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First blood to Roche in Hemlibra patent fight with Shire

The new haemophilia drug does not infringe Baxalta’s patent, rules Tokyo court

Roche

Roche’s defence of its haemophilia drug Hemlibra against a patent infringement challenge by Shire has been buoyed by a Japanese ruling.

A Tokyo court has found in favour of the Swiss group and recommended that Shire’s challenge against majority-owned Japanese affiliate Chugai should be dismissed. While the ruling doesn’t have a direct bearing on additional challenges outside Japan, Roche has been buoyed by the result.

In a statement, the company said the court ruled that Hemlibra (emicizumab) “does not infringe patent 4313531, held by Shire’s wholly-owned subsidiaries Baxalta Inc and Baxalta GmbH”.

Hemlibra has been approved in the US, Europe and Japan to prevent or reduce the frequency of bleeding episodes in patients with haemophilia A who have developed inhibitors to Factor VIII. It is a first-in-class bispecific factor IXa- and factor X-directed antibody - delivered by subcutaneous injection once a week - and in trials has been shown to reduce the number of bleeding episodes in these patients as well as improve physical functioning.

With Hemlibra, Roche is trying to break into a market for haemophilia drugs worth around $7bn in the world's top seven markets (US, France, Germany, Italy, Spain, the UK and Japan) last year. The haemophilia A with inhibitors category is currently dominated by Shire and Novo Nordisk with its Feiba and NovoSeven bypassing agents (PBAs).

Approval of the drug came after a protracted battle with Shire which - along with allegations of patent infringement in the US filed in a Delaware district court - has also focused on what Shire claims was deliberate misinformation about its drugs made by Roche.

A ruling on the US patent battle could come later this year, according to Shire, which filed a motion for preliminary injunction against Roche and Chugai last December claiming that Hemlibra infringes its US patent 7,033,590.

At the time, Shire said it was “not seeking a blanket prohibition of emicizumab sales, but rather the request proposes a carve-out to enable those patients with the greatest need to continue to have access to the treatment”.

Analysts have suggested Hemlibra could eventually become a $1.5bn product at peak, eclipsing Shire’s inhibitor therapies, which made around $450m in sales last year.

Article by
Phil Taylor

28th March 2018

From: Regulatory

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