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US Court Of Appeals affirms Cumberland's victory in patent litigation case

Published 31 January 2017

The US Court of Appeals for the Federal Circuit ruled in favor of Cumberland Pharmaceuticals in a patent case associated with its Acetadote product.

The Appeals Court ruling affirmed the September 30, 2015 decision reached by the United States District Court for the Northern District of Illinois upholding Cumberland's patent and expressly rejecting Mylan Inc. and Mylan Institutional LLC's challenge of patent validity. 

Cumberland developed, registered, and launched Acetadote, which is now a standard of care for the leading cause of poisoning in the U.S.  The patent that was challenged has claims associated with Cumberland's next-generation formulation of Acetadote that is free of EDTA or any other preservative, chelating, or stabilizing agent.

Through this new formulation of Acetadote, Cumberland has been able to retain a significant market share in spite of generic competition that utilizes the old formulation of the product. By ruling in Cumberland's favor, the Appeals Court upheld the validity of the patent which encompasses Cumberland's EDTA-Free formulation and has a term until August 2025.

"We are very pleased with this outcome," said A.J. Kazimi, Cumberland CEO. "We look forward to continuing the supply of this potentially life-saving product in support of the healthcare professionals who administer it, and especially the patients who need it. Meanwhile, we will also continue to protect and defend Cumberland's intellectual property."

The Company continues to seek additional patent claims to protect its intellectual property associated with Acetadote and has additional patent applications related to Acetadote® pending with the US Patent Trademark Office (USPTO).

Source: Company Press Release