CAFC Opinion in Exela v Lee

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Case: 13-1206 Document: 63-1 Page: 1 Filed: 03/26/2015 (1 of 21)

13-1206 - Exela Pharma Sciences, LLC v. Lee United States District Court for the Eastern District of Virginia, Case No. 12-CV-0469


United States Court of Appeals for the Federal Circuit

______________________

EXELA PHARMA SCIENCES, LLC, EXELA PHARMSCI, INC., EXELA HOLDINGS, INC.,

Plaintiffs-Appellants

v.

MICHELLE K. LEE, Deputy Director, U.S. Patent and Trademark Office,

Defendant-Appellee

CADENCE PHARMACEUTICALS, INC., SCR PHARMATOP,

Intervenors ______________________

2013-1206

______________________

Appeal from the United States District Court for the Eastern District of Virginia in No. 12-CV-0469, Judge Liam O'Grady.

______________________

Decided: March 26, 2015 ______________________

MATTHEW JAMES DOWD, Wiley Rein, LLP, Washing-

ton, DC, argued for plaintiffs-appellants. Also represent-ed by CLAIRE JOY EVANS; CLARENCE EDWARD POLK, JR., Exela Pharma Sciences, LLC, Ashburn, VA; ANTHONY H. SON, Andrews Kurth, LLP, Washington, DC.


EXELA PHARMA SCIENCES, LLC v. LEE 2

DENNIS C. BARGHAAN, JR., Office of the United States Attorney for the Eastern District of Virginia, Alexandria, VA, argued for defendant-appellee. Also represented by DANA J. BOENTE; NATHAN KELLEY, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA.

RICHARD P. BRESS, Latham & Watkins LLP, Washing-

ton, DC, argued for intervenors. Intervenor Cadence Pharmaceuticals, Inc., also represented by GABRIEL BELL, Washington, DC; STEPHEN P. SWINTON, San Diego, CA; MARC NATHAN ZUBICK, KENNETH G. SCHULER, Chicago, IL. Intervenor SCR Pharmatop represented by CHARLES A. WEISS, Holland & Knight, LLP, New York, NY.

______________________

Before NEWMAN and DYK, Circuit Judges.∗ Concurring opinion filed by Circuit Judge NEWMAN

Concurring opinion filed by Circuit Judge DYK PER CURIAM.

This appeal presents the question of whether a third party has the right to challenge, by way of the Adminis-trative Procedure Act (APA), a ruling of the Patent and Trademark Office reviving a patent application that had become abandoned by failure to meet a filing schedule established by the Patent Cooperation Treaty and its implementing statute. The challengers are Exela Pharma Sciences, LLC; Exela Pharmsci, Inc.; and Exela Holdings, Inc. (collectively “Exela”). Exela petitioned the PTO to “reconsider and withdraw” its revival of the national stage

∗ Randall R. Rader, who retired from the position of Circuit Judge on June 30, 2014, did not participate in this decision.



application and to cancel the issued patent. The patent is United States Patent No. 6,992,218 (“the ’218 patent”), assigned to SCR Pharmatop.

The PTO declined to consider Exela’s petition, stating that no law or regulation authorizes non-party challenge to a PTO ruling to accept a tardy filing. Exela then brought suit under the APA in the United States District Court for the Eastern District of Virginia, arguing that the PTO’s action was ultra vires and that Exela’s petition should have been considered and favorably decided. The PTO moved to dismiss Exela’s complaint on several grounds.

The district court initially held that Exela was enti-tled to challenge the PTO’s decision under the APA, but on reconsideration and in view of new Fourth Circuit precedent, the district court dismissed Exela’s complaint for failing to meet the statute of limitations for claims filed against the United States, including APA claims.1

We affirm the dismissal, on the ground that PTO re-vival rulings are not subject to third party collateral challenge, thereby precluding review regardless of wheth-er Exela’s claims were time-barred.

BACKGROUND Patentee SCR Pharmatop filed its initial patent appli-

cation in France on June 6, 2000 and, in conformity with the Patent Cooperation Treaty (PCT), filed an interna-tional patent application identifying the United States, among others, as a designated state on June 6, 2001. The

1 Exela Pharma Sciences, LLC v. Kappos, No. 1:12-cv-469, 2012 WL 3638552 (E.D. Va. Aug. 22, 2012); Exela Pharma Sciences, LLC v. Kappos, No. 1:12-cv-469, 2012 WL 6697068 (E.D. Va. Dec. 21, 2012) (Reconsideration Decision).



PCT implementing statute, 35 U.S.C. §351 et seq., re-quires the applicant to fulfill certain United States docu-mentary and fee requirements within 30 months after the filing of the foreign priority application, here by December 6, 2002. See 35 U.S.C. §371(c), (d); PCT art. 22. SCR Pharmatop did not file the required materials by Decem-ber 6, 2002, and consequently the United States applica-tion was deemed abandoned. On January 2, 2003 SCR Pharmatop filed a petition to revive the application, stating that the delay was “unintentional,” using the form provided by the PTO for revival requests. The PTO granted the petition on April 25, 2003. The application was duly examined, and the ’218 patent issued on Janu-ary 31, 2006.

In August 2011 SCR Pharmatop and exclusive subli-censee Cadence Pharmaceuticals, Inc. (collectively “Pharmatop”) sued Exela in the United States District Court for the District of Delaware for infringement of the ’218 patent. The suit was brought under the Hatch-Waxman Act, 35 U.S.C. §271(e)(2), in response to Exela’s notice and filing of an Abbreviated New Drug Application and Paragraph IV Certification relating to Pharmatop’s injectable acetaminophen-based drug Ofirmev.

On November 30, 2011 Exela filed the subject petition in the PTO, under the APA and 37 C.F.R. §§1.181, 1.182, and 1.183, challenging the PTO’s revival of the patent application that led to the ’218 patent. Exela argued that “unintentional” delay was not an available ground for revival of a U.S. patent application claiming priority under the PCT-implementing statute as then in effect. Exela pointed out that 35 U.S.C. §371(d) limited the revival of such national stage applications to those in which the non-compliance was “unavoidable”:

The requirements with respect to the national fee . . ., the translation . . ., and the oath or declara-tion . . . shall be complied with by the date of the



commencement of the national stage or by such later time as may be fixed by the Director. . . . Failure to comply with these requirements shall be regarded as abandonment of the application by the parties thereof, unless it be shown to the satis-faction of the Director that such failure to comply was unavoidable. . . . 2

35 U.S.C. §371(d) (2002). Exela argued that the PTO erred in applying its general revival regulation, 37 C.F.R. §1.137, which provides:

Revival of abandoned application, terminated reexamination proceeding, or lapsed patent. (a) Unavoidable. If the delay in reply by applicant

or patent owner was unavoidable, a petition may be filed pursuant to this paragraph to re-vive an abandoned application, a reexamina-tion proceeding . . . , or a lapsed patent. A grantable petition pursuant to this paragraph must be accompanied by: . . .

(b) Unintentional. If the delay in reply by appli-cant or patent owner was unintentional, a peti-tion may be filed pursuant to this paragraph to revive an abandoned application, a reexamina-tion proceeding . . . , or a lapsed patent. A grantable petition pursuant to this paragraph must be accompanied by: . . .

37 C.F.R. §1.137 (2000). Exela asserted that a PTO regulation cannot override a statute, and therefore, the PTO lacked discretion to grant SCR Pharmatop’s revival petition for “unintentional” delay.

2 The statute was amended, effective December 18, 2013, removing the clause stating the “unavoidable” standard.



The PTO declined to consider Exela’s petition, stating that no statute or regulation authorizes third party challenge to a PTO ruling concerning revival of a patent application. See PTO letter to Exela’s counsel, February 17, 2012 (returning petition fee).

Following the PTO’s rejection of its petition, Exela filed this district court action under the APA, asking the court to compel the PTO to vacate its revival decision. The PTO moved to dismiss Exela’s complaint under Federal Rules 12(b)(1) and (6) on several grounds, includ-ing that Exela lacks standing to challenge the PTO’s revival ruling, that Exela’s APA action is time-barred, and that a PTO revival ruling is not subject to judicial review at the request of a third party challenger.

The district court initially denied the PTO’s motion to dismiss on all grounds, but while its decision was pend-ing, the Fourth Circuit issued its decision in Hire Order, Ltd. v. Marianos, 698 F.3d 136, 170 (4th Cir. 2012), holding that for facial challenges to a federal regulation, the six-year limitations period of 28 U.S.C. §2401(a) starts to accrue when the regulation is adopted. The district court, on reconsideration, observed that the regulation here at issue, 37 C.F.R. §1.137, was adopted in 1982, and that Exela presented a facial challenge to the regulation, for it sought a declaration “regarding which standard to apply across the board.” Reconsideration Dec. at 4–6. Applying Hire Order, the district court held Exela’s action time-barred by the six-year period of limitations.

This appeal followed. DISCUSSION

Exela argues that its complaint was improperly dis-missed and that it is entitled to proceed, citing the APA’s purpose of providing remedy to any “person suffering legal wrong because of agency action, or adversely affect-ed or aggrieved by agency action within the meaning of a



relevant statute.” 5 U.S.C. §702. Exela stresses that the dominating consideration in APA actions is the “strong presumption that Congress intends judicial review of administrative action,” Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667, 670 (1986). Exela states that the PTO’s action in reviving the Pharmatop applica-tion was contrary to the PCT statute, and that unless judicial review is available, an ultra vires PTO action will escape correction, thereby enabling enforcement of a patent that should not have issued.

The PTO responds that there is no authority for third parties to collaterally challenge the correctness of PTO revival rulings. Thus the PTO contends that the merits should be decided in its favor, even if dismissal is not appropriate on limitations grounds.

Exela argues that although such third party action is not explicitly authorized by statute or regulation, it is available under the APA. Exela cites the Court’s state-ment in Block v. Community Nutrition Institute that “where substantial doubt about the congressional intent exists, the general presumption favoring judicial review of administrative action is controlling.” 467 U.S. 340, 350–51 (1984).

We conclude that Congress did not intend to permit judicial review for challenges such as the one brought here. Whether the APA confers such a cause of action upon third parties raises a substantial question of patent law, and is reviewable by this court applying Federal Circuit law. See Helfgott & Karas, P.C. v. Dickinson, 209 F.3d 1328, 1334 (Fed. Cir. 2000) (holding “[T]he question of whether the Commissioner has violated the APA in applying the PCT rules and regulations, as well as its own regulations, raises a substantial question under the patent laws. . . .”).

The question on this appeal is not whether a patent applicant may challenge a PTO revival ruling as to its



application; that question was resolved in the affirmative by this court’s decision in Morganroth v. Quigg, 885 F.2d 843 (Fed. Cir. 1989). The issue here is whether a third party may collaterally challenge and obtain judicial review of a PTO revival ruling concerning an unrelated patent application. The Patent Act’s “intricate scheme for administrative and judicial review of PTO patentability determinations,” and “the Patent Act’s careful framework for judicial review at the behest of particular persons through particular procedures” demonstrate that third party challenge of PTO revival rulings under the APA is not legislatively intended. Pregis Corp. v. Kappos, 700 F.3d 1348, 1357 (Fed. Cir. 2012) (“[A] third party cannot sue the PTO under the APA to challenge a PTO decision to issue a patent.”).

We conclude that PTO revival actions are not subject to third party challenge under the APA. On this ground, the dismissal of the Exela complaint is affirmed.

AFFIRMED



______________________



v.


Defendant-Appellee

CADENCE PHARMACEUTICALS, INC., SCR PHARMATOP,

Intervenors

______________________

2013-1206 ______________________

Appeal from the United States District Court for the

Eastern District of Virginia in No. 12-CV-0469, Judge Liam O'Grady.

______________________ NEWMAN, Circuit Judge, concurring.

I join the court’s decision, for neither the Patent Act nor the Administrative Procedure Act provides a cause of action in which third persons may challenge the revival by the PTO of an application that was deemed abandoned for failure to meet a filing date.



I write separately to address the concerns raised in Judge Dyk’s concurring opinion, in which he criticizes the court’s ruling in Aristocrat Technologies Australia Pty Ltd. v. International Game Technology, 543 F.3d 657 (Fed. Cir. 2008). With all respect to my colleague, I do not share the view that Aristocrat was wrongly decided.

In Aristocrat the defendant in an infringement suit argued that the PTO erroneously revived Aristocrat’s Patent Cooperation Treaty application (which was one day late), and sought invalidity on that ground. This court stated that the PTO’s revival of an application “is neither a fact or act made a defense by title 35 nor a ground specified in part II of title 35 as a condition for patentability.” 543 F.3d at 663. The court explained:

If any prosecution irregularity or procedural lapse, however minor, became grist for a later as-sertion of invalidity, accused infringers would in-undate the courts with arguments relating to every minor transgression they could comb from the file wrapper. This deluge would only detract from the important legal issues to be resolved – primarily, infringement and validity.

Id. The Patent Act is explicit as to the grounds for chal-

lenges to issued patents; these grounds do not include challenge to PTO discretionary actions in revival of deemed-abandoned applications. A PTO decision to excuse a tardy filing is not a statutory ground of invalidi-ty or defense to infringement under 35 U.S.C. §282, nor is it a ground on which third persons can initiate and partic-ipate in post-issuance disputes, see Chapter 30 (prior art citations and requests for reexamination), Chapter 31 (inter partes review), and Chapter 32 (post-grant review). Rather, it is an irregularity in prosecution that “becomes irrelevant after the patent has issued.” Magnivision, Inc. v. Bonneau Co., 115 F.3d 956, 960 (Fed. Cir. 1997); see



also Norian Corp. v. Stryker Corp., 363 F.3d 1321, 1324 (Fed. Cir. 2004) (“[T]he presumption of validity is not subject to being diluted by ‘procedural lapses’ during prosecution.”). The patent statutes are specific as to legislative intent, and do not extend to “prosecution irregularities and procedural lapses.” Aristocrat, 543 F.3d at 663. The Supreme Court in Block v. Community Nutri-tion Institute, 467 U.S. 340 (1984), discussed the princi-ples of challenge to administrative actions, and summarized:

Whether and to what extent a particular statute precludes judicial review is determined not only from its express language, but also from the struc-ture of the statutory scheme, its objectives, its leg-islative history, and the nature of the administrative action involved.

467 U.S. at 345. The recently enacted America Invents Act (AIA), which provides new mechanisms for third party attacks on issued patents, did not change the principle that internal PTO procedures are not subject to third party collateral attack.

The Court stated in Block: “In a complex scheme of this type, the omission of such a provision is sufficient reason to believe that Congress intended to foreclose [the action].” 467 U.S. at 346. The statute concerning filing schedules under the Patent Cooperation Treaty was recently amended to remove the requirement that delay be unavoidable, see 35 U.S.C. §371(d) (2013), demonstrat-ing legislative knowledge of the issue decided in Aristo-crat. However, Congress made no new amendments to the scope of infringement defenses available in the dis-trict courts. Aristocrat warrants stability, not judicial taint as “problematic.”

Judge Dyk correctly points out that there are areas in which “a non-listed defense has been recognized by courts,” conc. op. at 4, citing cases in which antitrust



violation, patent misuse, and shop right have been recog-nized as defenses to patent infringement. With all re-spect, my colleague errs in stating that such major substantive issues, each of which is a traditional defense, “cannot be so easily distinguished” from an excuse for a missed filing date. Conc. Op. at 5. If judges cannot easily distinguish the significance of antitrust violation from a missed date, we must try harder.



______________________



v.


Defendant-Appellee

CADENCE PHARMACEUTICALS, INC., SCR PHARMATOP

Intervenors ______________________

2013-1206

______________________

Appeal from the United States District Court for the Eastern District of Virginia in No. 12-CV-0469, Judge Liam O'Grady.

______________________ DYK, Circuit Judge, concurring. I join the majority opinion holding that the structure of the Patent Act bars third party Administrative Proce-dure Act (“APA”) challenges to patent validity based on an improper revival of an abandoned patent application.



In my view, the Patent Act is structured to channel third party challenges to patent validity to either of two routes: as defenses to infringement actions or as challeng-es brought at the PTO utilizing statutorily authorized proceedings such as inter partes review, post-grant re-view, or inter partes reexamination. This statutory scheme is inconsistent with APA review by third parties in the district court. See Pregis Corp. v. Kappos, 700 F.3d 1348, 1357 (Fed. Cir. 2012) (“[A] third party cannot sue the PTO under the APA to challenge a PTO decision to issue a patent.”). The heart of Exela’s argument to the contrary is that it is entitled to proceed under the APA because there is a “strong presumption that Congress intends judicial re-view of administrative action,” Bowen v. Michigan Acad-emy of Family Physicians, 476 U.S. 667, 670 (1986), and because, since our precedent in Aristocrat Technologies Australia Pty Ltd. v. International Game Technology, 543 F.3d 657 (Fed. Cir. 2008), barred review of improper revival as a defense in infringement actions, the only available route to review is under the APA. In Aristocrat, this court held that a defendant in an infringement action could not assert improper revival of an abandoned patent application as a defense in that action. See 543 F.3d at 660–61. We need not decide here whether Aristocrat was correctly decided. Whether it was or not, the Patent Act is inconsistent with third party APA review. However, I write separately to explain why I think our decision in Aristocrat was problematic. The panel in Aristocrat held that improper revival could not be raised as a defense to an infringement action because improper revival was not literally among the catalog of defenses listed in 35 U.S.C. § 282. See id. at 663–64. The panel noted that we have held that a “provi-sion of the Patent Act not falling within the literal scope



of section 282 may nevertheless provide a defense of noninfringement or invalidity.” Id. at 664 (relying on Quantum Corp. v. Rodime, PLC, 65 F.3d 1577, 1584 (Fed. Cir. 1995) (holding that a patentee who improperly en-larged the scope of its claims during reexamination, violating 35 U.S.C. § 305, was subject to a defense of invalidity)). But the panel distinguished Quantum on the ground that the concern in Quantum that “failure to impose invalidity for violation of the statute would en-courage noncompliance” was not present where there is “no legitimate incentive for an applicant to intentionally abandon its application, much less to attempt to persuade the PTO to improperly revive it.” Id. There are four aspects of the Aristocrat opinion that in my view warrant its reconsideration. First, Aristocrat did not discuss the presumption of judicial review of agency action. See Sackett v. Envtl. Prot. Agency, 132 S. Ct. 1367, 1373 (2012); Bowen, 476 U.S. at 670; Block v. Cmty. Nutrition Inst., 467 U.S. 340, 348–49 (1984); see also 5 U.S.C. § 702 (conferring a general cause of action upon persons “adversely affected or aggrieved by agency action within the meaning of a relevant statute”). As we hold today, there is no APA review for improper revivals and no alternative mechanism for review, so an invalidity defense would be the only route available for judicial review. Second, contrary to the suggestion in Aristocrat and by my colleague in her concurrence, this is not a case involving a minor procedural error in the PTO process. See Magnivision, Inc. v. Bonneau Co., 115 F.3d 956, 960 (Fed. Cir. 1997) (holding that “[p]rocedural lapses during examination [such as in that case, an examiner’s not recording a phone call] . . . do not provide grounds of invalidity”). Here, Congress thought the issue of timely filing to be sufficiently important that it provided that a



patent would be treated as abandoned for noncompliance, and it allowed the PTO to reinstate the patent only when specific criteria were satisfied. See 35 U.S.C. § 371(d) (2002). Third, in Morganroth v. Quigg, 885 F.2d 843, 846 (Fed. Cir. 1989), we held that review of the PTO’s refusal to revive a patent application was available under the APA. That case is not cited in Aristocrat, and it is indeed difficult to understand why a third party facing liability for infringement of the patent cannot seek judicial review of a revival decision if the patent applicant can do so, even though the patent applicant and accused infringer must pursue different avenues for review (a defense for the accused infringer and review under the APA for the patent applicant). Fourth, Aristocrat failed to recognize that Quantum was hardly the only example of situations in which a non-listed defense has been recognized by courts. Obvious-ness-type double patenting, for example, is a well-established defense that is not specified in the statute. See, e.g., Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1212 (Fed. Cir. 2014). Patent “misuse” is also a defense. See, e.g., Brulotte v. Thys Co., 379 U.S. 29 (1964) (holding that charging royalties beyond life of the patent impermissibly enlarges monopoly of the patent); Princo Corp. v. Int’l Trade Comm’n, 616 F.3d 1318, 1326–29 (Fed. Cir. 2010) (describing patent misuse and calling it “mainly a judicially created defense”). The “shop rights” doctrine is also a “judicially created defense to patent infringement” that “applies when an employer is sued for patent infringement by an employee who created the patented invention with the employer’s resources while under its employment, even though the employer other-wise has no legal rights to the resultant invention.” Beriont v. GTE Labs, Inc., 535 F. App’x 919, 923 (Fed. Cir.



2013). These other cases cannot be so easily distinguished from the situation in Aristocrat itself. In the future, en banc action to reconsider Aristocrat may be appropriate.


UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

Questions and Answers

Petitions for Rehearing (Fed. Cir. R. 40) and

Petitions for Hearing or Rehearing En Banc (Fed. Cir. R. 35) Q. When is a petition for rehearing appropriate? A. Petitions for rehearing are rarely considered meritorious. Consequently, it is easiest to first answer when a petition for rehearing is not appropriate. A petition for rehearing should not be used to reargue issues already briefed and orally argued. If a party failed to persuade the court on an issue in the first instance, they do not get a second chance. This is especially so when the court has entered a judgment of affirmance without opinion under Fed. Cir. R. 36, as a disposition of this nature is used only when the appellant has utterly failed to raise any issues in the appeal that require an opinion to be written in support of the court’s judgment of affirmance. Thus, as a usual prerequisite, the court must have filed an opinion in support of its judgment for a petition for rehearing to be appropriate. Counsel seeking rehearing must be able to identify in the court’s opinion a material error of fact or law, the correction of which would require a different judgment on appeal. Q. When is a petition for hearing or rehearing en banc appropriate? A. En banc decisions are extraordinary occurrences. To properly answer the question, one must first understand the responsibility of a three-judge merits panel of the court. The panel is charged with deciding individual appeals according to the law of the circuit as established in the court’s precedential opinions. While each merits panel is empowered to enter precedential opinions, the ultimate duty of the court en banc is to set forth the law of the Federal Circuit, which merit panels are obliged to follow. Thus, as a usual prerequisite, a merits panel of the court must have entered a precedential opinion in support of its judgment for a suggestion for rehearing en banc to be appropriate. In addition, the party seeking rehearing en banc must show that either the merits panel has failed to follow identifiable decisions of the U.S. Supreme Court or

Federal Circuit precedential opinions or that the merits panel has followed circuit precedent, which the party seeks to have overruled by the court en banc. Q. How frequently are petitions for rehearing granted by merits panels or petitions for rehearing en banc accepted by the court? A. The data regarding petitions for rehearing since 1982 shows that merits panels granted some relief in only three percent of the more than 1900 petitions filed. The relief granted usually involved only minor corrections of factual misstatements, rarely resulting in a change of outcome in the decision. En banc petitions were accepted less frequently, in only 16 of more than 1100 requests. Historically, the court itself initiated en banc review in more than half (21 of 37) of the very few appeals decided en banc since 1982. This sua sponte, en banc review is a by-product of the court’s practice of circulating every precedential panel decision to all the judges of the Federal Circuit before it is published. No count is kept of sua sponte, en banc polls that fail to carry enough judges, but one of the reasons that virtually all of the more than 1100 petitions made by the parties since 1982 have been declined is that the court itself has already implicitly approved the precedential opinions before they are filed by the merits panel. Q. Is it necessary to have filed either of these petitions before filing a petition for certiorari in the U.S. Supreme Court? A. No. All that is needed is a final judgment of the Court of Appeals. As a matter of interest, very few petitions for certiorari from Federal Circuit decisions are granted. Since 1982, the U.S. Supreme Court has granted certiorari in only 31 appeals heard in the Federal Circuit. Almost 1000 petitions for certiorari have been filed in that period.

July 21, 2008


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CAFC Opinion in Exela v Lee

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