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.
* 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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