Practical Guidance for Pharmaceutical Method-of-Use Patent Claims After Teva v. Eli Lilly and In re Xencor

Short summary

Two recent Federal Circuit decisions—Teva v. Eli Lilly and In re Xencor—clarify what patent specifications must disclose for method-of-use claims involving known compound genera under 35 U.S.C. § 112. Teva upheld claims where the genus was well-known and all members worked for the specific therapeutic use, while Xencor rejected broad, undifferentiated treatment language lacking evidentiary support. The article distills five practical drafting and prosecution lessons emphasizing claim specificity, documented known-in-the-art status, mechanistic rationale, careful claim format selection, and evidentiary record preservation.

• •Teva upheld method-of-use claims where the compound genus was well-known and all members worked for the specific use
• •Xencor rejected broad 'treating a patient' language untethered to any disease, population, or outcome
• •Five drafting lessons: claim specificity, document known-art status, explain mechanism, avoid format reliance, preserve evidentiary record

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