Apotex’s Generic Eye Formulation Infringes Roche’s Patent, Federal Circuit Rules

Holding:

The U.S. Court of Appeals for the Federal Circuit affirmed a district court’s ruling that Apotex’s generic version of the anti-inflammatory eye formulation called Acular LS infringed a patent held by Roche Palo Alto LLC and licensed to Allergan LLC. Specifically, the Federal Circuit agreed with the district court that Apotex failed to set forth a prima facie case of non-infringement under the reverse doctrine of equivalents because it did not properly establish the principle of the patent at issue. The principle or equitable scope of the claims of the patented invention is supposed to be determined in light of the specification, prosecution history, and the prior art. Here, however, Apotex relied exclusively on the declaration of its expert, and such reliance was insufficient to support its argument of non-infringement. Likewise, the Federal Circuit found that the district court did not err in holding that Apotex’s validity challenges to the patent were barred by claim preclusion. In particular, the district court correctly determined that Apotex’s prior generic formulation that was previously found to be infringing and its present formulation were essentially the same because both formulations were encompassed by the patent claims. On the basis of the foregoing, the Federal Circuit affirmed the district court’s grant of Roche’s motion for summary judgment that the Apotex’s generic formulation literally infringed the claims of Roche’s patent and that Apotex’s invalidity and unenforceability challenges to the patent were barred by claim preclusion.

Detailed Summary:

This is a patent infringement case under the Hatch-Waxman Act. Defendant-appellant Apotex, Inc. and Apotex Corp. (collectively “Apotex”) appealed the grant of summary judgment by the United States District Court for the Northern District of California that the patent held by plaintiff-appellee Roche Palo Alto LLC and Allergan, Inc. (collectively “Roche”) is valid and infringed by the formulation covered by Apotex’s abbreviated new drug application (“ANDA”). Opinion, p. 1, citing Roche Palo Alto, LLC v. Apotex, Inc., 526 F. Supp. 2d 985 (N.D. Cal. 2007).

Roche is the owner of U.S. Patent No. 5,110,493 (“the ’493 patent”), which is directed to a drug formulation for treatment of eye inflammation, such as that caused by glaucoma, conjunctivitis, eye surgery, or eye injury.  Id., p. 2, citing ’493 patent, col. 1, ll. 14-28.

Over the years, Apotex filed two different ANDAs on two different generic drug formulations, each containing a paragraph IV certification that the ’493 patent is invalid, unenforceable, or will not be infringed by the generic version of the drug. In 2001, Apotex filed its first ANDA (“ANDA-1”), directed to a generic version of Roche’s ACULAR. Subsequently, in 2005, Apotex filed its second ANDA (“ANDA-2”), directed to a generic version of Roche’s ACULAR LS.

On June 6, 2001, Roche’s predecessor, Syntex (U.S.A.) LLC (“Syntex”) sued Apotex for infringement of the ’493 patent based on the ANDA-1 formulation. The district court issued a claim construction order. Id., p.3, citing Syntex (U.S.A.) LLC v. Apotex, Inc., No. 01-2214 (N.D. Cal. Nov. 19, 2002). On May 18, 2005, the Federal Circuit affirmed the district court’s claim construction and holding of no inequitable conduct, but reversed its holding of validity based on non-obviousness. Id., p. 4, citing Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371 (Fed. Cir. 2005) (“Syntex II”). On remand, the district court again held that the ’493 patent was not invalid for obviousness, Id., citing Syntex (U.S.A.) LLC v. Apotex, Inc., No. 01-2214, 2006 WL 1530101 (N.D. Cal. June 2, 2006) (“Syntex III”), and the Federal Circuit affirmed without opinion. Id., citing 221 Fed. Appx. 1002 (Fed. Cir. Apr. 9, 2007).

On May 24, 2005, Roche sued Apotex for infringement of the ’493 patent based on the ANDA-2 formulation. Apotex asserted the defenses of non-infringement; invalidity under 35 U.S.C. §§ 101, 103, and 112; and unenforceability due to inequitable conduct. Thereafter, Roche filed a motion for summary judgment that the ANDA-2 formulation infringed the ’493 patent and that the validity and unenforceability defenses should be barred based on the earlier Syntex litigation (Syntex I, Syntex II, and Syntex III) under the doctrines of issue preclusion and claim preclusion.  On September 11, 2007, the district court granted Roche’s motion for summary judgment. Id., p. 5, citing 526 F. Supp. 2d 985 (N.D. Cal. 2007).

In this appeal, Apotex argued that the district court erred in failing to find non-infringement by the ANDA-2 formulation under the reverse doctrine of equivalents. The Federal Circuit however rejected this argument. Specifically, it agreed with the district court that Apotex failed to set forth a prima facie case of non-infringement under the reverse doctrine of equivalents because it did 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. Id., p. 9, citing Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565, 1581 (Fed. Cir. 1991). Here, however, Apotex relied exclusively on the declaration of its expert.

Said the Federal Circuit: “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 O40. 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.” Id., p.10.

In this regard, the Federal Circuit found no error in the district court’s rejection of Apotex’s defense under the reverse doctrine of equivalents, and grant of summary judgment of literal infringement of the claims of the ’493 patent by the ANDA-2 formulation.

Apotex further argued that the district court erred in holding that its validity challenges to the ’493 patent were barred by claim preclusion.  Again, the Federal Circuit rejected this argument. The district court correctly determined that the ANDA-1 formulation and the ANDA-2 formulation were “essentially the same” because any differences between them are unrelated to the claims of 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.”

The district court likewise correctly recognized that there was no “change of law” or fairness exception to prevent application of claim preclusion. Id., p. 14, citing Federated Dep’t Stores, Inc. v. Moitie, 452 U.S. 394, 398 (1981).  Accordingly, it did not err in rejecting Apotex’s argument that claim preclusion is not absolute and that this is a case where an exception to the finality rule should apply. Although there may be a rare exception in cases involving “momentus changes in important, fundamental constitutional rights,” Id., p. 14, citing Precision Air Parts, Inc. v. Avco Corp., 736 F.2d 1499, 1504 (11th Cir. 1984), no such right is involved here.  Accordingly, the district court did not err in concluding that Apotex’s validity challenges to the ’493 patent were barred by the doctrine of claim preclusion.

On the basis of the foregoing, the Federal Circuit affirmed the district court’s grant of Roche’s motion for summary judgment that the ANDA-2 formulation literally infringed the claims of the ’493 patent and that Apotex’s invalidity and unenforceability challenges to the ’493 patent were barred by claim preclusion.

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