## Facts

- Bristol-Myers Squibb Company manufactured Taxol (paclitaxel) and owned method-of-use patents covering chemotherapy uses of paclitaxel (U.S. Patent Nos. 5,641,803 and 5,670,537).
- Zenith Goldline Pharmaceuticals, assisted by IVAX and IVAX’s subsidiary Baker Norton, filed an ANDA seeking FDA approval to market generic paclitaxel.
- Bristol sued IVAX and Zenith Goldline, alleging the ANDA filing was an act of infringement under 35 U.S.C. § 271(e)(2)(A).
- Zenith Goldline and Baker Norton asserted counterclaims for unfair competition, estoppel, monopolization-related claims under Sherman Act § 2, and declaratory relief.
- The counterclaims alleged, among other things, that Bristol obtained competitive advantages through interactions with government actors (including FDA submissions, efforts to secure rights connected to government research, and statements to Congress), and that Bristol made misrepresentations regarding pricing.
- Bristol moved under Rule 12(b)(6) to dismiss all Baker Norton counterclaims and Zenith Goldline’s estoppel counterclaim, and moved under Rule 12(b)(6) and/or Rule 12(f) to dismiss or strike counterclaim allegations premised on petitioning conduct allegedly immunized by Noerr-Pennington.

## Issues

1. Whether Baker Norton pleaded legally sufficient counterclaims to survive dismissal under Rule 12(b)(6).
2. Whether Zenith Goldline’s estoppel counterclaim stated a claim upon which relief could be granted.
3. Whether counterclaim allegations premised on Bristol’s petitioning of governmental bodies (including FDA-related submissions and congressional testimony) were barred by Noerr-Pennington, absent adequately pleaded sham petitioning.

## Decision

- The court granted Bristol’s Rule 12(b)(6) motion dismissing all of Baker Norton’s counterclaims.
- The court granted Bristol’s Rule 12(b)(6) motion dismissing Zenith Goldline’s estoppel counterclaim (Count II).
- The court granted Bristol’s motion to dismiss and/or strike, under Rules 12(b)(6) and 12(f), those portions of Counts I–IV premised on immunized petitioning activity.
- The court declined to recognize a “commercial exception” to Noerr-Pennington based on the government’s alleged commercial stake in the matters being petitioned.
- The court held that the counterclaimants did not plead facts sufficient to invoke the sham exception to Noerr-Pennington.

## Legal Principles

- Under Rule 12(b)(6), a claim is dismissed when, accepting well-pleaded facts as true and drawing reasonable inferences for the pleader, the allegations do not state a legally cognizable basis for relief.
- Noerr-Pennington generally immunizes efforts to influence governmental action (legislative, executive, judicial, or administrative) from antitrust liability, including petitioning directed to agencies and other government bodies.
- A party cannot avoid Noerr-Pennington merely by alleging the government acted with some commercial interest; a broad “commercial exception” is not recognized.
- The sham exception requires well-pleaded facts showing petitioning that is objectively baseless and used as a means to interfere with a competitor rather than to obtain legitimate governmental action.
- Allegations of anticompetitive intent, without sufficient facts meeting the sham standard, do not defeat Noerr-Pennington immunity.

## Conclusion

The court substantially narrowed the defendants’ counterclaims by dismissing Baker Norton’s counterclaims in full, dismissing Zenith Goldline’s estoppel claim, and removing counterclaim theories and allegations that depended on Bristol’s protected petitioning activity, holding that Noerr-Pennington applied and that the sham exception was not adequately pleaded.


Bristol-Myers Squibb Co. v. IVAX Corp., 77 F. Supp. 2d 606 (D.N.J. 2000)