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Last Updated : Sep 23, 2013 01:56 PM IST | Source: PTI

Genzyme corp files patent infringement suit against DRL

In its petition filed in the District Court of Delaware, Genzyme alleged that DRL intimated though a letter that it had submitted an Abbreviated New Drug Application with US FDA seeking approval to engage in the commercial manufacture, importation, use, and sale of 20 mg/ml Plerixafor injection as a generic version of Mobozil drug.

 
 
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Genzyme Corporation, a fully-owned subsidiary of drug major Sanofi-Aventis, has filed a suit against Dr Reddy's Laboratories alleging that the Indian drug maker infringed patents of its blockbuster cancer drug Mozobil on three counts.


Mozobil (plerixafor injection) is a hematopoietic stem cell mobiliser indicated to patients with non-Hodgkin's lymphoma (blood cancer) and multiple myeloma.


In its petition filed in the District Court of Delaware, Genzyme alleged that DRL intimated though a letter that it had submitted an Abbreviated New Drug Application with US FDA seeking approval to engage in the commercial manufacture, importation, use, and sale of 20 mg/ml Plerixafor injection as a generic version of Mobozil drug.


Also read: US FDA alert puts Ranbaxy under scanner of other regulators


"DRL's ANDA was submitted to obtain FDA approval to engage in the commercial manufacture, importation, use, and sale of DRL's Plerixafor ANDA Injection Product prior to the expiration of '152 patent, the '590' patent, and '102' patent, all of which are listed in the FDA publication entitled 'Approved Drug Products with Therapeutic Equivalence Evaluation' (the Orange Book) as being applicable to Genzyme's Mozobil drug product," Genzyme said in the petition.


While one of the patents of the drug would expire on December 10, 2018 while other two patents--patent '590' and patent '102' on July 22, 2023, the US drug-maker said.


Genzyme sought the court to declare that DRL's making, using, selling, offering to sell, or importing its Plerixafor ANDA Injection Product by DRL is infringement of one or more claims of the patents.


According to Sanofi's 2012 annual report, Mozobil contributed Euros 96 million to its revenues.

However, patent litigation against generic drug makers is common in USA and the legal process will not have any significant implications on DRL, according to an industry expert.

First Published on Sep 22, 2013 01:58 pm
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