While the agreements at issue here did not end the litigation between Biovail and Anchen, they nevertheless implicate the kinds of concerns articulated in Actavis by delaying the entry of mg generic Wellbutrin XL and by delaying the entry of an authorized generic version of both and mg Wellbutrin XL.
The fourth agreement was between Biovail and Impax, in which Biovail agreed to dismiss its infringement suit against Impax and agreed not to sue Impax for selling or manufacturing generic versions of Wellbutrin XL outside of Anchen's day exclusivity period.
That is especially true in the Hatch-Waxman context, where many details about the potentially infringing drug details that could shape a plaintiff's claim construction position cannot be known at the time a suit is filed and where there are congressionally designed pressures to file suit quickly.
While Article III standing is rooted in the Constitution, antitrust standing is a judge-made doctrine. And we have already rejected the Appellants' arguments that GSK was engaged in a conspiracy with Biovail. Caribbean Cruise Lines, Ltd.
If an objective litigant could conclude that the suit is reasonably calculated to elicit a favorable outcome, the suit is immunized under Noerr, and an antitrust claim premised on the sham exception must fail.
It included several tables listing the ingredients that would be present in Anchen's drug, along with the relative percentages of each. Eight days before Biovail filed its Petition, GSK employees sent an internal email expressing uncertainty as to whether Biovail had filed a petition. On the contrary, the record indicates that GSK was not aware of Biovail's specific plans to file a petition, 29 that neither GSK nor Biovail wanted to collaborate on a petition, 30 that GSK refused to share its data with Biovail for use in a petition, 31 and that GSK disagreed with the general premise of Biovail's Petition.
However, indirect purchasers do have standing to assert antitrust claims in each of the state causes of action asserted here. Only by means of such a showing can the litigant overcome the presumptive immunity of the Noerr-Pennington doctrine.
The omnibus agreement required the parties to submit the agreements to the FTC within two days and to either revise or terminate the agreement in response to any FTC concerns. Without parsing the Abrika ANDA in the same detail as we did Anchen's, it suffices to say that the Appellants have not provided evidence to demonstrate that it was objectively unreasonable for Biovail and GSK to act on the technical act of infringement that the ANDA and paragraph IV certification provided.
That language provided GSK and Biovail with sufficient probable cause to file its infringement suit, and no reasonable jury — i. Pursuant to the terms of the agreements, Anchen waited until May to launch its mg generic version of Wellbutrin XL, and GSK waited days to launch authorized generic versions of both mg and mg Wellbutrin XL.
However, Biovail did not file against Impax within 45 days of receiving Impax's paragraph IV certification. With one exception, it filed its several suits within 45 days of receiving each of the would-be competitors' paragraph IV certifications.
Again, the fact that one might conclude, after a thorough investigation, that Anchen's ANDA did not definitively exclude the presence of hydrochloric acid does not mean it was unreasonable for GSK and Biovail to file their suit, as it was not unreasonable for them to take the ANDA at face value. Reverse Payment Settlement Agreement The second major point of contention on appeal relates to a set of agreements that resolved Biovail's infringement suits against Anchen, Impax, and Watson, and Andrx's infringement suits against GSK and Anchen.
Nevertheless, the court found that appellants lacked antitrust standing because they failed to raise a genuine issue as to the connection between their claimed injury and the alleged anticompetitive conduct.
It is not a jurisdictional requirement. If a patentee files an infringement suit against a generic manufacturer within 45 days of receiving notice of the filing of a paragraph IV certification, the patentee is rewarded with some breathing space before competition can begin: Keep up the good work, it's most appreciated!.
See Anchen's paragraph IV certification, JA referring to hydrochloric acid as a stabilizing agent. Noerr-Pennington immunity, however, is not absolute.
As explained above, the Appellants have not presented sufficient evidence upon which a reasonable jury could rely to conclude that it is more likely than not that Anchen and Andrx would have entered into a license agreement in the counterfactual world. After four companies sought approval to market generic versions of Wellbutrin XL, Biovail sued them for patent infringement and filed a citizen petition with the FDA requesting the imposition of conditions for approval of a generic Wellbutrin XL.
It sought to intervene in order to save the indirect purchasers' claims from dismissal.