Amerigen’s petition leads to U.S. Zytiga® patent invalidation



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Lyndhurst NJ, USA, January 18, 2018 — In relation to the recently announced decision by the Patent Trial and Appeal Board (“PTAB”) on Amerigen Pharmaceuticals Limited’s inter partes review (IPR2016-00286), challenging U.S. Patent 8,822,438 B2 (owned by Janssen Oncology, Inc.), John Lowry, Amerigen’s President & CEO commented as follows “We are very pleased with the decision by the PTAB to invalidate all claims of the ‘483 patent, which is the sole unexpired Orange Book listed patent for Zytiga® (abiraterone acetate). We believe that the PTAB’s decision demonstrates that the judges carefully considered all of the available evidence presented by the parties. The outcome validates our decision to be the first to file a petition on the ’438 patent and Amerigen will continue to work diligently to obtain FDA approval for its pending ANDA and bring a generic version of abiraterone acetate to patients as soon as possible.”

Amerigen was represented during the hearings on IPR2016-00286 by William Hare of McNeely Hare & War LLP.

Zytiga® is a trademark of Janssen.


Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ, USA. The group's Chinese subsidiary, Suzhou Amerigen Pharmaceutical Company Limited, is located in Suzhou, Jiangsu Province. The group has products on the market currently in both the US and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA's with the US FDA and the Chinese CFDA. Amerigen's focus is orally delivered products that are potential first generics, challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen's products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.