By Donald Zuhn --
Yesterday, the Federal Circuit affirmed the determination by the District Court for the Southern District of New York that Defendants-Appellees Mylan Laboratories, Inc., Mylan Pharmaceuticals, Incorporated, Esteve Quimica, S.A., and Laboratorios Dr. Esteve, S.A. (Mylan) did not infringe U.S. Patent Nos. 4,786,505 and 4,853,230, which relate to oral pharmaceutical preparations for omeprazole. Omeprazole is the active ingredient in Prilosec®, which is marketed by Plaintiffs-Appellants Astrazeneca, AB, Aktiebolaget Hassle, KBI-E, Inc., KBI, Inc., and Astrazeneca LP (Astrazeneca) for the treatment of gastric and duodenal ulcers, and which acts by inhibiting the production of gastric acid.
Astrazeneca developed the omeprazole oral formulation claimed in the '505 and '230 patents in order to overcome formulation problems with omeprazole resulting from the compound's susceptiblity to degradation in acid-reacting and neutral media, and sensitivity to heat, organic solvents, moisture, and light. In particular, the claimed oral formulation includes, inter alia, a core containing omeprazole and an alkaline reacting compound (ARC).
Seeking approval to market a generic version of Astrazeneca's omeprazole formulation, Mylan filed an Abbreviated New Drug Application (ANDA) with the FDA. Mylan's formulation includes an inert sugar/starch core with an active coating of omeprazole, talc, and hydroxypropyl methylcellulose.
In response to Mylan's ANDA filing, Astrazeneca filed suit for infringement of the '505 and '230 patents. Astrazeneca similarly filed infringement suits against a number of other generic drug manufacturers seeking to market generic omeprazole formulations. These suits were consolidated with the action against Mylan in a multi-district litigation, and then tried in two waves.
During a 42-day bench trial, both Astrazeneca and Mylan presented evidence as to whether Mylan's formulation contained an ARC in the active core region, as required by the claims. In particular, Astrazeneca argued that the talc in Mylan’s formulation was alkaline and that the source of this alkalinity was carbonates (i.e., the use of talc introduces carbonates into the active drug layer, and these carbonates are the ARCs required by the claims). Astrazeneca's expert performed tests that indicated that carbonates were present in Mylan’s talc, and that these carbonates were the source of the alkalinity of the talc. Mylan countered with tests that indicated that their talc contained no detectable amount of carbonates. After weighing the competing evidence, the District Court determined that Astrazeneca failed to prove that Mylan's talc contained carbonates, and found for Mylan on the issue of infringement.
On appeal, the Federal Circuit rejected each of Astrazeneca's arguments for reversal. The CAFC first rejected Astrazeneca's argument that the District Court had applied the wrong legal standard (i.e., something higher than a preponderance of the evidence), determining that the District Court "knew, understood, and applied the proper standard of proof." The Federal Circuit next rejected Astrazeneca's argument that it had met its burden of proof since the District Court had "ignored vast amounts of evidence that showed the presence of carbonates in the talc." The CAFC, however, noted that such an argument "amounts to mere disagreement with the court’s factual findings, which cannot serve as a basis for reversing the court." As a result, the Federal Circuit affirmed the District Court's finding of noninfringement.
In re Omeprazole Patent Litigation (Fed. Cir. 2008)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Bryson, and Gajarsa
Opinion by Circuit Judge Lourie
Comments