Akzo Nobel and Organon Considering Next Moves Following Adverse Summary Judgement Ruling in Remeron Lawsuit Against Generics

Business Wire, Dec 19, 2002

Business Editors

ARNHEM, the Netherlands & WEST ORANGE, N.J.--(BUSINESS WIRE)--Dec. 19, 2002

Akzo Nobel and Organon Inc. confirm that the U.S. Federal District Court in Newark, NJ, has granted summary judgement on non-infringement in favor of Teva Pharmaceuticals USA, Inc. and Mylan Pharmaceutical Inc. in the patent infringement lawsuit concerning Remeron(R) tablets.

Akzo Nobel and Organon are studying the court's ruling to determine their next course of action. The lawsuit against Teva and Mylan alleges infringement of a patent covering the use of the antidepressant Remeron (mirtazapine) in combination with one or more SSRIs (selective serotonin reuptake inhibitors) for the treatment of depression.

As a result of this summary judgement Teva and Mylan can bring their generic version of Remeron to market in the United States as soon as the U.S. Food and Drug Administration (FDA) changes its tentative approval to final approval.

"Organon is disappointed with the court's decision. We are studying the ruling and will be considering our options. These may include appealing against this summary judgement in favor of generic manufacture," said Hans Radder, President of Organon Inc.

Fritz Frohlich, Chief Financial Officer for Akzo Nobel, commented: "The ruling on the Remeron case in the United States is a setback. It is too early to assess the exact effect on our overall Pharma performance but we have good products in the market to contain the fallout. Furthermore we will intensify our cost cutting programs at Organon. However R&D remains a priority to secure future growth.

A number of generic companies have submitted Abbreviated New Drug Applications (ANDAs) to gain marketing approval from the FDA for generic versions of Remeron in the United States. Akzo Nobel and Organon have started legal proceedings against them for infringement of their U.S. Patent Number 5,977,099 for the use of Remeron (mirtazapine) in combination with one or more SSRIs for the treatment of depression.

A court case against Teva and Mylan had been scheduled for 2003. Nevertheless such a schedule does not preclude parties from filing motions that may have a bearing on the case, including motions for summary judgement, which can bring about an early decision as has been the case in this instance.

Note for the editor

Akzo Nobel, based in the Netherlands, serves customers throughout the world with healthcare products, coatings and chemicals. Consolidated sales for 2001 totaled EUR 14 billion. The Company currently employs over 67,000 people in more than 80 countries. Financial results for the full year 2002 will be published on February 11, 2003.

Internet: www.akzonobel.com

www.organoninc.com