Daiichi Sankyo unit accuses Pharmacosmos of patent infringement
American Regent, the US subsidiary of pharmaceutical company Daiichi Sankyo, has taken iron therapy specialist Pharmacosmos to court over an injectable treatment for anaemia.
Daiichi, which makes Injectafer (ferric carboxymaltose injection), a treatment option for iron deficiency anaemia, accused Pharmacosmos of infringing two patents through the sale of its own injectable treatment.
In the lawsuit, filed yesterday, February 11 at the US District Court for the District of New Jersey, Daiichi argued that Pharmacosmos was infringing the patents, US numbers 10,478,450 and 8,431,549, by obtaining regulatory approval for Monoferric (iron isomaltoside) in the US.
The US Food and Drug Administration approved Monoferric for the treatment of iron deficiency anaemia in late January and, according to the suit, the launch is “imminent”.
In the US, Daiichi recorded $362 million in sales of Injectafer in the nine months ended December 31, 2019, an increase of 59% from the same period in the prior year.
The patents-in-suit have been at the centre of a dispute between the companies before—in 2015, Pharmacosmos filed a petition for inter partes review (IPR) of the ‘549 patent.
However, the Patent Trial and Appeal Board (PTAB) declined to institute the IPR for some of the claims and concluded that Pharmacosmos hadn’t shown a reasonable likelihood of prevailing in its challenge for the other claims.
Last year, Pharmacosmos filed a second IPR petition against the patent, but the PTAB denied the petition in its entirety.
Pharmacosmos has filed a petition for a post-grant review of the ‘450 patent, seeking to invalidate all of the claims, in January 2020.
Daiichi has asked the court to stop sales of Monoferric and for a compensatory award of damages.
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