RMMS Defeats Motion for Temporary Restraining Order Involving Generic Piperacillin/Tazobactam Injections

On September 24, 2009, the U.S. District Court for the District of Columbia denied a motion for temporary restraining order that would have prevented the firm's client, Apotex Corporation, from continuing to distribute the first generic piperacillin/tazobactam product. Plaintiff Wyeth Pharmaceuticals filed its motion against the U.S. Food and Drug Administration in order to prevent the marketing of FDA-approved generic version of Zosyn® (piperacillin/tazobactam). The denial permits the firm's client to continue distributing the first generic version of Zosyn®, as Wyeth continues its case against FDA.

RMMS Secures Federal Circuit En Banc Ruling Affirming Summary Judgment Of Noninfringement Involving Generic Cefdinir

On May 19, 2009, the U.S. Court of Appeals for the Federal Circuit issued a ruling affirming the U.S. District Court of the Eastern District of Virginia's finding that Lupin's generic cefdinir drug product does not infringe U.S. Patent No. 4,935,507. In the litigation, Astellas Pharma and Abbott Laboratories sought to prevent Lupin's marketing of a generic equivalent to Omnicef® (cefdinir). After RMMS secured an early advantageous claim construction ruling, Lupin was able to secure a noninfringement victory on summary judgment on all claims. On appeal, the Federal Circuit affirmed the claim construction and noninfringement ruling. In that opinion, the Federal Circuit addressed en banc an issue that had been vexing prior district courts for nearly two decades: the appropriate way to construe claims known as "product by process" claims. This decision is expected to have long-ranging impact in the pharmaceutical, chemical and biotechnology areas.

This victory enables Lupin to continue marketing its generic cefdinir product, and continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.

Deanne Mazzochi argued the case before the Federal Circuit. Also involved in the underlying litigation and appeal were Paul Molino, William Rakoczy, Amy Brody, Tara Raghavan, John McGuirk and Eric Hunt.

RMMS is proud to congratulate our partner, Christine J. Siwik, on being named one of 2008's "40 Illinois Attorneys Under Forty To Watch" by the Law Bulletin Publishing Company, publisher of the Chicago Daily Law Bulletin and Chicago Lawyer.

Ms. Siwik was recognized for her national reputation as a patent litigator, her commitment to clients, her knowledge and experience in the pharmaceutical industry, her work on federal patent and food and drug legislation, and her contributions to the community.

Ms. Siwik has been helping clients develop legal strategies and litigating generic pharmaceutical patent cases since 1995. She works closely with clients that have drug applications pending before the U.S. Food and Drug Administration, and assists clients in developing long-term legal and business strategies for developing, obtaining regulatory approval for, and launching pharmaceutical products.

RMMS Defeats Motion for Temporary Restraining Order and Preliminary Injunction Involving Generic Ramipril Capsules

On June 10, 2008, the U.S. District Court for the District of Maryland denied a motion for temporary restraining order and preliminary injunction against the firm's clients, Lupin Limited and Lupin Pharmaceuticals, Inc. Plaintiffs King Pharmaceuticals, Inc. and King Pharmaceuticals Research and Development, Inc. filed their motion in order to prevent Lupin from bringing its FDA-approved generic version of Altace® (ramipril) capsules to the market pending resolution of the underlying patent infringement litigation. After considering the briefing and hearing oral argument from the parties, the Court ruled from the bench, finding that Plaintiffs had not established a likelihood of success on the merits, and denied Plaintiffs' motion.

This victory enabled Lupin to immediately launch its products and be among the first generic companies to offer generic ramipril capsules, 1.25 mg, 2.5 mg, 5 mg and 10 mg. This ruling follows the firm's successful challenge to another patent asserted against Lupin by King, which first opened the ramipril market to generic competition in 2007.

RMMS Defeats Motion for Preliminary Injunction Involving Generic Clobetasol Propionate Foam Products

On March 19, 2008, RMMS successfully defeated Plaintiffs Connetics Corporation and Connetics Australia Pty. Ltd.'s motion for preliminary injunction against the firm's client, Perrigo Israel Pharmaceuticals Ltd. (formerly Agis Industries (1983) Ltd.). After briefing and hearing argument on Plaintiffs' motion to enjoin Perrigo from launching its FDA-approved generic version of Olux®, the U.S. District Court for the District of New Jersey denied Plaintiffs' motion from the bench. As a result of this ruling, Perrigo is now on the market with its generic clobetasol propionate foam product.

RMMS Defeats Motion for Preliminary Injunction for Generic Client in Patent Dispute

On April 25, 2006, the U.S. District Court for the District of Arizona issued a 15-page opinion denying a motion for a preliminary injunction against RMMS's client, Prasco, LLC. After briefing and a hearing before the Court, RMMS defeated Plaintiff Medicis Pharmaceutical Corporation's motion, which called for the removal of Prasco's product from the market. As a result, Prasco was able to keep its generic product on the market pending the outcome of the underlying patent litigation against Medicis.

Please see "Pressure Rises for FDA, Congress in Latest Drug Duel" by Christine Hines of the Legal Times.

RMMS Partner Testifies Before Congress On Important Patent Reform Issues

In July 2005, Partner Christine J. Siwik testified before U.S. Senate, Committee on the Judiciary, Subcommittee on Intellectual Property, at a hearing entitled "Perspective on Patents: Harmonization and Other Matters." Presently, both the U.S. Senate and House of Representatives are considering legislation that could significantly change the patent laws. Through her testimony, Ms. Siwik sought to protect the interests of the generic pharmaceutical industry. A copy of Ms. Siwik's written testimony can be found at http://judiciary.senate.gov/hearing.cfm?id=1582.

RMMS Wins Summary Judgment of Non-Infringement for Generic Client in Patent Dispute Involving Pfizer's Blockbuster Prescription Drug Neurontin®

On August 22, 2005, the U.S. District Court for the District of New Jersey issued two 30-page decisions granting summary judgment on non-infringement for RMMS's generic client, Apotex, on Pfizer's U.S. Patent No. 6,054,482 for Neurontin®, a prescription drug approved to treat seizure and postherpetic neuralgia. In the long-running patent dispute dating back to 1998, RMMS attorneys have successfully obtained judgments for Apotex on all 3 of Pfizer's Neurontin® patents.