November 1, 2013
CUMBERLAND PHARMACEUTICALS INC., Plaintiff,
SAGENT AGILA LLC, and SAGENT PHARMACEUTICALS, INC., Defendants.
At Wilmington, this matter coming before the Court upon the motion to dismiss (D.I. 9) plaintiff Cumberland Pharmaceuticals Inc.'s ("Plaintiff or "Cumberland") Complaint (D.I. 1), filed by defendants Sagent Agilia LLC and Sagent Pharmaceuticals, Inc. (together, "Defendants" or "Sagent"), and having considered the parties' papers submitted in connection therewith;
IT IS HEREBY ORDERED that Defendants' motion to dismiss (D.I. 9) is GRANTED for the reasons that follow.
1. This patent litigation action arises under the Hatch-Waxman Act. On May 17, 2012, Sagent notified Cumberland that it had filed an Abbreviated New Drug Application ("ANDA"), ANDA No. 091684, for a generic Acetadote® formulation. Sagent's letter contained a "Paragraph IV" certification contending that Cumberland's U.S. Patent No. 8, 148, 356, entitled "Acetylcysteine Composition and Uses Therefor" ("the '356 patent"), was invalid, unenforceable, or would not be infringed by Sagent's generic formulation. (See D.I. 1 ¶ 19; D.I. 15 at 2)
2. On June 26, 2012, within 45 days of receipt of Sagent's notice letter, Cumberland filed suit for infringement, triggering an automatic 30-month stay of FDA approval of Sagent's ANDA. (See D.I. 10 at 1; 21 U.S.C. § 355(j)(B)(iii)) Cumberland alleges infringement of the '356 patent (Count I) and seeks a declaratory judgment of infringement of the '356 patent (Count II).
3. On August 29, 2012, Sagent filed its motion to dismiss. Sagent moves to dismiss the Complaint under Fed.R.Civ.P. 12(b)(6) for failure to state a claim. According to Defendants, all claims of the asserted patent cover only a formulation "free from a chelating agent, " yet the Complaint alleges that Sagent's product contains EDTA, which is "a chelating agent." (D.I. 10 at 1-2, 4, 6-7) Therefore, Sagent argues, "[a]s a matter of both common sense and controlling law, a formulation with a specific ingredient cannot infringe a patent claim that forbids that very ingredient." (D.I. 10 at 5) Indeed, in Sagent's view, paragraph 20 of Cumberland's Complaint states the opposite of a claim for patent infringement, as "Cumberland admits that '[o]n information and belief, Defendants' [Sagent's] proposed acetylcysteine product contains EDTA.'" (Id. at 7; see also D.I. 1 ¶ 20)
4. In opposing the motion, Plaintiff argues that Sagent improperly and "prematurely seeks a claim construction ruling and summary judgment of non-infringement based on factual matters in dispute." (D.I. 15 at 11) Plaintiff contends that neither the infringement allegations contained in the Complaint, nor the patent-in-suit, is limited to an EDTA-free product. (Id. at 2) Cumberland cites to examples of cases in which courts have refused to construe disputed claim terms in connection with a motion to dismiss and have denied dismissal of patent infringement actions.
5. The Court agrees with Sagent that its "there is no reasonable view of the facts pled in Cumberland's Complaint that would support a claim for relief, " specifically:
1. "[E]very claim of the '356 patent expressly requires a formulation that is "free of a chelating agent" or "free from a chelating agent' (D.I. 1-1, 9:19; 9:45; 10:22; 10:29);" and
2. "Cumberland admits that EDTA is a chelating agent, and that Sagent's product includes EDTA (D.I. 1, ¶¶ 13, 16, 20; D.I. 15 at )."
(D.I. 16 at 2)
a. Independent claim 1, which is representative of all of the claims of the patent-in-suit, covers only formulations that are "free from a chelating agent, " as is seen below:
A stable aqueous pharmaceutical composition comprising between 200 and 250 mg/mL acetylcysteine, wherein the composition is free from a chelating agent, or pharmaceutically acceptable salts thereof, wherein said composition is in a suitable form for intravenous injection, wherein the pH of the composition is from 6 to 7, and wherein said composition is sealed in an airtight container comprising a fill volume of said composition and a headspace volume occupied by a pharmaceutically inert gas.
('356 patent at col. 9, lines 17-25) (emphasis added) No claim construction is necessary in order to determine that "free from a chelating agent" means that a claimed composition may not include a chelating agent. Cumberland does not even suggest how "free from a chelating agent" could be construed to cover a composition containing a chelating agent. Indeed, to the contrary, the patent explains that the inventor developed a composition distinct from a prior art formulation in that the "old" formulation contained a chelating agent while the "new" formulation does not. (See, e.g., '356 patent, Abstract ("This invention relates to novel acetylcysteine compositions in solution, comprising acetylcysteine and which are substantially free of metal chelating agents, such as EDTA."); id, Summary of the Invention, col. 2, lines 45-50 ("It has been surprisingly found that an aqueous composition containing acetylcysteine, sterilized water, and a pH-adjusting agent, is stable without the addition of a chelating agent. Thus, the present invention relates to a solution containing acetylcysteine, which is substantially free of chelating agents.")) Likewise, the Complaint explains that Cumberland moved from an "old formulation" containing EDTA to a "new formulation" that does not. (See D.I. 1¶16 ("Contrary to the expectations and teaching in the field, Cumberland was successful in developing a new formulation that contained no EDTA or any other chelating agent yet offered surprisingly good stability."); id. at ¶¶ 13-18)
b. Plaintiffs Complaint alleges that the ingredient EDTA is an example of a "chelating agent." (Id. at ¶13) Additionally, the '356 patent identifies EDTA as an example of a class of compounds called chelating agents. ('356 patent at col. 4 lines 7-16) In fact, the patent identifies EDTA as a "widely used" example of a chelating agent. (Id.)
c. The Complaint alleges: "[o]n information and belief, Defendants' proposed acetylcysteine product contains EDTA." (D.I. 1 at ¶ 20)
d. It follows from the foregoing that Sagent's ANDA does not infringe any claim of the '356 patent.
6. Cumberland's attempts to avoid this conclusion are unavailing. No claim construction is required. Nor is there anything in any of the precedents relied on by Cumberland that provides any persuasive reason for allowing this case to proceed to discovery. Infringement under the doctrine of equivalents is unavailable because a finding of infringement would vitiate the "free from a chelating agent" claim limitation. Finally, even assuming that the Complaint satisfies the notice pleading requirements discussed in Phonometrics, Inc. v. Hospitality Franchise Sys., Inc., 203 F.3d 790, 794 (Fed. Cir. 2000) (per curiam) (reversing dismissal of patent infringement case where complaint met notice pleading requirements), that does not preclude dismissal, given the Complaint's failure (nonetheless) to state a claim for which relief may be granted, for the reasons already provided.
Accordingly, Sagent's motion (D.I. 9) is GRANTED. Cumberland's Complaint is DISMISSED. The Clerk of Court is directed to CLOSE this case.