Tips for Selecting a ‘Lead Compound’ in Compound Claim Challenges

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.

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