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Court Report

    By Sherri Oslick —

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About
Court Report:  Each week we will report briefly on recently filed
biotech and pharma cases, and a few interesting cases will be selected
for periodic monitoring.


Lonza Group AG v. Northwest Biotherapeutics Inc.
1:07-cv-00467; filed July 27, 2007 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,122,464 ("Method for Dominant Selection in Eucaryotic Cells," issued June 16, 2992), 5,591,639 ("Recombinant DNA Expression Vectors," issued January 7, 1997), 5,658,759 (same title, issued August 19, 1997), 5,770,359 ("Recombinant DNA Sequences, Vectors Containing Them and Method for the Use Thereof," issued June 23, 1998), 5,827,739 (same title, issued October 27, 1998), 5,879,936 ("Recombinant DNA Methods, Vectors and Host Cells," issued March 9, 1999), 5,891,693 (same title, issued April 6, 1999), and 5,981,216 ("Transformed Myeloma Cell-Line and a Process for the Expression of a Gene Coding for a Eukaryotic Polypeptide Employing Same," issued November 9, 1999) based on Northwest’s manufacture and anticipated sale of its DCVax® products, including DCVax®-Brain, used to treat brain cancer.  View the complaint here.


Astrazeneca AB et al. v. Dr. Reddy’s Laboratories, Ltd. et al.
1:07-cv-06790; filed July 27, 2007 in the Southern District of New York

Infringement of U.S. Patent Nos. 5,690,960 ("Pharmaceutical Formulation of Omeprazole," issued November 25, 1997) and 5,900,424 ("Omeprazole Magnesium Salt Form," issued May 4, 1999) following a paragraph IV certification as part of Dr. Reddy’s filing of an ANDA to manufacture a generic version of Astrazeneca’s Prilosec OTC (omeprazole magnesium, used to treat heartburn).  View the complaint here.  [NB: While the complaint recites Astrazeneca’s Nexium® as the subject of the ANDA filing, Patent Docs has reason to believe that this was an inadvertent error in the complaint, and that plaintiffs intended to refer to Prilosec OTC.]

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2 responses to “Court Report”

  1. Sandeep K. Rathod Avatar
    Sandeep K. Rathod

    In your latest patent report, you have mentioned that Astra has sued Dr. Reddys’ Laboratories on two patents ‘following a paragraph IV certification as part of Dr. Reddy’s filing of an ANDA to manufacture a generic version of Astrazeneca’s Nexium® (esomeprazole magnesium, used to treat heartburn)’. I downloaded the complaint that you had linked there.
    I saw that Astra only refers to the product as Omeprazole [used in Prilosec OTC]. It does not use the term “Esomeprazole” which is the drug used in Nexium.
    Importantly, Astra’s own 2007 Q 2 filing discloses the following:
    Losec™/Prilosec™ (omeprazole)
    ….
    In June 2007, AstraZeneca received a notice from Dr. Reddy’s Laboratories, Ltd. and from Dr. Reddy’s Laboratories, Inc. (Dr. Reddy’s) that Dr. Reddy’s had submitted an ANDA seeking FDA approval to market a 20mg delayed release omeprazole magnesium capsule for the over-the-counter (OTC) market. Dr. Reddy’s seeks approval to market a generic omeprazole OTC product before the expiration of the patents listed in the FDA Orange Book in reference to the Prilosec™ OTC product that is marketed by Procter & Gamble. AstraZeneca is evaluating Dr. Reddy’s notice.
    Is it possible that the present ANDA in question [78-878] is for the Prilosec OCT and not Nexium?

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  2. Sherri L. Oslick Avatar
    Sherri L. Oslick

    Sandeep – You raise an excellent point. It does appear from AZ’s Q2 filing that the ANDA at issue is most likely directed to Prilosec OTC, despite the fact that the complaint refers to Nexium. Perhaps the reference to Nexium was simply an inadvertent error in the complaint. While technically Nexium (esomeprazole magnesium) is a form of omeprazole magnesium (i.e., the S(-) enantiomer), “omeprazole magnesium” is commonly used in reference to Prilosec OTC. We have updated our post to reflect the likelihood that the suit is in fact based on an ANDA to manufacture a generic version of Prilosec OTC. Thanks for your diligence in noticing this and providing your thoughts. Much appreciated.

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