The litigation between Pfizer and Apotex over Apotex's ANDA for a generic version of Lipitor (atorvastatin calcium) presents the fairly typical scenario of a later ANDA filer (Apotex) trying to trigger the 180-day exclusivity of the first filer (in this case, Ranbaxy).
Pfizer and Ranbaxy settled their Lipitor ANDA litigation in 2008, agreeing that Ranbaxy would not market its generic version of Lipitor until November 30, 2011. Later ANDA filers like Apotex, therefore, must wait until at least mid-2012 to launch their own generic Lipitor--unless one of them triggers Ranbaxy's exclusivity earlier. In order to do so, the later filer must obtain a final decision of non-infringement or invalidity of the Lipitor patents. But this isn't easy to do if the patent owner doesn't sue the later filer: the later filer must obtain a declaratory judgment, which requires establishing declaratory judgment jurisdiction.
In this case, Pfizer listed six patents in the Orange Book for Lipitor. Apotex filed a Paragraph III certification on U.S. Patent No.4,681,893 (expiring March 2010) and Paragraph IV certifications on the other five. Pfizer sued Apotex on only two of the five challenged patents. In its Answer, Apotex filed declaratory judgment counterclaims of non-infringement and invalidity of all five challenged patents, as it must have in order to trigger Ranbaxy's exclusivity.
Pfizer then filed a motion to dismiss Apotex's counterclaims with respect to the three patents that Pfizer did not assert against Apotex (the "Unasserted Patents"), on the grounds that they did not present a "case" or "controversy" as required by Article III of the Constitution. In an Opinion and Order filed June 30, the district court denied Pfizer's motion, allowing Apotex's declaratory judgment counterclaims--and its attempt to trigger Ranbaxy's exclusivity--to proceed.
In its motion to dismiss, Pfizer argued that Apotex lacked standing to assert its counterclaims. To establish standing, a plaintiff must demonstrate (1) an injury-in-fact, (2) that is fairly traceable to the defendant's conduct, and (3) that can be redressed by the court. Apotex alleged two injuries-in-fact: first, by not suing on the Unasserted Patents while reserving the right to do so in the future, Pfizer created uncertainty as to Apotex's legal rights under its ANDA; second, by refusing to litigate all of its patents and settling its litigation with Ranbaxy, Pfizer erected a barrier to FDA approval of Apotex's product, thereby barring Apotex from entering the market.
Pfizer countered that Apotex's alleged injuries were "not sufficiently imminent in light of Apotex's Paragraph III certification to the '893 patent, which prevents the FDA from approving Apotex's ANDA until the '893 patent expires."
Siding with Apotex, the court found that the facts of this case were more like those in Teva v. Novartis (where the Federal Circuit held that the "threat of litigation" on unasserted patents and the "legal undertainty" caused when a patent holder sues an ANDA filer on some but not all of Orange Book-listed patents create a justiciable controversy) and Caraco v. Forest (where the Federal Circuit held that blocking a generic drug company from selling a non-infringing product presents a justiciable controversy) than in Janssen v. Apotex (in which the Federal Circuit found no justiciable controversy because Apotex had stipulated to infringement and validity of one of the Orange Book-listed patents).
On July 14, Pfizer filed a motion for reconsideration of the district court's June 30 decision. In addition, today Pfizer filed a second motion to dismiss, arguing that the circumstances have changed in two important ways since the court's June 30 decision: first, "in light of the Court's decision Pfizer has now given Apotex a covenant not to sue on the Formulation Patents (two of the three Unasserted Patents) and thus there is no possibility of a future lawsuit on these patents"; and second, "also in light of the Court's decision, Pfizer has brought a counter-counterclaim against Apotex on (the third Unasserted Patent, U.S. Patent No. 5,969,156), which expires, including pediatric exclusivity, in January 2017, after the expiration of the Formulation Patents and after the November 30, 2011 date that Ranbaxy may enter the market under its settlement with Pfizer."
According to Pfizer, "the earlier-expiring Formulation Patents and the Ranbaxy settlement with its November 30, 2011 license date cannot prevent Apotex from overcoming Ranbaxy's 180-day exclusivity rights unless and until Apotex prevails on the '156 patent." Thus, Pfizer argues that any alleged injury to Apotex is "based solely on the possibility that the '156 patent is not infringed or is invalid" and "such a speculative injury is 'conjectural' and 'hypothetical', and does not rise the level of 'concrete and actual or imminent'," as required to be justiciable.
Of course, the longer the case lasts, the less likely Apotex is to obtain the declaratory judgment that it seeks, get the judgment affirmed by the Federal Circuit, and trigger Ranbaxy's exclusivity. Pfizer might simply run out the clock.
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Pfizer and Ranbaxy settled their Lipitor ANDA litigation in 2008, agreeing that Ranbaxy would not market its generic version of Lipitor until November 30, 2011. Later ANDA filers like Apotex, therefore, must wait until at least mid-2012 to launch their own generic Lipitor--unless one of them triggers Ranbaxy's exclusivity earlier. In order to do so, the later filer must obtain a final decision of non-infringement or invalidity of the Lipitor patents. But this isn't easy to do if the patent owner doesn't sue the later filer: the later filer must obtain a declaratory judgment, which requires establishing declaratory judgment jurisdiction.
In this case, Pfizer listed six patents in the Orange Book for Lipitor. Apotex filed a Paragraph III certification on U.S. Patent No.4,681,893 (expiring March 2010) and Paragraph IV certifications on the other five. Pfizer sued Apotex on only two of the five challenged patents. In its Answer, Apotex filed declaratory judgment counterclaims of non-infringement and invalidity of all five challenged patents, as it must have in order to trigger Ranbaxy's exclusivity.
Pfizer then filed a motion to dismiss Apotex's counterclaims with respect to the three patents that Pfizer did not assert against Apotex (the "Unasserted Patents"), on the grounds that they did not present a "case" or "controversy" as required by Article III of the Constitution. In an Opinion and Order filed June 30, the district court denied Pfizer's motion, allowing Apotex's declaratory judgment counterclaims--and its attempt to trigger Ranbaxy's exclusivity--to proceed.
In its motion to dismiss, Pfizer argued that Apotex lacked standing to assert its counterclaims. To establish standing, a plaintiff must demonstrate (1) an injury-in-fact, (2) that is fairly traceable to the defendant's conduct, and (3) that can be redressed by the court. Apotex alleged two injuries-in-fact: first, by not suing on the Unasserted Patents while reserving the right to do so in the future, Pfizer created uncertainty as to Apotex's legal rights under its ANDA; second, by refusing to litigate all of its patents and settling its litigation with Ranbaxy, Pfizer erected a barrier to FDA approval of Apotex's product, thereby barring Apotex from entering the market.
Pfizer countered that Apotex's alleged injuries were "not sufficiently imminent in light of Apotex's Paragraph III certification to the '893 patent, which prevents the FDA from approving Apotex's ANDA until the '893 patent expires."
Siding with Apotex, the court found that the facts of this case were more like those in Teva v. Novartis (where the Federal Circuit held that the "threat of litigation" on unasserted patents and the "legal undertainty" caused when a patent holder sues an ANDA filer on some but not all of Orange Book-listed patents create a justiciable controversy) and Caraco v. Forest (where the Federal Circuit held that blocking a generic drug company from selling a non-infringing product presents a justiciable controversy) than in Janssen v. Apotex (in which the Federal Circuit found no justiciable controversy because Apotex had stipulated to infringement and validity of one of the Orange Book-listed patents).
On July 14, Pfizer filed a motion for reconsideration of the district court's June 30 decision. In addition, today Pfizer filed a second motion to dismiss, arguing that the circumstances have changed in two important ways since the court's June 30 decision: first, "in light of the Court's decision Pfizer has now given Apotex a covenant not to sue on the Formulation Patents (two of the three Unasserted Patents) and thus there is no possibility of a future lawsuit on these patents"; and second, "also in light of the Court's decision, Pfizer has brought a counter-counterclaim against Apotex on (the third Unasserted Patent, U.S. Patent No. 5,969,156), which expires, including pediatric exclusivity, in January 2017, after the expiration of the Formulation Patents and after the November 30, 2011 date that Ranbaxy may enter the market under its settlement with Pfizer."
According to Pfizer, "the earlier-expiring Formulation Patents and the Ranbaxy settlement with its November 30, 2011 license date cannot prevent Apotex from overcoming Ranbaxy's 180-day exclusivity rights unless and until Apotex prevails on the '156 patent." Thus, Pfizer argues that any alleged injury to Apotex is "based solely on the possibility that the '156 patent is not infringed or is invalid" and "such a speculative injury is 'conjectural' and 'hypothetical', and does not rise the level of 'concrete and actual or imminent'," as required to be justiciable.
Of course, the longer the case lasts, the less likely Apotex is to obtain the declaratory judgment that it seeks, get the judgment affirmed by the Federal Circuit, and trigger Ranbaxy's exclusivity. Pfizer might simply run out the clock.
Disclaimer- In addition to Terms and Conditions of this blog, the content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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