whether the clause “wherein the composition contains no sucralfate” required evidence that sucralfate is “contraindicated”. The FC disagreed, however, finding that “a person of ordinary skill in this field…would have understood from the specification that disadvantages of sucralfate may be avoided by the [claimed] formulation” (“no sucralfate is adequately supported by statements in the specification expressly listing the disadvantages of using sucralfate.”) Regarding obviousness, Santarus unsuccessfully argued that claims reciting specific blood serum concentrations resulting from a known composition (known from a parent patent (see dissent)) were patentable but the panel responded that “an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations…[t]o hold otherwise would allow any formulation – no matter how obvious – to become patentable merely by testing and claiming an inherent property.” (citing In re Kao, FC 2011) The FC also concluded that the prior art taught away from certain, but not all, non-enteric coated formulations (citing Medichem, FC 2006 (“development flowing from the reference’s disclosure is unlikely to be productive of the result sought”) and Syntex (FC 2005) (“statement that a particular combination is not a preferred embodiment does not teach away absent clear discouragement of that combination.”)) And certain claims were found to “require amounts of buffering agent not disclosed in the prior art” (e.g., 2-25 mEq in the claims compared to 40 mEq in the prior art). Thus, the DC conclusion of obviousness was reversed for some of the claims. For those affirmed as obvious, the panel agreed with the DC that evidence regarding skepticism and sales were unpersuasive. Judge Newman disagreed with the written description analysis (“incorrect…that the reason for any negative limitation must be included in the specification, on pain of invalidity under §112”), regarding the prior art effect of the parent patent (“incorrect…that the ’737 patent is a reference against its common subject matter in the later applications in the chain of filings”), and the conclusions of obviousness (“[p]roceeding contrary to the accepted scientific knowledge is ‘strong evidence of nonobviousness’” (W.L. Gore, FC 1983); “classical example of ‘teaching away’” (Ricoh, FC 2008)).

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