795 F. Supp. 2d 300
E.D. Pa.2011Background
- Flonase is a brand-name nasal spray containing fluticasone propionate (FP) developed and marketed by GSK.
- Roxane filed an ANDA for a generic FP nasal spray, triggering Hatch-Waxman framework and FDA BE/BE considerations.
- GSK petitioned the FDA via citizen petitions and sued in Maryland, arguing antitrust immunity under Noerr-Pennington.
- FDA guidance history: 1999 Draft Guidance, 2003 Draft Guidance, and related citizen petitions; FDA rejected several GSK requests in 2006.
- Roxane's ANDA was approved by the FDA in Feb. 2006; GSK challenged this approval and pursued TRO/PI proceedings.
- The court denied GSK’s summary-judgment motion on Noerr-Pennington immunity, finding genuine issues of material fact as to the sham-petitioning doctrine.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether petitioning was objectively baseless under PRE | Plaintiffs contend petitions had no merit and were aimed at delaying competition. | GSK argues petitions had objective merit and sought permissible regulatory input. | Genuine issues of material fact remain; not resolved on summary judgment. |
| May Petition: objective baselessness of delaying ANDA approvals before final guidance | FDA could have expedited approvals without final guidance; expert testimony shows merit to delay. | Final guidance not required; petitions could be reasonably interpreted as seeking clarifications. | Issue disputed; fact questions about objective baselessness survive. |
| May Petition: objective baselessness of requiring PNAR/PAR data | Data across all indications is necessary to ensure BE; lack of statutory requirement renders baselessness plausible. | Redundancy of PNAR/PAR data; four SAR data sufficient for BE decisions. | Genuine factual questions remain as to objective baselessness. |
| Maryland lawsuit: whether lawsuit itself was sham petitioning | Lawsuit and TRO sought to delay approval and interfere with competition. | Lawsuit pursued legitimate judicial review; not per se sham. | Question for the jury remains; not conclusively sham at summary judgment. |
| Whether the FDA's responses to petitions were proper signals of objective merit | FDA rejection letters show the petitions were baseless in light of the agency's technical reasoning. | FDA's reasons were appropriate and based on scientific and regulatory standards. | Factual disputes over objective baselessness persist; cannot grant summary judgment. |
Key Cases Cited
- Professional Real Estate Investors, Inc. v. Columbia Pictures Industries, Inc., 508 U.S. 49 (U.S. Supreme Court, 1993) (two-pronged PRE test for sham petitioning)
- Cheminor Drugs, Ltd. v. Ethyl Corp., 168 F.3d 119 (3d Cir. 1999) (Noerr-Pennington immunity framework in Third Circuit)
- Noerr Motor Freight, Inc. v. Penn., 365 U.S. 127 (U.S. Supreme Court, 1961) (Noerr-Pennington immunity from petitioning)
- In re DDAVP Direct Purchaser Antitrust Litig., 585 F.3d 677 (2d Cir. 2009) (applies PRE framework to FDA petitions)
- USS-POSCO Indus. v. Contra Costa Cnty. Bldg. & Constr. Trades Council, AFL-CIO, 31 F.3d 800 (9th Cir. 1994) (pattern/practice approach to claim of sham petitioning)