Fed. Cir. Clarifies that for infringement, product-by process claims are limited by the process

In  Abbott Laboratories v. Sandoz, Inc., 566 F.3d 1282, No. 07-1400, –1406,  (Fed. Cir. May 19, 2009), the Federal Circuit held that “process terms in product-by-process claims serve as limitations in determining infringement.”  That is a product-by process claim is interpreted as a process claim for determining infringement and that a product-by process claim is not infringed by products made using non-claimed processes.  With this decision, the court settled a long standing split in the court’s precedent. This case appears to reduce the value of product-by process claims.


The court adopted the rule from Atlantic Thermoplastics Co., Inc. v. Faytex Corp., 970 F.2d 834 (Fed. Cir. 1992)  which “construed
product-by-process claims as limited by the process. Id. at 846-7.”    The court expressly overruled the Scripps Clinic & Research Foundation  v. Genetech, Inc., 927 F.2d 1565 (Fed. Cir. 1991) holding that process terms are not considered claim limitations for determining infringement.
From a policy viewpoint, product by process claims developed from a need to enable a patentee to claim a  patentable product that could  not be defined, measured or characterized other than by the process by which it is made. The court’s majority appears to think that with modern technology, that most products can be described by structure or composition and  that claiming a product by it’s process is not needed and is detrimental.
The claims at issue from U.S. Patent No. 4,935,507 (the '507 patent) were:  (Emphasis added)

2. Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) which is obtainable by acidifying a solution containing 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) at room temperature or under warming.

3. Crystalline substance of claim 2, wherein a solution containing 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) is an aqueous solution of an alkali metal salt of said compound.
4. Crystalline substance of claim 3, wherein the acidifying of the solution is carried out at the temperature from room temperature to 40.degree. C. at the pH from 1 to 4.

The court held that Claim 2,  “which is obtainable by” to be a product-by process claim.
The dissenting opinions raise many interesting issues. 
Note: that the USPTO evaluates the patentability of product-by process claims only by the structure implied by the steps, not by the process limitations. See MPEP 2113. 
The Abbott labs ruling has wide ramifications for patent practitioners, applicants, and potential infringers of product by process claim patents.  Patentee’s should be try to obtain product claims and realize that process limitations in product by process claims can be avoided by potential infringers by using a different process. It is best to avoid product-by process claims unless the product can not be distinguished prior prior art using structure/composition.  Applicants with pending applications should evaluate whether additional claims types or applications should be prosecuted.  Parties accused of infringement of only product-by process claims can consider the process limitation and also consider changing their process to a process not claimed in the product-by process claims.