Genzyme Corp. v. Dr. Reddy’s Labs., Ltd.

Validity of patent-in-suit upheld in light of art determined to be non-analogous by patent examiner.

July 21, 2016

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Genzyme Corp. v. Dr. Reddy’s Labs., Ltd., C.A. No. 13-1506-(GMS), 2016 U.S. Dist. LEXIS 62056 (D. Del. May 11, 2016) (Sleet, J.)

Drug Product and Patent(s)-in-Suit: Mozobil® (plerixafor solution); U.S. Pat. No. 7,897,590 (“the ’590 patent”)

Nature of the Case and Issue(s) Presented: Genzyme owns the ’590 patent, which covers Mozobil, a drug that is used in combination with granulocyte-colony stimulating factor (“G-CSF”) for mobilizing hematopoietic stem cells to the peripheral blood collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma. Defendants Dr. Reddy’s (“DRL”) and Teva both filed ANDAs seeking approval from the FDA to market generic versions of Mozobil. DRL and Teva stipulated that if the ’590 patent were found to be valid, their generic products would infringe. The parties conducted a four-day bench trial, after which the District of Delaware concluded that the ’590 patent was valid.

Why Genzyme Prevailed: Defendants asserted that three prior-art references rendered the ’590 patent obvious. The first, the Hendrix publication, evaluated the safety of plerixafor in treating HIV. The patent examiner had previously determined that Hendrix was not analogous art. Defendants argued that the examiner did so without the benefit of testimony from hematologists regarding HIV-related research. Nevertheless, the court concluded that a POSA would not consider Hendrix pertinent to harvesting stem cells. Thus, as the examiner determined, Hendrix was not analogous art.

The other two prior-art patents taught the use of VLA-4 antigens to cause stem cell mobilization. Defendants argued that a POSA, based on Hendrix, would analogize plerixafor to VLA-4, rendering the claims obvious. The court disagreed, as it already rejected Defendants’ argument that Hendrix was analogous art.

Further, the secondary considerations of non-obviousness were in Genzyme’s favor. There was a long-felt, unmet, need for an improved stem-cell-mobilizing agent. Moreover, the use of plerixafor with G-CSF to produce rapid stem-cell mobilization defied expectations. Previously, mobilization agents were slow and unpredictable. Mozobil, on the other hand, was relatively fast-acting. Mozobil also received wide-spread industry praise throughout the world. For these reasons, the Court concluded that the ’590 patent was valid, and thus infringed by Defendants.

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