Plerixafor – USA

Plerixafor – USA

On Aug 16, 2019, Federal Circuit affirmed (Rule 36 judgment) district court that found Mozobil® patent valid & infringed.

District court decision:

Plaintiffs (Genzyme/Sanofi) alleged infringement of U.S. Patent No. 6,987,102 and U.S. Patent No. 7,897,590 both entitled “Methods to Mobilize Progenitor/Stem Cells,” against Zydus, which filed ANDA with USFDA. Zydus stipulates to infringement, but responds in counterclaims that the asserted claims of the patents-in-suit are invalid. A four-day bench trial was held on March 26-27, 2018, and April 10-11, 2018. District court on Aug 8, 2018 rendered judgment & held that both patents are valid as Zydus failed to prove by clear & convincing evidence that asserted claims are obvious over cited prior arts. Specifically, court said that though there was motivation to combine the prior arts but there was no reasonable expectation of success. Because: 
1. Mechanism of action of stem cell mobilisation was unclear. 
2. Known agent such as G-CSF was known to increase the CXCR4 activity rather than decrease & 
3. Though some CXCR4 antagonist or antibodies have blocking activity but they were failed to mobilise sufficient quantity of stem cells. 
Moreover, some secondary considerations supported non-obviousness.

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