Hydrocodone – USA

On Feb 22, 2017, District court of Delaware decided in favor of Reco/Pernix on Zohydro (Hydrocodone ER capsule) patents and found that Actavis' proposed generic products infringe claims of U.S. Patent   No. · 9, 13 2, 096 ("the '096 patent") and U.S. Patent No. 6,902,742 ("the '742 patent").

Zohydro® ER extended-release capsules contain hydrocodone bitartrate and are indicated "for the management of pain severe enough to require daily, around-the-clock, longterm opioid treatment and for which alternative treatment options are inadequate." Recro licenses the '742 and '096 patents to Pernix Therapeutics Holdings, Inc. ("Pernix") and Pernix markets and sells Zohydro® ER capsules in the United States.

Patented claims require a permeable or semi-permeable coating selected from the group consisting of an ammonio methacrylate copolymer, a methacrylic acid copolymer and a mixture thereof.  Actavis uses Ethyl cellulose in its formulation. Actavis maintains that Recro dedicated ethylcellulose to the public because cellulosic polymers were disclosed in the specification, but not claimed. Disclosure dedication occurs when the patentee "discloses but declines to claim subject matter”.

The court however found that a person skilled in the art would not have been able to clearly identify that ethylcellulose was disclosed and not claimed, given the generality of the phrase "cellulosic polymers". The court finds, therefore, that ethylcellulose was not dedicated to the public.

Ethylcellulose provides same function by same way to have same result in comparison to claimed polymer. The specification of the '096 patent explicitly states that the functions of the placebo bead coating are to "provide a physical barrier essentially separating or sequestering the gelling agent from the other components of the composition" and to "control (i.e. delay or otherwise limit) the ingress of water into the second bead population, thus restraining the gelling action of the gelling agent."

In sum, the court finds infringement of all of the asserted claims of the '096 and '742 patents.