By Kevin E. Noonan —
In an otherwise unremarkable decision affirming the district court's claim construction and summary judgment of noninfringement in Abbott Laboratories v. Sandoz, Inc., the Court of Appeals for the Federal Circuit took the opportunity to reconcile a long-standing conflict in its precedent. Deciding this portion en banc, the court expressly overruled its earlier panel decision in Scripps Clinic & Research Foundation v. Genentech, Inc. in favor or the contrary panel decision in Atlantic Thermoplastics Co. v. Faytex Corp.; the decision affirms the Atlantic Thermoplastics view that a product by process claim is infringed only if the accused infringer practices the process steps recited in the claim, not merely produces the product by any method.
In an opinion by Judge Rader, joined by Judges Michel, Bryson, Gajarsa, Linn, Dyk, Prost, and Moore (and over a dissent by Judge Newman joined by Judges Mayer and Lourie, and a separate dissent by Judge Lourie; Judge Schall not participating in the en banc opinion), the Federal Circuit reviewed the history of the split between the separate panels in the Scripps Clinic and Atlantic Thermoplastics cases. This portion of the opinion, Section III.A.2, was taken up en banc sua sponte but was prompted by plaintiff Abbott's argument that the District Court erred in construing claims 2-5 of U.S. Patent No. 4,935,507 as product by process claims. The claims at issue recite:
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°C. at the pH from 1 to 4.
5. Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) which is obtainable by dissolving 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) in an alcohol, continuing to stir the solution slowly under warming, then cooling the solution to room temperature and allowing the solution to stand.
Abbott joined the issue directly, arguing that the District Court erred in construing the "process" claims as requiring performance of the process steps in the claims to constitute infringement according to Atlantic Thermoplastics rather than under the more inclusive Scripps Clinic test.
Judge Rader's majority opinion cites "extensive support" for its decision in prior Supreme Court precedent, including:
The Federal Circuit opined that in these cases, the Supreme Court had consistently held that process terms used to define a product in product by process claims constitute "enforceable limitations" in construing the claims; these canons of construing product-by-product claims were supported by numerous cases decided by the CCPA. The majority also turned to appellate opinions by different courts of appeal (including the 1st Circuit (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" and the 3rd Circuit (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.")). Some of this precedent had to do with ensuring that the accused product was actually the claimed product, so that the Supreme Court held that "unless it is shown that the process of [the patent claim] 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 [the patent claim]." Cochrane v. Badische Anilin & Soda Fabrik, Id. at 296. The majority opinion also cited Warner-Jenkinson Co. v. Hilton Davis Chemical Co. for the proposition that "each element contained in a patent claim is deemed material in defining the scope of the patented invention." "To the extent that Scripps Clinic is inconsistent with this rule, this court hereby expressly overrules Scripps Clinic":
Judge Newman's dissent (perhaps predictably, since she wrote the Scripps Clinic decision) accuses the majority of "overturn[ing] a century of precedent and practice" in making its decision. She reviews the history of product by process practice and precedent, as well as providing her own assessment (as she did in her In re Bilski dissent) of the cases cited by the en banc majority. She dissents on both substantive and procedural grounds, noting that "[t]he court has given no notice of this impending en banc action," which she asserts is contrary to the Federal Rules of Appellate Procedure as well as the Federal Circuit's own procedural rules. Her lengthy dissent focused on the en banc Court's abrogation of the (heretofore) "inviolate rule that patent claims should be construed the same way for validity and infringement" and on how the panel decision misapplied the en banc Court's product by process claim decision.
Judge Lourie, on the other hand, was succinct, making essentially three arguments. First, he noted that the Supreme Court cases cited by the majority in support of its decision in some instances "applied overly broad language to fact situations involving old products or used vague language that makes it difficult to determine whether the products were old or new." Second, he cautioned that "[t]here is arguably a different situation that should apply to chemical-biological products today than to mechanical products of more than a century ago," saying that Supreme Court precedent does not foreclose treating product by process claims as product claims regardless of how the product was obtained. Finally, he raised perhaps the most important issue (in light of recent Supreme Court disapproval of the many Federal Circuit "bright line" tests), reminding the CAFC that "there may be differing results depending upon the exact wording of a claim at issue" and that "[b]right lines have their uses, but judging should take account of differing circumstances."
Panel: Circuit Judges Rader, Plager, and Bryson
Chief Judge Michel and Circuit Judges Rader, Bryson, Gajarsa, Linn, Dyk, Prost, and Moore joined Section II.A.2 of opinion; dissenting opinion by Circuit Judge Newman, joined by Circuit Judges Mayer and Lourie; dissenting opinion by Circuit Judge Lourie
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