809 F.3d 610
Fed. Cir.2015Background
- Momenta owns U.S. Patent No. 7,575,886 (the '886 patent), which claims methods for analyzing enoxaparin samples (quality-control testing) to ensure batch composition meets USP/FDA criteria.
- Momenta sued Teva and Amphastar (generic enoxaparin manufacturers) for infringement: Teva imports finished product manufactured and tested abroad; Amphastar manufactures and tests in the U.S.
- The district court granted summary judgment for both defendants: Teva was found protected by the § 271(e)(1) safe harbor and not liable under § 271(g); Amphastar was found not to infringe under § 271(g) and its testing was held within § 271(e)(1).
- On appeal this court affirmed that the accused products are not “made by” Momenta’s patented process for purposes of 35 U.S.C. § 271(g), and thus affirmed summary judgment for Teva on that ground.
- The court vacated the district court’s grant for Amphastar to the extent it rested on § 271(e)(1) protection for Amphastar’s routine, post-approval commercial quality-control testing, and remanded for further proceedings.
- The court held that routine, repeated batch release QC testing is not "reasonably related" to development/submission of information under § 271(e)(1), distinguishing pre-approval or non-routine submissions.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether accused enoxaparin products are “made by” Momenta’s patented process under 35 U.S.C. § 271(g) | Momenta: "made by" includes testing/quality-control steps used as an intermediary in manufacture; testing selects batches that are then further processed | Teva/Amphastar: Patented method only analyzes already-made substance and does not itself create or transform the product | Held: "Made by" means manufacture/creation; QC testing that only generates information (does not create/transform product) is not a § 271(g) making step — defendants’ products are not "made by" the patented process; Teva affirmed |
| Whether Amphastar’s in‑U.S. routine, post‑approval QC testing is immunized by § 271(e)(1) safe harbor | Momenta: post‑approval manufacturing testing is commercial and not reasonably related to regulatory submissions | Amphastar: safe harbor covers uses reasonably related to development/submission to FDA even if part of commercial production | Held: Routine, repetitive batch release testing is not "reasonably related" to development/submission; § 271(e)(1) does not shield Amphastar for those commercial QC uses; summary judgment vacated in part and remanded |
| Whether the panel must follow the preliminary‑injunction stage ruling in Momenta I (law of the case) that Amphastar’s testing was protected | Momenta: earlier preliminary determination was tentative and not binding on the merits | Amphastar: Momenta I already decided Amphastar’s testing falls within § 271(e)(1) and law of the case applies | Held: Preliminary injunction findings are not binding at trial; law of the case does not bar reconsideration; court revisited and reached a different conclusion on routine post‑approval testing |
| Whether Momenta should have been allowed to amend infringement contentions in district court | Momenta: sought to add accused procedures and evidence | Amphastar: amendments were untimely and futile | Held: District court denied leave partly based on its (now partly vacated) § 271(e)(1) rationale; because § 271(e)(1) ruling was vacated-in-part, district court may reconsider amendment denial on remand |
Key Cases Cited
- Bilski v. Kappos, 561 U.S. 593 (statutory words are to be read with their ordinary meaning)
- Bayer AG v. Housey Pharm., Inc., 340 F.3d 1367 (Fed. Cir.) (patented research/screening processes not "used in the actual synthesis"; product not "made by" such processes)
- Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (safe harbor § 271(e)(1) broadly construed to permit pre‑approval experimentation reasonably related to FDA submissions)
- Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (safe harbor covers activities necessary to obtain regulatory approval for medical devices)
- Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir.) (§ 271(e)(1) tied to expediting regulatory approval; routine post‑approval reporting may fall outside exemption)
- Bio‑Tech. Gen. Corp. v. Genentech, Inc., 80 F.3d 1553 (Fed. Cir.) (intermediate steps that are integral to overall process can make a product "made by" a patented process)