IP Law Daily Actavis’ proposed hydrocodone capsules infringe Recro’s patents
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Thursday, February 23, 2017

Actavis’ proposed hydrocodone capsules infringe Recro’s patents

Actavis’ proposed hydrocodone bitartrate extended-release capsules in 10, 15, 20, 30, 40, and 50 mg strengths infringe all of the asserted claims of two patents assigned to drugmaker Recro Gainseville, the federal district court in Wilmington, Delaware, has decided. Therefore, the effective date of any Food and Drug Administration approval of Actavis' underlying abbreviated new drug application ("ANDA") No. 20-6952 shall be a date not earlier than the later expiration date of the two asserted Recro patents, including any extensions and marketing exclusivities (September 12, 2034). Furthermore, Actavis was enjoined from engaging in the commercial manufacture, use, offer to sell, sale or importation of Actavis' ANDA products prior to the expiration of Recro’s two patents (Recro Gainesville LLC v. Actavis Laboratories FL, Inc., February 22, 2017, Sleet, G.).

Recro alleged infringement of U.S. Patent Nos. 6,902,742 ("the ’742 patent") and 9,132,096 (''the ’096 patent") against Actavis under 35 U.S.C. § 271(e)(2)(A). The ’742 patent, entitled "Multiparticulate Modified Release Composition," issued on June 7, 2005. The ’096 patent, entitled "Abuse Resistant Pharmaceutical Compositions," issued on September 15, 2015.

Zohydro® ER extended-release capsules contain hydrocodone bitartrate and are 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 licenses the ’742 and ’096 patents to Pernix Therapeutics Holdings, and Pernix markets and sells Zohydro® ER capsules in the United States. The ’742 and ’096 patents have been listed in the Orange Book in connection with Zohydro® ER capsules.

Actavis submitted ANDA No. 206952 to the FDA seeking approval to market hydrocodone bitartrate extended-release capsules in the 10, 15, 20, 30, 40, and 50 mg strengths. Recro asserted infringement of the following claims against Actavis: claims 1-4, 6, 9, 13-14, 16 and 19 of the ’742 patent; and claims 1-2 and 4-5 of the '096 patent.

The ’096 patent. Recro asserted that Actavis’ ANDA products infringe claims 1, 4, and 5 of the ’096 patent. The focus of the dispute concerns 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 is equivalent to the claimed polyacrylic coatings—"ammonio methacrylate copolymer, a methacrylic acid copolymer and mixtures thereof." Actavis contended that not only does their ethylcellulose-based coating fail to satisfy the function-way-result test, it also includes a cellulosic polymer that Recro dedicated to the public and other excipients not permitted by the claims.

Actavis maintained that Recro dedicated ethylcellulose to the public because cellulosic polymers were disclosed in the specification, but not claimed. The Federal Circuit has held that the written description's disclosure of alternatives to the claimed subject matter does not always dedicate those alternatives to the public, the court noted. 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.

Here, the court did not find that the disclosure of cellulosic polymers dedicates ethylcellulose to the public. 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." Therefore, ethylcellulose was not dedicated to the public.

Recro conceded that the Actavis ANDA does not literally infringe the asserted claims of the ’096 patent. Instead, Recro contended that Actavis' ethylcellulose-based coating "is equivalent to the claimed coatings ‘consisting of an ammonio methacrylate copolymer, a methacrylic acid copolymer and mixtures thereof.’" Recro's argument was persuasive because the ethylcellulose-based coating performed substantially the same function, in substantially the same way, to obtain the same result, the court explained. The combination of the statements in the ANDA along with Dr. Felton's testimony was enough to conclude that Actavis' ethylcellulose-based coating functions in substantially the same way as the claimed coating.

Actavis argued that Recro failed to prove infringement under the doctrine of equivalents because Recro's expert, Dr. Siepmann, did not properly account for the excipients in Actavis' coating. Recro contended that because the claim language requires the coating be "selected from the group consisting of an ammonio methacrylate copolymer, a methacrylic acid copolymer and a mixture thereof," the presence of any other excipients is explicitly excluded. The court was not persuaded.

Excipients are not excluded by the language of claim 1 of the ’096 patent, the court decided. Although the claim phrase "consisting of" is ordinarily found to signify exclusion, in the ’096 patent, "consisting of" only serves to limit the universe of polymers that can be present in the coating. The phrase does not limit the presence of excipients, solvents or carriers ubiquitous to pharmaceutical preparations.

There was no dispute that Actavis' ANDA products meet the limitations of dependent claims 4 and 5, according to the court. Actavis' ANDA document discloses a "[q]uality [t]arget [p]roduct [p]rofile (QTPP) for [h]ydrocodone [b]itartrate ER [c]apsules" where the dosage strength is 10, 15, 20, 30, 40, and 50 milligrams. Thus, Actavis' ANDA products infringe dependent claims 4 and 5 in addition to independent claim 1.

The ’742 patent. Recro asserted that Actavis' ANDA products infringe claims 1, 6, 13, 14, 16, and 19 of the ’742 patent. The dispute centered around two claim limitations: (1) "comprising a first population of active ingredient-containing particles and at least one subsequent population of active ingredient containing particles;" and (2) "delivers the active ingredients of the first and subsequent populations in a pulsatile manner." Recro argued that Actavis' products literally infringe both claim limitations, and alternatively that Actavis' ANDA products infringe the first claim limitation under the doctrine of equivalents.

The evidence presented at trial demonstrated that Actavis' active ingredient-containing beads do not comprise a first and subsequent population of active ingredient containing particles.

Instead, Actavis' ANDA products can be described as a multilayer tablet and Recro's argument was unpersuasive. Because the court concluded that Actavis did not literally infringe the first and subsequent population of active ingredient-containing particles limitation, it must determine whether Actavis infringed under the doctrine of equivalents.

Because the court determined that Actavis' multilayer tablet differs insubstantially from Recro's claimed first and subsequent population of active ingredient-containing particles, Actavis' products meet the first limitation of claim 1. Further, Because Actavis' products contain two active ingredient-containing components falling within the scope of claim 1, as evidenced by its statements in the ANDA, Actavis products meet the first and subsequent pulse claim limitation in claim 1 of the ’742 patent, the court held.

The court construed claim 1 to require not just a first and subsequent pulse of active ingredient, but also "a plasma concentration profile characterized by two or more peaks interspersed with low concentration troughs." Actavis contended that its three bioequivalence studies show no evidence that administering its product to patients causes plasma concentration profiles that meet the court's construction. Recro argued, however, that because some patients experienced plasma concentration profiles characterized by two or more peaks interspersed with low concentration troughs, Actavis' ANDA products meet the claim limitation. Recro's argument was persuasive, the court concluded.

Finally, the court also determined that dependent claims 6, 13, 14, 16, and 19 were infringed by Actavis’ ANDA products.

The case is No. 1:14-cv-01118-GMS.

Attorneys: Jack B. Blumenfeld (Morris, Nichols, Arsht & Tunnell LLP) for Recro Gainesville LLC. Kelly E. Farnan (Richards, Layton & Finger, PA) for Actavis Laboratories FL Inc.

Companies: Recro Gainesville LLC; Actavis Laboratories FL Inc.

MainStory: TopStory Patent DelawareNews

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