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Impax Laboratories, Inc. v. Actavis Laboratories FL, Inc.

United States District Court, D. New Jersey

May 9, 2017

IMPAX LABORATORIES, INC., Plaintiff,
v.
ACTAVIS LABORATORIES FL, INC. et al., Defendants.

          OPINION & ORDER

          Stanley R. Chesler, U.S.D.J.

         This matter comes before the Court on the application for claim construction by Plaintiff Impax Laboratories, Inc. (“Impax”) and Defendants Actavis Laboratories FL, Inc. and Actavis Pharma Inc. (collectively, “Actavis”). In this patent infringement suit involving pharmaceutical patents, the parties seek construction of claims in U.S. Patent No. 8, 377, 474 (“the '474 patent”). The Court heard oral argument on April 26, 2017.

         ANALYSIS

         I. The law of claim construction

         A court's determination “of patent infringement requires a two-step process: first, the court determines the meaning of the disputed claim terms, then the accused device is compared to the claims as construed to determine infringement.” Acumed LLC v. Stryker Corp., 483 F.3d 800, 804 (Fed. Cir. 2007). “[W]hen the district court reviews only evidence intrinsic to the patent (the patent claims and specifications, along with the patent's prosecution history), the judge's determination will amount solely to a determination of law.” Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841 (2015).

The focus of claim construction is the claim language itself:
It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude. Attending this principle, a claim construction analysis must begin and remain centered on the claim language itself, for that is the language the patentee has chosen to ‘particularly point[] out and distinctly claim[] the subject matter which the patentee regards as his invention.'

Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d 1111, 1115-1116 (Fed. Cir. 2004) (citations omitted).

         The Federal Circuit has established this framework for the construction of claim language:

We have frequently stated that the words of a claim ‘are generally given their ordinary and customary meaning.' We have made clear, moreover, that the ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application. The inquiry into how a person of ordinary skill in the art understands a claim term provides an objective baseline from which to begin claim interpretation. . .
In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words. In such circumstances, general purpose dictionaries may be helpful. In many cases that give rise to litigation, however, determining the ordinary and customary meaning of the claim requires examination of terms that have a particular meaning in a field of art. Because the meaning of a claim term as understood by persons of skill in the art is often not immediately apparent, and because patentees frequently use terms idiosyncratically, the court looks to those sources available to the public that show what a person of skill in the art would have understood disputed claim language to mean. Those sources include the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.

Phillips v. AWH Corp., 415 F.3d 1303, 1312-1314 (Fed. Cir. 2005) (citations omitted).

         II. Claim construction of the disputed terms

         This claim construction dispute arises in the context of a Hatch-Waxman case: in short, the Complaint alleges that Actavis seeks to make and sell a generic version of Plaintiff's Rytary® (levodopa/carbidopa) capsules prior to the expiration of the relevant patents. The parties initially briefed the claim construction issues in five related patents at once, and this Court instructed them to start by rebriefing the claim construction issues in only the parent patent, the '474 patent. The parties simultaneously submitted revised briefs limited to the claim construction issues for this patent.

         The parties have divided the claim construction issues into four groups.

         A. Claim construction issues for Group I

         In brief, as to Group I, the parties dispute the meaning of the phrase “distinct component” in three independent claims:

1. A controlled release oral solid formulation of levodopa comprising: a. a controlled release component comprising levodopa, a decarboxylase inhibitor and one or more rate controlling excipients, b. a carboxylic acid component comprising a carboxylic acid that is not levodopa or the decarboxylase inhibitor and one or more rate controlling excipients, and c. an immediate release component comprising levodopa and a decarboxylase inhibitor, wherein the carboxylic acid component of (b) is a distinct component and is coated with an enteric polymer; and wherein the controlled release component (a), the immediate release component (c) and the carboxylic acid component (b) comprise beads or granules.
7. A multiparticulate, controlled release oral solid formulation of levodopa comprising: a. a controlled release component comprising levodopa, carbidopa and one or more rate controlling excipients; b. an immediate release component comprising levodopa and carbidopa, and c. a carboxylic acid component comprising a carboxylic acid that is not levodopa or carbidopa and one or more rate controlling excipients, wherein the carboxylic acid component of (c) is a distinct component and is coated with an enteric polymer and wherein the controlled release component (a), the immediate release component (b) and the carboxylic acid component (c) comprise beads or granules.
59. A controlled release oral solid formulation of levodopa comprising: a. a controlled release component comprising levodopa and a decarboxylase inhibitor, wherein the component is coated with a rate controlling excipient, b. a carboxylic acid component coated with a rate controlling excipient, and c. an immediate release component comprising levodopa and a decarboxylase inhibitor, wherein the carboxylic acid component of (b) is a distinct component and wherein the carboxylic acid component (b) comprises a carboxylic acid that is not in (a) and (c).

         The crux of the dispute is the question of what these claims mean in requiring the carboxylic acid component to be a “distinct component.” Impax contends that “distinct component” means “sub-unit of the formulation, ” adding that “distinct” here means “separated in some way from the other components.” (Impax Br. 6.) Actavis contends that this means: “wherein the carboxylic acid component is a bead that contains a carboxylic acid and is coated with an enteric polymer and is physically separate from the controlled and immediate release components.” (Actavis Br. 25.)

         The dispute turns on the meaning of the word, “distinct.” “Distinct” has multiple ordinary meanings. The layers in a layer cake may be described as “distinct” from each other, but one cake that is completely physically unconnected to another cake might be described as “distinct” as well. In order to reduce ambiguity in this discussion, this Court will employ the phrase “freely separable” to express the latter idea, that the two units of interest may be moved independently, separated in space without affecting the integrity or structure of either unit.[1] The layers in a layer cake, on the other hand, cannot be freely separated without changing the integrity of the cake; the Court will refer to this kind of distinctness as “not intermixed” or “layer cake distinctness.”

         Actavis contends that, during prosecution, to overcome a rejection, the applicants disclaimed coverage of formulations in which the carboxylic acid component is not freely separable from the controlled release and immediate release components. Impax disagrees, contending that the prosecution history statements identified do not meet the test for finding prosecution history disclaimer.

         The Federal Circuit law of prosecution disclaimer is well-settled and straightforward:

where the patentee has unequivocally disavowed a certain meaning to obtain his patent, the doctrine of prosecution disclaimer attaches and narrows the ordinary meaning of the claim congruent with the scope of the surrender. . .
To balance the importance of public notice and the right of patentees to seek broad patent coverage, we have thus consistently rejected prosecution statements too vague or ambiguous to qualify as a disavowal of claim scope. Rather, we have required the alleged disavowing statements to be both so clear as to show reasonable clarity and deliberateness, and so unmistakable as to be unambiguous evidence of disclaimer. Consequently, for prosecution disclaimer to attach, our precedent requires that the alleged disavowing actions or statements made during prosecution be both clear and unmistakable.

Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314, 1324-1326 (Fed. Cir. 2003) (citations omitted).

         Actavis points to the following events in the history of the prosecution of the '474 patent. On March 27, 2012, the PTO rejected pending claims 1 and 27 (which ultimately became claims 1 and 7 when the patent issued) as anticipated by US2007/0148238 (the “Nangia” reference). (IMPAX00265852.) The applicants submitted three rounds of amendments in response to the March 27 office action: on June 11, 2012 (IMPAX00265824-48), a supplemental amendment on Auguist 2, 2012 (IMPAX00312279-97), and a supplemental amendment on September 25, 2012 (IMPAX00312304-33). On December 6, 2012, the PTO issued a notice of allowance. (IMPAX00265788-94.)

         Actavis argues that, in order to distinguish Nangia and overcome the rejection, the applicants made unmistakable disclaimers of claim scope. Actavis first points to these statements in the June 11, 2012 amendment:

Nangia describes a pharmaceutical composition comprising a therapeutically effective amount of levodopa (LD) and carbidopa (CD), dispersed in a hydrophilic matrix, the composition further comprising an organic acid. In Nangia, the organic acid is mixed together with the LD and CD in a single pellet or bead.

(IMPAX00265839.) The last sentence has some ambiguity, as “mixed together” may be understood to mean that: 1) the organic acid, LD, and CD are intermixed with no separation throughout a single bead; or 2) the organic acid, LD, and CD are all present in a single bead, but not necessarily intermixed; they are “mixed together” only in the sense that single beads contain all three components.[2] The remarks continue as follows:

For example, in Nangia, the CD and LD may be in beads which are fully or partially coated by a bioadhesive polymeric material which may comprise an acidic component (Nangia at paragraph 109). In another embodiment, Nangia describes LD containing controlled release (CR) beads coated with a bioadhesive polymer (Nangia at paragraphs 132 and 136.) In a further embodiment, Nangia describes granulating the CD and LD formulation using a mineral or organic acid (Nangia at paragraph 153.)

(IMPAX00265839-40.) The applicants thus point to three examples in Nangia: 1) in the first, the acid is in a coating on the bead which contains the CD and LD; 2) the second mentions a coating on a bead without specifying where the acid is; and 3) the third speaks of granulating the CD and LD, possibly by using an organic acid.

         In terms of the present inquiry, the first example is significant. In this example, the applicants distinguish Nangia by pointing to a Nangia embodiment with a coating which includes an acidic component. The applicants then state:

However, Nangia does not describe formulations comprising (1) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor (e.g., carbidopa) and a rate controlling excipient, (2) a carboxylic acid component, and (3) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor (e.g., carbidopa), wherein the carboxylic acid component (b) is a ...

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