Opinion ID: 4469830
Heading Depth: 2
Heading Rank: 3

Heading: Amneal’s Product

Text: Amgen next challenges the district court’s specific noninfringement finding for both Amneal and Piramal. We consider its arguments for each appellee in turn. Amgen asks us to reverse the district court’s fact findings that Amneal’s ANDA product does not meet the binder limitation. The literal infringement question for the binder limitation is straightforward: does Amneal’s formulation contain “from about 1% to about 5% by weight of at least one binder selected from the group consisting of povidone, hydroxypropyl methylcellulose [“HPMC”], hydroxypropyl 20 AMGEN INC. v. AMNEAL PHARMACEUTICALS LLC cellulose, sodium carboxymethylcellulose, and mixtures thereof”? ’405 patent col. 13 ll. 26–30. Amneal’s ANDA states that its product uses “Opadry” as a binder. Decision, 328 F. Supp. 3d at 383. It was undisputed below that Opadry is a composite product comprised of HPMC, polyethylene glycol (“PEG”) 400, and PEG 8000. J.A. 3770:14–22; 3977:5–3978:13. By containing Opadry, Amneal’s formulation necessarily contains HPMC. HPMC is a binder listed in the binder Markush group of claim 1, so, provided that Amneal’s formulation contains from about 1% to about 5% HPMC, irrespective of whether PEG is present, the formulation literally meets the binder limitation of claim 1. The district court’s analysis was more complex. The district court considered whether Opadry was “literally HPMC.” Decision, 328 F. Supp. 3d. at 383. The court then identified differences between Opadry and HPMC, including that “HPMC is a single molecule, whereas Opadry is a molecular dispersion” of HPMC, PEG 400 and PEG 8000; that HPMC is a powder while the “three ingredients in Opadry make a ‘slurry’”; and that Opadry is “manufactured by a single company, Colorcon, using a proprietary method, whereas HPMC is not.” Id. at 383–84. The court also found that Opadry acts as a wet granulation binder by “spreading and surrounding the drug and excipient particles, forming a granule from the outside, in,” but HPMC, also a wet granulation binder, acts “by sticking different types of particles together, forming a granule from the inside, out.” Id. These factual findings may be sound and perhaps accurately recite the differences between HPMC and HPMC in the presence of PEG. But they are not relevant to the question here—whether Amneal’s formulation contains a listed binder. HPMC is a listed binder, and HPMC is present in Amneal’s formulation. There will of course be differences between HPMC alone as compared to Opadry, which is HPMC combined with PEG. But those differences AMGEN INC. v. AMNEAL PHARMACEUTICALS LLC 21 cannot alter the conclusion that HPMC is present in Amneal’s formulation, even if it was added as a component of another commercially available product. The claim requires only that HPMC be present, not that HPMC’s physical characteristics or function be unaffected by additional ingredients. Because the district court erred in its analysis of the binder in Amneal’s formulation, we vacate its finding that Amneal does not infringe the asserted claims because of the identity of Opadry. On remand, the court should consider whether Amneal’s formulation contains “from about 1% to about 5% by weight” of HPMC, irrespective of the HPMC’s pairing with PEG.