爱美津上诉申请导致美国Zytiga®专利无效

2018年1月18日

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美国新泽西州林德赫斯特,2018年1月18日,消息 – 就专利上诉委员会最近宣布的关于爱美津制药有限公司挑战美国专利8,822,438 B2(专利拥有人强生肿瘤股份有限公司)双方专利复审(IPR2016-00286)的决定,爱美津总裁兼首席执行官John Lowry表示:“我们对于专利上诉委员会有关8,822,438专利所有权申请无效的决定感到十分高兴,这是Zytiga®(醋酸阿比特龙)唯一未到期的橙皮书专利。我们认为,专利上诉委员会的决定表明,法官仔细考量了各方提供的所有证据。该结果验证了我们的成为第一个针对8,822,438专利上诉申请的决定,爱美津将继续努力获得美国食品药品监督管理局批准其正在申请的简略新药申请,并尽快为患者提供醋酸阿比特龙的仿制药产品。
爱美津出席了来自McNeely Hare & War LLP律师事务所的 William Hare的双方专利复审(IPR2016-00286)听证会。
Zytiga®是强生所拥有的商标。

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 8,822,438 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 8,822,438 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.


关于爱美津 About Amerigen

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.

爱美津制药致力于仿制药所涉及到的全部阶段的业务,是一家包括美国和中国多成员企业的集团公司。集团由爱美津制药控股。美国市场的注册和商业活动由位于新泽西州,林赫斯特的美国爱美津负责;集团的中国分公司,苏州爱美津制药有限公司,位于中国江苏省苏州市。爱美津制药集团目前在美国以及中国均有药品上市和销售,同时,我们拥有活跃的在研产品组,面向美国食品药品监督管理局(FDA)注册和已申报若干个仿制药品种(ANDA),并且计划开展向中国食品药品监督管理局(CFDA)注册和申报产品的工作。爱美津从事开发的口服制剂产品,是开发难度高,需要专门的技术,或生产要求高度严格管理控制,以及法规复杂,需要规避或挑战专利的仿制药。爱美津集团旗下公司或合作方开发和生产的所有产品,都满足高质量标准,包括美国FDA。