Genzyme takes on Mylan in patent suit

Biotechnology company Genzyme has sued generic manufacturer Mylan in a lawsuit claiming that the company has infringed one of Genzyme’s patents covering the Clolar (clofarabine) injection drug.

The complaint, filed at the US District Court for the Northern District of West Virginia on September 23, was made after Mylan sought approval from the US Food and Drug Administration to produce a generic version of the paediatric leukaemia treatment.

The Abbreviated New Drug Application was filed before the expiration of US patent number 5,661,136. With a patent term extension, the patent will expire in January 2018.

Mylan notified Genzyme on August 9 that it was seeking approval to manufacture the proposed drug.

In its notice, Mylan claimed that the patent was invalid and unenforceable and therefore would not be infringed by its proposed generic.

“These acts have led and will lead to foreseeable harm and injury to plaintiffs,” said the filing.