cumberland pharm. inc. v. innopharma, inc., c.a. no. 12-618-lps (d. del. nov. 1, 2013); cumberland...

8/14/2019 Cumberland Pharm. Inc. v. Innopharma, Inc., C.A. No. 12-618-LPS (D. Del. Nov. 1, 2013); Cumberland Pharm. Inc

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IN THE UNITED ST TES DISTRICT COURTFOR THE DISTRICT OF DEL W RE

CUMBERLAND PHARMACEUTICALS INC.,

Plaintiff,v. C.A. No. 12-618-LPS

INNOPHARMA, INC.,Defendant.

MEMOR NDUM ORDER

At Wilmington this 1st day ofNovember, 2013, this matter coming before the Court uponthe motion to dismiss (D.I. 7) plaintiff Cumberland Pharmaceuticals Inc.'s ( Plaintiff' orCumberland ) Complaint (D.I. 1), filed by defendant InnoPharma, Inc. ( Defendant orInnoPharma ), and having considered the parties' papers submitted in connection therewith;

IT IS HEREBY ORDERED that Defendant's motion to dismiss (D.I. 7) is GRANTEDfor the reasons that follow.

1. This patent litigation action arises under the Hatch-Waxman Act. On April 4,2012, InnoPharma notified Cumberland that it had filed an Abbreviated New Drug Application( ANDA''), ANDA No. 200644, for a generic acetylcysteine formulation (for use in treatment ofacetaminophen overdose patients). InnoPharma's letter contained a Paragraph IV certificationcontending that Cumberland's U.S. Patent No. 8,148,356, entitled Acetylcysteine Compositionand Uses Therefor ( the '356 patent ), was invalid, unenforceable, or would not be infringed byInnoPharma's generic formulation. See D.l. 1 -r 15; D.l. 8 at 5; D.l. 12 at 1

2. On May 17, 2012, within 45 days of receipt oflnnoPharma s notice letter,Cumberland filed suit for infringement, triggering an automatic 30-month stay of FDA approval


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oflnnoPharma's ANDA. (See D.I. 12 at 1-2; 21 U.S.C. 355G)(B)(iii)) Cumberland allegesinfringement of the '356 patent (Count I and seeks a declaratory judgment of infringement of the'356 patent (Count II).

3. On June 8, 2012, InnoPharma filed its motion to dismiss. InnoPharma moves todismiss the Complaint under Fed. R. Civ. P. 12(b)(l) (lack of subject matter jurisdiction), 112(b)(6) (failure to state a claim),2 and 12(c) (for judgment on the pleadings). 3 According toDefendant, all claims of the patent-in-suit cover only a formulation free from a chelating agent,yet the Complaint alleges that InnoPharma's product contains EDTA, which is a chelatingagent. (D.I. 8 at 1) Therefore, InnoPharma argues, its product logically and legally cannotpossibly infringe the asserted patent. (D.I. 8 at 1 Indeed, in InnoPharma's view, paragraph 16of Cumberland's complaint states the opposite of a claim for patent infringement, alleging that

Rule12(b)(l) precludes actions where there is no reasonable basis to allege infringement.See Astrazeneca Pharms. P v. Apotex Corp., 2010 WL 5376310, at *1 (D. Del. Dec. 22, 2010)(dismissing Hatch-Waxman case on jurisdiction grounds where generic manufacturer excludesfrom its ANDA all patented methods of use ).

Evaluating a motion to dismiss under Rule 12(b)( 6) requires the Court to accept as trueall material allegations ofthe complaint. See Spruill v. Gillis, 372 F.3d 218,223 (3d Cir. 2004).Thus, the Court may grant such a motion to dismiss only if, after accepting all well-pleadedallegations in the complaint as true, and viewing them in the light most favorable to plaintiff,plaintiff is not entitled to relief. Maio v. Aetna, Inc., 221 F.3d 472,481-82 (3d Cir. 2000)(internal quotation marks omitted). However, [t]o survive a motion to dismiss, a civil plaintiffmust allege facts that 'raise a right to relief above the speculative level on the assumption that theallegations in the complaint are true (even if doubtful in fact). ' Victaulic Co. v . Tieman, 499F.3d 227, 234 (3d Cir. 2007) (quoting Bell At . Corp. v. Twombly, 550 U.S. 544 (2007)). Whileheightened fact pleading is not required, enough facts to state a claim to relief that is plausibleon its face must be alleged. Twombly, 127 S. Ct. at 1974.

3The standard for deciding a Rule 12(c) motion for judgment on the pleadings is the sameas the standard for reviewing a motion to dismiss brought pursuant to Rule 12(b)(6). SeeCelgene Corp. v. Teva Pharms. USA Inc., 412 F. Supp. 2d 439, 443 (D.N.J. 2006) (grantingjudgment on pleadings under Rule 12(c)).

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InnoPharma's product contains exactly the ingredient that the asserted patent forbids. ( d.; salso D.l. 16)

4. In opposing the motion, Plaintiff argues that InnoPharma improperly asks theCourt to prematurely construe terms and make factual findings that certainly are in dispute.(D.I. 12 at 10) Plaintiff contends that neither the infringement allegations contained in theComplaint, nor the patent-in-suit, are limited to an EDTA-free product. ( d. at 2) Cumberlandcites to examples of cases in which courts have refused to construe disputed claim terms inconnection with a motion to dismiss and have denied dismissal of patent infringement actions.

5. The Court agrees with InnoPharma that its motion rests upon three facts, alldrawn from the complaint and the asserted patent attached to the complaint, specifically:

(D.I. 13 at 1

1 All patent claims cover only formulations free from a chelatingagent.2. EDTA is chelating agent.3. InnoPharma's product contains EDTA.

a. Independent claim 1, which is representative of all of the claims of thepatent-in-suit, covers only formulations that are free from a chelating agent, as is seen below:

A stable aqueous pharmaceutical composition comprising between200 and 250 mg/mL acetylcysteine, wherein the composition isfree rom a chelating agent, or pharmaceutically acceptable saltsthereof, wherein said composition is in a suitable form forintravenous injection, wherein the pH of the composition is from 6to 7, and wherein said composition is sealed in an airtight containercomprising a fill volume of said composition and a headspacevolume occupied by a pharmaceutically inert gas.

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('356 patent at col. 9 lines 17-25) (emphasis added)4 No formal process of claim construction isnecessary in order to determine that free from a chelating agent means that a claimedcomposition may not include a chelating agent. Cumberland does not even suggest how freefrom 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 distinctfrom a prior art formulation in that the old formulation contained a chelating agent while thenew 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 ofthe 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 substantiallyfree of chelating agents. )) Likewise, the Complaint explains that Cumberland moved from anold formulation containing EDTA to a new formulation that does not. See D.l. 12

( Contrary to the expectations and teaching in the field, Cumberland was successful indeveloping a new formulation that contained no EDTA or any other chelating agent yet offeredsurprisingly good stability. ); id t ~ ~ 9-14)5

4Cumberland's claims are, obviously, based on the 356 patent, which is attached to theComplaint. It is appropriate for the Court to consider the '356 patent for purposes of evaluatingthe pending motion. See, e.g., Fed. R. Civ. P. 10(c).

5Cumberland insists, in a conclusory manner, that neither the infringement allegations inthe Complaint nor the patent-in-suit is limited to an EDTA-free product. (D.I. 12 at 2) To theextent Cumberland means to suggest that its patent is not limited to products free of a chelatingagent, Cumberland identifies no basis for such a contention. The Court agrees with InnoPharmathat the patent contains no claim that llows a chelating agent. (D.I. 13 at 3)


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b Plaintiff's Complaint alleges that the ingredient EDTA is an example of achelating agent. ( d. at -r 12) Additionally, the '356 patent identifies EDTA as an example of a

class of compounds called chelating agents. ('356 patent at col. lines 7-16) In fact, the patentidentifies EDT A as a widely used example of a chelating agent. Id)

c The Complaint alleges: [o]n information and belief, InnoPharma'sproposed acetylcysteine product contains EDTA. (D.I. 1 at -r 16) The Court must accept thiswell-pleaded factual allegation as true.

d It follows from the foregoing that InnoPharma'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 Cumberlandthat provides any persuasive reason for allowing this case to proceed to discovery. Infringementunder the doctrine of equivalents is unavailable because a finding of infringement would vitiatethe free from a chelating agent claim limitation. Finally, even assuming that the Complaintsatisfies the notice pleading requirements discussed in Phonometries, Inc. v HospitalityFranchise Sys., Inc., 203 F.3d 790, 794 (Fed. Cir. 2000) (per curiam) (reversing dismissal ofpatent infringement case where complaint met notice pleading requirements), that does notpreclude dismissal, given the Complaint 's failure (nonetheless) to state a claim for which reliefmay be granted, for the reasons already provided.


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IN THE UNITED ST TES DISTRICT COURT

FOR THE DISTRICT OF DEL W RE

CUMBERLAND PHARMACEUTICALS INC.,Plaintiff,

v

SAGENT AGILA LLC, and SAGENTPHARMACEUTICALS, INC.,

Defendants.

C.A. No. 12-825-LPS

MEMOR NDUM ORDERAt Wilmington this 1st day ofNovember, 2013, this matter coming before the Court upon

the motion to dismiss (D I 9) plaintiff Cumberland Pharmaceuticals Inc.'s ( Plaintiff' orCumberland ) 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 GRANTEDfor 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 containeda Paragraph IV certification contending that Cumberland's U.S. Patent No. 8,148,356, entitledAcetylcysteine 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.l.15 at 2)


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2 On June 26, 2012, within 45 days of receipt of Sagent ' s notice letter, Cumberlandfiled suit for infringement, triggering an automatic 30-month stay of FDA approval ofSagent'sANDA (See D.l. 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 ofthe '356 patent (CountII).

3. On August 29, 2012, Sagent filed its motion to dismiss. Sagent moves to dismissthe Complaint under Fed. R. Civ. P. 12(b)(6) for failure to state a claim. 1 According toDefendants, 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 chelatingagent. (D.I. 10 at 1-2, 4, 6-7) Therefore, Sagent argues, [a]s a matter ofboth common senseand controlling law, a formulation with a specific ingredient cannot infringe a pa tent claim thatforbids that very ingredient. (D.I. 10 at 5) Indeed, in Sagent's view, paragraph 20 ofCumberland's Complaint states the opposite of a claim for patent infringement, as Cumberlandadmits that ' [o]n information and belief, Defendants' [Sagent' s] proposed acetyl cysteine productcontains EDTA. ' ( d. at 7; see also D.l. 1 20)

4 In opposing the motion, Plaintiff argues that Sagent improperly and prematurely

1Evaluating a motion to dismiss under Rule 12(b)(6) requires the Cour t to accept as trueall material allegations of the complaint. See Spruill v Gillis, 372 F.3d 218, 223 (3d Cir. 2004).Thus, the Court may grant such a motion to dismiss only if, after accepting all well-pleadedallegations in the complaint as true, and viewing them in the light most favorable to plaintiff,plaintiff is not entitled to relief. Maio v Aetna, Inc., 221 F .3d 4 72, 481-82 (3d Cir. 2000)(internal quotation marks omitted). However, [t]o survive a motion to dismiss, a civil plaintiffmust allege facts that 'raise a right to relief above the speculative level on the assumption that theallegations in the complaint are true (even if doubtful in fact). ' Victaulic Co v Tieman, 499F.3d 227, 234 (3d Cir. 2007) (quoting Bell At . Corp. v Twombly, 550 U.S. 544 (2007)). Whileheightened fact pleading is not required, enough facts to state a claim to relief that is plausibleon its face must be alleged. Twombly, 127 S Ct. at 1974.

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seeks a claim construction ruling and summary judgment of non-infringement based on factualmatters in dispute. (D.I. 15 at 11) Plaintiff contends that neither the infringement allegationscontained in the Complaint, nor the patent-in-suit, is limited to an EDTA-free product. ( d. at 2)Cumberland cites to examples of cases in which courts have refused to construe disputed claimterms in connection with a motion to dismiss and have denied dismissal of patent infringementactions.

5. The Court agrees with Sagent that its there is no reasonable view of the facts pledin Cumberland's Complaint that would support a claim for relief, specifically:

D.I.16at2)

1. [E]very claim of the '356 patent expressly requires aformulation that is free of a chelating agent or free from achelating agent' (D.I. 1-1, 9:19; 9:45; 10:22; 10:29); and2. Cumberland admits that EDTA is a chelating agent, and thatSagent's product includes EDTA (D.I. 1 13, 16, 20; D.I. 15 at[3]).

a. Independent claim 1 which is representative of all of the claims of thepatent-in-suit, covers only formulations that are free from a chelating agent, as is seen below:

A stable aqueous pharmaceutical composition comprising between200 and 250 mg/mL acetylcysteine, wherein the composition isfree rom a chelating agent, or pharmaceutically acceptable saltsthereof, wherein said composition is in a suitable form forintravenous injection, wherein the pH of the composition is from 6to 7 and wherein said composition is sealed in an airtight containercomprising a fill volume of said composition and a headspacevolume occupied by a pharmaceutically inert gas.

('356 patent at col. 9 lines 17-25) (emphasis added) No claim construction is necessary in order

Cumberland's claims are, obviously, based on the '356 patent, which is attached to theComplaint. It is appropriate for the Court to consider the '356 patent for purposes of evaluating

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to determine that free from a chelating agent means that a claimed composition may notinclude a chelating agent. Cumberland does not even suggest how free from a chelating agentcould 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 artformulation in that the old formulation contained a chelating agent while the newformulation does not. (See, e.g., '356 patent, Abstract ( This invention relates to novelacetylcysteine compositions in solution, comprising acetylcysteine and which are substantiallyfree 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 substantiallyfree of chelating agents. )) Likewise, the Complaint explains that Cumberland moved from anold 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 indeveloping a new formulation that contained no EDT A or any other chelating agent yet offeredsurprisingly good stability. ); id t ~ ~ 13-18)3

b. laintiffs Complaint alleges that the ingredient EDTA is an example of achelating agent. ( d. 13) Additionally, the '356 patent identifies EDTA as an example of a

the pending motion. See, e.g., Fed. R. Civ. P. 10(c).3Cumberland insists, in a conclusory manner, that neither the infringement allegations in

the Complaint nor the patent-in-suit is limited to an EDTA-free product. (D.I. 13 at 2) To theextent Cumberland means to suggest that its patent is not limited to products free of a chelatingagent, Cumberland identifies no basis for such a contention. The Court agrees with Sagent thatall claims ofthe '356 patent require a formulation free from a chelating agent. (D.I. 10 at 1


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class of compounds called chelating agents. ( 3 56 patent at col. 4 lines 7-16) In fact, the patentidentifies EDTA as a widely used example of a chelating agent. /d.)

c The Complaint alleges: [o]n information and belief, Defendants'proposed acetylcysteine product contains EDTA. (D.I. 1 20)

d It follows from the foregoing that Sagent's ANDA does not infringe anyclaim of the '356 patent.

6 Cumberland's attempts to avoid this conclusion are unavailing. No claimconstruction 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. Infringementunder the doctrine of equivalents is unavailable because a finding of infringement would vitiatethe free from a chelating agent claim limitation. Finally, even assuming that the Complaintsatisfies the notice pleading requirements discussed in Phonometries, Inc. v HospitalityFranchise Sys., Inc., 203 F.3d 790, 794 (Fed. Cir. 2000) (per curiam) (reversing dismissal ofpatent infringement case where complaint met notice pleading requirements), that does notpreclude dismissal, given the Complaint 's failure (nonetheless) to state a claim for which reliefmay be granted, for the reasons already provided.

Accordingly, Sagent's motion (D.I. 9) is GRANTED. Cumberland's Complaint isDISMISSED. The Clerk of Court is directed to CLOSE this case.

Wilmington, Delaware

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cumberland pharm. inc. v. innopharma, inc., c.a. no. 12-618-lps (d. del. nov. 1, 2013); cumberland...

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