Par Pharmaceutical, Inc. v. Hospira, Inc.
1:17-cv-00944
D. Del.Jun 4, 2019Background
- Par Pharmaceuticals owns U.S. Patents 9,119,876 and 9,295,657 covering its Adrenalin® (epinephrine) product; Hospira filed an ANDA seeking to market a generic prior to patent expiry.
- Disputed claim terms are three generic-designation degradants in the patents: “Impurity A,” “Impurity B,” and “Unknown C.” Parties agreed these terms have no plain and ordinary meaning.
- Magistrate Judge issued a Report & Recommendation (R&R) construing those terms by reference to the patent specification and extrinsic evidence, adopting constructions proposed by Par.
- Hospira objected, arguing the constructions improperly import specification limitations into the claims and that the claims are indefinite; Hospira did not propose alternative constructions, only indefiniteness.
- District Court reviewed de novo, agreed with Magistrate that the specification supplies an objective standard (chemical structures and chromatographic data) sufficient to inform a person of ordinary skill, and overruled Hospira’s objections.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether "Impurity A," "Impurity B," and "Unknown C" are definite and can be construed | Par: Specification (chemical structures, chromatographic data) gives objective meaning; constructions proposed by Par are appropriate | Hospira: Terms are indefinite; constructions improperly import specification limitations into claims | Held: Terms are definite; adopt Magistrate's constructions based on specification and POSITA understanding |
| Whether using the specification to construe these terms improperly imports limitations | Par: Court may rely on specification to inform how a POSITA would understand terms without limiting claims to a single embodiment | Hospira: Reliance on specification here crosses line into importing limitations | Held: Court: use of specification to identify objective standard is proper and does not impermissibly limit claims |
| Whether Magistrate's R&R should be modified under standard of review | Par: Magistrate correctly applied law and evidence; R&R should be adopted | Hospira: Objected to R&R; sought reversal on legal grounds | Held: District Court conducted de novo review and adopted R&R in full; Hospira's objections overruled |
| Whether expert testimony and specification support claim construction | Par: Expert and specification teach a POSITA the meaning of the impurity terms | Hospira: Evidence insufficient to cure indefiniteness | Held: Court found expert testimony and specification sufficient to provide an objective standard |
Key Cases Cited
- Gomez v. United States, 490 U.S. 858 (1989) (distinguishes magistrate judge authority for nondispositive vs. dispositive matters)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claim construction: specification may inform meaning but does not automatically limit claims to embodiments)
- EEOC v. City of Long Branch, 866 F.3d 93 (3d Cir. 2017) (procedures for magistrate judge reports and objections)
- Haines v. Liggett Group, Inc., 975 F.2d 81 (3d Cir. 1992) (review of magistrate judge legal conclusions is plenary)