Case Filed: Oct 13, 2011
Case Closed: Aug 23, 2013
Court: New Jersey District Court
Judge: Jose L. Linares
Case Summary:
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
See case 2:11-cv-06067
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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
+
MaxVal offers Patent Assignment Alert
service where subscribers receive email alerts when assignments relating to
target applications, patents or entities of interest are recorded.
± Patent Marker provides an online
environment where patentees can virtually mark products and search products for
patent-related information.
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