NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

____________________________________

:

PROMOTE INNOVATION LLC, :

:

Plaintiff, : Civil Action No. 11-607 (JAP)

v. :

: OPINION

ORTHO-MCNEIL PHARMACEUTICAL, :

LLC and ORTHO-MCNEIL-JANSEN :

PHARMACEUTICAL, INC., :

:

Defendants. :

___________________________________ :

PISANO, District Judge:

Before the Court is a motion to dismiss filed by Defendants Ortho-McNeil 

Pharmaceutical, LLC and Ortho-McNeil-Jansen Pharmaceuticals, Inc. Plaintiff Promote 

Innovation, LLC opposes the motion. For the reasons that follow, Defendants‟ motion will be 

granted.

Plaintiff filed a qui tam relator complaint on behalf of the United States under Section 

292 of the Patent Act, 35 U.S.C. § 292. Section 292 provides, in relevant part:

(a) . . . Whoever marks upon, or affixes to, or uses in advertising in connection 

with any unpatented article, the word “patent” or any word or number importing 

that the same is patented for the purpose of deceiving the public . . . [s]hall be 

fined not more than $500 for every such offense.

(b) Any person may sue for the penalty, in which event one-half shall go to the 

person suing and the other to the use of the United States.

35 U.S.C. § 292(a)-(b). According to Plaintiff‟s Second Amended Complaint (“Complaint”), the 

patent at issue expired no later than October 4, 2005, and Defendants continued to mark their 

Retin-A Micro products (the “Products”) with the patent number after the patent expired. The 

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Complaint also asserts that a package insert for the Products bears a copyright date of 2006, 

indicating that Defendants revised the package insert after the patent expired but nonetheless 

included the patent number on the package insert. The Complaint continues to claim that 

Defendants are “large, sophisticated companies” that retain “sophisticated legal counsel,” and 

that Defendants knew that the patent had expired and that it was a false statement to include the 

patent number on its Products.

Rule 9(b) of the Federal Rules of Civil Procedure requires that “[i]n alleging fraud or 

mistake, a party must state with particularity the circumstances constituting fraud or mistake.” 

The Federal Circuit recognized in In re BP Lubricants USA Inc., 637 F.3d 1307 (Fed. Cir. 2011), 

that Rule 9(b)‟s particularity requirement applies to false marking claims under Section 292, 

such as the claims in the instant case. See id. at 1309. The Federal Circuit also noted that “„the 

bar for proving deceptive intent in false marking cases is particularly high,‟ requiring that relator 

show „a purpose of deceit, rather than simply knowledge that a statement is false.‟” Id. at 1313 

(quoting Pequignot v. Solo Cup Co., 608 F.3d 1356, 1362-63 (Fed. Cir. 2010)). “[A]lthough 

„knowledge‟ and „intent‟ may be averred generally . . . under Rule 9(b), „[Federal Circuit] 

precedent, like that of several regional circuits, requires that the pleadings allege sufficient 

underlying facts from which a court may reasonably infer that a party acted with the requisite 

state of mind.‟” Id. at 1311 (quoting Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 

1327 (Fed. Cir. 2009)).

Plaintiff‟s pleadings fail to satisfy the requirements of Rule 9(b) as articulated in BP 

Lubricants. As in that case, the Complaint before the Court asserts only various allegations that 

Defendants were sophisticated companies that knew a patent had expired and nonetheless 

marked their Products with its number. That Defendants were “large, sophisticated companies” 

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and therefore knew or should have known that a patent expired is nothing more a conclusory 

allegation that is “not entitled to an assumption of truth at any stage in litigation.” Id. at 1312 

(citing Ashcroft v. Iqbal, 129 S. Ct. 1937, 1952 (2009)).

Plaintiff‟s only allegation of fact is that Defendants revised a package insert after the 

expiration of the patent. Plaintiff asserts that this is a fact from which the Court can reasonably 

infer that Defendants knew the patent was expired, but nonetheless chose to continue to mark its 

Products with it. The inclusion of the expired patent number on the package insert after a single 

revision, however, is a mere statement “where the relationship between factual falsity and state 

of mind is not . . . apparent” enough that the falsity of the statement automatically shows 

scienter. See id., 637 F.3d at 1312 (citing Merck & Co. v. Reynolds, 130 S. Ct. 1784, 1793 

(2010)). Therefore, the Court agrees with several other district courts that have determined that a 

packaging revision does not, alone, evidence a purpose of deceit. See Brinkmeier v. BIC Corp., 

733 F. Supp. 2d 552, 563 (D. Del. 2010) (“To the extent that plaintiff is arguing that [defendant]

had knowledge that the patents were expired because the packaging of these products was 

updated following patent expiration, this argument fails to prove [defendant] had intent to 

deceive the public.”); Herengracht Group LLC v. Intelligent Products, Inc., 2011 WL 938995, 

*4 (S.D. Fla. 2011) (holding that packaging that contains an expired patent number, though 

revised after its expiration, is not evidence of intent to deceive); Shizzle Pop, LLC v. Wham-O, 

Inc., 2010 WL 3063066, *4 (C.D. Cal. 2010) (“[C]reating new packaging does not create a 

reasonable inference that Defendant knew the . . . patent had expired.”).1

 

1 Also before the Court is a motion by Plaintiff to file a sur-reply in response to 

Defendants‟ contention that the package insert does not qualify as a “marking” of the Products 

under Section 292. The Court, however, will dismiss Plaintiff‟s Complaint without relying or 

ruling on this particular aspect of Defendants‟ argument. Accordingly, Plaintiff‟s motion to file 

a sur-reply will be denied as moot.

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Accordingly, because the only factual allegation in Plaintiff‟s Complaint fails to satisfy 

the pleading requirements of Rule 9(b), the Court must grant Defendants‟ motion to dismiss.2

Defendants also contend that their motion should be granted with prejudice because 

Plaintiff has already amended its pleadings twice to respond to various motions filed by 

Defendants. Plaintiff responds that the two amendments were irrelevant to the issue before the 

Court and therefore leave should be granted to amend. The Court will not grant Plaintiff leave to 

amend its pleadings. Defendants have, from their first motion to dismiss, Docket Entry no. 7, 

filed May 26, 2010, provided Plaintiff with notice that its pleadings may be deficient for failure 

to plead intent and for failing to meet the requirements of Rule 9(b). After Plaintiff first

amended its complaint, mooting the original motion to dismiss, Defendants again moved to 

dismiss, reiterating their argument that Plaintiff‟s pleadings were deficient under Rule 9(b). See

Mot. to Dismiss, Docket Entry no. 18, filed July 10, 2010. On August 12, 2010, Defendants 

filed notice with the Court of recent court decisions that supported their argument under Rule 

9(b). After a second amended complaint, Defendants filed another motion to dismiss with the 

same Rule 9(b) argument. See Mot. to Dismiss, Docket Entry no. 40, filed Nov. 5, 2010. 

Finally, after a transfer of venue to the District of New Jersey, Defendants filed the instant 

motion. Plaintiff has long been on notice and frequently reminded of its deficient pleadings. 

Nothing in the pleadings nor in its papers opposing the motion to dismiss indicates that Plaintiff 

could allege any facts that imply an intent to deceive on the part of Defendants. Accordingly, the 

Court will grant Defendants‟ motion to dismiss with prejudice.

 

2 The Court notes that an amendment to the Patent Act that recently passed the United 

States Senate and now sits before the House of Representatives contains a provision that would 

prohibit qui tam false marking suits altogether. See America Invents Act, S. 23, 112th Cong. § 

2(k) (2011)). Obviously, if such a bill was enacted it would moot the instant case. See id.

§2(k)(2) (“The amendments made by this subsection shall apply to all cases, without exception, 

pending on or after the date of the enactment of this Act.”).

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An appropriate Order will issue.

/s/ JOEL A. PISANO 

United States District Judge

Dated: July 14, 2011 

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