Roche Palo Alto and Allergan v. Apotex (Fed. Cir. 2008)
Roche’s patent covers drug formulations for treating eye inflammation and covers products sold as ACULAR and ACULAR LS. The two formulations differ in their proportion of various drugs such as an ammonium preservative and a surfactant.
Hoping to sell generic versions, Apotex filed two ANDAs with the FDA – one for each formulation. In response, Roche filed two separate infringement actions against Apotex (the ACULAR and ACULAR LS cases respectively). In 2007 the CAFC put a final nail in the ACULAR case by affirming the district court’s holding that the patent was not invalid and not unenforceable (infringement had already been decided). This appeal involves ACULAR LS.
Reverse Doctrine of Equivalents Remains Dead: In the 1950 Graver Tank opinion, the Supreme Court discussed how the reverse DOE can be used to limit the scope of claim coverage: “where a device is so far changed in principle from a patented article that it performs the same or a similar function in a substantially different way, but nevertheless falls within the literal words of the claim." Although Graver Tank stands as good law, the CAFC has “never affirmed a finding of non-infringement under the reverse doctrine of equivalents.” Here, the CAFC continued to reject the doctrine of reverse equivalents.
Relying on a technical expert, Apotex argued that its formulation – although covered by the literal claims – operated under a different principle (involving the formation of micelles). The CAFC rejected this argument for several reasons: (1) the principle was derived from expert testimony without relying on the prosecution history which was not entered into evidence in the case; (2) the principle was not required in the specification; and (3) there was no evidence that the examiner relied on the principle in allowing the patent to issue.
Claim Preclusion: Apotex hoped to challenge the patent’s validity a second time — this time with the benefit of the new KSR standards for obviousness. The district court, however, refused a second go-round — finding the claims precluded. In the Ninth Circuit, claim preclusion applies to prevent subsequent litigation where “(1) the same parties … 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.” In patent cases, the second suit is considered the “same claim” when the accused products are “essentially the same.” The party asserting claim preclusion has the burden of proving that the accused products are essentially the same.
Essentially the Same: On appeal, the CAFC held that analysis of whether two products are essentially the same (for claim preclusion) should focus on the claims. Here, the court affirmed that both the ACULAR and ACULAR LS formulations are essentially the same “because both formulations are encompassed by the [patent] claims.”
“Though the court recognized that there are differences in the concentrations of the ingredients in the ANDA-1 and ANDA-2 formulations, it also realized that all of the concentrations are well within the ranges claimed in the ’493 patent. The fact that they are stabilized by different mechanisms, even if true, is irrelevant because both formulations are encompassed by the claims of the ’493 patent. Thus, any difference in composition between the two formulations is merely colorable and the two formulations are “essentially the same.”
In addition, the CAFC confirmed that there is no “change of law” exception to claim preclusion — what is done is done. Thus, KSR gives no right to re-open closed claims. (*There are of course some exceptions to this role of no exception.).
- Claim preclusion is also known as res judicata. The CAFC did not need to reach whether issue preclusion should also apply.
- The CAFC’s claim preclusion jurisprudence appears to be developing a pro-patentee bias. Compare this Roche with the Acumed v. Stryker (a patentee does not lose rights by filing suit against only some of an accused infringer’s products).