Aurobindo, Merck, BMS End Trial over Sustiva Patents

Case Filed: Sep11, 2013

Case Closed: Jan 27, 2014

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, Indian generic drug maker, Aurobindo pharmaceutical 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 Sustiva, prescribed for the treatment of infections with HIV. The suit revolves around the 2 patents:

•       US6673372 entitled ‘Crystalline Efavirenz’, issued on Jan 06, 2004 and expiring* by Jun 10, 2019
•       US6639071 and US6939964 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 and expiring* by Jan 20, 2018

The ‘372 patent is currently assigned+ to BMS and the ‘071 and ‘964 patents are currently assigned+ to MSD (source: MaxVal’s Assignment Database). Plaintiffs alleged that Aurobindo’s abbreviated new drug application (ANDA) no. 205322 to manufacture a generic version of Sustiva filed with FDA infringed the ‘372, 071 and ‘964 patents, all of which cover the composition of the drug. 

BMS is the current holder± of 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.

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).

The parties filed a stipulation and order of dismissal, pursuant to which 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 manufacturers of efavirenz including Cipla, Hetero and a few others.

See 1:13-cv-05442 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

* Expected expiration date using Patent Term Estimator, use our free tool or download our free Android app on Google Play Store.

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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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± Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.