Sunovion Pharma. Inc. v. Dey Pharma., L.P.

April 09, 2012

GENERICally Speaking
Case Name:  Sunovion Pharma. Inc. v. Dey Pharma., L.P., Case No. 06-113-LPS, 2012 U.S. Dist. LEXIS 5669 (D. Del. Jan. 18, 2012) (Stark, J.).  (Anticipation/Incorporating by reference - When a host document clearly links the importance of a disclosure described in another reference to its claimed invention, both disclosures within the host document are considered a "single reference" for purposes of an anticipation analysis). 

Drug Product and Patent(s)-in-Suit: Xopenex® (levalbuterol hydrochloride); U.S. Pat. Nos. 5,362,755; 5,547,994; 5,760,090; 5,844,002; and 6,083,993

Nature of the Case and Issue(s) Presented:  In 2009, the parties filed cross-motions for summary judgment on the issue of anticipation.  The Court issued an opinion and order denying Sunovion's motion and granting in part and denying in part Dey's motion.  The Court reserved decision on the issue of whether and to what extent GB '494 incorporated by reference GB '886.  That issue was before the Court.  Dey contended that the patents-in-suit are invalid for anticipation in view of British patent GB 1 298 494 ("the GB '494 patent"), which they contend incorporates by reference additional material separately described in another British patent, GB 1 200 886 ("the GB '886 patent").  In particular, the issue concerns whether the GB '494 patent adequately incorporates by reference the practical utility of the racemic compounds separately described in the GB '886 patent, such that the pertinent material from both patents properly can be considered a "single reference" for purposes of anticipation.  The Court concluded that it did.

Why Dey Prevailed:  First, the Court relied on Federal Circuit precedent where analogous statements containing similar levels of detail were sufficiently specific for incorporation-by-reference.  In view of this precedent, the Court found that the GB '494 patent adequately referenced the GB '886 patent with sufficiently "detailed particularity" regarding the practical utility of the compounds disclosed in the GB '886 patent.

Next, the Court rejected Sunovion's argument that the GB '494 patent refers to the compounds' practical utility merely as "background."  Instead, the Court relied on several portions of the GB '494 patent specification that described the GB '886 patent compounds as an integral aspect of the invention claimed in the GB '494 patent.  For example, GB '494 patent disclosed that the racemic compounds of the GB '886 patent "stimulate β-adrenergic receptors" and that "the practical utility of such activity is more fully described" in the specification of the GB '886 patent.  This, coupled with additional factors-the GB '886 patent is the only prior art document referenced in the GB '494 patent; the GB '886 patent is prominently discussed right at the outset of the GB '494 patent; and the GB '494 and the GB '886 patents are owned by the same entity-lead the Court to find that the patentee clearly linked the advantage and importance of the claimed invention of the GB '494 patent to the practical utility of the pharmacological activity described in the GB '886 patent so that it is clear that this "material is effectively part of the host [GB '494 patent] document."

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