Hetero, Merck, BMS End Patent Dispute over Generic HIV Drug

Case Filed: Mar 07, 2013

Case Closed: Sep 20, 2013

Court: New Jersey District Court

Judge: Jerome B. Simandle

Case Summary:

Merck Sharp & Dohme (MSD) and Bristol-Myers Squibb (BMS) jointly filed a patent infringement suit against Hetero, India-based pharmaceuticals claiming that three of their patents related to HIV drug were infringed.  The patents involved in suit are:

• US6673372 entitled Crystalline Efavirenz, issued on Jan 06, 2004 and expiring* by Jun 10, 2019
• US6639071 and US6939964 both entitled Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-ben zoxazin-2-one, issued on Oct 28, 2003 and Sep 06, 2005, both expiring* by Jan 20, 2018

The ‘372 patent is currently assigned+ to Bristol-Myers Squibb and the ‘071 and ‘964 patents are currently assigned+ to MSD (source: MaxVal’s Assignment Database). 

The Court document said defendant by filing an abbreviated new drug application (ANDA) no. 204411 with FDA seeking approval to engage in commercial manufacturing of the drug containing 600 mg efavirenz tablets, a generic version of BMS’s Sustiva® drug product have infringed ‘372, ‘071 and ‘964 patents.

BMS currently holds± the new drug application (NDA) no. 021360 (source: MaxVal’s Patent Marker), approved by FDA for 600 mg efavirenz tablets in Feb 1, 2002, which is sold under the trade name Sustiva. It was originally produced by DuPont Pharmaceuticals and is now manufactured by Bristol-Myers Squibb for sale in the United States. The trade name Stocrin is used by Merck Sharp & Dohme, who market the same drug in Europe and many other parts of the world. This drug is used with other HIV medications to help control HIV infection, which lowers the chance of getting HIV complications (such as new infections, cancer).

As per the complaint, “Defendants have committed an act of infringement of the patents and such infringement will cause Plaintiffs irreparable harm unless enjoined by this Court.”  So, 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.

It appears that the parties filed a stipulation and proposed order of dismissal, pursuant to which the Court granted and ordered all claims and counterclaims asserted in this civil action be dismissed without prejudice. Each party will bear their own costs and expenses.

Plaintiffs have sued other generic version manufacturers of efavirenz including Cipla, Aurobindo and a few others.

See 1:13-cv-01402 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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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.