Wednesday, May 22, 2013

Verdict in Purdue, Varam Suit over OxyContin


Purdue, a biopharmaceutical company has reached a settlement agreement on May 16, thereby ending a patent dispute over Varam’s plans to make a generic version of Purdue’s OxyContin® brand of oxycodone hydrochloride.


Case Filed: Aug 07, 2012

Case Closed: May 16, 2013


Judge: Sidney H. Stein


Court: New York Southern District Court


Other Plaintiffs: The P.F. Laboratories and Rhodes Technologies


Other Defendant: KVK-Tech 


Case Summary:

Purdue, current holder[i] of NDA no. 20-553 (source: Patent Marker) and the owner of the four patents covering the drug, OxyContin. It alleged that Varam’s abbreviated new drug application for generic version of 10-, 15-, 20-, 30-, 60- and 80-milligram controlled-release tablets had infringed on their patent rights. The patents are currently assigned[ii] to Purdue (source: MaxVal’s Assignment Database). 


Purdue said Varam submitted an abbreviated new drug application no. 20-1523 with the U.S. Food and Drug Administration, seeking approval to manufacture and sell a generic version of OxyContin, which is used to treat moderate to severe pain that is expected to last for an extended period of time. According to the complaint, if allowed to pursue its generic, Varam would infringe the following U.S. patents that protect the branded pain reliever. The patents-in-suit are


·         US5508042 - Controlled release oxycodone compositions, issued on Apr 16, 1996 and expired* by Apr 16, 2013

·         US7674799 - Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone, issued on Mar, 09, 2010 and expires* by Mar 30, 2025

·         US7674800 - Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone, issued on Mar, 09, 2010 and expires* by Mar 30, 2025

·         US7683072 - Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone, issued on Mar 23, 2010 and expires* by Mar 30, 2025


The case ended as the parties have reached ‘Settlement Agreement’. The Court ordered that all the claims and counterclaims to be dismissed with prejudice. At this point, there are no further details available, on the terms of settlement. 


See 1:12-cv-06047 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.


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[i] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.
[ii] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
* Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patent

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