Actavis loses testosterone patent case at Federal Circuit

The US Court of Appeals for the Federal Circuit has affirmed a district court’s patent ruling in favour of global pharma company Endo and Scotland-based Strakan International in a case against Actavis.

The US District Court for the Eastern District of Texas had ruled that the patent claims centring on Fortesta (testosterone) are not invalid for either anticipation or obviousness, and that Actavis’s marketing of a generic product would infringe all the claims asserted by Endo and Strakan.

On Friday, October 14, the Federal Circuit affirmed the ruling.

Strakan is the owner of the patents involved in the case, US numbers 6,579,865 and 6,319,913, and Endo is the exclusive US licensee.

Fortesta is used to treat adult males with low testosterone.

In 2013, Watson Laboratories, which later transferred its relevant interests to Actavis, filed an Abbreviated New Drug Application with the Food and Drug Administration (FDA) seeking to market a generic version of Fortesta.

Endo and Strakan alleged that this would infringe claims of the ‘865 and ‘913 patents.

Actavis claimed in the district court that all of the claims cited by Endo and Strakan were invalid based on anticipation and obviousness.

The company also claimed that the generic product described in its FDA application did “not meet a limitation” of certain claims in the ‘865 patent, and therefore the marketing of the product would not infringe the claims. However, Actavis had agreed to infringing other claims in the patent.

The decision is non-precedential.