Janssen and Genmab sued for patent infringement in US

pharmafile | April 5, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Genmab, Janssen, darzalex, morphosys, patent infringement 

German biotech company, Morphosys, is suing Janssen and Genmab for alleged patent infringement in their oncology drug, Darzalex (daratumumab).

The claim relates to a patent filed in the US in February 2005 relating to antibodies that can be used to treat, among others, conditions such as multiple myeloma. Darzalex was approved by the FDA for the treatment of multiple myeloma in November and was approved in Europe in April of this year.

Darzalex is described as the first human CD38 monoclonal antibody to have been approved anywhere in the world. The 2005 Morphosys patent lays claim to “antigen-binding regions that are specific for CD38”.

US patent 8263746 B2 states: “The present invention provides recombinant antigen-binding regions and antibodies and functional fragments containing such antigen-binding regions that are specific for CD38, which plays an integral role in various disorders or conditions… The invention also provides nucleic acid sequences encoding the foregoing antibodies, vectors containing the same, pharmaceutical compositions and kits with instructions for use.”

In a statement, Morphosys says: “By its complaint, Morphosys seeks redress for the infringing manufacture, use and sale of Janssen’s and Genmab’s daratumumab, an antibody targeting CD38. Janssen and Genmab recently obtained FDA approval on daratumumab and are marketing the product as Darzalex in the US. Morphosys continues to develop MOR202, its own investigational human antibody to CD38, for the treatment of cancer, including multiple myeloma.”

A statement issued by Genmab simply stated that they, in cooperation with Janssen would determine the appropriate action in response to the complaint. The complaint has been filed at the US District Court of Delaware.

Sean Murray

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