Fresenius Kabi wins preliminary injunction against thyroid drug

Healthcare company Fresenius Kabi has won a preliminary injunction in a patent infringement lawsuit against a rival company.

Fresenius Kabi won the injunction against US-based Fera Pharmaceuticals at the US District Court for the District of New Jersey on September 20.

The company had brought two motions—dismissal of Fera’s inequitable conduct counterclaims and the grant of a preliminary injunction—in a suit against Fera.

These motions are part of Fresenius’s underlying suit for patent infringement against Fera.

The disputed patents are US numbers 9,006,289; 9,168,238; and 9,168,239. All three patents are formulations of levothyroxine, a hormone produced by the thyroid.

Further, the patents claim a form of lyophilised (freeze-dried) levothyroxine that can be reconstituted and injected into patients who lack a properly functioning thyroid.

The Food and Drug Administration approved Fresenius’s New Drug Application in June 2011. The ‘289 patent was issued in April last year and is due to expire in October 2032.

Additionally, the ‘238 and ‘239 patents were issued in October last year and are set to expire in August 2032.

Fera filed an Abbreviated New Drug Application that sought approval to market a generic version of Fresenius’s patented levothyroxine formulations.

Fresenius claimed it would infringe the patents and sued Fera.

In his opinion, District Judge Kevin McNulty granted the motion for preliminary injunction but denied the motion for inequitable conduct.

McNulty referred to Amazon.com v Bamesandnoble.com, where the US Court of Appeals for the Federal Circuit set the standard on which district courts hearing patent cases should review preliminary injunctions.

They should be judged by the “likelihood of success on the merits”, he said.

“If the alleged infringer ‘raises a substantial question concerning either infringement or validity, ie, asserts an infringement or invalidity defence that the patentee cannot prove lacks substantial merit, the preliminary injunction should not issue.’”

McNulty added that Fera was unable to raise a substantial question of invalidity.

According to Schiff Hardin, the law firm that represented Fresenius, this ruling shows that although they are very hard to obtain, injunctions are still a viable option for patent owners.

Imron Aly, co-head of Schiff Hardin’s intellectual property practice, said: “After this, companies will have to look carefully at each particular patent and product, in order to evaluate business opportunities.”

A spokesperson for Fresenius told LSIPR that it typically doesn't comment on matters related to IP litigation.