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US Court rules in favour of Zydus in ulcerative colitis drug patent case

It ruled that Zydus' generic version of Lialda (mesalamine) does not infringe patent of Shire

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Last Updated : May 10 2017 | 3:43 PM IST

The US Court of Federal Circuit has affirmed judgement in favour of Zydus Pharmaceuticals (USA) Inc, the US-based subsidiary of Zydus Cadila, holding that its proposed generic version of Lialda (mesalamine) does not infringe US Patent (No 6,773,720) of Shire. Zydus was the first pharmaceutical company to file an abbreviated new drug application (ANDA) for a generic version of Lialda.

Lialda is indicated for the induction of remission of active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC. Ulcerative colitis - a chronic inflammatory bowel disease that causes inflammation in the digestive tract - affects approximately 700,000 people in the US.

Earlier, in September 2016, the US District Court for the District of Delaware ruled that a proposed Lialda generic made by Zydus Pharmaceuticals does not infringe US Patent No 6,773,720. Following this ruling, Shire had appealed to the Court of Appeals to the Federal Circuit.

With the Court of Appeals ruling in Zydus flavour, the company has taken a major step towards providing a generic version of Lialda (mesalamine) in the US. Shire has reported annual sales of $ 714 million for this product in 2016 in the US.

Pankaj Patel, chairman and managing director, Zydus Cadila, said, "We welcome this decision which is a positive step and will help us further our mission of making available high-quality, affordable generic products to our customers and their patients."