Antrim Pharm. LLC v. Bio-Pharm, Inc.
310 F. Supp. 3d 934
E.D. Ill.2018Background
- Antrim (generic drug sponsor) and Bio-Pharm (contract manufacturer) negotiated under a 2009 Term Sheet envisioning a joint venture; no definitive entity or fully executed definitive agreement was ever completed.
- Parties continued communications (emails and calls) through 2015 about formalizing terms; dispute arose over whether Bio-Pharm would receive an equity interest or instead a profit‑share and reimbursement for manufacturing costs (Antrim says profit‑share; Bio‑Pharm asserts it was promised equity).
- Bio‑Pharm manufactured samples used in Antrim’s ANDA submissions; FDA approved Antrim’s escitalopram ANDA but never approved the ondansetron ANDA.
- After escitalopram approval, Bio‑Pharm withheld shipment of the manufactured escitalopram (conceded); no commercial sales occurred. Bio‑Pharm claims ~$277,000 in manufacturing costs.
- Antrim sued for breach of contract and unjust enrichment; Bio‑Pharm counterclaimed for promissory estoppel and breach of contract. Both parties moved for summary judgment.
Issues
| Issue | Plaintiff's Argument (Antrim) | Defendant's Argument (Bio‑Pharm) | Held |
|---|---|---|---|
| Whether Bio‑Pharm can prevail on its counterclaims (promissory estoppel / breach) | Bio‑Pharm says a contract (or promissory estoppel) entitled it to equity; it seeks recovery of manufacturing costs incurred in reasonable reliance | Antrim says Bio‑Pharm cannot prove damages and caused its own losses by withholding shipment | Court denied Antrim SJ on counterclaims — genuine fact issues exist on formation, repudiation, and damages for manufacturing costs ($277k) |
| Whether Antrim can recover on its breach claim for ondansetron | Antrim claims lost‑profits/damages from Bio‑Pharm’s breach generally include ondansetron | Bio‑Pharm: ANDA for ondansetron was never FDA‑approved, so Antrim could not lawfully market it; no causation of lost profits | Court granted SJ to Bio‑Pharm as to ondansetron breach claim — Antrim cannot show recoverable damages for that product |
| Whether Antrim can recover lost profits on escitalopram (new business rule) | Antrim offers expert lost‑profits model (IMS data) showing recoverable, non‑speculative damages despite being a new business | Bio‑Pharm invokes the new business rule to bar lost profits as speculative | Court denied SJ for Bio‑Pharm — Antrim’s expert evidence meets Milex standard to avoid new business bar |
| Whether Antrim’s unjust enrichment claim succeeds | Antrim contends Bio‑Pharm was unjustly enriched by withholding or selling product through other channels | Bio‑Pharm says no evidence it gained a benefit from withholding; unjust enrichment requires disgorgement of a benefit | Court granted SJ to Bio‑Pharm on unjust enrichment — Antrim failed to show a benefit retained by Bio‑Pharm |
Key Cases Cited
- Omnicare, Inc. v. UnitedHealth Grp., 629 F.3d 697 (7th Cir.) (summary judgment standard and construing inferences for nonmovant)
- TAS Distrib. Co. v. Cummins Engine Co., 491 F.3d 625 (7th Cir.) (causation and certainty required for contract damages)
- In re Marriage of Olsen, 124 Ill.2d 19 (Ill.) (anticipatory repudiation requires clear manifestation of intent not to perform)
- Milex Prods., Inc. v. Alra Labs., Inc., 237 Ill. App. 3d 177 (Ill. App.) (new business rule exception allowed where expert establishes lost profits with reasonable certainty)
- Tri‑G, Inc. v. Burke, Bosselman & Weaver, 222 Ill.2d 218 (Ill.) (new business rule is not inviolate)
- Blythe Holdings, Inc. v. DeAngelis, 750 F.3d 653 (7th Cir.) (unjust enrichment seeks disgorgement of defendant's benefit)
