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Roche, Shire court fight escalates over haemophilia drug

From Reuters - December 16, 2017

ZURICH (Reuters) - Roches patent dispute with London-listed Shire over the Swiss drugmakers new haemophilia drug Hemlibra has escalated, with Shire filing a new motion in a U.S. court that Roche says aims to stop some patients from getting its medicine.

Shires motion for a preliminary injunction is part of an ongoing case in which it contends Roche infringed on a key patent to develop Hemlibra, approved in November by the U.S. Food and Drug Administration.

The patent dispute at the U.S. district court of Delaware underscores Hemlibras potential to take business from Shire, with some analysts estimating Roches roughly $450,000-per-year drug will hit $5 billion in annual sales by muscling in on older drugs for the genetic disease whose sufferers blood does not clot properly.

In a press release late last week, Shire said it expected a judge to rule next year.

Until the courts decision on the motion for the preliminary injunction, expected summer 2018, is made there will be no patient impact, Shire said in a statement.

Shire has proactively proposed a carve-out provision to facilitate access for patients, but the scope of the provision is ultimately a matter for the court to decide.

There are about 20,000 people in the United States with the disease and 400,000 worldwide, according to the National Hemophilia Foundation.

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