Opinion ID: 4469830
Heading Depth: 2
Heading Rank: 5

Heading: Zydus’s Product

Text: In its cross-appeal, Zydus asks us to reverse the district court’s finding that Zydus’s product infringes the ’405 patent. At issue here is the starch in Zydus’s formulation. As the district court noted, Zydus’s ANDA states that the pregelatinized starch in Zydus’s formulation functions as a diluent. But starch is listed in the diluent Markush group of claim 1, so, if the starch in Zydus’s formulation truly functions as a diluent, Zydus infringes claim 1. Before the district court, Amgen argued that pregelatinized starch in Zydus’s formulation functions as a diluent, but Zydus argued that the starch functions as a binder. To support its position, Zydus adopted the testimony of Dr. Davies, Amgen’s expert, that Amgen had proffered for its argument about Piramal’s formulation. Dr. Davies opined that pregelatinized starch’s native starch fraction functions as a diluent but that its cold water soluble fraction functions as a binder. The district court did not find Dr. Davies’s testimony credible for several reasons. For example, the court first found that Dr. Davies’s opinion was inconsistent between defendants. For Aurobindo 3 and Piramal, Dr. Davies provided his fractions opinion regarding the function of pregelatinized starch, but for Zydus, Dr. Davies simply accepted Zydus’s identification in its ANDA that pregelatinized starch functions as a diluent. At trial, Dr. Davies modified his opinion and testified that he was also applying his 3 Amgen also accused Aurobindo Pharma Ltd. and Aurobindo Pharma USA, Inc. (collectively, “Aurobindo”) of infringing the ’405 patent, and Amgen’s claims against Aurobindo were tried alongside its claims against Amneal, Piramal, and Zydus but are not at issue in this appeal. 26 AMGEN INC. v. AMNEAL PHARMACEUTICALS LLC fractions opinion to Zydus. As a result, Dr. Davies testified that Zydus’s product, which already uses 4.98% of hydroxypropyl cellulose as a binder, also includes 3.97% of pregelatinized starch as a binder. Dr. Davies thus opined that Zydus’s formulation contains 8.95% by weight of binder, which exceeds the “about 5%” binder limitation in claim 1. When this opinion was challenged, Dr. Davies provided a third opinion that was inconsistent with the court’s claim construction. The district court also discounted Dr. Davies’s testimony because, while he consistently asserted that the function of pregelatinized starch was context-specific and could vary based on the amount of pregelatinized starch, other excipients present, and the manufacturing process, he did not provide testimony applying those contextual factors to each ANDA product. The court contrasted Dr. Davies’s testimony with that of Aurobindo’s expert, Dr. Fassihi, and Amneal’s expert, Dr. McConville, who did provide such analysis. Because the district court ultimately did not credit Dr. Davies’s fraction opinion concerning pregelatinized starch, it rejected Zydus’s noninfringement argument. The court thus found that Zydus’s ANDA product infringed claim 1. Zydus now argues on appeal that Amgen failed to prove that pregelatinized starch is a listed binder in Zydus’s product. Zydus again cites Dr. Davies’s fraction opinion and testimony that pregelatinized starch functions as a second binder in Zydus’s product. According to Zydus, the district court required Zydus to disprove infringement, contrary to this court’s precedent. Zydus further contends that the court’s consideration of testimony from other defendants’ experts in evaluating Zydus’s products was improper because it amounts to comparing the accused products to one another. Zydus Br. 42. Amgen responds that it met its burden to show in- fringement. According to Amgen, it presented the district AMGEN INC. v. AMNEAL PHARMACEUTICALS LLC 27 court with Zydus’s ANDA, which explicitly discloses that Zydus’s product uses pregelatinized starch as a diluent. Amgen points further to Dr. Davies’s testimony that the starch in Zydus’s product functions as a diluent. Amgen suggests that the court was free to credit some aspects of Dr. Davies’s testimony and reject others, which it chose to do here. We agree with Amgen that the district court did not clearly err in finding that the pregelatinized starch in Zydus’s product functions as a diluent. Zydus thus is an infringer. Dr. Davies undoubtedly provided a wide range of opinions regarding the starch in Zydus’s product. But the district court repeatedly identified problems in Dr. Davies’s “fractions opinion,” but not in his opinion that the pregelatinized starch in Zydus’s product functions only as a diluent. And the court was not required to reject all of Dr. Davies’s testimony once finding any individual part of it incorrect. See Bluebonnet Sav. Bank, F.S.B. v. United States, 466 F.3d 1349, 1359 (Fed. Cir. 2006) (quoting White Mountain Apache Tribe of Arizona v. United States, 11 Cl. Ct. 614, 663 (1987)). Thus, the court was permitted to rely on Dr. Davies’s initial opinion that the pregelatinized starch in Zydus’s product functions as a diluent. See J.A. 3433:23–3434:5. And, expert testimony aside, the court was certainly permitted to credit the statements in Zydus’s own ANDA that the starch in its product functions as a diluent. Zydus’s argument that the district court incorrectly compared the accused products is unfounded. In evaluating whether Dr. Davies’s testimony was credible, the court was entitled to consider the record, including testimony from other experts regarding the multifunctional nature of excipients, before reaching its conclusion. At no point, however, did the court compare Aurobindo’s or Piramal’s products to Zydus’s in its analysis. 28 AMGEN INC. v. AMNEAL PHARMACEUTICALS LLC