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Archived updates for Monday, July 14, 2008

Reverse Doctrine of Equivalents Still Dead

In Roche Palo Alto LLC v. Apotex Inc. (June 9, 2008) the Federal Circuit confirmed that the reverse doctrine of equivalents is still dead in the U.S.:

The reverse doctrine of equivalents is an equitable doctrine designed “to prevent unwarranted extension of the claims beyond a fair scope of the patentee’s invention.”
Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565, 1581 (Fed. Cir.
2008). According to the Supreme Court: "[W]here a device is so far changed in principle from a patented article that it performs the same or similar function in a
substantially different way, but nevertheless falls within the literal words of the claim, the [reverse] doctrine of equivalents may be used to restrict the claim and defeat the patentee’s action for infringement." Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608-609 (1950) (emphases added). While the patentee bears the burden of proving infringement, if the patentee establishes literal infringement, the burden shifts to the accused infringer to set forth a prima facie case of non-infringement under the reverse doctrine of equivalents. SRI Int’l, 775 F.2d at 1123-24. If the accused infringer is successful in making a prima facie case, the patentee must then rebut that prima facie case. Id. at 1124. The reverse doctrine of equivalents is rarely applied, and this court has never affirmed a finding of non-infringement under the reverse doctrine of equivalents. Tate Access Floors, Inc. v. Interface Architectural Res., Inc., 279 F.3d 1357, 1368 (Fed. Cir. 2002).
Apotex asserted that the concentration of O-40 in the formulation is far below the concentration required to form micelles. Instead, NaCl acted to ionically shield KT and BAC, preventing them from interacting. Thus, Apotex asserted, the formulation was stabilized by a completely different ingredient and mechanism, and functions in a “substantially different way” from the formulation claimed in the ’493 patent.

According to the opinion by Circuit Judge Prost,

We agree with the district court that Apotex has failed to set forth a prima facie case of non-infringement under the reverse doctrine of equivalents because it does not properly establish the principle of the ’493 patent. The “principle” or “equitable scope of the claims” of the patented invention is determined in light of the specification, prosecution history, and the prior art. Scripps Clinic, 927 F.2d at 1581. Here, however, Apotex relies exclusively on the declaration of its expert, Dr. Mitra.

As the district court noted, there is no mention of “micelle” in the claims, specification, or prosecution history of the ’493 patent. Further, we previously held that there was no error in the district court’s construction of claim 1 of the ’493 patent to regard “stabilizing amount” not as a claim limitation, but as an intended result, given that the claim expressly sets forth a concentration range for O-40. Syntex II, 407 F.3d at 1378. Thus, there is no support in the claims or specification for micelle formation or for robust stabilization of the formulation by prevention of KT/BAC interactions. The prosecution history is not in evidence in this case and was not relied on by Apotex before the district court in establishing the principle of the invention. Nonetheless, there is no indication that the examiner, in allowing the claims, attributed the unexpected results of O40 to its superiority in forming micelles. The intrinsic evidence is therefore inconsistent with Apotex’s proffered “principle” of the ’493 invention.

. . . For these reasons, we agree with the district court that Apotex did not properly support its alleged “principle” of the patented invention and consequently failed to make out a prima facie case of non-infringement under the reverse doctrine of equivalents. Roche, therefore, was not required to rebut the prima facie case. Accordingly, we find no error by the district court in rejecting Apotex’s defense under the reverse doctrine of equivalents and in granting summary judgment of literal infringement of the claims of the ’493 patent by the ANDA-2 formulation.
The Federal Circuit was also unepersuaded by Apotex's assertion that "given the change in the law of obviousness following the Supreme Court’s opinion in KSR," principles of fairness should prevent application of claim preclusion for a second formulation with merely colorable differences from the first such that the two formulations are “essentially the same.”
. . . In essence, Apotex argues that claim preclusion is not absolute and that this is a case where an exception to the finality rule should apply.

The district court, however, correctly recognized that there is no “change of law”
or fairness exception to prevent application of claim preclusion. Federated Dep’t
Stores, Inc. v. Moitie, 452 U.S. 394, 398 (1981); see also Clifton v. Att’y Gen. of Cal., 997 F.2d 660, 663 (9th Cir. 1993) (“For us to conclude, under the facts of this case, that the district court’s order has become an ‘instrument of wrong’ merely because it rests on a since repudiated rationale would be to nullify the doctrine of res judicata.”); Wilson v. Lynaugh, 878 F.2d 846, 850-51 (5th Cir. 1989); Precision Air Parts, Inc. v. Avco Corp., 2008-1021 13 736 F.2d 1499, 1503 (11th Cir. 1984) (“The general rule . . . throughout the nation, is that changes in the law after a final judgment do not prevent the application of res judicata and collateral estoppel, even though the grounds on which the decision was based are subsequently overruled.”); Hardison v. Alexander, 655 F.2d 1281, 1288-89 (D.C. Cir. 1981). Although there may be a rare exception in cases involving “momentus changes in important, fundamental constitutional rights,” Precision Air Parts, 736 F.2d at 1504, no such right is involved here.
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