In Re Wellbutrin XL Antitrust Litigation Indirect Purchaser Class
868 F.3d 132
3rd Cir.2017Background
- Wellbutrin XL (GSK) prompted ANDA paragraph IV filings by Anchen, Abrika, Impax, and Watson seeking generic entry; Biovail (patentee) sued those generics and filed an FDA Citizen Petition; GSK was Biovail’s licensee and participated variably in the disputes.
- Biovail and GSK sued or supported suits against the ANDA filers; some suits were joined by GSK then GSK later withdrew; Biovail’s petition received mixed FDA responses and timed with Anchen’s ANDA approval.
- In February 2007 a multi‑agreement settlement (including a no-authorized-generic, sublicenses, and supply commitments) resolved many disputes; Anchen delayed launch of 150 mg generic until May 2008 and GSK delayed launching authorized generics for 180 days.
- Plaintiffs (direct and indirect purchasers) alleged: (a) sham litigation and sham petitioning to trigger Hatch‑Waxman stays; and (b) an anticompetitive reverse‑payment / no‑AG settlement that delayed generic competition and raised prices. Biovail settled separately before appeal; GSK remained the defendant.
- District Court granted summary judgment for GSK (sham litigation, petition, and reverse‑payment claims), excluded plaintiffs’ economic expert (Daubert), decertified indirect‑purchaser class, and denied Aetna’s intervention; Third Circuit affirmed summary judgment on merits.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Sham litigation (suits vs. Anchen, Abrika, Impax, Watson) | Suits were objectively baseless shams to invoke 30‑month stays and delay generics | Suits were brought with probable cause based on ANDA content and Hatch‑Waxman mechanics; GSK/ Biovail actions protected by Noerr unless objectively baseless | Court: Noerr immunity defeat not shown; Anchen/Abrika suits had probable cause from ANDA disclosures; summary judgment for GSK affirmed |
| Conspiracy / serial petitioning (coordination between GSK & Biovail) | Communications, common‑interest agreement, and timing show coordinated scheme to suppress competition | Communications reflect legitimate common interest between licensee and patentee; insufficient evidence to infer an unlawful agreement | Court: Plaintiffs failed to present evidence excluding independent action; no conspiracy or serial‑petition pattern; affirmed |
| Reverse‑payment / no‑AG settlement (rule of reason applicability) | The no‑AG promise and related concessions functioned as a large reverse payment that delayed entry | Settlement preserved litigation risk and did not improperly eliminate patent challenge; value transfers were justified business terms | Court: Under Actavis and King Drug, no‑AG and similar transfers fall within rule‑of‑reason scrutiny for the 150 mg Anchen claim; agreements not categorically immune from antitrust review |
| Antitrust standing / causation (did settlement cause plaintiffs’ injury?) | But for the settlement, Anchen (and partners) would have lawfully launched earlier and plaintiffs would have paid lower prices | Launch would have been blocked by Andrx’s ’708 patent and other legal/regulatory constraints; plaintiffs must prove it was more likely than not that launch would have been lawful without the settlement | Court: Plaintiffs failed to show a license or likely litigation win (assignor estoppel, expert probabilities); blocking patent broke causation chain; plaintiffs lack antitrust standing — summary judgment affirmed |
Key Cases Cited
- FTC v. Actavis, Inc., 133 S. Ct. 2223 (2013) (reverse‑payment settlements can violate antitrust laws; apply rule of reason)
- Professional Real Estate Inv’rs v. Columbia Pictures Indus., 508 U.S. 49 (1993) (Noerr‑Pennington doctrine; two‑part sham litigation test)
- Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574 (1986) (standards for inferring conspiracy at summary judgment)
- King Drug Co. of Florence, Inc. v. SmithKline Beecham Corp., 791 F.3d 388 (3d Cir. 2015) (no‑AG agreements and other non‑cash transfers can be treated as reverse payments under Actavis)
- Brunswick Corp. v. Pueblo Bowl‑O‑Mat, Inc., 429 U.S. 477 (1977) (definition of antitrust injury and causation requirement)
- Associated Gen. Contractors of Cal. v. Cal. State Council of Carpenters, 459 U.S. 519 (1983) (prudential factors for antitrust standing)
- Illinois Brick Co. v. Illinois, 431 U.S. 720 (1977) (limitations on indirect‑purchaser standing under federal law)