Courts have long held that “an old product made by a new process is not novel and cannot be patented.” The validity of  product claims have generally focused on the product and not the particular process of making the product, as illustrated in Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326 (Fed. Cir. 2020). However, in biotechnology (e.g., recombinant and cellular products), the process or source from which a product is produced can confer distinct, yet difficult to define, structural and/or functional differences. Here, we discuss exemplary cases, and assess whether process-related limitations can still distinguish a claimed product over the art in certain circumstances.

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