Recently, the Federal Circuit and lower courts have applied a new test to assess the question of obviousness for chemical compounds. While courts have always considered the presence of some lead compound to be relevant to the question of obviousness, beginning at the turn of the millennium, the Federal Circuit began assessing obviousness in a more formulaic fashion, applying what is commonly referred to as the lead compound analysis to determine if a litigant has established a prima facie case of obviousness. This Paper describes the development of the lead compound analysis, and its application. This Paper then discusses some of the shortcomings and weaknesses of the doctrine’s applications and how understanding the lead compound analysis and how it is likely to be applied in typical situations can be useful in understanding both how to draft stronger patents and what ways might be available to attack the obviousness of a chemical compound or a court’s application of the lead compound analysis.
Structural Uncertainty: Understanding the Federal Circuit's Lead Compound Analysis,
16 Marq. Intellectual Property L. Rev. 401
Available at: https://scholarship.law.marquette.edu/iplr/vol16/iss2/1