The Diminished Value of Product-By-Process Claims

Chao Gao and Carl Pledger

October 30, 2015

A Product-by-Process (PBP) claim defines a product by its method of production. MPEP 2113. Even though PBP claims are defined by the recited process, patentability of the claim is determined based on the product itself and does not depend on the recited method. Id. Therefore, a prior art product may anticipate or suggest a PBP claim even if the prior art product is made by a different method than that recited in the PBP claim. Id.

However, for infringement purposes, an en banc panel of the Court of Appeals for the Federal Circuit held that a PBP claim is limited by the recited process steps. See Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282, 1293 (Fed. Cir. 2009). Therefore, a PBP claim is not infringed by a product made by a process that is different from the one claimed. Id.

After Abbott, a three judge panel of the Federal Circuit further acknowledged that the focus for determining the validity of a PBP claim is different from the focus for determining infringement of the same claim. See Amgen Inc. v. F. Hoffmann-La Roche, Ltd., 580 F.3d 1340, 1369-1370 (Fed. Cir. 2009). In particular, the panel acknowledged that in determining the validity of a PBP claim, the focus is on the claimed product and not the process of making it; “[i]n determining infringement of a product-by-process claim, however, the focus is on the process of making the product as much as it is on the product itself.” Id.

The impact of these different analyses is significant. For product-by-process claims, that which anticipates if earlier does not necessarily infringe if later. That is because a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim. Similarly, that which infringes if later does not necessarily anticipate if earlier. That is because an accused product may meet each limitation in a claim, but not possess features imparted by a process limitation that might distinguish the claimed invention from the prior art. Id. at 1370.

In view of the decisions in Abbott and Amgen, it appears that the scope of infringement is narrower for a PBP claim than a standard product claim (i.e., a product claim which only contains structural limitations), because to infringe a PBP claim, the accused product must be made by the method recited in the claim. On the other hand, the product of a standard product claim is infringed by a same accused product regardless of the method of achieving the accused product.

It is further believed that the scope of infringement for a PBP claim is narrower than a standard method claim directed to the same process. Specifically, the process recited in the PBP claim must necessarily result in the claimed product. Thus, if the accused product is made by a different process or if the accused process does not result in the claimed product, than the PBP claim is not infringed. On the other hand, a method claim may be infringed even by a process that contains the recited method steps, but results in a different product.

Accordingly, where possible, Applicants should assert standard product claims (reciting only structural limitations) and standard method claims to obtain the broadest scope of protection. In this regard, standard product claims and standard method claims will likely further reduce uncertainty during litigation, because the focus of the validity and infringement determinations of each of these types of claims is the same.