OPINION & ORDER
This matter comes before the Court on appeals (Doc. Nos. 157 and 201) filed by Defendants Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries, Ltd., and Gate Pharmaceuticals (hereinafter collectively “Defendants” or “Teva”) from two orders of Magistrate Judge Esther Salas, as well as the motion for summary judgment (Doc. No. 214) filed by Plaintiffs Eisai Co., Ltd. and Eisai, Inc. (hereinafter collectively “Plaintiffs” or “Eisai”). The Complaints in these consolidated cases assert patent infringement against Teva with
In a February 13, 2008 Order, Magistrate Judge Salas granted Eisai’s motion to strike portions of Teva’s Amended Answers.
Eisai Co. v. Teva Pharms. USA, Inc.,
Teva also appeals (Doc. No. 201) from two portions of a subsequent bench Order issued by Magistrate Judge Salas on May 29, 2008 (“May Bench Order”) that denied some of Teva’s discovery requests. These discovery requests concern the matters that Magistrate Judge Salas ordered to be stricken from Teva’s Amended Answers, as well as related issues.
For the following reasons, this Court will reverse the February Order, vacate the appealed portions of the May Bench Order, and refer this matter to the Magistrate Judge for further proceedings consistent with this Opinion. This Court will stay consideration of Eisai’s motion for summary judgment pending completion of any additional discovery allowed by Magistrate Judge Salas in accordance with this Opinion.
Background
I. Litigation History and Teva’s Motion to Amend its Answer
In the late 1980s, Eisai developed a new drug called donepezil hydrochloride that it would eventually market as Aricept®, which is the drug claimed in Eisai’s '841 patent. The '841 patent was issued on January 23,1990, and arose from the prosecution of U.S. Patent Application No. 07/207,339 (“the '339 application”). The '841 patent expires in November 2010.
In October 2004, Teva filed an Abbreviated New Drug Application (“ANDA”) with the Food and Drug Administration (FDA), seeking approval to market its own generic version of Aricept®. Teva’s ANDA contained a Paragraph III certification with regard to the '841 patent, indicating that it would not distribute its generic version prior to the patent’s expiration in November 2010. See 21 U.S.C. § 355(j)(2)(A)(vii)(III). 1 One year after filing this ANDA, in October 2005, Teva amended its ANDA to include a Paragraph IV certification claiming that the '841 patent is invalid for obviousness. Shortly thereafter, Eisai filed this patent infringement suit (No. 05-5727) against Teva pursuant to 35 U.S.C. § 271(e)(2), based on Teva’s Paragraph IV certification.
Eisai’s second Complaint in this matter arose in a similar fashion. In November 2005, Defendant Gate Pharmaceuticals (“Gate”), an unincorporated division of
In Teva’s initial Answer to Eisai’s first Complaint, filed in early 2006, it asserted the affirmative defense of patent invalidity for obviousness. The parties extensively litigated the obviousness defense and engaged in substantial discovery relating to that defense. 2 More than a year later, in May 2007, Teva filed a motion to amend its Answer to add the affirmative defense of inequitable conduct. This defense amounts to an argument that the '841 patent is unenforceable because Eisai failed to disclose known material information to the Patent and Trademark Office (“PTO”) during the prosecution of its patent with an intent to deceive the PTO.
In its Proposed Amended Answer submitted in conjunction with the motion to amend, Teva alleged that Eisai failed to disclose four sets of its own co-pending patent applications to the PTO examiner of the '339 application. The majority of the inequitable conduct allegations in Teva’s Proposed Amended Answer concerned Eisai’s alleged failure to disclose a family of patent applications known as “the '459 application.” Eisai initially filed the '459 application in December 1986. While this application was pending, Eisai filed the '339 application in June 1988. The applications were assigned to different PTO examiners. The '459 application resulted in the issuance of U.S. Patent No. 4,849,-431 (“the '431 patent”) in July 1989. The '339 application resulted in the issuance of the patent-in-suit, the '841 patent, in January 1990. Teva chiefly alleged in its Proposed Amended Answer that Eisai, in prosecuting the '339 application that led to the patent-in-suit, failed to disclose the co-pending '459 application, the '431 patent that issued from that application, and the existence of a 1984 article in the Journal of Medicinal Chemistry authored by Richard A. Kenley. Teva alleged that these materials, to which the Court will refer collectively as the “'459 application,” were material to consideration of the '339 application and were withheld with the intent to deceive the PTO.
In addition to the inequitable conduct allegations regarding the '459 application, Teva’s Proposed Amended Answer also alleged similar inequitable conduct in Eisai’s failure to disclose to the PTO examiner for the '339 application three other sets of its co-pending patent applications, all under consideration by different PTO examiners: the '035 application, the '662 application, and the '971 application (collectively the “other co-pending applications”). Eisai opposed Teva’s motion to amend its Answer. 3
II. The December Order
In the December Order, Magistrate Judge Salas granted Teva’s motion to amend only with respect to inequitable conduct based on failure to disclose the '459 application. In the analysis relevant
Before turning to the specific allegations, Magistrate Judge Salas also limited the temporal scope of any claimed basis of inequitable conduct. Eisai’s initial '339 application to the PTO was rejected by the PTO examiner, apparently for reasons not directly related to the co-pending applications allegedly withheld by Eisai during the prosecution of that initial application. (See Patunas Decl., Ex. B (“Proposed Amended Answer”) at ¶ 43 (alleging that initial '339 application was rejected as being “anticipated and/or obvious ... over U.S. Patent 3,746,759”).) Eisai subsequently amended its '339 application to include a narrower set of claims than the initial application. This narrowed application was eventually approved by the PTO and issued as the '841 patent-in-suit. Magistrate Judge Salas deemed any inequitable conduct with regard to the initial '339 application irrelevant to the enforceability of the '841 patent-as-issued. Therefore, the Magistrate Judge held that only inequitable conduct allegations arising from non-disclosures during the prosecution of the amended '339 application would be allowed, and that leave to amend with allegations arising from conduct during the prosecution of the initial '339 application would be denied.
Based on these initial rulings, Magistrate Judge Salas proceeded to consider Teva’s allegations with regard to each of the four co-pending applications. Although the court disallowed Teva’s allegations regarding non-disclosure of the '459 application 'that specifically addressed the initial '339 application, it granted leave to amend with regard to the '459 application allegations that implicated conduct involving the '841 patent-as-issued, i.e., conduct regarding the amended '339 application. The Magistrate Judge emphasized that with regard to these allowable '459 application allegations, Teva pled with particularity the undisclosed prior art, knowledge of the prior art by an Eisai official, and why the undisclosed items were material.
Id.
at 451-52. With regard to the three other families of co-pending applications, Magistrate Judge Salas found Teva’s allegations lacking in particularity. Teva’s allegations regarding the other three sets of
III. Teva’s Corrected Amended Answers and the February Order
Teva did not appeal the December Opinion to this Court. Rather, on December 17, 2007, it filed Corrected Amended Answers in an attempt to comply with the December Order. 5 These Corrected Amended Answers added the inequitable conduct defense solely with regard to the '459 application, consistent with the scope permitted by the December Order. The '459 application allegations included the same general averment that Eisai withheld material information “with an intent to deceive the PTO.” (Patunas Deck, Ex. C (“Corrected Amended Answer”) at ¶ 39.) 6
However, Teva also included references to the other co-pending applications on which Magistrate Judge Salas had denied leave to amend. This time, Teva clarified its purpose for invoking these other co-pending applications: that collectively, they constituted a “pattern of non-disclosure” that “further supports the conclusion that the failure by Applicants to disclose the co-pending '459 application and Kenley was done intentionally to deceive the Examiner of the '339 application.” (Corrected Amended Answer at ¶41.) In other words, Teva converted what it claimed was implicit in its Proposed Amended Answer into an explicit allegation: that the nondisclosure of the other co-pending applications constituted only evidence of intent to deceive with regard to the '459 application, rather than separate bases of inequitable conduct. Teva included additional allegations in its Corrected Amended Answers regarding Eisai’s “pattern of filing and prosecuting a series of overlapping patent applications” and a “pattern of conduct.”
(Id.
at ¶¶ 31, 32, 40.) The Corrected Amended Answers did not contain any specific allegation that the other eo-pending applications were “material.” Teva merely alleged that the other co-pending applications had “claims overlapping those of the '459 and '339 applications,” that they were all assigned to different PTO examiners, and that Eisai did not disclose any of them to any of the other examiners handling any of the other applications.
(Id.
at ¶ 41.) Complaining that these allegations regarding the other co-pending applications and a “pattern of conduct” exceeded the scope of allegations permitted by the December Order, Eisai moved to strike these allegations (Paragraph 31 and portions of Paragraphs 32, 40, and 41)
In the February Order, Magistrate Judge Salas granted Eisai’s motion. First, the court specifically applied the particularity requirement of Rule 9(b) to both elements of inequitable conduct, materiality and intent. February Order,
[T]he fact of the matter is that co-pending applications are only relevant insofar as they are material. Without alleging materiality, Teva has no basis upon which to assert that the co-pending applications should have been disclosed to the patent examiner. It follows that those co-pending applications do not evidence an intent to deceive and cannot be used in that manner. As Eisai argues, “[o]ne cannot intend to deceive by not disclosing information not alleged to be material.” This Court agrees. Failure to alert a patent examiner to a co-pending application cannot be deceitful if the application is not material.
Id. at 493-94 (internal citation omitted). Magistrate Judge Salas finally observed that all of the cases Teva cited to support its theory actually stood for the opposite proposition, namely that “co-pending applications, when used as evidence of an intent to deceive, must be material.” Id. at 494. Teva appealed the February Order to this Court (Doc. No. 157). 7
IV. May Bench Order
While Teva’s appeal of the February Order was pending, the parties engaged in discovery. Teva served Eisai with certain discovery requests. Teva’s Interrogatory 17, Rule 30(b)(6) deposition topic 4, and Document Request 79 sought information regarding 1) the other co-pending applications struck by Magistrate Judge Salas in the February Order; and 2) other patent applications filed by Eisai that had been abandoned over a six-year period culminating in the issuance of the patent-in-suit. As Teva conceded at oral argument before the Magistrate Judge, Teva’s right to conduct discovery with regard to the other co-pending applications depended upon this Court’s reversal of the February Order.
From the bench on May 29, 2008, Magistrate Judge Salas orally denied without prejudice Teva’s motion to compel discov
Analysis
I. Standard of Review
Pursuant to 28 U.S.C. § 636(b)(1)(A), Federal Rule of Civil Procedure 72(a), and Local Civil Rule 72.1(a), a United States Magistrate Judge may hear non-dispositive motions. On appeal, a district court may modify or set aside a magistrate judge’s non-dispositive order if the ruling was “clearly erroneous or contrary to law.” Fed.R.Civ.P. 72(a); L. Civ. R. 72.1(c)(1)(A);
see also Haines v. Liggett Group Inc.,
II. This Court Will Reverse the February Order
In granting Eisai’s motion to strike, Magistrate Judge Salas misapplied Rule 9(b). Furthermore, Federal Circuit precedent does not foreclose Teva from supporting its allegations of intent as it proposes with a prior pattern of non-disclosures. This Court cannot say, as a matter of law, that Teva’s allegations have no possible relation to its defense. Therefore, the drastic remedy of striking allegations was not warranted. Although, as this Court will discuss, this error is understandable in the context of this complicated case, this Court is duty-bound to reverse the February Order as contrary to law.
A. Rule 12(f)
Teva’s appeal of the February Order requires this Court to review Magistrate Judge Salas’s grant of Eisai’s Rule 12(f) motion to strike. Rule 12(f) provides the means to challenge the sufficiency of affirmative defenses.
See Mars Inc. v. JCM Am. Corp.,
No. 05-3165,
Motions to strike are highly disfavored.
See Garlanger v. Verbeke,
Furthermore, Rule 12(f) motions often will not be granted where the challenged allegations depend on disputed issues of fact, due to the “practical difficulty of deciding cases without a factual record.”
Tonka Corp.,
B. Inequitable Conduct
Determination of the relevance of Teva’s allegations, and whether they were pled sufficiently, requires an understanding of the law of inequitable conduct. “A patent may be rendered unenforceable for inequitable conduct if an applicant, with intent to mislead or deceive the examiner, fails to disclose material information or submits materially false information to the PTO during prosecution.”
Larson Mfg. Co. of S.D., Inc. v. Aluminart Prods. Ltd.,
The Federal Circuit has instructed that “[t]o satisfy the intent to deceive element of inequitable conduct, ‘the involved conduct, viewed in light of all the evidence, including evidence indicative of good faith, must indicate sufficient culpability to require a finding of intent to deceive.’ ”
Impax Labs., Inc. v. Aventis Pharms. Inc.,
C. The December Order Did Not Resolve the Issue Presented in This Appeal
At the outset, this Court rejects Eisai’s contention that Teva’s failure to appeal the December Order prevents it from seeking to include the intent allegations at issue and precludes this appeal. In its initial motion to amend, Teva contended that it asserted one single basis of inequitable conduct: the failure to disclose the '459 application. The allegations in its Proposed Amended Answer regarding the other co-pending applications, according to Teva, served only as support for the required element of intent to deceive with regard to the failure to disclose the '459 application. However, Teva framed these allegations in its Proposed Amended Answer with the use of separate headings for each co-pending application and the mere allegation that each was “material.” This Court agrees with Magistrate Judge Salas’s reasonable conclusion in the December Order that Teva’s pleading appeared to assert that each “presents a new and separate instance of inequitable conduct.”
Teva did not appeal this ruling, and thus Teva accepted Magistrate Judge Salas’s conclusion that it had pled four independent bases of inequitable conduct, and that it failed to plead adequately the ones involving non-disclosure of the other co-pending applications. In its Corrected Amended Answers filed after the December Order, Teva attempted to clarify the purpose for its invocation of the other co-pending applications. Teva carefully limited its allegations regarding the other co-pending applications such that they only serve to support intent, rather than provide independent bases of inequitable conduct. Magistrate Judge Salas viewed these renewed allegations with suspicion, as they appeared to the court to recycle the “single basis of inequitable conduct” argument that she rejected in the December Order. However, the Magistrate Judge in the December Order did not specifically hold that allegations regarding the other co-pending applications were irrelevant to Eisai’s intent to deceive in relation to the allowed basis for inequitable conduct: the failure to disclose the '459 application. The court only held that the allegations concerning the other co-pending allegations could not stand alone as separate instances of fraud in the prosecution of the '841 patent such that they could be invoked separately to render the '841 patent unenforceable.
Therefore, Teva’s failure to appeal the December Order does not foreclose the instant appeal of the February Order. Only in the February Order did the Magistrate Judge rule that the allegations concerning the other co-pending applications were insufficient as indicia of intent. However, by applying a heightened pleading standard to these allegations, and deeming them irrelevant to Teva’s defense, the Magistrate Judge erred as a matter of law.
D. Rule 9(b)
Rule 9(b) states that “[i]n alleging fraud ..., a party must state with particularity the
circumstances constituting fraud.”
Fed.R.Civ.P. 9(b) (emphasis added). The Federal Circuit has held that inequitable conduct must be pled in accordance with the heightened pleading standard of Rule 9(b).
Ferguson Beauregard/Logic Controls, Div. of Dover Res.,
Magistrate Judge Salas held that Teva must plead
both
elements of inequitable conduct — materiality
and
intent — with particularity. February Order,
While Rule 9(b) requires the “circumstances constituting fraud” to be pled with particularity, the Rule also states that “intent ... and other conditions of a person’s mind may be alleged generally.” Fed. R.Civ.P. 9(b). The court did not cite this latter portion of Rule 9(b) regarding state of mind. This Court reads the plain text of the Rule to state that intent need not be pled with any substantive particularity.
This Court’s review of the relevant case-law reinforces its reading of the Rule. In
Central Admixture,
the Federal Circuit affirmed a district court’s dismissal of an inequitable conduct defense based on noncompliance with Rule 9(b), faulting the defendant’s pleading because it “fail[ed] to provide the required particularity to give notice to the other party of the facts on which the defense is premised.”
Magistrate Judge Salas imposed a higher pleading standard on Teva’s intent allegations concerning the other co-pending applications by requiring those intent allegations to be pled with particularity, and specifically by requiring that the intent allegations include particularized allegations of materiality. The particularity standard of Rule 9(b) has been applied to require more than “vague allegations of fraud and deception,” and to “instead ... specify the time, place and content of any alleged misrepresentations to the PTO.”
Sun Microsystems, Inc. v. Dataram Corp.,
No. 96-20708,
Some courts have required that an inequitable conduct pleading state “specifically” that the patent owner had an intent to deceive the PTO by literally including
Requiring heightened pleading with regard to intent “would not serve to further the aims of the heightened pleading standard, which is to discourage bald assertions of fraudulent misconduct without sufficient factual underpinnings.”
Vita-Mix Corp. v. Basic Holdings, Inc.,
No. 06-2622,
This Court agrees with the approach of the court in
Mars.
Teva’s Corrected Amended Answers contained a general averment of “intent to deceive,” along with detailed, particularized allegations regarding the circumstances of the fraud: the non-disclosure of the '459 application, knowledge of that application by Eisai, and the materiality of that application to the '841 patent-as-issued. Rule 9(b) simply does not require anything more particular with regard to intent at the pleading stage, and Teva’s allegations “provide the required particularity to give notice to the
E. The Relevance of a Pattern of Prior Non-Disclosure to Showing Intent
In addition to requiring intent to be pled with particularity, the Magistrate Judge concluded that “co-pending applications are only relevant insofar as they are material,” because “[w]ithout alleging materiality, Teva has no basis upon which to assert that the co-pending applications should have been disclosed to the patent examiner.” February Order,
The Magistrate Judge relied on several cases that the court read as “agree[ing] with the fundamental proposition that co-pending applications, when used as evidence of intent to deceive, must be material.”
Id.
at 494 (citing cases). These cases focused on attempts to prove intent to deceive based on the circumstances surrounding the actual non-disclosure that formed the basis for the inequitable conduct, including the materiality of that nondisclosure.
See Semiconductor Energy Lab. Co. v. Samsung Elecs. Co.,
The cases cited in the February Order indeed “use a pattern of failing to disclose
material
information as evidence of intent to deceive.” February Order,
A recent Federal Circuit decision suggests that a prior pattern of non-disclosure, if proven, could be relevant to intent to deceive. In affirming a finding of no inequitable conduct based on a lack of intent to deceive, the Federal Circuit in
Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.
highlighted the patentee’s “highly consistent pattern of disclosing references [with a certain common feature] in the prosecution of hundreds of its other patent applications.”
Eisai relies on
Kimberly-Clark Corp. v. Johnson & Johnson,
in which the Federal Circuit stated that “the key issues of materiality and intent should be decided with reference to the claims of the patent.”
Most importantly,
Kimberly-Clark
involved an appeal from a final judgment on inequitable conduct following a bench trial, and did not address whether intent needed to be
pled
with particularized reference to the claims of the patent, i.e. with reference to materiality.
Id.
at 1440. Furthermore, the opinion makes clear that in this statement, the Federal Circuit was addressing the circumstances of the fraud itself, not intent
per se.
The court commented that, with regard to inequitable conduct, defendants “had little or nothing to say” about the claims of the patent, and that they did not show that “non-disclosure of prior art would have had any effect” on whether that patent would have issued.
Id.
This reasoning illustrates that the defendants in
Kimberly-Clark
sought to base their inequitable conduct defense
entirely
on non-disclosures relevant to the initial application, and failed to present any evidence of
That situation differs greatly from the instant case, aside from the different stages of the two litigations. Here, Teva does not seek to build a case of fraud solely by reason of nonmaterial non-disclosures. Teva bases its inequitable conduct defense on the non-disclosure of the '459 application, and Magistrate Judge Salas correctly held that Teva has sufficiently alleged the materiality of this non-disclosure to the '841 patent-as-issued. Teva has much to say about the effect of the non-disclosure of the '459 application on the claims finally patented in the '841 patent. It only raises the other co-pending applications as additional evidence to support intent, and seeks to show that the non-disclosures of the other co-pending applications were material at the time of the non-disclosures. At this stage, this Court must focus on the sufficiency of Teva’s allegations, not what it might ultimately prove.
Magistrate Judge Salas struck Teva’s challenged allegations because they did not plead materiality, either to the patent-as-issued or at some prior time. Yet, as discussed above, Rule 9(b) does not require any such particularized pleading for intent allegations, even if an eventual showing of materiality might be essential for the relevance of the evidence. The Federal Circuit has not held that a prior pattern of non-disclosure is irrelevant to intent to deceive. Such a pattern could be relevant, at a minimum, to intent as part of consideration of the surrounding circumstances.
At the pleading stage, on a Rule 12(f) motion, mere relevance is sufficient, as this Court cannot say that these allegations “have no possible relation to the controversy.”
Garlanger,
F. Conclusion
While this Court concludes that Magistrate Judge Salas erred in granting Eisai’s
This Court shares the Magistrate Judge’s evident reluctance to allow unwarranted exploration of rather thin allegations, but concludes that Teva should be permitted, within the limits of the law, to develop its case for intent to deceive in this complex case. Nevertheless, this Court expects the parties to litigate this issue without succumbing to the unwelcome distraction of an extended fishing expedition resulting in a virtual side-trial on prior co-pending applications relevant only to intent. The parties should focus at all times on the only asserted basis of inequitable conduct here — the failure to disclose the '459 application — and the relevance of the other co-pending applications to intent to deceive with regard to this sole basis of inequitable conduct.
This Court will reverse the Magistrate Judge’s February Order and refer this matter to Magistrate Judge Salas for further case management proceedings consistent with this Opinion.
III. This Court Will Vacate the Appealed Portions of the May Bench Order
Because this Court will reverse the February Order, this Court will also vacate the appealed portions of Magistrate Judge Salas’s May Bench Order. Teva appeals Magistrate Judge Salas’s denial of its motion to compel discovery with respect to the other co-pending applications and with respect to other applications filed by Eisai but later abandoned. First, Magistrate Judge Salas denied Teva’s motion to compel discovery regarding the other co-pending applications without prejudice, observing that “discovery as to those applications would be in play” if this Court reversed the February Order. (Michael Deck, Ex. 1 (Tr. 5/29/08) at 99:9-11.) Because this Court will reverse the February Order, this Court will vacate the Magistrate Judge’s decision on this issue.
Next, the Magistrate Judge viewed the abandoned applications issue as not affected by the pending appeal, finding that it “[fell] outside the scope of discovery permitted, even if Judge Ackerman reverses this Court.” (Id. at 99:16-17.) Teva’s discovery request sought information about abandoned applications to determine whether the prosecution of those applications might have involved non-disclosure of information material at that time, and therefore could conceivably support Teva’s “pattern of non-disclosure” theory of intent. While Teva’s discovery request in this regard appears speculative, this Court will vacate the decision on this issue to allow for full reconsideration at this stage and in light of this Opinion.
This Court expresses no view on the permissibility or scope of discovery regarding the two issues implicated in Teva’s appeal of the May Bench Order. A magistrate judge’s ruling on a non-dispositive matter such as a discovery motion is
IV. This Court Will Stay Eisai’s Motion for Summary Judgment
During the pendency of the instant appeals, Eisai filed a motion for summary judgment. In opposition to Eisai’s summary judgment motion, Teva argues that it has met its burden with regard to intent to deceive, but that if this Court disagrees, then this Court should deny Eisai’s motion or grant a continuance to allow the discovery regarding intent denied by Magistrate Judge Salas in the May Bench Order. (Teva Summ. J. Br. at 37.) In light of this Opinion, this Court will stay consideration of Eisai’s motion for summary judgment, pending completion of any additional discovery that might be allowed. Indeed, arguments regarding the sufficiency of intent allegations “would be more appropriately raised in summary judgment motions or at trial,” rather than on a motion to strike.
Mars,
Conclusion and Order
For the foregoing reasons, it is hereby ORDERED that Magistrate Judge Salas’s February 13, 2008 Order granting Eisai’s motion to strike portions of Teva’s Amended Answers is hereby REVERSED. It is hereby further ORDERED that the appealed portions of Magistrate Judge Salas’s May 29, 2008 Bench Order denying Teva’s motion to compel certain discovery are VACATED. Accordingly, it is hereby ORDERED that both of Teva’s appeals (Doc. Nos. 157 and 201) are GRANTED. These matters are referred to the Magistrate Judge for further proceedings consistent with this Opinion. This Court hereby STAYS consideration of Eisai’s motion (Doc. No. 214) for summary judgment, pending the completion of any additional discovery that Magistrate Judge Salas might order and pending submission of any supplemental briefs and materials.
Notes
. When submitting an ANDA to the FDA, the generic manufacturer must make one of the following four certifications with respect to each of the patents listed in the Orange Book for the drug for which the applicant seeks approval: (1) that no patent information has been filed (a "Paragraph I” certification), (2) that the patent has expired (a "Paragraph II” certification), (3) that the patent will expire on a specific date (a "Paragraph III” certification), or (4) that the patent “is invalid or will not be infringed by the manufacture, use, or sale of the drug for which the application is submitted” (a "Paragraph IV” certification). 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV).
. On April 16, 2007, Teva stipulated that its generic drug would constitute infringement of claims 8, 10, and 13 of the '841 patent, "unless Teva proves in this litigation that claims 8, 10, and 13 are invalid or unenforceable.” (Doc. No. 65.) The parties have only litigated affirmative defenses in this case.
. During the pendency of the motion to amend, Teva filed its Answer to Eisai's second Complaint (No. 07-5489). This Answer was substantially identical to the Proposed Amended Answer filed with Teva's motion to amend in the first-filed action with regard to the inequitable conduct allegations.
. Rule 9(b) states that "[i]n alleging fraud .. a party must state with particularity the circumstances constituting fraud,” Fed.R.Civ.P. 9(b), and the Federal Circuit has held that inequitable conduct must be pled with particularity,
Ferguson Beauregard/Logic Controls, Div. of Dover Res., Inc. v. Mega Sys., LLC,
. These Corrected Amended Answers also effectively withdrew the affirmative defense of obviousness. Based on this withdrawal and the parties’ prior stipulation of infringement, the only remaining liability issue in this case is inequitable conduct. In addition, Teva filed Corrected Amended Answers in both Civil Action Nos. 05-5727 and 07-5489. Shortly after Teva filed these Corrected Amended Answers, Magistrate Judge Salas entered an Order consolidating the two cases. (Doc. No. 113.)
. In this Opinion, this Court will cite to the Corrected Amended Answer filed in No. OS-5727. The Corrected Amended Answer in No. 07-5489 contains different numbering, but its inequitable conduct allegations are identical to the Corrected Amended Answer in No. 05-5727.
. On the same date that Teva filed its appeal, it filed its Second Corrected Amended Answer in which it complied with Magistrate Judge Salas’s two orders by removing any references to the other co-pending applications and focusing solely on inequitable conduct based on failure to disclose the '459 application.
.
See, e.g., Probert v. Clorox Co.,
No. 07-139,
. Although this Court does not apply Third Circuit law to this question because Federal Circuit law controls, this standard comports with our Circuit’s reading of Rule 9(b). To satisfy the strictures of Rule 9(b) in our Circuit, a party alleging fraud "must state the circumstances of the alleged fraud with sufficient particularity to place the defendant on notice of the 'precise misconduct with which [it is] charged.' ”
Frederico v. Home Depot,
. Indeed, in the December Order, Magistrate Judge Salas properly rejected Teva's inequitable conduct allegations with regard to the other co-pending applications in part for a similar failure even to use the words "intent to deceive” with regard to those applications.
. The court in
Nisus
discussed an "ongoing pattern of failures” as supporting intent to deceive. However, the pattern referenced by the court constituted the conduct that formed the basis of inequitable conduct defense, not an additional, prior pattern as implicated here.
Nisus,
. The Federal Circuit has cited
Kimberly-Clark
for the notion that “materiality and intent to deceive are necessarily intertwined.”
Aventis Pharma
S.A. v.
Amphastar Pharms., Inc.,
