Clarifying patent infringement of "Product by Process" claims
In Abbott Labs. v. Sandoz, Ins. (“Abbott”), an en banc Court of Appeals for the Federal Circuit has clarified its own previously issued inconsistent holdings on determining infringement of product-by-process claims.
Historically, product-by-process claims have been limited to claims in chemical patents and were originally used to claim products that could not be analyzed to determine their precise chemical composition. The inventor knows how he made it and what it does, but not exactly what it is. If a chemical product cannot be precisely defined except by the process that produces it, a claim to such a product defined by its method of preparation is proper. Manual of Patent Examining Procedure § 706.03(e). The so-called "product-by-process" format utilizes process limitations to define the composition. Despite the process limitations, the claim has always been considered a “product” or “composition of matter” claim by the USPTO and not a “process” claim. The USPTO defines a product-by-process claim as a product claim in which the product is defined, in whole or in part, by the process used to make the product.
The applicability of the product-by-process claim with modern laboratory analytics is limited, but still may be appropriate in some cases. However, patent practitioners still often include a product-by-process claim in a case with other structurally defined product claims. This use of the product-by-process claims is outside the original intent of the claim format. There should be an either/or situation, either you can define the product structurally or you can only define it by the process used to make it, not both. However, practitioners feel adding a product-by-process claim to in addition to the structurally defined claim may broaden patent protection and more easily capture infringers.
In Abbott, the CAFC clarified the test for infringement of product-by-process claims. There was uncertainty due to previous CAFC holdings; in Atlantic Thermoplastics, the CAFC held that to infringe a product-by-process claim the accused infringer must have performed all the process steps defined in the claim, however, in Scripps the CAFC stated that the process steps were not important in determining infringement, the court should only consider whether the accused product infringed the claim regardless of the process steps performed to prepare the product. Reasonable minds can disagree, but when the reasonable minds are the decision makers, uncertainty results.
The en banc panel in Abbott held that to infringe a product-by-process claim, you must infringe the process steps and the product is irrelevant to the infringement analysis. Therefore, while determining infringement is based upon the process limitations, the USPTO continues to determine patentability of product-by-process claims based upon the product.
In Abbott Labs. v. Sandoz, Ins. (“Abbott”), an en banc Court of Appeals for the Federal Circuit has clarified its own inconsistent holdings on determining infringement of product-by-process claims.
The CAFC clarified that the “process terms in a product-by-process claim serve as limitations in determining infringement” as in Atlantic Thermoplastics. This may seem reasonable, but contrary to the original purpose, “product-by-process” claims were intended to protect products that could not be clearly described structurally or by their specific compositions. The CAFC is now stating that product-by-process claims are merely method claims limited to producing the stated product.
The law provides that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C. 101.
U.S. Patent Law defines the patentable statutory subject matter into four distinct statutory classes, processes, machines, manufactures, or compositions of matter. The U.S. Supreme Court interpreted this law as "anything under the sun that is made by man" is statutory subject matter. Diamond v. Chakrabarty, 447 U.S. 303, 308-09, 206 USPQ 193, 197 (1980).
At times, chemical processes have produced novel and useful compositions of matter that were not capable of being clearly identified. However, the U.S. patent laws require that an applicant for patent must prepare “one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.” 35 U.S.C. §112.
This can be a problem for the inventor that can’t precisely identify the product or composition of matter, which he created. The inventor knows the process he used and that the product is useful but cannot describe it sufficiently to particularly point out or distinctly claim it. Perhaps, there are insufficient analytical methods available to identify it. However, the product is a “composition of matter” and, therefore, should be patentable subject matter.
A form of claiming such a composition of matter developed is called a “product-by-process” claim. The claim is not a process claim but a composition of matter claim and was meant to protect the product. Typically, if a new composition of matter is invented, the applicant will attempt, if possible, to claim the new “process” and the new “composition of matter.” Product-by-process claims allowed you to do that without being able to identify the product or the “invention” clearly.
Patentability and infringement of these special claims has present problems for the patent office and the courts. The patent office has determined that since the claim is a composition of matter claim, the patentability relies on the patentability of the product, not the method steps. This seems reasonable; the applicant can also attempt to patent process claims. However, the inventor has not been able to concisely identify the product. That is why he is using the product-by-process claim form!
The patent office attempts to overcome this conundrum by finding the closest prior art and rejecting the claims. The rejection pushes the burden to the applicant to provide sufficient details of the inventive composition of matter to the patent office. Seems fair. The patent office explains that they do not have the facilities to make the inventive product and compare it with the prior art products.
The courts have had similar difficulty determining infringement of product-by-process claims. The Court of Appeals of the Federal Circuit has been split in two camps on the issue. The first camp provided patent protection for the product no matter what process was used to produce it. The second camp provided protection only for products produced by the process steps in the claims. The first camp in Scripps has been voted off the island.
