Agenix Limited has announced that Japan's Patent Office had granted a key patent covering the manufacturing process of its ThromboView® imaging agent for the detection of blood clots in humans.
Agenix Chairman and Chief Executive Officer, Nicholas Weston said, "The granting of patent protection in Japan confers further certainty and significantly increases the commercial value of the ThromboView diagnostic technology globally. In conjunction with the other patents covering the use and production of ThromboView, this new patent delivers a major commercial advantage to Agenix in one of the world's leading markets for diagnostic imaging and manufacturing.”
Japanese Patent Application Number 2003-507139 covers humanized antibodies derived from DD-3B6/22 specific for the D-dimer fragment of fibrin provides long-term protection for the company's technology through broad claims over methods of manufacture and use.
It is a major asset in the commercialization of ThromboView and establishing strategic business partnerships with global pharmaceutical and medical diagnostic companies.
ThromboView is now protected by multiple patents in the Japan, the United States, Europe, Singapore, Australia and New Zealand, with the granting of patents for China and Canada pending.
The patents provide protection for ThromboView out to 2022 with possible Hatch-Waxman term extension out to 2027.
Legislation in the EU, US and Japan grant biologics a period of 10, 12 and 6 years of data exclusivity, respectively, from the time of registration and this is likely to considerable enhance ThromboView’s protection in those markets.
Building upon and continuing to expand its international patent portfolio is fundamental to the commercial strategies of Agenix.
ThromboView will potentially provide medical professionals with a new way to accurately detect live blood clots and pulmonary embolisms in the human body without the exposure to high chest radiation and toxic chemicals used currently.
ThromboView has successfully completed two Phase II human clinical trials in the United States and there is a large body of independent clinical evidence that shows ThromboView is safe and effective.
Agenix is in discussions with potential partners in multiple geographies to partner or license the technology in order to complete its Phase III clinical study ahead of its market launch.