354 F. Supp. 3d 330
S.D. Ill.2019Background
- Elysium Health sold Basis, a supplement containing NR and PT; CMDX manufactured branded ingredients (NIAGEN®, pTeroPure®) and had previously supplied Elysium but the supply relationship ended in 2016.
- CMDX tested Elysium's reformulated Basis (Aug 2017+) and alleged the product contained chemically different NR/PT and detectable toluene, a potentially harmful solvent.
- CMDX filed a Citizen Petition with the FDA seeking (1) findings that Basis was adulterated because of toluene and as an unnotified new dietary ingredient, and (2) enforcement (including seizure/injunction) against Elysium.
- Elysium sued under the Lanham Act and various state-law theories, alleging the Petition was false/misleading and filed solely to harm Elysium; it invoked ICH standards and CMDX's own COAs to argue CMDX knew Basis was safe.
- CMDX moved to dismiss (later converted in part to a summary judgment motion) arguing its Citizen Petition is protected by the Noerr-Pennington doctrine; Elysium invoked the sham exception.
- The court considered whether the Petition was "objectively baseless" under PRE's two-part sham test and granted CMDX summary judgment, finding the Petition was not objectively baseless because it produced the favorable outcome it sought (Elysium removed toluene).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether CMDX's Citizen Petition is protected by Noerr-Pennington or excluded by the sham exception | Petition was objectively baseless because (a) asserted toluene levels were consistent with ICH standards relied on by Elysium, (b) CMDX's own COAs showed similar toluene levels, and (c) FDA cannot grant requested enforcement relief via a citizen petition | Petition was a genuine attempt to obtain government redress; it reasonably sought determinations about adulteration and NDIN issues and produced a favorable outcome (Elysium removed toluene) | Petition not objectively baseless; Noerr-Pennington immunity applies and sham exception does not bar immunity |
Key Cases Cited
- Eastern R.R. Presidents Conference v. Noerr Motor Freight, 365 U.S. 127 (1961) (Noerr-Pennington doctrine protects petitioning activity)
- United Mine Workers v. Pennington, 381 U.S. 657 (1965) (extension of petitioning immunity to executive/administrative actions)
- Prof'l Real Estate Investors, Inc. v. Columbia Pictures Indus., 508 U.S. 49 (1993) (two-part test for sham: objective baselessness then subjective intent)
- City of Columbia v. Omni Outdoor Advertising, 499 U.S. 365 (1991) (distinguishes improper means from lack of genuine aim to procure favorable government action)
- Cal. Motor Transp. Co. v. Trucking Unlimited, 404 U.S. 508 (1972) (right to petition extends to all government branches)
- Apotex Inc. v. Acorda Therapeutics, Inc., 823 F.3d 51 (2d Cir. 2016) (Noerr-Pennington applies to FDA citizen petitions)