A product-by-process claim is a claim to a new product that claims the product according to the process by which it is made. An example of such a claim follows.
A widget made by the following process:
step A;
step B; and
step C.
Normally a claim like the one above would only be written if the claim to the structure or properties of the product itself would be difficult or impractical. Such is sometimes the case in the chemical or pharmaceutical field.
The Federal Circuit had a split of authority on how such a claim should be interpreted in an infringement suit. One set of cases indicated that this type of claim could only be infringed by a product that was made according to the claimed process. Another set of cases indicated that since this type of claim is a product claim, it is irrelevant for infringement purposes how the infringing product was made.
In the consolidated appeal of Abbot Labs. v. Sandoz, Inc., the Federal Circuit has chosen the former approach.
[P]rocess terms in product-by-process claims serve as limitations in determining infringement.
The court held that it was bound to this outcome by Supreme Court precedent.
This is not to say that old products can be repatented based on their preparation by a new process. The PTO has never taken this approach. The Manual of Patent Examination Procedure (MPEP) § 2113 states that such products are not limited by the steps recited in the processes, but by the structure implied by the process steps. The Federal Circuit appears to have sanctioned this procedure for determining patentability of product-by-process claims.
[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.
Thus, this decision means that if an old product is made by a new process, the product cannot be patented again, even using a product-by-process claim. The new process for making the product may be patentable if it is non-obvious. If an accused infringer determines a new way to make a product covered by a product-by-process claim, the accused infringer does not infringe the product-by-process claim.
Dissents
Judge Newman, joined by Judges Mayer and Lourie, filed a lengthy dissent. She argues that the procedure for taking a small part of the opinion en banc without notice to the parties violates the Federal Rules of Appellate Procedure, the Federal Circuit’s own rules, and principles of fairness. She argues that the parties should have had notice and the opportunity to specifically brief the issue for the en banc court to decide. She also continues by arguing against the court’s result as well. She argues in favor of the rule that infringement of the process steps are not necessary to infringe a product-by-process claim. She argues that the court is taking away a long established right with little or no notice to interested parties.
Judge Lourie filed an interesting dissent where he acknowledged the Supreme Court precedent, but argued that since all of those cases were old they could be disregarded.
I agree that there is substantial Supreme Court precedent that holds that product-by-process claims require use of the recited process for there to be infringement. . . . The Court years ago did not have occasion to consider today’s innovations or decide whether a distinction should be made between a new chemical-biological product and an old product made by a new process.
Bottom Line
The bottom line is to only use such claims when absolutely necessary, such as when the product is difficult or impossible to describe without resort to the process by which it was made.
