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Hastings Science and Technology Law Journal

Abstract

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.

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