PAR PHARMACEUTICAL, INC. v. EAGLE PHARMACEUTICALS, INC.

Par manufactures and sells Vasostrict®, a vasopressin injection product used to treat patients with critically low blood pressure. Once approved by the FDA, Vasostrict® was added to the Orange Book, which identified Par’s U.S. Patent Nos. 9,744,209 and  9,750,785 as encompassing Vasostrict®.  Eagle filed an ANDA to manufacture and sell a generic version of Vasostrict® before the ’209 and ’785 patents expired. Par sued Eagle for infringement, and the district court found Par had not established Eagle’s product would infringe, and denied Par’s request for declaratory judgment. Par appeals. The CAFC finds that the district court did not clearly err in finding that Eagle’s ANDA defines a product outside the scope of Par’s claims, noting that Par’s unsupported conjecture that Eagle will not abide by its representations is inadequate to establish infringement.  Par also argues the district court erred by finding no discernable upward drift in pH and rejecting the relevance of even minor pH fluctuations, but the CAFC sees no clear error in this finding since Eagle’s expert testified only that there were fluctuations—both upward and downward—in the pH, which is entirely consistent with the district court’s finding.  Par further alleges that the district court erroneously focused on pH measurements of products made according to Eagle’s optimized manufacturing processes (post-optimization data), which reduced the magnitude of pH fluctuations in Eagle’s products, but the CAFC finds that Par is simply challenging the district court’s weighing of the evidence, and holds that the district court’s reliance on post-optimization data was not clear error. The CAFC concludes that Eagle’s ANDA specification controls and defines a non-infringing product, that the district court did not abuse its discretion in denying Par’s request for declaratory judgment, and therefore affirms. 

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