Opinion ID: 1035421
Heading Depth: 3
Heading Rank: 2

Heading: “Approximately 6:2:5:1”

Text: Appellants argue that the district court erred in its analysis of “approximately 6:2:5:1.” They contend that the 6:2:5:1 ratio captures relative proportions of the four amino acids in copolymer-1 to one another. Appellants argue that the court “eviscerated” these relationships by analyzing “approximately 6:2:5:1” in terms of an aggregate amount of percent variation in the amino acid content. Mylan Br. 30. Appellants urge that examples of copolymer-1 in the references cited in the specification define the scope of “approximately 6:2:5:1,” and argue that these examples allow for at most 16% variation of any particular amino acid from the “ideal” 6:2:5:1 ratio. Appellants point out that their products contain the four amino acids in the ratios 4.6: 1.6: 3.7: 1.0 (Mylan TEVA PHARMACEUTICALS USA v. SANDOZ INC. 17 product) and 4.6: 1.5: 3.7: 1.0 (Sandoz product). They argue that the accused products do not literally infringe the asserted claims because, for example, the ratio of lysine to tyrosine, 3.7: 1, deviates by more than 16% from the “ideal” ratio of 5:1. Appellants further contend that the district court erred in its finding of infringement under the doctrine of equivalents because its analysis vitiated the “6:2:5:1” requirement. Teva counters that the district court rightly decided, based on the intrinsic record and expert testimony, that “approximately 6:2:5:1” covers compositions that differ from the “ideal” percentages by an aggregate of at most 12%. Teva argues that Appellants improperly seek to limit the scope of the claims to prior art examples of copolymer-1. It also contends that Appellants fail to adequately explain why the district court’s analysis should have focused on the relative ratios of the four amino acids to one another rather than their proportions relative to the whole. Teva further contends that Appellants perform a “mathematical sleight of hand” by normalizing the ratio relative to tyrosine, the least abundant amino acid in copolymer-1. Teva Br. 32. Teva points out that, while the 6:2:5:1 ratio sets the scale at 14 (= 6 + 2 + 5 +1), Appellant Mylan’s expression of the ratio in its product bases the scale on the incommensurate value of 10.9 (= 4.6 +1.5 + 3.7 + 1.0). 3 Teva argues that, in order to properly compare the Mylan accused product to the claims, the correct way to express the accused amino acid ratio is 6.0: 2.0: 4.7: 1.3 (i.e., a total of 14) or to perform the comparison in terms of percentages. Teva contends that either of these approaches demonstrates that the accused products meet the “copolymer-1” limitation as construed by the district 3 These arguments apply equally to Sandoz’s ac- cused product. 18 TEVA PHARMACEUTICALS USA v. SANDOZ INC. court. Teva further argues that, when rounding error is taken into account, it becomes clear that the accused products contain the four amino acids in the 6:2:5:1 ratio. Finally, it contends that the district court correctly determined that Appellants infringe under the doctrine of equivalents because the differences between the claims and the accused products are insubstantial. We agree with Teva that the district court did not clearly err in concluding that the accused products literally infringe the asserted claims. We see no basis for overturning the district court’s finding that the 6:2:5:1 ratio must be converted to percentages to ensure a comparison on the same scale with the amino acid percentages in the accused products. That comparison reveals that, in the aggregate, the four percentages in Mylan’s product (42.7%, 14.4%, 33.6%, and 9.2%) differ from the “ideal” percentages (42.9%, 14.3%, 35.7%, and 7.1%) by only 4.5%. 4 Furthermore, no single amino acid differs from its corresponding “ideal” percentage by more than about 2%. Id. at 338. The district court did not clearly err in determining that these small differences from the “ideal” percentages mean that the accused products literally infringe. The court’s conclusion is supported by its findings regarding prior art examples of copolymer-1. See id. at 339–40. These examples show that, even when one of the amino acids (lysine) differs from its “ideal” percentage by more than 5%, the material is still considered “copolymer-1.” Id. (discussing “Batch 2”); J.A. 49042. The district court’s conclusion is reinforced by the undisputed testimony of Teva’s expert, Dr. George Gokel, that the amino acid content in copolymer-1 is uncertain due to experimental 4 In Sandoz’s product, the corresponding percentages are 43.6%, 14.7%, 33.4%, 8.3%, amounting to an aggregate difference of 4.5% from the “ideal” percentages. TEVA PHARMACEUTICALS USA v. SANDOZ INC. 19 variations and measurement errors. Id. at 339; J.A. 19825–28. We need not decide whether a material that differs by 12% from the 6:2:5:1 ratio (expressed in percentages) infringes the asserted claims because the Mylan and Sandoz accused products deviate from the ratio by less than 5%. We see no clear error in the district court’s determination that these products, which differ from the “ideal” percentages by less than 5% in the aggregate, meet the “approximately 6:2:5:1” limitation. Given this conclusion, we do not need to reach the parties’ arguments regarding infringement under the doctrine of equivalents. 3. Prosecution Disclaimer The district court also rejected Appellants’ argument that Teva disclaimed copolymer-1 compositions having Mw greater than 10 kDa during prosecution. Markman Order, 810 F. Supp. 2d at 596–98. Appellants challenge this conclusion on appeal. They contend that their proposed products have Mw less than 10 kDa and thus do not infringe. During prosecution of several of the asserted patents, Teva overcame rejections based on the Teitelbaum patent by arguing that, in contrast to Teitelbaum’s copolymer-1 with a “minimum molecular weight of 10 kilodaltons,” the pending claims cover “copolymer-1 having a molecular weight of about 5 to 9 kilodaltons.” E.g., J.A. 34747. Teitelbaum does not explain whether its references to “molecular weight” mean Mp or Mw, but cites an article that describes the measurement process in more detail. Teitelbaum, col. 4 ll. 31–32 (citing J.A. 49043). Appellants argue that Teva’s statements constitute a disclaimer of copolymer-1 compositions with Mw greater than 10 kDa. They contend that the article cited in Teitelbaum describes a technique that can measure only Mw. Appellants argue that an ordinary artisan would thus understand the prosecution history statements to 20 TEVA PHARMACEUTICALS USA v. SANDOZ INC. refer to Mw and to surrender coverage of any copolymer-1 with Mw greater than 10 kDa. We agree with Teva that its prosecution history statements do not constitute a clear and unmistakable disclaimer. The phrase “molecular weight of 10 kilodaltons” does not expressly refer to any specific molecular weight measurement—indeed, Group I claims are indefinite due in part to the ambiguity in the meaning of “molecular weight.” The connection between this statement and the article cited in Teitelbaum is too attenuated to limit the scope of the claims to copolymer-1 with Mw less than 10 kDa. Moreover, the technique discussed in that article can yield Mw or a different type of molecular weight measure, which fails to resolve the ambiguity.