Category Archives: Safe Harbor, FDA exemptions (271(e)(1))

DC decision of no infringement by Eagle’s ANDA specification and denial of DJ affirmed

Par Pharmaceutical, Inc. et al. v. Eagle Pharmceuticals, Inc. Docket No. 2021-2342 ( MOORE, PROST, HUGHES August 18, 2022 Brief Summary:   DC finding of no infringement under 271(e)(2) affirmed based on Eagle’s ANDA specification to which Eagle is bound, … Continue reading

Posted in Claim Construction, Generics / ANDA, Infringement, Method claims, Safe Harbor, FDA exemptions (271(e)(1)) | Leave a comment

DC decision of infringement and no Safe Harbor (§ 271(e)(1)) for Hospira’s EPO affirmed

Amgen Inc. et al. v. Hospira, Inc. Docket Nos. 2019-1067, -1102 MOORE, BRYSON, CHEN December 16, 2019 Brief Summary: DC denial of JMOL and new trial after jury findings of infringement, no anticipation and no Safe Harbor for certain batches … Continue reading

Posted in Anticipation (35 USC 102), Claim Construction, Infringement, Safe Harbor, FDA exemptions (271(e)(1)), Uncategorized | Leave a comment