Opinion ID: 208706
Heading Depth: 3
Heading Rank: 2

Heading: proper interpretation of product-by process claims[1]

Text: This court addresses Part III.A.2 of this opinion en banc, which addresses the proper interpretation of product-by-process claims in determining infringement. Claims 2-5 of the '507 patent begin by reciting a product, crystalline cefdinir, and then recite a series of steps by which this product is obtainable. The Eastern District of Virginia correctly categorized claims 2-5 as product-by-process claims. On appeal, Abbott argues that the Eastern District erred in construing the process steps of claims 2-5 under the rule in Atlantic Thermoplastics, 970 F.2d at 846-47, that process terms in product-by-process claims serve as limitations in determining infringement, rather than in accordance with Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565, 1583 (Fed.Cir.1991) ([T]he correct reading of product-by-process claims is that they are not limited to product prepared by the process set forth in the claims.). This court takes this opportunity to clarify en banc the scope of product-by-process claims by adopting the rule in Atlantic Thermoplastics. In Atlantic Thermoplastics, this court considered the scope of product-by-process claim 26 in the patent at issue: [t]he molded innersole produced by the method of claim 1. 970 F.2d at 836. The patentee urged that competing, indistinguishable innersoles made by a different method nonetheless infringed claim 26. Id. at 838. This court rejected the patentee's position. This court in Atlantic Thermoplastics construed product-by-process claims as limited by the process. Id. at 846-47. This rule finds extensive support in Supreme Court opinions that have addressed the proper reading of product-by-process claims. See Smith v. Goodyear Dental Vulcanite Co., 93 U.S. 486, 493, 23 L.Ed. 952 (1877) (The process detailed is thereby made as much a part of the invention as are the materials of which the product is composed.); Goodyear Dental Vulcanite Co. v. Davis, 102 U.S. 222, 224, 26 L.Ed. 149 (1880) ([T]o constitute infringement of the patent, both the material of which the dental plate is made ... and the process of constructing the plate ... must be employed.); Merrill v. Yeomans, 94 U.S. 568, 24 L.Ed. 235 (1877); Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293, 4 S.Ct. 455, 28 L.Ed. 433 (1884) ( BASF ); The Wood-Paper Patent, 23 Wall. 566, 90 U.S. 566, 596, 23 L.Ed. 31 (1874); Plummer v. Sargent, 120 U.S. 442, 7 S.Ct. 640, 30 L.Ed. 737 (1887); Gen. Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 58 S.Ct. 899, 82 L.Ed. 1402 (1938); see also Atl. Thermoplastics, 970 F.2d at 839-42 (discussing each of these cases). In these cases, the Supreme Court consistently noted that process terms that define the product in a product-by-process claim serve as enforceable limitations. In addition, the binding case law of this court's predecessor courts, the United States Court of Customs and Patent Appeals ( see In re Hughes, 496 F.2d 1216, 1219 (CCPA 1974) (acknowledging that true product claims are broader in scope than product-by-process claims)), and the United States Court of Claims ( see Tri-Wall Containers v. United States, 187 Ct.Cl. 326, 408 F.2d 748, 751 (1969)), followed the same rule. This court's sister circuits also followed the general rule that the defining process terms limit product-by-process claims. See, e.g., Hide-Ite Leather v. Fiber Prods., 226 F. 34, 36 (1st Cir.1915) (It is also a well-recognized rule that, although a product has definite characteristics by which it may be identified apart from the process, still, if in a claim for the product it is not so described, but is set forth in the terms of the process, nothing can be held to infringe the claim which is not made by the process.); Paeco, Inc. v. Applied Moldings, Inc., 562 F.2d 870, 876 (3d Cir. 1977) (A patent granted on a product claim describing one process grants no monopoly as to identical products manufactured by a different process.). Indeed, this court itself had articulated that rule: For this reason, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. In re Thorpe, 777 F.2d 695, 697 (Fed.Cir.1985) (emphasis added). The Supreme Court has long emphasized the limiting requirement of process steps in product-by-process claims. In BASF, the Court considered a patent relating to artificial alizarine. Specifically, the patent claimed [a]rtificial alizarine, produced from anthracine or its derivatives by either of the methods herein described, or by any other method which will produce a like result. 111 U.S. at 296, 4 S.Ct. 455 (quoting U.S. Patent Reissue No. RE 4,321). In turn, the specification generally described a method for making artificial alizarine involving anthracine or its derivatives. Alizarine had been in use for thousands of years as a red textile dye, traditionally extracted from madder root. Pure alizarine has the chemical formula C14H8O4, but artificial alizarines available in the market at the time of the litigation varied from almost completely pure alizarine, to combinations of alizarine and anthrapurpurine, to pure purpurine containing no alizarine whatsoever. Id. at 309-10, 4 S.Ct. 455. The defendant's product contained approximately sixty percent anthrapurpurine. Thus both alizarine and artificial alizarines were known in the prior art. The Supreme Court clearly articulated some of the scope and validity problems that arise when process limitations of product-by-process claims are ignored: [The defendant's product] is claimed by the plaintiff to be the artificial alizarine described in No. 4,321, and to be physically, chemically, and in coloring properties similar to that. But what that is is not defined in No. 4,321, except that it is the product of the process described in No. 4,321. Therefore, unless it is shown that the process of No. 4,321 was followed to produce the defendant's article, or unless it is shown that that article could not be produced by any other process, the defendant's article cannot be identified as the product of the process of No. 4,321. Nothing of the kind is shown.    If the words of the claim are to be construed to cover all artificial alizarine, whatever its ingredients, produced from anthracine or its derivatives by methods invented since Graebe and Liebermann invented the bromine process, we then have a patent for a product or composition of matter which gives no information as to how it is to be identified. Every patent for a product or composition of matter must identify it so that it can be recognized aside from the description of the process for making it, or else nothing can be held to infringe the patent which is not made by that process. Id. at 310, 4 S.Ct. 455 (emphasis added). After BASF, the Supreme Court continued to emphasize the importance of process steps in evaluating the infringement of product-by-process claims. See, e.g., Plummer, 120 U.S. at 448, 7 S.Ct. 640 ([W]hatever likeness that may appear between the product of the process described in the patent and the article made by the defendants, their identity is not established unless it is shown that they are made by the same process.); Gen. Elec. Co., 304 U.S. at 373, 58 S.Ct. 899 ([A] patentee who does not distinguish his product from what is old except by reference, express or constructive, to the process by which he produced it, cannot secure a monopoly on the product by whatever means produced. (footnote omitted)). Thus, based on Supreme Court precedent and the treatment of product-by-process claims throughout the years by the PTO and other binding court decisions, this court now restates that process terms in product-by-process claims serve as limitations in determining infringement. Atl. Thermoplastics, 970 F.2d at 846-47. As noted earlier, this holding follows this court's clear statement in In re Thorpe that product by process claims are limited by and defined by the process. 777 F.2d at 697. More recently, the Supreme Court has reiterated the broad principle that [e]ach element contained in a patent claim is deemed material to defining the scope of the patented invention. Warner-Jenkinson, 520 U.S. at 19, 117 S.Ct. 1040. Although Warner-Jenkinson specifically addressed the doctrine of equivalents, this rule applies to claim construction overall. As applied to product-by-process claims, Warner-Jenkinson thus reinforces the basic rule that the process terms limit product-by-process claims. To the extent that Scripps Clinic is inconsistent with this rule, this court hereby expressly overrules Scripps Clinic. The dissenting opinions lament the loss of a right that has never existed in practice or precedentthe right to assert a product-by-process claim against a defendant who does not practice the express limitations of the claim. This court's en banc decision in no way abridges an inventor's right to stake claims in product-by-process terms. Instead this decision merely restates the rule that the defining limitations of a claimin this case process termsare also the terms that show infringement. Thus this court does not question at all whether product-by-process claims are legitimate as a matter of form. The legitimacy of this claim form was indeed a relevant issue in the nineteenth century when Ex parte Painter, 1891 C.D. 200, 200-01 (Comm'r Pat. 1891), and some later cases were before the Commissioner of Patents. However, this court need not address that settled issue. The issue here is only whether such a claim is infringed by products made by processes other than the one claimed. This court holds that it is not. The jurisprudence of the Court of Customs and Patent Appealsa court with virtually no jurisdiction to address infringement litigationcan shed little light on the enforcement of the only claim limitations that an applicant chooses to define the invention. Indeed, this court's venerable predecessor expressed its ambivalence towards the relevant infringement analysis: The policy of the Patent Office in permitting product-by-process type claims to define a patentable product, where necessary, has developed with full cognizance of the fact that in infringement suits some courts have construed such claims as covering only a product made by the particular process set forth in the claim and not to the product per se. In re Bridgeford, 53 C.C.P.A. 1182, 357 F.2d 679, 683 n. 5 (1966). The reference to some courts in this prior citation, as this court notes en banc, includes the United States Supreme Court and every circuit court to consider the question, including this circuit. See also Jon S. Saxe & Julian S. Levitt, Product-by-Process Claims and Their Current Status in Chemical Patent Office Practice, 42 J. Pat. Off. Soc'y 528, 530 (1960) ([P]roduct-by-process claims have met with a most strict interpretation in the courts in infringement proceedings.... [T]he courts uniformly hold that only a product produced by the claim-designated process may be held to infringe the claim.) (citing Gen. Elec. Co., 304 U.S. 364, 58 S.Ct. 899, 82 L.Ed. 1402 and BASF, 111 U.S. at 310, 4 S.Ct. 455). Product-by-process claims, especially for those rare situations when products were difficult or impossible to describe, historically presented a concern that the Patent Office might deny all product protection to such claims. See In re Butler, 17 C.C.P.A. 810, 813, 37 F.2d 623 (1930) (Process claims are valuable, and appellant thinks he is entitled to them; but it is submitted that he should not be limited to control of the process when the article which that process produces is new and useful.). In the modern context, however, if an inventor invents a product whose structure is either not fully known or too complex to analyze (the subject of this casea product defined by sophisticated PXRD technologysuggests that these concerns may no longer in reality exist), this court clarifies that the inventor is absolutely free to use process steps to define this product. The patent will issue subject to the ordinary requirements of patentability. The inventor will not be denied protection. Because the inventor chose to claim the product in terms of its process, however, that definition also governs the enforcement of the bounds of the patent right. This court cannot simply ignore as verbiage the only definition supplied by the inventor. This court's rule regarding the proper treatment of product-by-process claims in infringement litigation carries its own simple logic. Assume a hypothetical chemical compound defined by process terms. The inventor declines to state any structures or characteristics of this compound. The inventor of this compound obtains a product-by-process claim: Compound X, obtained by process Y. Enforcing this claim without reference to its defining terms would mean that an alleged infringer who produces compound X by process Z is still liable for infringement. But how would the courts ascertain that the alleged infringer's compound is really the same as the patented compound? After all, the patent holder has just informed the public and claimed the new product solely in terms of a single process. Furthermore, what analytical tools can confirm that the alleged infringer's compound is in fact infringing, other than a comparison of the claimed and accused infringing processes? If the basis of infringement is not the similarity of process, it can only be similarity of structure or characteristics, which the inventor has not disclosed. Why also would the courts deny others the right to freely practice process Z that may produce a better product in a better way? In sum, it is both unnecessary and logically unsound to create a rule that the process limitations of a product-by-process claim should not be enforced in some exceptional instance when the structure of the claimed product is unknown and the product can be defined only by reference to a process by which it can be made. Such a rule would expand the protection of the patent beyond the subject matter that the inventor has particularly point[ed] out and distinctly claim[ed] as his invention, 35 U.S.C. § 112 ¶ 6. Thus, the Eastern District of Virginia correctly applied the rule that the recited process steps limit the product-by-process claims 2-5 for any infringement analysis.