By James DeGiulio --
Eisai's Motion to Dismiss Granted in Aricept Suit with Apotex
Apotex's Abbreviated New Drug Application (ANDA) to market a generic version of Aricept remains unapproved following the dismissal of the generic drug company's declaratory judgment suit seeking invalidity or noninfringement of Eisai's patent on the drug.
In 2003, Ranbaxy was the first to file an ANDA for generic Aricept, also asserting that U.S. Patent Nos. 5,985,864, 6,140,321, 6,245,911, and 6,372,760 were either invalid or would not be infringed by its generic version of the drug. However, Ranbaxy did not challenge the U.S. Patent No. 4,895,841, which also covered Aricept, and Eisai declined to sue Ranbaxy for infringement of the four patents it had challenged. Apotex filed its ANDA in July 2007, and then in July 2009, filed a declaratory judgment suit in the U.S. District Court for the Middle District of North Carolina (see "Court Report," July 5, 2009). Apotex sought to obtain a noninfringment ruling on the four patents it had challenged in order to obtain final approval for its ANDA. In response, Eisai filed a motion to dismiss the action.
On August 27, Judge James A. Beaty Jr. granted Eisai's motion to dismiss the case, finding that Apotex failed to show it had standing. Judge Beaty noted that Eisai disclaimed two of the allegedly infringed patents and granted Apotex a covenant not to sue on the other two, thus removing any conflict between the parties on the infringement of those patents. However, Apotex argued that there remained a case or controversy between the parties because Eisai was manipulating the Hatch-Waxman Act in a way that was blocking approval for Apotex's ANDA. Apotex claimed that Eisai's refusal to sue Apotex over four of its five Orange Book patents for Aricept was preventing them from getting their ANDA approved because it could not get a court ruling declaring the patents invalid or not infringed. The judge rejected this argument, noting that since Apotex had already admitted that the '841 patent is valid, Apotex's ANDA would still not be approved.
Judge Beaty's memorandum opinion can be found here, and the accompanying order granting the dismissal can be found here.
Jazz Pharmaceuticals and Anchen Settle Luvox Patent Litigation
Jazz Pharmaceuticals has reached a settlement with Anchen in the patent infringement case stemming from Anchen's campaign to market a generic version of the anxiety drug Luvox.
In 2009, Jazz filed suit against Anchen in the U.S. District Court for the District of Delaware for infringement of its U.S. Patent No. 7,465,426 after Anchen filed an ANDA seeking approval to market its own version of Luvox (see "Court Report," October 11, 2009). On August 26, Jazz and Anchen requested that the suit be stayed, notifying the District Court that the companies were in settlement negotiations.
According to Jazz's 8-K filing with the SEC, Anchen and Jazz reached a deal that contains a licensing agreement that will allow Anchen to manufacture a generic version of Luvox starting in February 2013. According to the settlement, Jazz and Anchen have agreed to dismiss all claims without prejudice, and Anchen has agreed not to challenge the validity or enforceability of Jazz's '426 patent covering Luvox. The settlement remains subject to review by the Federal Trade Commision and the Department of Justice.
Salix and Norgine Settle with Novel in Patent Dispute over MoviPrep
Salix Pharmaceutical and Norgine have entered into an agreement with Novel Laboratories, thus settling the patent litigation over Novel's generic version of the colon-cleansing drug MoviPrep.
In May 2008, Salix and Norgine sued Novel in the U.S. District Court for the District of New Jersey after it submitted an ANDA for generic MoviPrep and challenged U.S. Patent No. 7,169,381 (see "Court Report," May 18, 2008). Novel denied infringement and claimed that the '381 patent was invalid, and Salix argued in response that Novel's invalidity and non-infringement arguments were incomplete. Novel further claimed that the patent was unenforceable, arguing that Salix submitted false and misleading statements to the U.S. Patent and Trademark Office during prosecution. Novel also sought to get the '381 patent removed from the Orange Book listing for MoviPrep.
On August 27, the parties announced that they had reached an agreement that would resolve the case after court approval. According to Salix, Novel will obtain a license to the MoviPrep patents that will take effect no later than Sept. 24, 2018. Under the terms of a separate supply agreement, Novel will also manufacture and supply MoviPrep for Salix as its U.S. supply source.
Salix's May 2008 complaint can be found here.
James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law. Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at [email protected].
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