Monday, July 8, 2013

Sandoz sues Amgen and Roche on Enbrel seeking invalidity and non-infringment of 182 and 522 patent

Sandoz has initiated a Phase 3 trial comparing its biosimilar version to Amgen's Enbrel. The trial will enroll 372 patients and is expected to complete in 2015. However, even if Sandoz is able to prove its copy is biosimilar to Amgen's Enbrel, it may still not be able to enter the market, as Enbrel continues to be protected by 182 and 522 patent which are set to expire in 2028 and 2029 respectively. 

Sandoz believes that the 522 and 182 patent and invalid and  hence Sandoz Inc. is seeking an declaratory judgment of patent non-infringement and invalidity against  Amgen Inc., and Hoffmann-La Roche Inc.   Hoffman la Roche is the owner of the patents 522 and 182, and it has exclusively licensed the same to Amgen.

According to Sandoz,  the original application to which the '182 patent claims priority, U.S. Patent
Application No. 07/580,013, was filed in 1990, more than twenty-one years before the '182 patent issued. Throughout the prosecution of the '182 patent, the claims were primarily, and for a time exclusively, focused on a protein and method of manufacturing the protein that is not etanercept. It was not until 2005, fifteen years later and around the time that Sandoz began its development program, that the prosecution focus shifted to a protein that Amgen claims is etanercept. No substantive prosecution began on the claim that purportedly cover etanercept until 2005.

The '522 patent claims priority to the same original 1990 application, the '013 application as the '182 patent. Like the '182 patent, the prosecution of the '522 patent was unreasonably and inexplicably delayed due to Amgen's and Roche s belated change in the focus of the claims late in prosecution to those purportedly cover ng etanercept. Prior to issuance, Sandoz acquired intervening rights. According to Amg n, the term of the '522 patent is presently set to expire April 24, 2029, 39 years after the riginal application was filed.

Sandoz alleges as follows

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