Limits on Hard-to-Reproduce Inventions: Process Elements and Biotechnology's Compliance with the Enablement Requirement

In the recently decided case of Abbott Laboratories v. Sandoz, Inc., the Federal Circuit resolved a long-standing split of authority between its panels by holding that a claim to a product that includes process elements (a "product-byprocess" claim) is infringed only if the product is made using that process. This article advances the proposal that product-by-process claims can help patentees meet the enablement requirement of the Patent Act, while still offering a reasonably broad scope of protection. For claims to new materials whose behavior and utility can be highly process-dependent and whose structure cannot be fully ascertained by analytical methods known as of the time of the invention, such as biosynthetic proteins, process limitations offer a logical solution that provides for commensurability between disclosure and claim scope.