A patent infringement suit was filed by Schering, Merck Sharp & Dohme and MSP Singapore against Actavis as a result of the latter filing an Abbreviated New Drug Application (ANDA) with the FDA concerning their intent to market a generic version of Vytorin, which is used to lower cholesterol. The suit revolves around the 2 patents:
US5846966 entitled ‘Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors’, issued on Dec 08, 1998 and expiring* by Sep 21, 2013
RE42461 entitled ‘Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents’, issued on Jun 14, 2011 and expiring* by Jun 14, 2028
The patents are currently assigned+ to MSD (source: MaxVal’s Assignment Database). According to the complaint, Schering is the assignee of the patent and MSP Singapore is the exclusive licensee of Schering’s product Vytorin. Plaintiffs alleged that Actavis’ abbreviated new drug application (ANDA) no. 202-968 to manufacture generic version of Vytorin, filed with FDA had infringed the ‘966 and ‘461 patents all of which cover the composition of the drug.
MSD currently holds± the New Drug Application (NDA) no. 21-687 (source: MaxVal Patent Marker), approved by FDA on July 23, 2004, which is sold under the trade name Vytorin®. It is a prescription medication to treat several conditions including: high total cholesterol, high LDL cholesterol, high triglycerides, high apoB cholesterol and low HDL cholesterol. Plaintiffs wanted judgment that defendant has infringed the patents and an injunction barring their products until expiration of the patents, along with costs and expenses.
The Court rendered its final verdict pursuant to the parties agreeing upon a consent judgment. The Judge ordered:
Judgment in favor of plaintiffs against defendant
The ‘461 patent to be valid and enforceable
Parties to bear their own costs and expense
Defendant is enjoined from manufacturing/ marketing a generic version of Vytorin until April 26, 2017
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*Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents
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