Federal Circuit Again Refuses Reverse Doctrine of Equivalents Defense To Infringement Claim

In Roche Palo Alto LLC v. Apotex, Inc. ( No. 2008-1021; July 9, 2008), a Federal Circuit panel affirms a district court's grant of summary judgment that the patent for treatment of eye inflammation (the "'493 patent") held by the patentee is valid and infringed by the formulation covered by Apotex's abbreviated new drug application ("ANDA"). The Federal Circuit finds no error in the district court's holding that the reverse doctrine of equivalents is inapplicable and that claim preclusion prohibits Apotex from raising other validity challenges. The claim preclusion defense to invalidity in this case is based on an earlier litigation brought by Roche's predecessor, Syntex (U.S.A.) LLC against Apotex for infringement of the '493 patent based on an earlier ANDA formulation ("ANDA-1"). In the ANDA-1 challenge, the district court held that the '493 patent was both valid and enforceable and the Federal Circuit affirmed the district court's claim construction and a finding of validity based on non-obviousness.

In the case currently on appeal, Apotex argues that the doctrines of issue preclusion and claim preclusion are inapplicable because the new ANDA ("ANDA-2") and ANDA-1 are distinct, and that, in view of the new KSR standards for obviousness, a change in law exception prevents the application of the preclusion doctrines. The Federal Circuit, however, confirms that there is no "change in law" exception to claim preclusion (in any circuit) and finds that in the Ninth Circuit, claim preclusion applies where "(1) the same parties, or their privies, were involved in the prior litigation, (2) the prior litigation involved the same claim or cause of action as the later suit, and (3) the prior litigation was terminated by a final judgment on the merits." The Federal Circuit applies its own precedent to the issue of whether the two claims for infringement of ANDA-1 and ANDA-2 constitute the "same claim." In patent cases, the second suit is the "same claim" when the accused products are "essentially the same," or the "differences between them are merely colorable." Here, the Federal Circuit affirms that ANDA-1 and ANDA-2 are essentially the same because "any differences between them are unrelated to the claims of the '493 patent."

Apotex also argues the reverse doctrine of equivalents, but the Federal Circuit, after acknowledging that it has "never affirmed a finding of non-infringement" under the doctrine, finds that Apotex has failed to set forth a prima facie case of non-infringement under this doctrine. Apotex argues that its ANDA-2 operates under a different principle (or equitable scope) than the patented invention, but relies solely on expert testimony to establish the principle of the patent instead of relying on the specification, prosecution, and the prior art, as required.