Teva sues two Indian generics over Huntington’s treatment
Teva Pharmaceuticals has filed lawsuits in New Jersey against two Indian generics manufacturers to stop them from developing a generic version of its Huntington’s disease treatment.
The Israeli pharma company filed both lawsuits with the US District Court for the District of New Jersey on Thursday, July 1, accusing the companies of filing Abbreviated New Drug Applications (ANDAs) to develop a generic of Teva’s Austedo drug prior to the expiration of the related patents.
The complaints accuse Lupin Pharmaceuticals of infringing four patents related to the Austedo, and Aurobindo of infringing six. The patents-in-suit are assigned to Teva subsidiary Auspex.
Lupin and Aurobindo sent letters to Teva on May 20, 2021, notifying the company that they had filed Paragraph IV Certifications—an FDA certification that asserts that certain patents are invalid, unenforceable or won’t be infringed by the manufacturing of a generic.—for the patents-in-suit.
Whereas Aurobindo held that all six of the patents related to Austedo were invalid or unenforceable, Lupin did not dispute the validity of US patent number 8,524,733 and US patent number 10,959,996.
Both generic manufacturers also notified Teva that they were seeking approval from the Food and Drug Administration (FDA) to develop a generic of Austedo.
Teva seeks a preliminary and permanent injunction against the generics manufacturers, barring them from manufacturing, marketing and selling the generics, as well as damages.
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