STARK, U.S. District Judge:
Pending before the Court is Defendants' Rule 12(b)(1) Motion to Dismiss for Lack of Subject Matter Jurisdiction Based on the Expiration of Asserted U.S. Patent No. RE38,115. (D.I.371) For the reasons discussed below, the Court will deny the motion.
Avanir Pharmaceuticals, Inc., Avanir Holding Company, and Center for Neurologic Study (collectively, "Avanir" or "Plaintiffs") filed this patent infringement action against Actavis South Atlantic LLC, Actavis, Inc., Par Pharmaceutical, Inc., Par Pharmaceutical Companies, Inc., Impax Laboratories, Inc., Wockhardt, Ltd., Wockhardt USA, LLC, Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., and Watson Pharma, Inc. (collectively, "Defendants") on August 10, 2011.
On August 5, 2013, Defendants filed a motion to dismiss Plaintiffs' claims arising under the '115 patent. (D.I.371) After full briefing, the Court heard argument on this motion during the pretrial conference on September 3, 2013. A bench trial was then conducted from September 9 to September 13, with an additional day on October 15, 2013. During the September phase of the trial, both sides presented evidence relating to the motion to dismiss, particularly with respect to the prosecution history of the '115 patent. After hearing that evidence, the Court ordered the parties to provide supplemental briefing relating to the motion to dismiss, briefing which the parties completed on September 30, 2013. (See D.I. 419 ¶ 6; D.I. 420-26)
The prosecution history related to the '115 patent involves three interrelated lines of filings, consisting of (1) a series of original filings, (2) a series of Patent Cooperation Treaty ("PCT") filings, and (3) a reissuance proceeding.
On June 9, 1992, Dr. Richard Smith filed U.S. Patent Application Serial No. 07/896,053 (the "'053 application"). (DTX 32 at AVAN-0403490) An examiner with the United States Patent and Trademark Office
On September 22, 1994, Drs. Richard Smith and Jonathan Licht filed PCT International Application No. PCT/US94/10771 (the "'771 application"). (DTX 638 at AVAN-0207672-710) Subsequently, on September 19, 1996, Drs. Smith and Licht filed a U.S. national stage application of the '771 application, known as U.S. Patent Application Serial No. 08/464,792 (the "'792 application"). (DTX 179 at AVAN-0207665) Neither the '771 application (see DTX 638) nor the national stage '792 application (see DTX '179 at AVAN-0207667) included priority claims to either the '053 or '845 applications.
On March 10, 1997, during prosecution of the '792 application, the examiner rejected claims 1-4 as obvious under 35 U.S.C. § 103(a) over the Zhang 1992 reference.
On January 18, 2002, the applicants filed U.S. Patent Application Serial No. 10/052,698 (the "'698 application") for reissuance of the '927 patent. (DTX 180 at AVAN-0209475-77) The applicants sought to claim
During the present litigation, on March 26, 2013, Plaintiffs filed an ePetition to revive the '053 application and correct what Defendants allege was a lack of co-pendency with the '845 application. (D.I. 371 Ex. B; see also D.I. 397 at 3) Plaintiffs did not file a terminal disclaimer with the ePetition. (See D.I. 371 Ex. B) The ePetition was granted on the same date it was filed, March 26, 2013. (Id. at 4)
Federal Rule of Civil Procedure 12(b)(1) authorizes dismissal of a complaint for lack of jurisdiction over the subject matter. As the question of subject matter jurisdiction under Rule 12(b)(1) is not unique to patent law, it is governed by the law of the regional Circuit, here the Third Circuit. See Toxgon Corp. v. BNFL, Inc., 312 F.3d 1379, 1380 (Fed.Cir.2002) ("We review a dismissal for lack of subject matter jurisdiction according to regional circuit law, since it is a procedural question not unique to patent law.").
Motions brought under Rule 12(b)(1) may present either a facial or factual challenge to the Court's subject matter jurisdiction. See Gould Elec., Inc. v. United States, 220 F.3d 169, 176 (3d Cir.2000). In reviewing a factual challenge to the Court's subject matter jurisdiction, the Court is not confined to the allegations of the complaint, and the presumption of truthfulness does not attach to those allegations. See Mortensen v. First Fed. Sav. & Loan Ass'n, 549 F.2d 884, 891 (3d Cir.1977). Instead, the Court may consider evidence outside the pleadings, including affidavits, depositions, and testimony, to resolve any factual issues bearing on jurisdiction. See Gotha v. United States, 115 F.3d 176, 179 (3d Cir.1997). Once the Court's subject matter jurisdiction is challenged, the plaintiff bears the burden of proving jurisdiction exists. See Mortensen, 549 F.2d at 891.
Plaintiffs contend that the '115 patent claims priority to June 9, 1992, the filing date of the '053 application, through the '845 application.
Plaintiffs respond on multiple grounds. First, Plaintiffs contend that this Court is the wrong forum to address Defendants' contentions, as improper revival and prosecution irregularities are not grounds on which the Court may invalidate a patent. Next, Plaintiffs assert that there was no gap in co-pendency of the pertinent patent applications and, even if there were, the ePetition corrected any resulting problems. Plaintiffs further insist that no terminal disclaimer was required to accompany the ePetition. Finally, Plaintiffs contend that even if they are incorrect on each of the preceding points, Defendants are entitled to no relief, and especially not a judicial declaration that the '115 patent is expired.
The Court considers each of these issues below.
As a threshold issue, the Court must determine if this Court is an appropriate forum to decide the issues Defendants have raised in their motion. Plaintiffs, relying on the Federal Circuit's decision in Aristocrat Technologies Australia PTY Ltd. v. Int'l Game Tech., 543 F.3d 657 (Fed.Cir.2008), assert that "any determination of whether a terminal disclaimer was required is within the exclusive province of the PTO," so Defendants may only litigate their present contentions via a separate
While Aristocrat holds that "improper revival may not be asserted as a defense in an action involving the validity or infringement of a patent," 543 F.3d at 663, Aristocrat did not consider a challenge to a court's subject matter jurisdiction.
Therefore, the Court will proceed to the next steps of the analysis.
The Court must determine whether there was a lack of co-pendency between the '053 application and the '845 application. Having considered the evidence of record as well as the parties' arguments, including the trial testimony and extensive briefing, the Court finds that there was a three-day gap between the abandonment of the '053 application and the filing of the '845 application. Specifically, the '053 application was abandoned on August 30, 1993, but the '845 application was not filed until September 2, 1993. (D.I. 127 at
Plaintiffs' own expert, Nicholas Godici, acknowledges the gap that occurred between the '053 application's abandonment and the '845 application's filing. (D.I. 409 Ex. A at 89 (stating that nothing in file history indicates that '053 application had extension beyond August 30); id. at 81 (noting that '845 application has September 2 filing date); Trial Tr. at 1006 (agreeing that '845 application's filing date was September 2); id. at 1007 (agreeing generally that there would have been no need to file petition to revive '053 application if it had been co-pending with '845 application))
Plaintiffs offer several, unconvincing arguments for the purported existence of co-pendency. Plaintiffs contend that the "'053 application's abandonment was conditional upon the granting of the filing date for the '845 application." (D.I. 420 at 3; see also D.I. 397 Ex. A at ParPharma DEX 0014480) While it seems clear from the prosecution history that the applicant
Plaintiffs next argue that "even if the conditional abandonment of the '053 application was ineffective to initially establish co-pendency, the evidence shows that the PTO exercised its discretion to establish co-pendency and grant the '845 application ... priority to the '053 application." (D.I. 420 at 3; see also D.I. 422-1 Ex. K at AVAN-0316838 (examiner writing that '053 and '845 applications were co-pending)) Essentially, Plaintiffs contend that because the PTO considered the '053 and '845 applications to be co-pending during prosecution (before the ePetition was filed), it is improper for the Court even to question the PTO's decision on this point. In making this argument, Plaintiffs rely again on Aristocrat, as well as Magnivision, Inc. v. Bonneau Co., 115 F.3d 956 (Fed.Cir.1997), for the proposition that "[a]bsent proof of inequitable conduct, the examiner's or the applicant's absolute compliance with the internal rules of patent examination becomes irrelevant after the patent has issued." Aristocrat, 543 F.3d at 663 (citing Magnivision, 115 F.3d at 960).
Again, however, Plaintiffs read too much into these decisions, which are predicated on the principle that "[t]here is good reason not to permit procedural irregularities during prosecution, such as the one at issue here, to provide
Plaintiffs have cited no authority for the proposition that the PTO has "discretionary authority" to treat two applications as co-pending when, as a matter of fact, they were not co-pending.
Plaintiffs contend that the issuance of the '115 reissue patent, in which Plaintiffs successfully added the '053 and '845 applications to the language of the specification under "Related Applications" (D.I. 422 Ex E at 1), is dispositive of co-pendency.
Because there was a lack of co-pendency, and the '053 application was abandoned, the Court must next consider Plaintiffs' attempt to revive that application. Plaintiffs filed a petition to revive; however, Plaintiffs did not include a terminal disclaimer with their petition. The Court agrees with Defendants that, under the circumstances here, a grantable petition to revive would have to be accompanied by a terminal disclaimer.
On March 26, 2013, Plaintiffs filed an ePetition, which sought to claim priority for the '115 patent back to a revived '053 application. (D.I. 371 Ex. B at 3) To determine whether this ePetition required a terminal disclaimer, the Court must apply 37 C.F.R. § 1.137(d)(1) & (2),
Section 1.137(d)(1) & (2) required a terminal disclaimer to be filed with the ePetition. With regard to the conditions set out in paragraph (d)(1), (i) Plaintiffs submitted a petition to revive pursuant to § 1.137 (D.I. 371 Ex. B) and (ii) the utility application being revived, the '053 application, was filed on June 9, 1992, predating June 8, 1995. Accordingly, to be grantable, the petition to revive the '053 application required a terminal disclaimer. (See 37 C.F.R. § 1.137(b); see also Trial Tr. at 958-60)
Plaintiffs' arguments against this conclusion are unavailing. Plaintiffs contend that the '115 patent does not come within the scope of § 1.137(d)(2) because it is a reissue application and the reissue application's actual filing date is after June 8, 1995. (D.I. 422 at 5) However, the statute provides that "every reissue patent shall have the same effect and operation in law" as the original patent and, further, "shall constitute a continuation thereof and have effect continuously from the date of the original patent." 35 U.S.C. § 252. Plaintiffs cite no authority to contradict the logical conclusion from this statutory language that a resissue application is, indeed, a "continuing ... application" within the meaning of § 1.137(d)(2). Hence, the '115 resissue patent is, for these purposes, a continuation of the '927 patent, which is traced back to the '771 application, which was filed before June 8, 1995, on September 22, 1994. It follows that Plaintiffs' contention that the applicable application date is January 18, 2002 (D.I. 422 at 5) — the filing date of the '698 reissue application — is incorrect.
Plaintiffs argue no terminal disclaimer was required because the '053 application never issued as a patent and, therefore, the rationale behind terminal disclaimers does not apply, because there is no improper extension of the '053 patent term. (D.I. 397 at 11) As an initial matter, Plaintiffs cite no authority for what they purport to be the rationale for the terminal disclaimer requirement.
Plaintiffs also suggest that if a terminal disclaimer were required, the PTO would have rejected their ePetition, so the PTO's acceptance of the ePetition indicates that no terminal disclaimer was necessary. (See id. at 5) This contention overlooks the undisputed evidence that the PTO's automated system automatically granted the ePetition based on Plaintiffs' checking a box indicating
In sum, in order to be properly granted, Plaintiffs' ePetition was required to include a terminal disclaimer, which would have dedicated to the public any portion of the '115 patent's term extending beyond June 9, 2012.
Having determined that Plaintiffs' ePetition was required to be accompanied by a terminal disclaimer, which would have resulted in the '115 patent's expiration, and it being undisputed that Plaintiffs did not file a terminal disclaimer, the Court next confronts the difficult matter of discerning the appropriate consequences. Defendants request that the Court either require Plaintiffs to return to the PTO and file a petition accompanied by the necessary terminal disclaimer or, alternatively, simply find that the '115 patent is expired. (D.I. 421 at 8-9) Plaintiffs, understandably, oppose both of these proposed remedies. Plaintiffs observe that, had the PTO determined that the March 2013 ePetition required a terminal disclaimer, the PTO's response would have been to dismiss the petition and provide Plaintiffs the
It follows, in the Court's view, that Plaintiffs should not be left with something less than they would have had if the PTO had reviewed the ePetition on its merits and determined that a terminal disclaimer was required. Defendants cite no authority for the proposition that the Court is obligated to order Plaintiffs to refile their petition with a terminal disclaimer or to
Unfortunately, Plaintiffs' proposed "remedy" is untenable as well. Plaintiffs ask the Court to do nothing, allowing them to retain the '115 patent's term until January 26, 2016 while also obtaining a priority date back to June 9, 1992. (See D.I. 422 at 10) For this conclusion, Plaintiffs rely again on Aristocrat, but again their position is unavailing. In Aristocrat, the defendants sought to invalidate the '215 patent, contending the original '215 application was abandoned by an improperly granted petition to revive and that this, alone, was sufficient grounds for a defense of invalidity. See 543 F.3d at 660.
Aristocrat is further distinguishable on other grounds as well. In reaching its holding in Aristocrat, the Federal Circuit observed that improper revival is not a defense that is found either in § 282 or elsewhere in the Patent Act. The Court further reasoned that it could reject recognition of the proposed improper revival defense because it did not, in Aristocrat, confront a situation in which the "failure to impose invalidity for violation of the statute would encourage noncompliance." 543 F.3d at 664. The Court could "discern no legitimate incentive for a patent applicant to intentionally abandon its application, much less to attempt to persuade the PTO to improperly revive it." Id. Specifically, the Court concluded that because "patents filed
Here, by contrast, the '115 patent relates to a
Additionally, here, unlike what was attempted by the defendants in Aristocrat, the Court is not permitting Defendants to argue that improper revival, or any other prosecution irregularity, invalidates the '115 patent. Instead, under the circumstances here, the Court is faced with issues relating to the determination of a priority date, and the Court's resolution of the parties' dispute does not mandate invalidation of the patent. Therefore, the Court is not permitting "procedural irregularities... to provide a basis for invalidity," Aristocrat, 543 F.3d at 663; instead, the Court is considering the entirety of the prosecution history for purposes of determining the correct priority date for a patent-in-suit.
Having rejected both parties' positions with respect to an appropriate remedy, the Court must determine what to do. The resolution to this question begins from the premise that had the PTO dismissed the ePetition, while the '115 patent would not expire until January 26, 2016, the '115 patent also would not claim priority to the '053 application filing date; rather, the '115 patent could only claim priority to the '845 application, which was filed on September 2, 1993 and was not abandoned. Under the circumstances, the Court concludes that the '115 patent may either (i) claim priority back to June 9, 1992 —
Accordingly, the Court concludes that Plaintiffs' ePetition to revive the abandoned '053 application was inoperative,
At this point, the '115 patent continues to enjoy a presumption of validity, see 35 U.S.C. § 282; Cardinal Chern. Co. v. Morton Int'l, Inc., 508 U.S. 83, 93 n. 15, 113 S.Ct. 1967, 124 L.Ed.2d 1 (1993), and has not been determined by either the PTO or this Court to have expired. It follows that the Court continues to have subject matter jurisdiction over the parties' disputes relating to the '115 patent. Accordingly, the Court will deny Defendants' motion to dismiss.
For the foregoing reasons, the Court will deny Defendants' Rule 12(b)(1) motion to dismiss. An appropriate Order follows.
At Wilmington, this 25th day of
For the reasons set forth in the Memorandum Opinion issued this date,
1. Defendants' Rule 12(b)(1) Motion to Dismiss for Lack of Subject Matter Jurisdiction Based on the Expiration of Asserted U.S. Patent No. RE38, 115 (D.I.371) is
2. The Court will reconsider its subject matter jurisdiction with respect to the '115 patent should it be advised by the parties that Plaintiffs hereafter file a petition to revive the '053 application accompanied by a terminal disclaimer.
35 U.S.C. § 120 (1993). There is no material difference, for the purposes of the issues before the Court, between the 1993 version of the statute and the current version. The parties evidently agree on this point, as they do not address the fact that the statute has been amended. Indeed, even Plaintiffs acknowledge that § 120
The '053 application was abandoned for more than nineteen years; hence, the period of the required disclaimer is determined pursuant to (d)(l)(ii), and is equal to any patent term beyond twenty years from the '053 application's filing date, i.e., the time between June 9, 2012 and January 26, 2016.