is Manager (Sr Scientist) at Cadila Healthcare Ltd (a.k.a. Zydus Cadila), where he is responsible for patent drafting, filing and prosecution and freedom to operate, patentability and invalidity analysis. He holds an LL.B. from the Faculty of Law, Maharaja Sayajirao University of Baroda, Vadodara (Gujarat, India).
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)).
Patent challenges are an indispensable part of the drug approval process under the provisions of the Hatch-Waxman Act (Hatch-Waxman). To gain early market access, multiple types of invention claims, ranging from compositions to method of use and from combinations to “kits”, are frequently challenged under the Hatch-Waxman provisions by abbreviated new drug application (ANDA) filers. However, challenges to claims for chemical compounds are quite rare compared to claims for other types of inventions. Though the overall approach for challenging any patent/claim remains broadly similar, a compound claim challenge involves a relatively different approach compare to other types of invention claims involved in the Hatch-Waxman context. The chief difference is the types of art that may be available for citation.