Par Pharmaceutical, Inc. v. Hospira, Inc.
1:17-cv-00944
D. Del.Jun 4, 2019Background
- Par (Plaintiffs) holds patents covering Adrenalin® epinephrine compositions and alleges Hospira’s ANDA product will infringe before patent expiry.
- Par requested physical samples of Hospira’s ANDA product for infringement testing; initially denied because earlier samples had expired; Magistrate ordered Hospira to produce stability data and testing under patent-claimed conditions.
- After that order, Hospira produced a laboratory/pilot batch for FDA photostability testing; Par learned of this batch during deposition and requested samples.
- Hospira declined to produce pilot batch samples, saying the batch was not representative of the ANDA product and samples were unavailable; Par moved for spoliation sanctions.
- The Magistrate Judge denied sanctions, finding the pilot batch non-representative, no bad faith, and that the ANDA/stability data sufficed to adjudicate infringement.
- The District Court conducted de novo review, agreed with the Magistrate, found no spoliation or prejudice, and denied Par’s sanctions request.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Hospira spoliated evidence by failing to produce pilot-batch samples | Hospira manufactured a pilot batch and failed to produce or disclose samples, warranting sanctions | The pilot batch was created for limited FDA testing, not representative of the ANDA product, and samples were unavailable | No spoliation; sanctions denied |
| Whether the pilot batch was "representative" and therefore relevant | Pilot-batch samples are relevant to ANDA infringement analysis and should be producible | ANDA itself and produced stability data are sufficient; pilot batch differed (R&D vs. GMP) and not representative | Pilot batch deemed non-representative; not required to prove infringement |
| Whether Hospira acted in bad faith to suppress evidence | Par alleges withholding shows intentional suppression and bad faith | Hospira used the batch for FDA-required testing and lacked intent to hide evidence | No evidence of bad faith or egregious conduct found |
| Whether Par was prejudiced and whether lesser sanctions suffice | Par claims prejudice because samples could affect infringement testing | Par’s expert prepared/tested representative samples and ANDA data sufficed; no unfairness shown | No prejudice; lesser or no sanction appropriate |
Key Cases Cited
- Bull v. United Parcel Serv., Inc., 665 F.3d 68 (3d Cir. 2012) (spoliation elements and sanction factors)
- Gomez v. United States, 490 U.S. 858 (1989) (magistrate judges' authority under 28 U.S.C. § 636)
- EEOC v. City of Long Branch, 866 F.3d 93 (3d Cir. 2017) (standards for review of magistrate judge reports and recommendations)
- Haines v. Liggett Group, Inc., 975 F.2d 81 (3d Cir. 1992) (plenary review of magistrate judge legal conclusions)