Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
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In a nonprecedential decision, the U.S. Court of Appeals for the Federal Circuit affirmed a 2016 ruling from a federal district court in Delaware upholding Genzyme’s patent on the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 Cir., 2016-2206, 2016-2207, nonprecedential 12/18/17 .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 firstname.lastname@example.org
To contact the editor responsible for this story: Brian Broderick at email@example.com
The ruling is at http://src.bna.com/u52.
Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)