333 F. Supp. 3d 135
E.D.N.Y.2018Background
- Allergan developed and marketed Restasis (cyclosporine ophthalmic emulsion) under an earlier patent (Ding I) that expired May 17, 2014; Restasis had exclusive market position and high sales.
- Multiple generic manufacturers filed ANDAs seeking approval to market generic Restasis beginning in 2011–2014; plaintiffs allege at least some ANDAs were substantially complete by early 2014.
- Allergan pursued (and initially failed) to obtain narrower "second‑wave" patents covering the Restasis formulation, then obtained six such patents (2014–2016) after submitting a challenged declaration to the USPTO.
- Allergan listed those second‑wave patents in the FDA Orange Book, filed citizen petitions with the FDA opposing in vitro bioequivalence for Restasis generics, and sued ANDA filers, triggering 30‑month statutory stays on FDA approval.
- Allergan later transferred the patents to the Saint Regis Mohawk Tribe and leased them back, invoking tribal sovereign immunity to attempt to block USPTO IPRs; PTAB and Federal Circuit rejected sovereign‑immunity defense.
- Plaintiffs (DPPs and EPPs) allege these coordinated acts were fraudulent/anticompetitive and caused delay in generic entry; Allergan moved to dismiss for failure to plausibly plead causation and argued Noerr‑Pennington immunity for citizen petitions.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Allergan's citizen petitions are protected by Noerr‑Pennington | Petitions were objectively baseless (repetitive, unsupported science) and filed to delay generics; thus sham and unprotected | FDA's responses and partial grants show petitions were not objectively baseless and are protected speech | Court denied Noerr immunity at dismissal stage: factual disputes about baselessness; petitions not shielded as a matter of law |
| Whether Allergan plausibly caused delay in FDA ANDA approvals via petitions and litigation | Aggregate conduct (sham petitions, fraudulent patents, Orange Book listing, sham suits, tribal transfer) foreseeably diverted FDA resources and triggered procedural stays, plausibly causing delay | FDA statutory rule (21 U.S.C. § 355(q)(1)(A)) and fact that FDA never granted tentative approval show petitions/lawsuits did not cause delay | Court held plaintiffs plausibly pleaded but‑for causation and material causation for pleading stage; dismissal denied |
| Whether fraudulent procurement and Orange Book listings deprived petitions/litigation of legitimacy | Schiffman declaration and other misrepresentations procured patents; listing those patents forced Paragraph IV process and potential 30‑month stays | Allergan conceded many factual allegations for motion and argued even so they caused no injury | Court treated fraud/allegations as sufficient at pleading stage to support inference that listing and suits were used to delay generics |
| Whether tribal patent transfer insulated Allergan from IPR and supported delay claim | Transfer to Mohawk Tribe was a rent‑a‑tribe tactic to avoid invalidation and further delay competition | Allergan argued transfer was lawful and could stop proceedings | Court accepts plaintiffs' allegation that transfer was aimed at delay; whether successful is factual and not resolved on motion |
Key Cases Cited
- E. R.R. Presidents Conference v. Noerr Motor Freight, 365 U.S. 127 (sham‑petition doctrine origins)
- United Mine Workers v. Pennington, 381 U.S. 657 (Noerr‑Pennington doctrine application to petitions)
- Prof'l Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49 (two‑prong PRE sham litigation test)
- Allied Tube & Conduit Corp. v. Indian Head, Inc., 486 U.S. 492 (sham exception to Noerr‑Pennington)
- In re Actos End‑Payor Antitrust Litig., 848 F.3d 89 (2d Cir. 2017) (causation standard and presumption discussion in antitrust delays)
- In re Lipitor (Atorvastatin Calcium) Antitrust Litig., 868 F.3d 231 (3d Cir. 2017) (citizen petition merits and sham allegations at dismissal stage)
- In re DDAVP Direct Purchaser Antitrust Litig., 585 F.3d 677 (2d Cir. 2009) (Noerr‑Pennington limits and sham petition fact questions)
- Anderson News, LLC v. American Media, 680 F.3d 162 (2d Cir. 2012) (on drawing inferences at Rule 12(b)(6) stage)
- Tellabs, Inc. v. Makor Issues & Rights, 551 U.S. 308 (pleading and inference standards)
- Ashcroft v. Iqbal, 556 U.S. 662 (pleading plausibility standard)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (antitrust plausibility pleading standard)