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Federal Circuit Puts Teeth in the 'Process' of Product-By-Process Claims

By Timothy C. Bickham and Houda Morad

Is a “product by process” claim infringed by products that are made by other processes? After 17 years of waiting, the Federal Circuit emphatically answered the question: No; product-by-process claims are only infringed by products made using the claimed process. Abbott Laboratories v. Sandoz, Inc., 2009 WL 1371410 (Fed. Cir. 2009) (“Abbott“). Tasked at its creation with harmonizing the nation's patent laws and strengthening the patent system, the Federal Circuit has had few internal conflicts with such a high level of visible acrimony. Although the law now appears to be clear, the strongly worded dissent questions the soundness of the ruling and warns of potentially far-reaching implications for the pharmaceutical and biotech industries.

Product-By-Process Claims

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