Sanofi, owner of the ‘590 patent covering the formula for the stem cell mobilizing agent called Mozobil, asserted its rights when the Defendants filed their ANDA request hoping to create a generic version of the drug.  The matter was presented to Judge Gregory Sleet, himself a veteran of hundreds of ANDA matters, and after months of hearings and a one-week presentation of witnesses and key evidence, Judge Sleet sided with TFP’s client and ruled that the patent was indeed novel and valid.

The Focal Point’s Role

The Focal Point worked with the client in the months leading up to trial creating demonstratives for Opening as well as numerous fact witnesses and expert witnesses.  The focus was to teach the court about the novelty of the patent and to prove, via the data of numerous in vitro tests, that the discovery of this compound for the use in stem cell mobilization was completely new and novel.  Defendants tried to compare the compound to a myriad of prior art to prove their case but the Court did not agree. The Focal Point was at meetings in Chicago, on site in Delaware and also provided quick turnaround graphics for various meetings and presentations to European-based experts. 


A week long bench trial in Delaware led to the Court’s finding that the Plaintiff’s asserted patent covering the stem cell mobilizing drug Mozobil was valid and that Defendants could not create a generic version prior to the patent’s expiration without a proper license. 


US District Court for the District of Delaware

The Focal Point’s Client

MBHBPaul Berghoff
Alison Baldwin
Paula Fritsch
Kurt Rhode