By James DeGiulio --
Elan and Abbott Drop Tricor Patent Suit with Teva
Elan and exclusive licensee Abbott have agreed to dismiss their case with Teva over its intended marketing of a generic version of the cholesterol drug Tricor. The dispute between the companies began in July 2010, when Abbott, subsidiary Fournier, and Elan brought suit against Teva in the U.S. District Court for the District of New Jersey (see "Court Report," July 25, 2010) after Teva announced its plans to make a generic version of Tricor and filed an ANDA in May 2010. The plaintiffs accused Teva of infringing U.S. Patent Nos. 5,145,684, 7,276,249, and 7,320,802. Abbott's Fournier unit developed the drug's active ingredient and is the exclusive licensee of the patents, while Elan has developed a system for controlling how the drug is absorbed by the body.
On June 30, Judge Garrett E. Brown signed off on the joint stipulation of dismissal between the parties. Under the agreement, the complaint against Teva and all of the counterclaims were dismissed without prejudice. According to the dismissal, no party admits liability and each will bear its own costs. Elan and Abbott have steadily been wrapping up Tricor-related lawsuits in recent months, having settled with Biovail (now owned by Valeant), Lupin, and Ranbaxy.
Sanofi Settles with Actavis in Allegra Suit
Sanofi and Actavis have settled a patent infringement suit over Actavis' planned generic version of the allergy drug Allegra. In May 2010, Sanofi brought suit against Actavis in the U.S. District Court for the District of New Jersey, alleging that Actavis' planned generic version of Allegra would infringe three patents: U.S. Patent Nos. 6,399,632, 6,187,791, and 6,037,353 (see "Court Report," June 6, 2010). Actavis had previously sent Sanofi its notice letter in April 2010 announcing that it had filed an ANDA, and claiming that the three Sanofi patents were invalid or would not be infringed by the proposed generic drug. Sanofi responded that not only would the generic version infringe the patents-in-suit, but that the infringement would be willful. The complaint further sought damages and an injunction barring Actavis from selling generic Allegra. Sanofi has been aggressive in protecting its patents for the medication, suing several generic makers for their efforts to introduce generic versions of the allergy drug. However, many of these cases are drawing to a close. In March, Sanofi settled a similar suit over generic Allegra with Impax, Mylan, and Dr. Reddy's. That case had been pending since 2002.
On June 30, Judge Garrett E. Brown signed off on an order of dismissal, which dismissed the action without prejudice, while retaining jurisdiction to enforce the terms of the settlement. No costs were awarded to either side and the terms of the settlement were not disclosed. The case can be reopened within 60 days if the settlement is not finalized.
Wyeth and Intellipharmaceutics Settle Effexor XR Patent Litigation
Wyeth has settled its lawsuit against Intellipharmaceutics, which was filed when Intellipharmaceutics applied for regulatory approval to produce a generic version of the antidepressant drug Effexor XR. The dispute between Wyeth and Intellipharmaceutics began in July 2010, when Wyeth filed suit in the U.S. District Court for the Southern District of New York against Intellipharmaceutics after its submission of an ANDA for a generic extended release version of venlafaxine HCl (see "Court Report," July 5, 2010). Wyeth asked the District Court to find that Intellipharmaceutics had infringed U.S. Patent Nos. 6,274,171, 6,403,120, and 6,419,958. Intellipharmaceutics responded by asserting that that patents were invalid and unenforceable. As of July 2011, Wyeth has filed at least seventeen suits over Effexor XR since the drug was approved in 2000, and has settled over half of these suits.
On June 20, Judge Laura Taylor Swain approved a stipulation of dismissal under Federal Rule 41 and a consent judgment. According to the stipulation, all of the claims, counterclaims, and affirmative defenses are dismissed with prejudice. No costs were awarded. Although the companies' filings did not disclose the terms of the settlement, the judgment references a licensing agreement between the parties. The judgment also stated that Intellipharmaceutics stipulated to the validity and enforceability of the three patents.
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