Allergan USA, Inc. v. Prollenium US Inc.

• Decision Date: 30 December 2019
• Docket Number: Civil Action No. 19-126-CFC-SRF
• Parties: ALLERGAN USA, INC. and ALLERGAN INDUSTRIE SAS, Plaintiffs, v. PROLLENIUM US INC. and PROLLENIUM MEDICAL TECHNOLOGIES INC., Defendants.
• Court: U.S. District Court — District of Delaware

ALLERGAN USA, INC. and ALLERGAN INDUSTRIE SAS, Plaintiffs, v. PROLLENIUM US INC. and PROLLENIUM MEDICALTECHNOLOGIES INC., Defendants.

Civil Action No. 19-126-CFC-SRF

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

December 30, 2019

REPORT AND RECOMMENDATION

I. INTRODUCTION

Presently before the court in this patent infringement action is the motion of plaintiffs Allergan USA, Inc. and Allergan Industrie SAS ("Allergan") to dismiss the inequitable conduct counterclaim and strike the inequitable conduct affirmative defense of defendants Prollenium US Inc. and Prollenium Medical Technologies Inc. ("Prollenium").¹ (D.I. 34) For the following reasons, I recommend that the court grant Allergan's motion to dismiss and strike without prejudice.

II. BACKGROUND

Allergan develops, manufactures, and distributes a line of dermal fillers under the JUVEDÈRM® mark that are injected into facial tissue to smooth wrinkles and folds. (D.I. 5 at ¶¶ 36, 39) Allergan's JUVEDÈRM® products are injectable hyaluronic acid ("HA") gels crosslinked with 1,4-butanediol diglycidyl ether ("BDDE"). (D.I. 29 at ¶¶ 8, 10) TheJUVEDÈRM® products contain a small amount of a local anesthetic called lidocaine to mitigate the pain and discomfort associated with the dermal filler injection. (Id. at ¶¶ 8, 10-11)

Allergan maintains the rights to six patents² (the "patents-in-suit") directed to HA-based compositions including lidocaine which are used as dermal and subdermal fillers. (D.I. 5 at ¶¶ 12-37) The patents-in-suit cover Allergan's JUVEDÈRM® products, and they claim priority to Provisional Application No. 61/085,956, which was filed by inventor Pierre Lebreton on August 4, 2008. (Id. at ¶¶ 41, 59; D.I. 35, Ex. A at 1) The provisional application is directed to HA-based dermal and subdermal fillers including lidocaine gel. (D.I. 35, Ex. A at 1) In the specification, the provisional application identifies several prior art references, including U.S. Application No. 10/743,557 by Sadozai et al. ("Sadozai"). (Id. at 2) Sadozai describes "a process for making an HA-based composition including lidocaine which includes hydrating dried HA particles with a phosphate buffer containing lidocaine." (Id.)

About six months after filing the provisional application, Dr. Lebreton filed U.S. Application No. 12/393,884 ("the '884 application"), which claims priority to the provisional application and is directed to HA-based dermal and subdermal fillers including an anesthetic agent. (D.I. 29 at ¶ 13; D.I. 35, Ex. B) The '884 application is the parent application of the patents-in-suit. (D.I. 29 at ¶ 13) Unlike the provisional application, the specification of the '884 application omits any reference to Sadozai. (D.I. 35, Exs. B & C) However, the applicant disclosed Sadozai in an August 2009 Information Disclosure Statement ("IDS") submitted to the U.S. Patent & Trademark Office ("PTO"). (Id., Ex. H) The examiner initialed the IDS toindicate that he had considered the references listed on it, including the Sadozai reference. (Id., Ex. D)

The examiner rejected the claims of the '884 application as obvious in view of prior art references teaching BDDE-crosslinked HA dermal fillers combined with references teaching the addition of lidocaine to other dermal fillers. (D.I. 29 at ¶ 14; D.I. 26, Ex. A at 5-9) Specifically, the examiner concluded that homogenously combining an HA composition and lidocaine would be obvious to a person of ordinary skill in the art at the time of the invention to anesthetize the tissue at the surgery site. (D.I. 29 at ¶ 15; D.I. 26, Ex. A at 7-8)

In response to the final rejection, Dr. Lebreton submitted a declaration dated May 2, 2012 which alleged that the prior art combinations were not obvious. (D.I. 26, Ex. B) According to Dr. Lebreton, a person of ordinary skill in the art would expect the addition of lidocaine to the HA composition to result in degradation of the HA prior to administration of the injection. (D.I. 29 at ¶¶ 17-18; D.I. 26, Ex. B at ¶ 5) Dr. Lebreton also represented that it was not known at the time whether HA compositions with lidocaine were stable in storage after undergoing high temperature sterilization. (D.I. 29 at ¶¶ 17, 19-20; D.I. 26, Ex. B at ¶¶ 6-7) For these reasons, Dr. Lebreton identified the combination of lidocaine with HA in a stable dermal filler gel as an unexpected result of the '884 application. (D.I. 29 at ¶¶ 22-24; D.I. 26, Ex. B at ¶¶ 9-10, 15) The examiner allowed the '884 application after concluding that Dr. Lebreton's declaration adequately established the existence of unexpected results. (D.I. 29 at ¶¶ 26-27; D.I. 26, Ex. D at 3) The '884 application issued as U.S. Patent No. 8,357,795 ("the '795 patent") on January 22, 2013. (D.I. 29 at ¶ 13, 16)

In December 2018, Prollenium launched a dermal filler product called Revanesse® Versa+, which is an injectable HA gel containing small quantities of lidocaine. (D.I. 5 at ¶ 42; D.I. 29 at ¶ 42) Allergan filed suit on January 22, 2019, alleging that Prollenium's Revanesse® Versa+ dermal filler products infringe the patents-in-suit. (D.I. 1; D.I. 5 at ¶ 44) Prollenium filed its answer, affirmative defenses, and counterclaims on May 6, 2019, alleging, among other things, that the patents-in-suit are unenforceable because they were obtained as a result of inequitable conduct before the PTO. (D.I. 11 at ¶¶ 9-21, 58-64) Allergan subsequently filed a motion to dismiss Prollenium's inequitable conduct counterclaim and affirmative defense, and Prollenium responded by amending its answer and counterclaim. (D.I. 20; D.I. 29) Allergan now moves to dismiss Prollenium's amended counterclaim and affirmative defense for inequitable conduct. (D.I. 34)

III. LEGAL STANDARDS

A. Rule 12(f)

Rule 12(f) permits "[t]he court [to] strike from a pleading an insufficient defense or any redundant, immaterial, impertinent, or scandalous matter." Fed. R. Civ. P. 12(f). The court must construe all facts in favor of the nonmoving party and deny the motion unless the defense is clearly insufficient as a matter of law. Symbol Techs., Inc. v. Aruba Networks, Inc., 609 F. Supp. 2d 353, 356 (D. Del. 2009). "A decision to grant or deny a motion to strike a pleading is vested in the trial court's discretion," but motions to strike under Rule 12(f) are generally disfavored. Aoki v. Benihana, Inc., 839 F. Supp. 2d 759, 764 (D. Del. 2012) (internal citations and quotation marks omitted); Fesnak & Assocs., LLP v. U.S. Bank Nat'l Ass'n, 722 F. Supp. 2d 496, 502 (D. Del. 2010).

In this case, Allergan moves to strike Prollenium's affirmative defense of inequitable conduct. Affirmative defenses for inequitable conduct are subject to the heightened pleading standard of Rule 9(b). See Senju Pharm. Co., Ltd. v. Apotex, Inc., 921 F. Supp. 2d 297, 306 (D. Del. 2013) ("Just as a claim for inequitable conduct must meet the heightened pleading requirements of Rule 9(b), a defendant is also required to plead this affirmative defense with particularity under Rule 9(b)."). Pursuant to the heightened pleading requirement of Rule 9(b), sufficiently pleading an affirmative defense of inequitable conduct requires identification of the "specific who, what, when, where, and how of the material misrepresentation or omission committed before the PTO." Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1328-29 (Fed. Cir. 2009).

B. Rule 12(b)(6)

Rule 12(b)(6) permits a party to move to dismiss a complaint for failure to state a claim upon which relief can be granted. Fed. R. Civ. P. 12(b)(6). When considering a Rule 12(b)(6) motion to dismiss, the court must accept as true all factual allegations in the complaint and view them in the light most favorable to the plaintiff. See Umland v. Planco Fin. Servs., Inc., 542 F.3d 59, 64 (3d Cir. 2008). "Courts use the same standard in ruling on a motion to dismiss a counterclaim under Rule 12(b)(6) as they do in assessing a claim in a complaint." Goddard Sys., Inc. v. Gondal, C.A. No. 17-1003-CJB, 2018 WL 1513018, at *4 (D. Del. Mar. 27, 2018).

To state a claim upon which relief can be granted pursuant to Rule 12(b)(6), a complaint must contain a "short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). Although detailed factual allegations are not required, the complaint must set forth sufficient factual matter, accepted as true, to "state a claim to relief thatis plausible on its face." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007); see also Ashcroft v. Iqbal, 556 U.S. 662, 663 (2009). A claim is facially plausible when the factual allegations allow the court to draw the reasonable inference that the defendant is liable for the misconduct alleged. Iqbal, 556 U.S. at 663; Twombly, 550 U.S. at 555-56.

The court's determination is not whether the non-moving party "will ultimately prevail," but whether that party is "entitled to offer evidence to support the claims." In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1420 (3d Cir. 1997) (internal citations and quotation marks omitted). This "does not impose a probability requirement at the pleading stage," but instead "simply calls for enough facts to raise a reasonable expectation that discovery will reveal evidence of [the necessary element]." Phillips v. Cty. of Allegheny, 515 F.3d 224, 234 (3d Cir. 2008) (quoting Twombly, 550 U.S. at 556). The court's analysis is a context-specific task requiring the court "to draw on its judicial experience and common sense." Iqbal, 556 U.S. 663-64.

Allegations of fraud are subject to the heightened pleading requirements of Federal Rule of Civil Procedure 9(b). U.S. ex rel. Whatley v. Eastwick Coll., 657 F. App'x 89, 93 (3d Cir. 2016). Under Rule 9(b), a plaintiff must "state with particularity the circumstances constituting fraud or mistake." Fed. R. Civ. P. 9(b). This heightened pleading standard was meant to "place the defendants on notice of the precise misconduct with which they are charged, and to...