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"Vitiation" is not an exception or threshold determination that forecloses resort to the doctrine of equivalents, but is instead a legal conclusion of a lack of equivalence based on the evidence presented and the theory of equivalence asserted. Characterizing an element of an accused product as the "antithesis" of a claimed element is also a conclusion that should not be used to overlook the factual analysis required to establish whether the differences between a claimed limitation and an accused structure or step are substantial vel non. The determination of equivalence depends not on labels like "vitiation" and "antithesis" but on the proper assessment of the language of a claimed limitation and the substantiality of whatever relevant differences may exist in the accused structure.
SCR Pharmatop and Cadence Pharmaceuticals, Inc. (collectively "Cadence") are the owner and exclusive licensee, respectively, of the '222 and '218 patents. These patents are directed to aqueous phenol formulations—particularly acetaminophen (sometimes referred to as "paracetamol"). Cadence Pharmaceuticals Inc. markets an injectable acetaminophen product, which is approved by the Food and Drug Administration ("FDA") and is distributed under the name Ofirmev®. The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (better known as the "Orange Book") lists the '222 and '218 patents in connection with Ofirmev®. Exela filed an Abbreviated New Drug Application ("ANDA") with the FDA, seeking approval of a generic equivalent of Ofirmev®. The ANDA included a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (2012) (commonly referred to as a "Paragraph IV certification") stating that the '222 and '218 patents were invalid and not infringed. In response, Cadence sued Exela for infringing claims 1, 3, 4, 5, 9, 10, 12 and 16-18 of the '222 patent and claims 1, 3, 4 and 19 of the '218 patent pursuant to 35 U.S.C. § 271(e)(2) (2012). The district court found the '222 patent not invalid and literally infringed and the '218 patent not invalid and infringed under the doctrine of equivalents.
Did the district court err in ruling that the scope of the doctrine of equivalents would vitiate a limitation of the claim arising from the 218 patent?
The district court did not accept Exela's argument that this scope of equivalents would vitiate a limitation of the claim. Exela challenges that determination and contends that deoxygenating after adding the active ingredient is the "antithesis" of deoxygenating before adding the active ingredient and that because such a substitution would "vitiate" the claimed limitation, there can be no finding of equivalence. It maintains that the facts here are analogous to Planet Bingo, LLC v. GameTech International, Inc., where the appellate court held that determining a winning combination after a game started could not be equivalent to a claim that recited "a predetermined winning combination." Exela's reliance on Planet Bingo is misplaced. Planet Bingo's holding was based on a finding that a combination determined before a game was substantially different, factually, from a combination determined after the game started. In essence, Exela fundamentally misunderstands the doctrine of claim vitiation. Since a reasonable trier of fact could (and, in fact, did) conclude that Exela's process is insubstantially different from that recited in the claims, the argument that a claim limitation is vitiated by the district court's application of the doctrine of equivalents is both incorrect and inapt.