Amphastar Pharmaceuticals Inc. v. Momenta Pharmaceuticals, Inc.
850 F.3d 52
1st Cir.2017Background
- Amphastar and Sandoz competed in the U.S. generic enoxaparin market; Momenta was Sandoz's contract lab and co-developer with a pending patent ('886).
- The United States Pharmacopeial Convention (USP) set an official test method (Method <207>) for enoxaparin; USP members must disclose IP conflicts.
- Momenta (through employee/inventor Shriver) and Sandoz participated in USP proceedings but did not disclose Momenta's pending patent application that later issued as the '886 patent.
- USP adopted Method 207; FDA required generic manufacturers to use it. Sandoz later sued Amphastar for infringement after Amphastar received FDA approval, obtaining a TRO and preliminary injunction that blocked sales for ~3 months.
- Amphastar sued under the Sherman Act seeking damages for lost profits during the injunction period, alleging defendants intentionally concealed the pending patent before the USP to secure adoption of Method 207.
- The district court dismissed under Noerr-Pennington immunity; the First Circuit reversed, holding the district court erred to the extent it applied Noerr without addressing the misrepresentation exception and other defenses.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does Noerr-Pennington bar Amphastar's antitrust claims based on conduct before the USP and subsequent patent litigation? | No — defendants' deception of the USP stripped any immunity; patent suit does not retroactively immunize prior misconduct. | Yes — petitioning the courts/administrative process (and alleged FDA adoption) is immune activity under Noerr-Pennington. | Noerr immunity does not automatically bar the claim; the misrepresentation exception applies and dismissal on Noerr was erroneous. |
| Do intentional misrepresentations to a private SSO (USP) fall within Noerr's protection? | Misrepresentation to an SSO defeats immunity; Allied Tube does not protect deceit. | Implied: petitioning-related activities are protected; immunity should apply. | Petitioning a private SSO generally does not get Noerr protection, and intentional misrepresentations can defeat immunity; Amphastar’s allegations suffice at pleading stage. |
| Can damages flowing from subsequent patent litigation (TRO/injunction) be recovered when earlier misconduct before the SSO caused the litigation? | Yes — litigation does not retroactively immunize antecedent anticompetitive conduct; the antitrust violation need only be a material cause of injury. | Litigation immunity should preclude damages tied to the judicial relief. | The fact that defendants brought litigation does not necessarily defeat an antitrust claim based on prior deception of an SSO; Noerr does not automatically shield such damages. |
| Choice of law: Should the Federal Circuit's law govern questions about stripping immunity for conduct related to patents? | First Circuit should apply its precedent because the conduct here was before a private SSO, not patent prosecution within Federal Circuit jurisdiction. | Defendants urged application of Federal Circuit law (Nobelpharma). | The First Circuit applied its own law; Nobelpharma was inapposite because the dispute concerned an SSO, not patent prosecution within the Federal Circuit’s exclusive jurisdiction. |
Key Cases Cited
- E. R.R. Presidents Conference v. Noerr Motor Freight, 365 U.S. 127 (establishes Noerr-Pennington immunity for petitioning government)
- United Mine Workers v. Pennington, 381 U.S. 657 (collective petitioning to influence government not per se antitrust violation)
- Cal. Motor Transp. Co. v. Trucking Unlimited, 404 U.S. 508 (Noerr extends to administrative agencies but misrepresentations may defeat immunity)
- Allied Tube & Conduit Corp. v. Indian Head, 486 U.S. 492 (private standard-setting organizations generally not covered by Noerr immunity)
- Walker Process Equip., Inc. v. Food Mach. & Chem. Corp., 382 U.S. 172 (fraudulent procurement of a patent can give rise to antitrust liability despite patent litigation)
- United States v. Singer Mfg. Co., 374 U.S. 174 (litigation cannot retroactively immunize prior anticompetitive conduct)
- Broadcom Corp. v. Qualcomm Inc., 501 F.3d 297 (intentional deception of standard-setting bodies can support antitrust claims)
- Premier Elec. Constr. Co. v. Nat'l Elec. Contractors Ass'n, 814 F.2d 358 (distinguishes immunized litigation from antecedent conduct that causes antitrust injury)