By James DeGiulio --
Endo Settles with Impax and
Sandoz in Opana Patent Suits
Endo Pharmaceuticals Inc. has settled patent
infringement suits against Sandoz Inc. and Impax Laboratories Inc. over generic
versions of painkiller Opana ER. The
agreement allows Impax to begin selling a version of the drug on January 1, 2013, and
allows Sandoz to enter the market on September 15, 2012.
In January 2008, Endo brought suit against Impax
and Sandoz after their ANDA filings, alleging infringement of two of Endo's patents (U.S. Patent Nos. 5,662,933
and 5,958,456), which cover Opana. Endo further alleged that Impax abused the
regulatory system for resolving patent disputes over ANDAs, arguing that Impax
violated FDA rules by continuing to send Paragraph IV notices even though the
agency rescinded its initial acceptance of Impax's ANDA.
The
settlements were announced shortly after a bench trial in the District of New
Jersey in front of Judge Katharine S. Hayden. Additional
details on the licensing agreements with Impax and Sandoz were not disclosed.
Sanofi, Abbott Unable to Block
Glenmark's Launch of Generic Tarka
Sanofi and Abbott have failed to
block Glenmark's launch of a generic version of Tarka after the U.S. District
Court for the District of New Jersey
denied their motion for preliminary injunction and a temporary restraining order.
In
October 2007, Glenmark notified Abbott and Sanofi that it had filed an ANDA with
the FDA to make a generic drug containing trandolapril and verapamil
hydrochloride, the active ingredients in Tarka. Sanofi and Abbott responded by
filing the current lawsuit in December 2007, alleging Glenmark was planning to
infringe the 5,721,244 patent which covers Tarka (see "Court Report," December 16, 2007). On May 14, Abbott and Sanofi asked the
court to preliminarily enjoin and temporarily restrain Glenmark from selling
generic versions of Tarka, arguing that denying this action would cause the
plaintiffs irreparable harm due mostly to market loss.
Judge Dennis M. Cavanaugh of the District
Court for the District of New Jersey denied the preliminary injunction due to
public interest and Glenmark's likelihood of success on invalidating the '544
patent due to obviousness. Glenmark presented strong prior art, including ten references
and a 1992 patent held by the plaintiffs. Judge Cavanaugh noted the commercial success of Tarka,
but found the prospective harm to Glenmark would be too great to grant the
preliminary injunction.
Judge Cavanaugh's opinion can be
read here.
James
DeGiulio has a doctorate in molecular biology and genetics from
Northwestern University and is a third-year law
student at the Northwestern University School of Law. Dr. DeGiulio
was a member of MBHB's 2009 class of summer associates, and he can be
contacted at degiulio@mbhb.com.
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