Abbott Laboratories v. Sandoz, Inc.: The Federal Circuit Finally Aligns Its Precedent On Product-By-Process Claims

For many years, there was a Federal Circuit split on the issue of product-by-process limitations. One panel of the Federal Circuit had declared that when a patent claim is directed to a product-by-process, the process is not a limitation for infringement. Another panel disagreed, asserting that process terms in product-by-process claims serve as limitations in determining infringement. In Abbott Laboratories v. Sandoz, Inc., the court, en banc, resolved the split and concluded that in a product-by-process claim, the process is a limitation for infringement.¹

I. Background

A product-by-process claim is one directed to a product, but with a statement in the claim of the process used to obtain the product. While the law of infringement of product-by-process claims had not been clear for years, a specific circuit split formed the early 1990s. In 1991, Judge Newman wrote the opinion in Scripps Clinic & Research Foundation v. Genentech, Inc., and declared that "the correct reading of product-by-process claims is that they are not limited to product prepared by the process set forth in the claims," reasoning that claims must be construed the same way for validity and for infringement.²

A year later Judge Rader authored the decision in...