In an earlier article, “Tips for Selecting a ‘Lead Compound’ in Compound Claim Challenges,” I introduced an approach derived by U.S. federal courts called the “lead compound analysis,” and discussed the first stage of the analysis – “Lead Selection”. This post discusses the second stage – “Lead Development”. The lead development analysis involves assessment of the efforts required for modifying the lead compound to arrive at the claimed compound. As with the case of lead selection, the lead development also involves reviewing the similarities and dissimilarities between the lead and the claimed compounds. The courts have approached this inquiry broadly as the obviousness analysis under the KSR framework (KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007)) and the Graham factors (Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966)).

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