A summary of the Federal Circuit decision, Amgen Inc. v. Hoechst Marion Roussel Inc.,

US Court Decision (1) Amgen Inc. v. Hoechst Marion Roussel Inc., 469 F.3d 1039 (Fed. Cir. November 22, 2006)

Background：

Amgen alleged that Hoechst (now known as Aventis) infringed its patent (and other patents) directed to production of the hormone erythropoietin (EPO), used in the treatment of blood disorders. The district court interpreted “therapeutically effective amount” to mean only EPO products effective in curing disease. Based on this claim interpretation, the district court held that the patent was not invalid over a prior art reference. Amgen appealed to the Federal Circuit. A panel of three Federal Circuit judges issued a decision in June 2006. The panel applied the well-known Cybor rule. The Cybor rule basically says claim interpretation is a question of law that is reviewed de novo, i.e. anew, by the Federal Circuit. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 46 USPQ2d 1169 (Fed. Cir. 1998) (en banc). Under the Cyber rule, the Federal Circuit independently interprets the disputed claim terms with no deference to the district court’s claim interpretation. In the June 2006 decision, the three-judge panel reversed the district court’s claim interpretation on the grounds it was too narrow. The panel made its own claim interpretation. Based on the specification and prosecution history of the patent, the three-judge panel held that a “therapeutically effective amount” is any EPO product that produces physiological effects, and those effects need not necessarily include curing disease. The panel remanded the case to the district court to determine if the claim was anticipated by the prior art reference based on the panel’s claim interpretation. Amgen petitioned the Federal Circuit for panel rehearing (the three-judge panel that heard the June 2006 case) and rehearing en banc (all 12 judges of the Federal Circuit).

Issue：

whether the Federal Circuit panel (that decided the June 2006 case), or alternatively the Federal Circuit en banc, should rehear the claim interpretation issue presented in the June 2006 case.

Ruling：

The petition for panel rehearing was denied. The petition for rehearing en banc was denied. Chief Judge Michel (joined by Judge Rader) dissented from the denial of the petition for en banc review. With respect to the Cybor no deference rule, he stated: “reconsideration is appropriate and revision may be advisable.” In his view, four practical problems have emerged under the no deference rule:

(1) a steadily high reversal rate of district court decisions on claim interpretation; (2) a lack of predictability about appellate outcomes, which may confuse district court judges and discourage settlements; (3) loss of the comparative advantage often enjoyed by the district court judges who heard or read all of the evidence and may have spent more time on the claim interpretations than the appellate court (CAFC); and (4) the CAFC being inundated with the minutia of interpreting numerous disputed claim terms in nearly every patent case. Judge Newman dissented from the denial of the petition for en banc review. She said deference should be granted to the district court’s claim interpretation when a claim’s “meaning is recognized as a case-specific finding of fact.”

Judge Rader dissented from the denial of the petition for en banc review. He urged the Federal Circuit “to accord deference to the factual components” of the district court’s claim interpretation. Judge Moore dissented from the denial of the petition for rehearing en banc. She said the Federal Circuit should have taken this case en banc to reconsider its Cybor rule. Judges Gajarsa, Linn and Dyk, concurred in the denial of en banc review. However, they said in “an appropriate case we would be willing to reconsider limited aspects of the Cybor decision.” They said an appropriate case would be one in which the district court “found it necessary to resolve conflicting expert evidence to interpret particular claim terms in the field of the art.” Judge Lourie concurred in the denial of the petition for en banc review. He said the issue in this case was case-specific, important only to the parties, not to the law. Accordingly, he said, this case does not raise an issue warranting en banc review.

Comment：

Rehearing the June 2006 Amgen case would have enabled the Federal Circuit to reconsider its 1998 Cybor rule of de novo review of district court claim interpretations. Although the vote against rehearing was 8 to 4, it is important to note the views expressed by the judges in the dissenting and concurring opinions. A majority of the judges indicated that in an appropriate case the Federal Circuit should reconsider its Cybor no deference rule. There also is a possibility that this case may go the U.S. Supreme Court. (Deadline to file a petition for review to the S.Ct. is March 22, 2007). Eventually, the Cybor no deference rule will be reconsidered, either by the Federal Circuit en banc, or by the U.S. Supreme Court.