Double Standards at the Federal Circuit



Generally, “product” claims in a patent define a product in terms of its structure, properties, or composition. A product claim could thus cover a pharmaceutical composition or formulation with a well-characterized compound and useful excipients, a light-weight alloy used in windmill blades for renewable power, or an electrolyte composition for a fuel cell. In contrast, a “product-by-process” claim defines the product partly by how it is made, i.e., the claim recites process or method steps. Product-by-process claims are typically used for newly discovered products with physical characteristics that are unknown or initially difficult to determine. A newly discovered chemical/pharmaceutical compound or a complex protein molecule might be a candidate for product-by-process claim coverage, because the claim includes the steps required to obtain the product without needing substantial information to characterize the product.

Because of the process steps recited in product-by-process claims, courts have been unclear how to determine what products would actually infringe such product-by-process claims. On the one hand, some courts interpreted the claims to require the products be made by the process recited. Other courts, however, found that the same type of claims covered the resultant product regardless of whether or not it was prepared by the process recited in the product-by-process claim. The Federal Circuit resolved the dispute in Abbott Laboratories v. Sandoz, Inc. But in doing so, it created a double standard between patentability and infringement of product-by-process claims.

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