Recro Gainesville LLC v. Actavis Labs. FL, Inc.

Defendant’s proposed ANDA products infringed all of the asserted patent claims under the doctrine of equivalents.

April 26, 2017

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Recro Gainesville LLC v. Actavis Labs. FL, Inc., Civ. No. 14-1118-GMS, 2017 U.S. Dist. LEXIS 24428 (D. Del. Feb. 22, 2017) (Sleet, J.) 

Drug Product and U.S. Patent: Zohydro® ER (hydrocodone bitartrate extended-release capsules); U.S. Patents Nos. 9,132,096 (“the ’900 patent”) and 6,902,742 (“the ’742 patent”)

Nature of the Case and Issue(s) Presented: Zohydro ER was indicated “for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” Recro argued that Actavis’ ANDA products infringed claims 1, 4, and 5 of the ’096 patent, focusing the dispute on one claim limitation: “a permeable or semi-permeable coating selected from the group consisting of an ammonio methacrylate copolymer, a methacrylic acid copolymer and a mixture thereof.” Recro argued that Actavis’ ethylcellulose-based coating was equivalent to the claimed polyacrylic coatings. In response, Actavis contended that not only did its ethylcellulose-based coating fail to satisfy the function-way-result test, it also included a cellulosic polymer that Recro dedicated to the public and other excipients not permitted by the claims.

Next, Recro asserted that Actavis’ product infringed claims 1, 6, 13, 14, 16, and 19 of the ‘742 patent. That dispute centered around two claim limitations: (i) “comprising a first population of active ingredient-containing particles and at least one subsequent population of active ingredient-containing particles;” and (ii) “delivers the active ingredients of the first and subsequent populations in a pulsatile manner.” Recro argued that Actavis’ products literally infringed both claim limitations, and alternatively that Actavis’ product infringed the first claim limitation under the doctrine of equivalents. After a three-day bench trial, the court find in favor of Recro.

Why Recro Prevailed: First, the court held that Recro did not dedicate ethylcelulose to the public because cellulosic polymers were disclosed in the specification, but not claimed. The disclosure in the specification must be specific enough that a skilled artisan could identify the subject matter that has been disclosed and not claimed. The patent lists types of polymers “such as cellulose acetates, cellulose alkanylates and cellulose acrylates.” Actavis’ expert stated that ethylcellulose would not fall into any of the subcategories listed after the disclosure of general cellulosic polymers. Therefore the court was persuaded by Recro’s point that the specification actually led one away from ethylcellulose. Thus, the court 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.”

Next, Recro conceded that the Actavis did not literally infringe the asserted claims of the ’096 patent. Instead, Recro argued that Actavis’ ethylcellulose-based coating was equivalent to the claimed coatings. The court conducted a “function-way-result” analysis and found, in large part based on statements in Actavis’ ANDA and testimony from Actavis’ expert, that Actavis’ product would infringe under the doctrine of equivalents.

The court then moved on to analyze infringement concerning the ’742 patent. The court first found that Actavis’ ANDA products did not literally infringe the ’742 patent. The evidence presented at trial demonstrated that Actavis’ active ingredient-containing beads did not comprise a first and subsequent population of active ingredient containing particles. Instead, Actavis’ product could be described as a multilayer tablet. Recro argued that Actavis’ product still fell within the scope of the claim because the specification explicitly allowed for a multilayer tablet. The patent made clear, however, that the first and second population of particles were different from each other. And it was made clear that both active ingredient layers are the same. The subsequent drug layer in Actavis’ product did not comprise a modified-release coating or a modified-release material. The release-controlling barrier layer was on top of the layer containing the active-ingredient. But the court did find that Actavis’ product infringed under the doctrine of equivalents. The function and result of both Recro and Actavis’ products were to deliver the drug in a specific manner. The issue was whether pulsatile delivery is achieved in the same way. Comparing the ANDA to the ’742 patent specification, the court found that Actavis’ product met this limitation. Moreover, because Actavis’ product contained two active ingredient-containing components falling within the scope of claim 1, as evidenced by its statements in the ANDA, the court found that Actavis’ product met the first and subsequent pulse claim limitation in claim 1 of the ’742 patent.

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