Apollo’s Covis sues over preterm-birth drug patents

Aurobindo’s subsidiary Eugia allegedly infringed two patents for an injectable treatment for reducing the risk of premature birth, according to a lawsuit by Covis Pharma, a Luxembourg-based unit of Apollo Global Management.

In the complaint filed yesterday, January 4, at the US District Court for the District of Delaware, Covis held that its competitor had infringed its treatment, the Makena Auto-Injector, which is covered by US patent numbers 9,844,558 and 10,471,075.

Unlike previous treatments, the Makena Auto-Injector enables clinicians to administer the ingredient hydroxyprogesterone caproate more easily by means of a quick injection in the expectant mother’s upper arm.

Hydroxyprogesterone caproate is a progestin medication used to prevent preterm birth in pregnant women with a history of the condition and to treat gynaecological disorders.

The dispute arose after Eugia applied for an Abbreviated New Drug Application (ANDA) at the US Food and Drug Administration (FDA) seeking approval to market generic versions of the product before the expiration of patents-in-suit in 2036.

According to the complaint, inventors Robert Birch and Michael Jozwiakowski acquired the ‘558 patent in 2017 and the ‘075 patent two years later and subsequently assigned both to AMAG Pharmaceuticals. The patents then transferred to Covis, following its acquisition of AMAG in October 2020, the filing said.

Covis has asked the court to prevent the generic maker from producing copies of the drug until the expiration date or to ensure that Eugia offers cash compensation if copies are made before then.

LSIPR has approached the companies for comment.

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