1 August 2018Americas

Amneal obtains non-infringement finding in Sensipar case

Generic drug maker Amneal has secured a finding of non-infringement in a Hatch-Waxman case over kidney disease drug Sensipar (cinacalcet hydrochloride).

Sensipar’s maker Amgen had sued Amneal, Piramal Healthcare, Watson Laboratories and Zydus Pharmaceuticals for infringing US patent number 9,375,405.

The patent, called “Rapid dissolution formulation of calcium receptor-active compound,” was issued in June 2016.

Sales for Sensipar exceeded $1.3 billion in the US last year.

Amneal’s Abbreviated New Drug Application, which Amgen claimed infringed the ‘405 patent, contained Opadry Clear YS-1-7006 as the binder.

“But claim 1 of the ‘405 patent does not list Opadry in the Markush group for binders, which means under my claim construction order, there is not a clear case of literal infringement,” said US District Judge Mitchell Goldberg of the US District Court for the District of Delaware on Friday, July 27.

He added: “Amgen nonetheless attempts to prove literal infringement by arguing that Opadry is a pseudonym for hydroxypropyl methylcellulose (‘HPMC’), which is a listed binder [in Amgen’s patent].”

Amgen alternatively argued that infringement is established through the doctrine of equivalents, but Goldberg disagreed with both arguments.

Following a four-day bench trial in March, Goldberg concluded that Amneal, Watson and Piramal did not infringe the ‘405 patent late last week. But the court found that Amgen had proven infringement by Zydus.

Robins Kaplan represented Amneal.

Jake Holdreith, partner at Robins Kaplan and lead trial counsel for Amneal, said: “This was a hard-fought case that required creativity and persistence from our legal team and from our client Amneal, and great cooperation among the defendants."

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More on this story

Americas
6 June 2017   A district court has granted a stipulated order to the US Food and Drug Administration and Amgen, after they jointly asked the court to end a case centring on paediatric exclusivity for Sensipar.
Americas
14 October 2016   Amgen has filed a complaint against Apotex for allegedly infringing a patent centring on Sensipar tablets.
Americas
10 September 2018   Amgen has accused India-based Emcure Pharmaceuticals of patent infringement, in a bid to protect its drug Sensipar.

More on this story

Americas
6 June 2017   A district court has granted a stipulated order to the US Food and Drug Administration and Amgen, after they jointly asked the court to end a case centring on paediatric exclusivity for Sensipar.
Americas
14 October 2016   Amgen has filed a complaint against Apotex for allegedly infringing a patent centring on Sensipar tablets.
Americas
10 September 2018   Amgen has accused India-based Emcure Pharmaceuticals of patent infringement, in a bid to protect its drug Sensipar.