Dr. Reddy’s Stymied on Stem Cell Transplant Generic Drug

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By Dana A. Elfin

Drugmaker Dr. Reddy’s Laboratories Ltd. lost its bid to overturn a patent ruling in favor of Genyzme Corp.

In a nonprecedential decision, the U.S. Court of Appeals for the Federal Circuit affirmed a 2016 ruling from a federal district court in Delaware upholding Genzyme’s patent on the stem cell transplant drug Mozobil against generic challengers.

The ruling means that generic Mozobil can’t come onto the market until its patent expires on July 22, 2023, according to the FDA’s Orange Book.

The Orange Book is a listing of patents that branded drugmakers claim cover their products and is formally titled “Approved Drug Products with Therapeutic Equivalence Evaluations.”

Mozobil (plerixafor solution 20 mg/mL for subcutaneous injection), which the Food and Drug Administration approved in 2008, mobilizes stem cells in the bloodstream for collection and subsequent transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma. The drug makes it more likely for patients with certain types of cancers to proceed to stem cell transplant.

The district court conclusion that Dr. Reddy’s and codefendant Teva Pharmaceuticals USA Inc. didn’t clearly and convincingly prove U.S. Patent No. 7,897,590 (the ’590 patent) was invalid for obviousness was buttressed by the record on the prior art, Judge Raymond T. Chen said, and didn’t support Dr. Reddy’s argument for reversal.

The ‘590 patent claims methods to mobilize progenitor/stem cells. Co-plaintiff Sanofi-Aventis US LLC is an exclusive licensee on the ‘590 patent and shares in the revenue from Mozobil sales.

Genzyme is based in Cambridge, Mass. Sanofi is based in Bridgewater, N.J.

Dr. Reddy’s Laboratories, based in Princeton, N.J., is a subsidiary of Indian company Dr. Reddy’s Laboratories Ltd. Teva Pharmaceuticals USA Inc., a subsidiary of Israeli company Teva Pharmaceuticals Ltd., is based in North Wales, Pa.

McDonnell, Boehnen, Hulbert & Berghoff, LLP represented Genzyme and Sanofi.

Cozen O’Connor represented Dr. Reddy’s and Teva.

Goodwin Procter LLP also represented Teva.

In addition to Chen, Judges Kimberly A. Moore and S. Jay Plager and also heard oral argument in the case.

The case is Genzyme Corp. v. Reddy’s Labs., Ltd , 2017 BL 451226, Fed. Cir., 2016-2206, 2016-2207, nonprecedential 12/18/17 .

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bloomberglaw.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bloomberglaw.com

For More Information

The ruling is at http://src.bna.com/u52.

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