Biotech/Pharma Docket

    By James DeGiulio --

Sanofi, Abbott Successfully Request Sanctions against Glenmark in Tarka Dispute

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.

Judge Cavanaugh also rejected Glenmark's claim that certain documents were privileged under the work-product doctrine, and issued sanctions on Glenmark for its destruction.  The amount of the sanctions was not disclosed in the order.

Judge Cavanaugh's sanction order can be found here.

Seven Actions Related to Enzo's Patents for Detecting DNA Stayed Pending Supreme Court Review

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.

The stayed suits, which were brought in the Southern District of New York between 2002 and 2004, include five infringement actions brought by Enzo, as well as two brought by Affymetrix and Roche seeking declaratory judgments of noninfringement and invalidity of the patents-in-suit, which are U.S. Patent Nos. 4,711,955, 5,328,824, 5,449,767, 5,476,928, 5,241,060, 5,175,269, 4,707,440, and 4,994,373.  The seven cases were initially stayed in March 2009, when Enzo appealed a District of Connecticut decision invaliding four of the patents to the Federal Circuit.  The Federal Circuit overturned the findings of indefiniteness and anticipation on the '824 and '767 patents, and denied en banc review (see Patent Docs report).  On June 9, Applera filed a motion to stay the suit while it petitioned the Supreme Court to challenge the Federal Circuit's decision upholding the '824 and '767 patents.

On June 30, Judge Richard J. Sullivan ruled that the seven suits can remain stayed pending Applera's resolution of its pending petition for writ of certiorari to the Supreme Court.  Judge Sullivan additionally ordered the other parties in the case -- PerkinElmer Inc., Roche Diagnostics GmbH, Amersham PC, Molecular Probes Inc., Affymetrix Inc. and Orchid Biosciences Inc. -- to submit a follow-up joint status letter by July 28, notifying the District Court of any developments from the Supreme Court.

Judge Sullivan's order can be found here.

Apotex's Second Request for Reexamination of Plavix Patent Denied by USPTO

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.

Apotex first asked the USPTO for reexamination of the patent claims of the '265 patent last year, seeking a finding of invalidity.  The USPTO agreed to conduct the first reexamination, but the agency upheld the claims in March.  On April 5, Apotex filed a request for a second reexamination.  However, on June 23, the USPTO decided that Apotex had raised no substantial new question of patentability with respect to the '256 patent claims, and denied the request for reexamination.  The '265 patent is due to expire in November 2011.

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 degiulio@mbhb.com.

Comments

[Skeptical]

RE: Apotex

Has the rubber-stamp of automatically finding SNQ started wearing thin?