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17 January 2022AmericasMuireann Bolger

Genentech prevails in Baxalta haemophilia treatment suit

Genentech has gained a win in a suit claiming that its haemophilia treatment Hemlibra infringes a patent owned by Takeda subsidiary, Baxalta, after a US federal judge held that parts of the patent were invalid.

Acting as a visiting judge for the case in the US District Court for the District of Delaware, Federal Circuit Judge Timothy Dyk, found in favour of Genentech on January 13.

In May 2017, Baxalta sued Genentech for allegedly infringing its patent, US number 7,033,590, through its marketing of an antibody used to treat haemophilia, Emcizumab (ACE-910).

The Food and Drug Administration (FDA) approved Hemlibra for haemophilia A patients with inhibitors in November, 2017, and Genentech launched the product in the US for that population later that month.

In December that year, Baxalta moved for a preliminary injunction barring further sales or offers to sell Hemlibra in the US with exceptions for certain patients.

Haemophilia is usually an inherited bleeding disorder in which the blood doesn't clot properly. This can lead to spontaneous bleeding as well as bleeding following injuries or surgery. Blood contains many proteins called clotting factors that can help to stop bleeding.

In its filings, Genentech denied Baxalta's allegations and counterclaimed for a declaratory judgment of noninfringement and invalidity.

Genentech argued that parts of Baxalta’s patent were invalid due to its lack of enablement holding that the disputed patent protects a large genus of antibodies preventing a skilled artisan from reproducing the invention without undue experimentation.

A group of potentially affected haemophilia patients, Patients for Access to Advanced Hemophilia Therapy (PAAHT), filed a brief as amicus curiae in opposition to Baxalta's motion.

On Thursday, Judge Dyk, rejected Baxalta’s argument and awarded Genentech summary judgment.

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More on this story

Big Pharma
29 June 2021   Roche subsidiary Genentech received $209.5 million in unnecessary payments from Novartis Pharma for a patent licensing deal and is now refusing to return the payment, the Swiss pharma giant has alleged in a redacted complaint.
article
14 June 2022   Baxalta, a subsidiary of Japan-headquartered pharmaceutical company Takeda, has asked the US Court of Appeals for the Federal Circuit to overturn a decision that invalidated its antibody patent.
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7 March 2023   The Roche subsidiary says the licensee owes payments on “stockpile” of MS drug Tysabri.