By James DeGiulio --
Seroquel Suit between AstraZeneca and Biovail Dismissed
AstraZeneca and Biovail have agreed to end their patent dispute over Seroquel XR after Biovail converted its Paragraph IV certification to a Paragraph III filing, thus agreeing not to market a generic version of Seroquel XR until after the expiration of the patents in the suit. The dispute between the drug companies began in January 2009, when AstraZeneca brought suit in the U.S. District Court for the District of New Jersey against Biovail, alleging that Biovail's Abbreviated New Drug Application (ANDA) covering three doses of extended-release quetiapine fumarate infringed U.S. Patent Nos. 4,879,288 and 5,948,437 (see "Court Report," January 18, 2009). In April 2009, Biovail countered that it did not infringe either patent, and that both patents were invalid. Biovail also argued that one of the patents was unenforceable because AstraZeneca engaged in inequitable conduct during prosecution of the patent by withholding internal information about compounds that could be considered atypical anti-psychotics.
On April 29, AstraZeneca and Biovail filed a joint stipulation of dismissal after Biovail changed its regulatory certification to a Pararaph III filing, agreeing not to commercially sell its generic drug until after the expiration of the '288 and '437 patents. The patents expire in 2011 and 2017, respectively. Judge Joel Pisano granted the parties' stipulation on May 2, dismissing all the claims and counterclaims in the action without prejudice, and ordered the parties to cover their own costs and attorneys' fees. The stipulation allows the AstraZeneca to retain some of Biovail's confidential information and other data for use in the related patent litigation against Handa, Torrent, and other generics.
Eli Lilly Successfully Blocks Release of Generic Cymbalta
Eli Lilly successfully secured an order that prohibits the defendants in the Cymbalta patent litigation from selling a generic version of duloxetine during the term of Eli Lilly's compound patent. In November 2008, Eli Lilly filed suit in the U.S. District Court for the Southern District of Indiana against Wockhardt, claiming the generic manufacturers' duloxetine oral capsules infringed U.S. Patent No. 5,023,269 (see "Court Report," November 23, 2008). Eli Lilly brought suit against several other generic companies, and these other suits were consolidated in February 2009 and stayed pending the outcome of Eli Lilly's case against Wockhardt. All defendants had alleged in their ANDAs that Eli Lilly's patent was invalid.
On April 27, Judge Tanya Walton Pratt entered final judgment against the defendants, prohibiting the sale of a Cymbalta generics and requiring that the defendants convert their certifications to a Paragraph III filing. The '269 patent provides protection for Cymbalta until at least June of 2013. The defendants also must notify the FDA that the defendants are no longer seeking approval for an ANDA. Eli Lilly argued that the group was bound by Judge Pratt's March approval of a settlement between the company and Wockhardt that favored the plaintiff. The judge's order ends Eli Lilly's case against Impax, Cobalt, Anchen, Actavis, Aurobindo, Lupin, Sandoz, and Sun.
Pfizer and Eon Settle Neurontin Patent Dispute
Pfizer and Eon Labs have reached an agreement ending their patent infringement suit over a generic version of the epilepsy drug Neurontin. In June 2000, Pfizer brought suit in the U.S. District Court for the District of New Jersey against Eon, after Eon filed an ANDA over gabapentin. In 2002, the case was joined with Pfizer's suits against other generic-drug makers Purepac and Teva. Despite the lawsuit, the defendants opted to begin selling their generic gabapentin products "at risk" before a court ruling on infringement liability had been issued. Pfizer asserted infringement of U.S. Patent No. 6,054,482 stemming from the ANDA and the sales of generic gabapentin. In August 2005, the District Court found no infringement because Pfizer failed to prove that the anions of the Neurontin generic drugs fall within the claims. Pfizer appealed the New Jersey court's decision to the Federal Circuit and it was reversed (see "In re Gabapentin Patent Litigation (Fed. Cir. 2007)").
On April 28, Judge Faith S. Hochberg signed off on a stipulation dismissing Eon and Sandoz from the case, leaving Purepac, Teva, and their affiliates as the only remaining defendants in the long-running patent suit, which is scheduled for trial on May 16. The companies stipulated that Eon's gabapentin capsules infringed Pfizer's patent and that all claims and counterclaims pending between the companies should be dismissed. The remaining terms of the settlement are confidential.
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