Green Leaf Pharmaceutical Risperidone Microsphere Development Progress Successfully Sino-US Listing Application Crossing Patent Barriers

On the evening of November 23, Beijing time, green leaf pharmaceutical issued an announcement confirming that the new drug risperidone sustained-release microsphere intramuscular injection preparation (LY03004) in the United States NDA (submitted for new drug marketing application) will not be adversely affected by any potential regulatory approval arising from Hatch-Waxman patent litigation (US6667061 filed by the owner of the '61 patent on the NDA challenging the LY03004).

Prior to this, the US Food and Drug Administration confirmed in October 2015 that Green Leaf Pharmaceuticals LY03004 submitted NDA and did not need to conduct any clinical trials.

During the LY03004 NDA process, there was doubt as to whether the LY03004 suspension fell within the scope of a patent now registered in the United States by a third party (the "'61 patent"). In view of this, on May 31, 2016, Luye Pharmaceuticals filed a mutual review ("IPR") petition to the Patent Trial and Appeal Board ("PTAB") of the United States Patent and Trademark Office regarding the validity of the '61 patent. PTAB initiated the IPR process on November 30, 2016, and conducted an oral hearing on August 28, 2017. According to the record of the oral hearing, the owner of the '61 patent confirms that the requirement in his patent that the viscosity of the suspension be "about 20cp" means that the viscosity is "greater than 19.7cp 」. Because the viscosity of the LY03004 is less than 19.7cp, Greenleaf Pharmaceuticals believes that LY03004 will not fall within the scope of the '61 patent, regardless of the final decision of PTAB on the validity of the '61 patent, based on the principle of estoppel. For the above reasons, Green Leaf Pharmaceuticals is confident that LY03004 NDA will not be adversely affected by potential regulatory approvals arising from any Hatch-Waxman patent litigation (filed by the '61 patent owner in relation to the NDA challenging the LY03004) (which patent litigation (if any) will delay the NDA process by 30 months).

Green Leaf Pharmaceutical Group has always valued and respected intellectual property rights. Before the establishment of the LY03004 research and development project, the relevant intellectual property rights have been investigated, and products that do not fall within the scope of patent protection for similar products have been developed, and clinical trials have been carried out in the United States. In order to avoid unnecessary infringement challenges for LY03004 in the NDA declaration stage in the United States, Green Leaf has successively initiated the confirmation procedure for the '61 patent and its and European family patents in China, the United States and Europe, and intends to confirm through the confirmation procedure that Green Leaf LY03004 does not fall into the protection scope of the '61 patent and its and European family patents. LY03004 was granted two US patents in 2016 and 2017 respectively.

In addition, on February 16, 2017, the Patent Reexamination Board of the State Intellectual Property Office of China made a reexamination decision, declaring all Chinese family patents of the '61 patent invalid.

Green leaf pharmaceutical has reached the international advanced level in the field of microsphere, liposome, transdermal drug release and other new preparation technology research, and the microsphere products to be launched in the future are also expected by the market at home and abroad.

News source:http://news.bioon.com/article/6713491.html

This news was re-edited and reorganized by the Huaxun team and added analytical comments.