Federal Circuit revives Apotex blood pressure case

A US appeals court has overturned a district court's decision to deny Apotex's request for a declaratory judgment that its proposed generic blood pressure drug would not infringe a patent owned by pharmaceutical company Daiichi Sankyo.

The US District Court for the Northern District of Illinois had thrown out the case, which centred on a proposed generic of Daiichi’s blood pressure drug Benicar (olmesartan medoxomil).

However, the US Court of Appeals for the Federal Circuit found that Apotex has a “concrete interest” in securing the judgment so that it may receive approval from the US Food and Drug Administration (FDA) to market the drug.

In 2012, Apotex filed an ANDA with the FDA for approval to make and sell generic olmesartan medoxomil tablets. It included a Paragraph IV certification that it would not infringe the patent. It then asked the Illinois court for a declaratory judgment that the product wouldn’t infringe the patent.

Drug maker Mylan was the first company to file an Abbreviated New Drug Application (ANDA) for FDA approval to market a generic Benicar. It also filed a motion to intervene in the Apotex case, which the district court denied.

The Federal Circuit also overturned that decision in its judgment.

Daiichi has two patents covering Benicar listed in the Orange Book. One of the patents, US number 5,616,599, covers the active ingredient and is due to expire in April 2016. The other patent, US number 6,878,703, covers methods of treatment, and is due to expire in November 2021.

Daiichi disclaimed the ’703 patent's claims upon receiving notice of Mylan’s ANDA filing for reasons unknown to the court. The FDA, however, did not remove the ’703 patent from the Orange Book as Daiichi had requested. The US Patent and Trademark Office defines a disclaimer as “a statement filed by an owner of a patent or of a patent to be granted, in which said owner relinquishes certain legal rights to the patent”.

A spokesperson for Daiichi Sankyo told LSIPR: “We strongly disagree with the decision of the US Court of Appeals for the Federal Circuit and intend to file a motion for reconsideration and/or rehearing en banc.”

Apotex was not available to comment. Mylan did not respond to LSIPR requests for comment.