Genzyme Corporation, Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Laboratories / Teva Pharm. USA, Inc.

Docket Nos. 2016-2206, -2207

December 18, 2017


Brief summary: DC decision of nonobviousness found not to be clearly erroneous due to a lack of reasonable expectation of success in arguments (e.g., based on non-analogous art that focused on HIV treatment, not “on mobilizing stem cells for subsequent harvest and transplantation”).

Summary: Dr. Reddy’s (DRL) appealed DC decision that it did not prove claim 19 of Genyzyme’s US 7,897,590 (exp. 7/22/23) directed to a combination of G-CSF and the CXCR-4 antagonist plerixafor (marketed as Mozobil® for use in transplantion; NDA N022311; US 6,987,102 (exp. 7/22/23) and RE42152 (exp. 12/10/18)) is invalid for obviousness. The FC panel explained that “[t]he determination of obviousness is a legal conclusion based on underlying facts” (Allergan, FC 2013), and that the DC’s factual findings (“the scope and content of the prior art, the differences between the prior art and the claimed invention, the level of ordinary skill in the art, and any relevant secondary considerations”) are reviewed “for clear error and its conclusions of law de novo” (Honeywell, FC 2010). DRL argued ‘590 claim 19 was invalid for obviousness in view of three references (Hendrix (safety and pharmacology of plerixafor for treating HIV), WO ‘814 (relationship between plerixafor and white blood cell elevation), and US 5,824,304 (method for increasing stem cell numbers in blood using a blocking agent of VLA-4 antigens and G-CSF)). DRL argued the only difference between the claimed invention and the ‘304 patent is that the latter “does not teach that the blocking agent can be plerixafor” but that “Hendrix expressly suggested” it “could function as a blocking agent for releasing stem cells from the marrow.” The DC concluded “that Hendrix was not analogous art” because it was focused on HIV treatment, not “on mobilizing stem cells for subsequent harvest and transplantation.” Agreeing “that a person of ordinary skill in the art would have been aware of the need for a better stem cell mobilizing regimen,”, the parties “disputed the likelihood that CXCR-4 (and using plerixafor as a CXCR-4 antagonist) would become the object of research as a stem cell mobilizing agent.” The DC concluded DRL did not “show that a POSA would have pursued CXCR-4 over the field of cytokines and other possible stem cell mobilizers” and, without that focus, “Hendrix would not have been reasonably pertinent to an ordinarily-skilled artisan focused on harvesting stem cells.” Furthermore, even if Hendrix was “deemed analogous art”, the DC found, the use of plerixafor for stem cell harvesting was not “reasonably predictable” due to “a history of failure in the field[.]” The FC panel “principally” considered whether there would have been a “reasonable expectation of success” (Insite, FC 2005), and concluded DRL had not shown the DC’s conclusion to be erroneous (e.g., “[t]he record…shows the CXCR-4 is in a completely different family of receptors than VLA-4” and “stem cell mobilization was highly unpredictable at the time of the invention”). The FC panel did note that this is so even though “Hendrix hypothesized in an isolated sentence, without explanation, that plerixafor may cause stem cell mobilization” since “the rest of the seven-page article focused on the elevation of WBC counts” and “[t]he discussion of CXCR-4 being widely expressed was also directed to different types of WBCs rather than stem cells.” The combination of WO ‘814 and the ‘304 patent was also unconvincing for similar reasons (“It is also significant that a gap exists between using plerixafor to enhance WBC counts and for stem cell mobilization.”) Based on these conclusions, the DC decision was found not to be clearly erroneous. The evidence of secondary considerations was not considered.

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