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In a boon for eye care specialist Nicox, the United States Patent and Trademark Office (USPTO) has confirmed that one of its three patents covering a glaucoma treatment could be extended by up to five years.
Under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (also known as the Hatch-Waxman Act) certain patents for pharmaceutical products in the US may be extended by up to five years once product approval from the US Food and Drug Administration (FDA) has been obtained.
Nicox’s patents are presently valid until 2025, but the France-based company contends that each of these patents could be extended by the maximum five years allowable under the Hatch-Waxman Act.
The company will have to await the FDA’s determination on the appropriate duration of the any granted extension, while the USPTO’s final decision regarding the patents’ extension is expected in two to three years. Nicox would then be able to select one of the three patents to be extended.
Nicox announced the decision today, April 22.
Michele Garufi, chairman and chief executive officer of Nicox, said “Vyzulta was launched in the US in December 2017 by our exclusive global licensee Bausch + Lomb. The extension of the patents covering this product would ensure a long-term revenue source for the company as we continue the development of our clinical assets NCX 470 in glaucoma and NCX 4251 in blepharitis.”
Nicox invented and patented latanoprostene bunod, which became the first product from the company’s proprietary nitric oxide-donating research platform to be approved for commercialisation.
Vyzulta is also marketed and sold in Canada, Argentina, Mexico and Hong Kong, and has been approved in five other countries including Brazil, Colombia, South Korea, Taiwan and Ukraine.
Under the terms of its exclusive global license agreement with Bausch + Lomb, Nicox receives increasing tiered royalties of 6% to 12% on net global sales of Vyzulta, plus up to $150 million in potential future milestone payments.
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Nicox, patents, extension, USPTO, FDA, Hatch-Waxman Act