By
James DeGiulio --
Sanofi
and Abbott were successful in their request for sanctions against Glenmark in
their patent suit over Tarka, after it was found that Glenmark destroyed evidence
relevant to the impending litigation.
The
dispute began in October 2007, when Glenmark notified Abbott and Sanofi that it
had filed an ANDA for 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 infringement of U.S. Patent No. 5,721,244 patent
which covers Tarka (see "Court
Report," December 16, 2007). Recently, Abbott and Sanofi asked the District Court to preliminarily enjoin and temporarily restrain Glenmark from selling
generic versions of Tarka, but the Court ruled against the injunction (see "Biotech/Pharma Docket,"
June 10, 2010).
In
a July 1 order, Judge Dennis Cavanaugh of the U.S. District Court for the
District of New Jersey found that Glenmark had destroyed evidence relevant to
the reasonably foreseeable litigation associated with filing an ANDA. Prior to implementing any litigation
holds, Glenmark practiced systematic document destruction. The plaintiffs argued that a litigation
hold arises as soon as a company decides to create a generic of a drug with an
unexpired patent. Glenmark claimed
its duty to impose a litigation hold did not arise until its ANDA filing. Judge
Cavanaugh refused to find that a litigation hold arises as early as a company's
decision to create a generic drug, but also found that the litigation hold
arises before the ANDA filing, depending on the facts in the case.
Seven
suits over Enzo Biochem Inc.'s patents claiming methods of detecting nucleic
acids were stayed while Applera Corp. petitions the U.S. Supreme Court to
decide the validity of the patents. The asserted patents involve the technology
of labeling, hybridizing and detecting nucleotides for use in assaying diseases
in a sample of blood.
Bristol-Myers
Squibb Co. and Sanofi-Aventis SA bolstered their case against Apotex Inc. for
infringement of their patent covering Plavix, after the U.S. Patent and
Trademark Office denied Apotex's second request for reexamination of U.S. Patent No. 4,847,265.
Sanofi
sued Apotex in 2002, shortly after the generics maker filed an ANDA to market a
generic version of clopidogrel bisulfate, the active ingredient in Plavix. Apotex asserted that the '265 patent
was invalid due to obviousness, but both the District Court and the Federal
Circuit ruled against Apotex, upholding the patent claims. The Federal Circuit denied Apotex's
request for rehearing, and the U.S. Supreme Court denied its petition in
November 2009. Apotex sought to
stay the District Court infringement action in April, pending the results of
the reexamination by the USPTO, but this motion was denied. The infringement action is currently in the damages stage
James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law. Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at [email protected].
RE: Apotex
Has the rubber-stamp of automatically finding SNQ started wearing thin?
Posted by: Skeptical | July 09, 2010 at 09:50 AM