Apotex Inc. v. Acorda Therapeutics, Inc.
2016 U.S. App. LEXIS 8915
2d Cir.2016Background
- Zanaflex (tizanidine) originally marketed as tablets; FDA later approved capsule form showing different pharmacokinetics: capsules taken with food have ~20% lower Cmax vs. tablets with food, and absorption is delayed.
- Elan/Acorda marketed both forms; Apotex sold a generic tablet and later filed an ANDA seeking approval for generic capsules.
- Acorda filed a citizen petition challenging Apotex’s ANDA; FDA denied Acorda’s petition and approved Apotex’s ANDA on the same day.
- Apotex sued under Section 2 of the Sherman Act (sham citizen petition that unlawfully delayed competition) and under the Lanham Act (false advertising by Acorda claiming capsules reduce somnolence/reduce Cmax).
- District court dismissed the Sherman Act claim (timing alone insufficient) and granted summary judgment for Acorda on Lanham claims except one challenged graph; that remaining claim failed for lack of evidence that the misrepresentation was material to purchasing decisions.
- Second Circuit affirmed: FDA guidance and statutory changes weaken an inference that contemporaneous denial/approval equals a sham petition; most challenged statements matched FDA-approved labeling and the lone literally false graphic lacked proof of materiality.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether filing a citizen petition that is denied the same day an ANDA is approved can state a Section 2 sham claim | The simultaneity supports an inference the petition was an objectively baseless, anticompetitive sham that delayed competition | FDA guidance and statutory changes make contemporaneous resolution appropriate; timing alone does not show objective baselessness or anticompetitive delay | Denied: timing alone insufficient; Apotex failed to plead objective baselessness or other facts showing sham petition |
| Whether district court abused discretion by denying leave to amend antitrust claim | Apotex sought to add FDA report showing petition abuses; amendment would cure pleading | Acorda argued report was available earlier and amendment delayed; judicial economy justified denial | Denied: no abuse of discretion—amendment untimely and unlikely to change outcome |
| Whether Acorda’s oral sales statements (capsules reduce Cmax/somnolence; dosing flexibility) were literally false or misleading under Lanham Act | Statements equated reduced Cmax with reduced somnolence and claimed dosing flexibility; thus false/misleading | Statements about Cmax and somnolence were consistent with FDA labeling; no evidence sales reps claimed tests proved somnolence reduction | Denied liability: statements largely consistent with FDA label; no test-proven superiority shown and no evidence of literal falsity or consumer confusion |
| Whether promotional materials (gatefold brochure/Figure 1 with superimposed text) were literally false and material | Superimposed text ("30% INCREASE for tablets; 20% DECREASE for capsules") on a mean concentration/time graph falsely represents Cmax and implies reduced somnolence; brochure imagery misleads | Most brochure content mirrored FDA label; only the labeled Figure 1 could be literally false but plaintiff must also show materiality (likely to influence purchases) | Brochure claims: most not literally false; Figure 1 with superimposed Cmax text could be literally false, but Apotex failed to show materiality—summary judgment for Acorda affirmed |
Key Cases Cited
- In re DDAVP Direct Purchaser Antitrust Litig., 585 F.3d 677 (2d Cir.) (sham citizen petition can support antitrust claim where petition was objectively baseless and caused delay)
- Prof'l Real Estate Inv'rs, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49 (U.S.) (two-part test for sham litigation: objective baselessness and subjective intent to interfere)
- Time Warner Cable, Inc. v. DIRECTV, Inc., 497 F.3d 144 (2d Cir.) (literal falsity presumes deception; evaluate advertisement message in full context)
- Castrol, Inc. v. Quaker State Corp., 977 F.2d 57 (2d Cir.) (test-proven-superiority doctrine: ads implying tests show superiority require proof that tests actually establish the claim)
- Nat'l Basketball Ass'n v. Motorola, Inc., 105 F.3d 841 (2d Cir.) (materiality defined as likely to influence purchasing decisions for Lanham Act claims)