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recognizing Larsen as an exception to sovereign immunity and stating “to fall within this exception to sovereign immunity, a plaintiff must demonstrate that the United States owed him a duty, which the defendant official failed to perform.”
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03 Civ. 6336 (SAS)
May 14, 2004
George Pieczenik, New York, New York, for Plaintiff
Lara K. Eshkenazi, New York, New York, for Defendants
OPINION AND ORDER
Dr. George Pieczenik, appearing pro se, brings this lawsuit against, inter alia, the Commissioners of the United States Patent and Trademark Office ("PTO") and the Food and Drug Administration ("FDA") (collectively "defendants"). Pieczenik seeks relief pursuant to the Mandamus and Venue Act and Racketeer Influenced and Corrupt Organizations Act ("RICO"). Defendants move to dismiss the action against them for lack of subject-matter jurisdiction. Pieczenik cross-moves for: (1) dismissal of defendants' motion and (2) a writ of mandamus requiring the U.S. Government to file a "Motion of Substitution" and a new "Amended Reply explaining the [National Institutes of Health ("NIH")], the Army and the Navy's infringement [of Pieczenik's patents]." For the following reasons, defendants' motion to dismiss for lack of subject-matter jurisdiction is granted and Pieczenik's cross-motions are denied.
28 U.S.C. § 1361. Pieczenik does not identify the statutory basis for his request to compel defendants to reexamine certain patents. However, because this relief is only available pursuant to this Court's mandamus jurisdiction, I will assume that the non-RICO claims are premised on section 1361.
18 U.S.C. § 1961 et seq.
Pieczenik seeks to strike defendants' motion for their failure to substitute the United States as the defendant by filing either a "Motion of Substitution" or "Declaration of Representative." Plaintiff's Reply Memorandum of Law in Further Opposition to Defendants' Motion to Dismiss ("Pl. Sur-Reply") at 2.
Id.
I. FACTS
A. Background
At the heart of this case are patent rights held by Pieczenik and allegedly infringed by various parties. Specifically, Pieczenik owns U.S. Patent Nos. 6,605,448 ("'448 Patent") and 5,866,363 ("'363 Patent"), both entitled "Method and Means for Sorting and Identifying Biological Information." Pieczenik alleges that these patents were filed on August 28, 1985 and issued by the PTO on August 12, 2003 and February 2, 1999, respectively. Additionally, Pieczenik filed a third patent application with the PTO, which was published on October 30, 2003 and addresses the "treatment of refractory human tumors with epidermal growth factor receptor and HER1 mitogenic ligand (EGFRML) antagonists." Pieczenik alleges that the PTO failed to issue the '448 and '363 patents in a timely manner, waiting for approximately eighteen years from the original filing date to issue the '448 patent and about twelve years to issue the '363 Patent.
Third Amended Complaint ("Compl") ¶¶ 23-24.
Id. ¶¶ 13-14. The filing dates listed in the PTO database are: November 18, 1998 for the '448 Patent and February 28, 1991 for the '363 Patent. See www.uspto.gov.
Id. ¶ 15 (citing U.S. Patent Application No. 2003/0202973).
Id. ¶ 43.
B. Allegations Relating to Mandamus Relief
1. The Commissioner of the PTO
Pieczenik avers that despite his request that the Commissioner of the PTO, "Biotechnology Section heads[,] and examiners reexamine all patents within the scope of the section 102(e) snap back of the '363 and '448 patents," they took no action. In particular, Pieczenik cites an e-mail message that he sent to PTO officials Nicholas Godici, Bruce Stoner, George Elliott, and John Brusca in which he states:
Id. ¶ 40.
Section 102(e) states:
A person shall be entitled to a patent unless — the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language[.]35 U.S.C. § 102(e).
Could you please tell me if the [PTO] will order its own re exams of patents containing phage display combinatorial libraries that were filed after my ['448 Patent] was filed in 1985 but issued in 2003 with a 102e "snap back" to 1985. I understand that I can pay a fee to request re exams, but it is quite expensive and the [PTO] took 18 years to issue this patent which now because of GATT has only 2 years of term and therefore I believe the [PTO] should have a responsibility to address its delay in issuing this patent and allowing all the other patents in the meantime that I would have to address individually. This would be prohibitively expensive, for a pro se inventor such as myself. . . .
Compl. ¶ 40 (excerpting e-mail message).
The projected scope of Pieczenik's request is significant — he asserts that the PTO has "issued over 1,000 patents, inter alia, in the 18 years while the '448 patent was secret," that should be reevaluated in light of his patent. To that end, Pieczenik requests reexamination of all Cambridge Antibody Technology ("CAT") and Domantis, Inc. ("Domantis") patents relating to combinatorial libraries subsequent to the filing of the '448 patent. Additionally, he seeks to compel the Commissioner of the PTO to review Bristol-Myers Squibb Co.'s ("Bristol-Myers") U.S. Patent No. 5,565,325 in light of the issued '363 and '448 patents.
Id. ¶ 43.
See id. ¶¶ 76-77.
Defendants respond with a sworn declaration indicating that Pieczenik has never formally applied for a reexamination of certain patents held by Bristol-Myers. See 1/30/04 Declaration of Gerald A. Dost, Senior Legal Advisor for the PTO ¶ 4 (citing U.S. Patent Nos.: 5,565,325 (Oct. 15, 1996); 5,709,859 (Jan. 20, 1998); 5,840,302 (Nov. 24, 1998); 5,840,854 (Nov. 24, 1998); 5,876,718 (Mar. 2, 1999); 6,046,314 (Apr. 4, 2000); 6,132,722 (Oct. 17, 2000); 6,372, 215 (Apr. 16, 2002)).
2. The Commissioner of the FDA
Pieczenik alleges that the FDA has "authority to maintain the Orange Book, [which lists] the unexpired and published patent applications relevant to the safety and efficacy and method of treatment of drugs." "In addition, the FDA requires applications for Biologic License Application [("BLA")] and for New Drug Application ("NDA") a form 356h, which in line 13 states `Patent information on any patent which claims the drug.'" Pieczenik avers that the approval of Erbitux required "filling out this form," suggesting that the FDA has authority to reexamine patents listed or omitted for purposes of this application.
Compl. ¶ 10.
Id.; see also Dep't of Health and Human Servs. Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use ("FDA Form 356h"), Ex. N to Compl.
Compl. ¶ 10.
C. Allegations Relating to RICO Conspiracies
The PTO and the FDA are alleged to have engaged in numerous unlawful conspiracies. First, the FDA conspired with Bristol-Myers, and Merck AG ("Merck") to "manipulate the price of Genetic Systems and Imclone stock [to] take control of their respective monoclonal antibodies used for cancer treatment and remove the Jewish scientists and founders from their respective corporations." Second, the FDA and the PTO colluded with the Department of Justice ("DOJ") to "ignore the fact that they are dealing and accepting filings and patents from a pharmaceutical company, Merck , that has never been de-nazified and, therefore, is still a criminal enterprise unto itself." Third, the FDA and the PTO, along with Bristol-Myers, Merck, and unnamed defendants, have created: (1) "`free patent zones' as policy to allow foreign corporations and US pharmaceutical companies to `walk over' individual American inventor patent rights in violation of the American Inventors Protection Act"; (2) "a non importation embargo of patent drugs from Canada in violation of [Pieczenik's] patent rights"; and (3) "a monopoly trust in violation of [Pieczenik's] patent rights." Fourth, the PTO engaged in wire fraud through its communications with Medical Research Council-Laboratory of Molecular Biology, CAT, Dyax Corp., and Domantis.
Id. ¶ 59.
Id. ¶ 60.
Id. ¶¶ 62-64.
Id. ¶ 67. Pieczenik also suggests, in his motion papers, that "Plaintiff showed evidence of direct infringement by the FDA by its purchases of NEB libraries and . . . that other Government individuals and agencies directly infringed and induced to infringe the Pieczenik patents by their purchase of NEB combinatorial laboratories, i.e.[,] the NTH, the Army, the Navy, etc." Pl. Sur-Reply at 2.
II. APPLICABLE LAW
A. Rule 12(b)(1)
"A case is properly dismissed for lack of subject matter jurisdiction under Rule 12(b)(1) when the district court lacks the statutory or constitutional power to adjudicate it." When the defendant challenges the legal sufficiency of the plaintiff's jurisdictional allegations, the court must take all facts alleged in the complaint as true and draw all reasonable inferences in favor of the plaintiff. However, "where evidence relevant to the jurisdictional question is before the court, `the district court . . . may refer to [that] evidence.'" Therefore, "[i]n resolving the question of jurisdiction, the court can refer to evidence outside the pleadings and the plaintiff asserting subject matter jurisdiction has the burden of proving by a preponderance of the evidence that it exists." The consideration of materials extrinsic to the pleadings does not convert the motion into one for summary judgment.
Makarova v. United States, 201 F.3d 110, 113 (2d Cir. 2000).
See Robinson v. Government of Malaysia, 269 F.3d 133, 140 (2d Cir. 2001) (quotation marks and citation omitted).
Id. (alterations in original) (quoting Makarova, 201 F.3d at 113).
Luckett v. Bure, 290 F.3d 493, 496-97 (2d Cir. 2002).
See CCS Int'l Ltd. v. United States, No. 03 Civ. 0507, 2003 WL 23021951, at *2 (Dec. 24, 2003).
B. Principles of Sovereign Immunity
"In any suit in which the United States is a defendant, there must be a cause of action, subject matter jurisdiction, and a waiver of sovereign immunity." This is so because the United States ("United States" or "Government") is immune from suit except "as it consents to be sued." Congress can waive the Government's sovereign immunity only through clear and unequivocal statutory language and may predicate such waiver on satisfaction of specific conditions. This waiver "is a prerequisite to subject-matter jurisdiction but the issues of subject-matter jurisdiction and sovereign immunity are nonetheless `wholly distinct.'"
Presidential Gardens Assocs. v. United States ex rel. Sec'y of Housing and Urban Dev., 175 F.3d 132, 139 (2d Cir. 1999). Section 1331, providing for federal question jurisdiction, is unrelated to a waiver of sovereign immunity. See, e.g., Doe v. Civiletti, 635 F.2d 88, 94 (2d. Cir. 1980) ("Section 1331 is in no way a general waiver of sovereign immunity. Such a waiver, if it exists at all, must be sought in the statute giving rise to the cause of action.").
United States v. Mitchell, 445 U.S. 535, 538 (1980) (quoting United States v. Sherwood, 312 U.S. 584, 586 (1941)).
See CCS Int'l Ltd., 2003 WL 23021951, at *2 (citing Lane v. Pena, 518 U.S. 187, 192 (1996) and United States v. Dalm, 494 U.S. 596, 608 (1990)).
Presidential Gardens Assocs., 175 F.3d at 139 (quoting Blatchford v. Native Village of Noatak, 501 U.S. 775, 786-87 n. 4 (1991)).
"An action against a federal agency or federal officers in their official capacities is essentially a suit against the United States." Thus, a plaintiff pursuing a claim against a federal officer must demonstrate either that the suit is permissible under a "specific statutory authorization to sue the United States, or that in effect, the proceeding is not a suit against the United States." For instance, courts have found that sovereign immunity does not shield the defendant officer who has acted: (1) in his "individual capacity, rather than on behalf of the United States, or outside the scope of his governmental authority"; (2) pursuant to his governmental authority, but in violation of the plaintiff's "clearly established constitutional or statutory rights"; or (3) pursuant to an unconstitutional grant of authority.
Robinson v. Overseas Military Sales Corp., 21 F.3d 502, 510 (2d Cir. 1994); see also 14 Charles Alan Wright, Arthur C. Miller Edward H. Cooper, Federal Practice and Procedure § 3655, at 344 (3d ed. 1998) ("Suits against federal agencies and officers may be barred by the doctrine of sovereign immunity if the conduct in question has been undertaken on behalf of the government."); Marshall v. National Ass'n of Letter Carriers Br. 36, Nos. 00 Civ. 3167, 01 Civ. 3086, 2003 WL 223563, at *6 (S.D.N.Y. Feb. 3, 2003) ("Suits against federal agencies or federal officials in their official capacities are suits against the United States and are similarly barred absent an applicable waiver.").
14 Wright, Miller Cooper, supra note 31, § 3655, at 344.
Id. at 376-79. Where a federal official is alleged to have personally violated a plaintiff's constitutional rights and no adequate remedial mechanisms are available to redress the injury, that plaintiff can assert a claim under Bivens v. Six Unknown Named Agents of the Fed. Bureau of Narcotics, 403 U.S. 388(1971).
C. Mandamus Relief
Section 1361 provides: "The district courts shall have original jurisdiction of any action in the nature of mandamus to compel an officer or employee of the United States or any agency thereof to perform a duty owed to the plaintiff." "Section 1361 `is intended to provide a remedy for a plaintiff only if he has exhausted all other avenues of relief and only if the defendant owes him a clear nondiscretionary duty.'" Accordingly, mandamus is not granted lightly — it "is a drastic remedy available only in extraordinary situations." A plaintiff seeking mandamus relief must demonstrate the following: "(1) [he] has a clear right to the relief sought, (2) [defendants have] a plainly defined and peremptory duty to perform the act in question, and (3) no other adequate remedy is available."
28 U.S.C. § 1361; see also Smith v. Lehman, 533 F. Supp. 1015, 1018 (E.D.N.Y. 1982) ("[Section 1361] do[es] not confer jurisdiction but merely provide[s] additional remedies where jurisdiction already exists."), aff'd, 689 F.2d 342 (2d Cir. 1982).
Franchi v. Manbeck, 972 F.2d 1283, 1289 (Fed. Cir. 1992) (quoting Heckler v. Ringer, 466 U.S. 602, 616 (1984)).
Morelli v. Alexander, 920 F. Supp. 556, 558 (S.D.N.Y. 1996).
Id. (emphasis added).
Courts have held that section 1361 does not by itself operate as a waiver of sovereign immunity. However, "[i]f a plaintiff seeks a writ of mandamus to force a public official to perform a duty imposed upon him in his official capacity[, under the so-called Larson-Dugan exception to sovereign immunity,] no separate waiver of sovereign immunity is needed." The Supreme Court has explained:
See, e.g., Washington Legal Found, v. U.S. Sentencing Comm'n, 89 F.3d 897, 901 (D.C. Cir. 1996) ("It is well settled that this statute does not by itself waive sovereign immunity.") (citing cases); Lonsdale v. United States, 919 F.2d 1440, 1444 (10th Cir. 1990) ("Sovereign immunity is not waived by general jurisdictional statutes such as . . . 28 U.S.C. § 1361."); Coggeshall Dev. Corp. v. Diamond, 884 F.2d 1, 3 (1st Cir. 1989) ("The provisions of 28 U.S.C. § 1361 creating the federal mandamus action do not constitute a waiver of sovereign immunity by the United States."); Smith v. Grimm, 534 F.2d 1346, 1352 n. 9 (9th Cir. 1976) ("We . . . note the bar of sovereign immunity as an additional impediment to plaintiff's allegation of mandamus jurisdiction. [Section 1361] is not a consent to suit by the sovereign.") (citation omitted). But see Drake v. Panama Canal Comm'n, 907 F.2d 532, 534 (5th Cir. 1990) ("[T]he mandamus statute . . . waives, for some purposes, the sovereign immunity of the United States.") (quotations and citations omitted).
Washington Legal Found., 89 F.3d at 901.
There may be, of course, suits for specific relief against officers of the sovereign which are not suits against the sovereign. . . . [W]here the officer's powers are limited by statute, his actions beyond those limitations are considered individual and not sovereign actions. The officer is not doing the business which the sovereign has empowered him to do or he is doing it in a way which the sovereign has forbidden. His actions are ultra vires his authority and therefore may be made the object of specific relief.
Larson v. Domestic Foreign Commerce Corp., 337 U.S. 682, 689 (1949); see also Dugan v. Rank, 372 U.S. 609, 621-22 (1963).
Thus, in order to fall within this exception to sovereign immunity, a plaintiff must demonstrate that the United States owed him a duty, which the defendant official failed to perform.
1. Patent Reexamination
Any person may file a request for reexamination, either on an ex parte or inter partes basis. Section 302, which provides for ex parte reexamination, states in relevant part:
See 35 U.S.C. § 302, 311.
Any person at any time may file a request for reexamination by the [PTO] of any claim of a patent on the basis of any prior art cited under the provisions of section 301 of this title. The request must be in writing and must be accompanied by payment of a reexamination fee established by the Director pursuant to the provisions of section 41. . . .
Section 301 permits "[a]ny person at any time" to write to the PTO to cite "prior art consisting of patents or printed publications which that person believes to have a bearing on the patentability of any claim of a particular patent." 35 U.S.C. § 301.
35 U.S.C. § 302; see also 37 C.F.R. § 1.510 (listing requirements to apply for ex parte reexamination).
Alternatively, section 311 governs inter partes reexamination and reads, in relevant part:
(a) Any third-party requester at any time may file a request for inter partes reexamination by the [PTO] of a patent on the basis of any prior art cited under the provisions of section 301.
(b) The request shall —
(1) be in writing, include the identity of the real party in interest, and be accompanied by payment of an inter partes reexamination fee established by the Director under section 41; and
(2) set forth the pertinency and manner of applying cited prior art to every claim for which reexamination is requested.
35 U.S.C. § 311; see also 37 C.F.R. § 1.913 (discussing process for filing a request for inter partes reexamination).
Either in response to an application for reexamination or on his own initiative, the Director of the PTO is responsible for "determin[ing] whether a substantial new question of patentability affecting any claim of the patent concerned is raised by the request, with or without consideration of other patents or printed publications." If the Director of the PTO finds that a substantial new question of patentability exists, reexamination proceedings are conducted pursuant to section 305, and may thereafter be appealed in accordance with sections 141 and 145. For instance, "a . . . third-party requester in an inter partes reexamination proceeding, who is in any reexamination proceeding dissatisfied with the final decision in an appeal to the Board of Patent Appeals and Interferences . . . may appeal the decision."
35 U.S.C. § 303(a); see also 37 C.F.R. § 1.520 ("The Director, at any time during the period of enforceability of a patent, may determine whether or not a substantial new question of patentability is raised by patents . . . which have been discovered by the Director or have been brought to the Director's attention, even though no request for reexamination has been filed. . . . The Director may initiate ex parte reexamination without a request for reexamination. . . .").
See 35 U.S.C. § 305.
35 U.S.C. § 141 (permitting appeal of reexamination decisions "only to the [Federal Circuit]"); see also 35 U.S.C. § 315(b) (describing appeals process for a third-party requestor).
2. Reexamination of BLAs
The FDA's regulation of biological products is governed by the Public Health Service Act ("PHSA"), pursuant to which the distribution of biological products is prohibited unless "a biologies license is in effect for the biological product" and certain other labeling and handling conditions are met. Pursuant to the PHSA, the Secretary of Health and Human Services must establish regulations for the approval, suspension, and revocation of biologies licenses.
42 U.S.C. § 201 et seq.
42 U.S.C. § 262(1)(A). "Biological product" refers to "a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings." 42 U.S.C. § 262(i).
42 U.S.C. § 262(a)(3) ("The Secretary shall prescribe requirements under which a biological product undergoing investigation shall be exempt from the requirements of paragraph (1).").
The Commissioner of Food and Drugs has the authority to promulgate regulations for the approval, suspension, and revocation of biologies licenses. Under these regulations, to qualify for such a license, a manufacturer must "submit an application to the Director, Center for Biologies Evaluation and Research ("CBER") . . . [as well as] data derived from nonclinical laboratory and clinical studies demonstrat[ing] that the manufactured product meets prescribed requirements of safety, purity, and potency." The Director for the CBER or the Commissioner of Food and Drugs may refuse a license pursuant to the following regulation, which states, in relevant part:
(a) A biologies license shall be issued upon a determination by the Director, [CBER] that the establishment(s) and the product meet the applicable requirements established in this chapter. A biologies license shall be valid until suspended or revoked.
(b) If the Commissioner determines that the establishment or product does not meet the requirements established in this chapter, the biologies license application shall be denied and the applicant shall be informed of the grounds for, and of an opportunity for a hearing on, the decision.
21 C.F.R. § 601.4.
D. RICO Claims
RICO provides for a private cause of action where a person has been "injured in his business or property by reason of a violation of section 1962." To establish a civil RICO claim pursuant to 18 U.S.C. § 1964(c), a plaintiff must prove an injury resulting from "(1) conduct (2) of an enterprise (3) through a pattern (4) of racketeering activity."
Sedima, S.P.R.L. v. Imrex Co., Inc., 473 U.S. 479, 491 (1985).
"Although the language of the RICO statute is broad, courts have held that the United States is not considered a `person' under RICO and therefore, as a matter of law, is not a proper party to a RICO claim." The Second Circuit has explained:
Spinale v. United States, No. 03 Civ. 1704, 2004 WL 50873, at *7 (S.D.N.Y. Jan. 9, 2004) (dismissing RICO claims against federal agents on sovereign immunity grounds).
Under RICO, a "person" can sue or be sued, and the statute does not distinguish between the definition of a potential plaintiff and defendant. The disadvantage of being a "person" within the meaning of RICO is that it subjects qualifying entities to the powerful and expansive criminal and civil liability provisions of the Act. Whether the government has standing to sue and whether it has waived its sovereign immunity may, in the abstract, be different questions, but in this case the answer to one is apparently the answer to both.
United States v. Bonanno Organized Crime Family of La Cosa Nostm, 879 F.2d 20, 22-23 (2d Cir. 1989).
"Along these lines, other courts have rejected RICO claims brought against the United States as a defendant, holding that the statute does not contain the requisite express and unequivocal waiver of the United States' sovereign immunity." Moreover, "some courts have stated that, while the legislative history of RICO may indicate an intention by Congress to render local governmental entities liable, it cannot be read to suggest that the United States or federal agencies should be liable."
Spinale, 2004 WL 50873, at *7 (citing cases).
Id. (citing cases).
III. DISCUSSION
A. Sovereign Immunity
As an initial matter, the parties' submissions have raised questions about the identity of the proper defendants in this action. Neither the United States nor any federal agency is named as a party defendant. Rather, this action is brought against the Commissioners of the PTO and the PDA. Pieczenik also purports to sue defendants in their "individual capacities."
See, e.g., Defendants' Reply Memorandum of Law in Further Support of Their Motion to Dismiss ("Def. Reply") at 2-3 (arguing, that despite plaintiff's objections, the "current action is properly construed as an action against the United States, and is barred by the doctrine of sovereign immunity.").
See generally Compl.
Plaintiff's Memorandum of Law in Opposition to Defendants' Motion to Dismiss and in Support of His Cross-Motions ("Pl. Opp.") at 7 ("Whereas Plaintiff has held in Third Amended Complaint that the Commissioner of the [PTO] and the Commissioner of the [PDA] in their individual capacities were proper RICO persons.").
The "denomination of the defendant is not dispositive of the question of whether the suit is, in reality, one against the United States." Although Pieczenik purports to sue defendants in their individual capacities, the requested relief is predicated on their authority as Government officials. As such, he is clearly suing defendants in their official capacity. This conclusion is further underscored by the allegations pled in the Complaint, where Pieczenik consistently avers that the complained-of action (or omission) was undertaken (or not undertaken) by the "PTO" and the "FDA." This is essentially a suit against the United States, and therefore Pieczenik's contention that the defendants "are not `sovereigns' in-and-for themselves" and are therefore not entitled to sovereign immunity lacks merit. Moreover, Pieczenik has not identified, nor has a survey of case law revealed, a basis for requiring the United States to move to substitute itself as a party defendant for the federal employees sued herein. Thus, the "cross-motions": (1) for denial of defendants' motion because the U.S. Government has "acted as if it has substituted itself for the [Commissioners of the PTO and FDA]," without filing a motion for substitution or "declaration of representative" and (2) to compel the Government to file a Motion of Substitution are denied.
Mendoza Toro v. Gil, 110 F. Supp.2d 28, 33 (D.P.R. 2000).
See Compl. ¶¶ 9-10.
Pl. Opp. at 2.
Where a plaintiff brings a federal tort claim, certification by the Attorney General "that the defendant employee was acting within the scope of his office or employment at the time of the incident out of which the claim arose" is required to substitute the United States as the party defendant. 28 U.S.C. § 2679(d)(1). However, Pieczenik's claims do not fall under the Federal Tort Claims Act, and section 2679(d)(1) does not govern.
Pl. Opp. at 2.
Pl. Sur-Reply at 2. Pieczenik's cross-motion to compel the Government to file an amended reply "explaining the NIH, Army and Navy's infringement" must also be denied as none of these entities is named as a defendant or is otherwise involved in this litigation.
B. Mandamus Relief
1. Patent Reexamination by the PTO
Pieczenik requests that this Court compel the Commissioner of the PTO to reexamine "patents in this litigation to be in complete compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 and which falls under 37 C.F.R. § 1.501, 37 C.F.R. § 1.502[,] 37 C.F.R. § 1.525, 37 C.F.R. § 1.520, 37 C.F.R. § 1.535, 37 C.F.R. § 1.510, and 35 U.S.C. § 102(e)." He argues that even though he did not file for patent reevaluation, he is nonetheless entitled to PTO review of certain patents because the administrative procedures associated with reexamination applications are prohibitively expensive.
Compl. ¶ 19. In general, these statutory and regulatory provisions describe the method for requesting patent reexamination. See, e.g., supra notes 10, 43.
Compl. ¶ 41. Pieczenik also argues that "the [PTO] and its regulations and laws do not allow a true inventor to question the validity, in a significant manner, of a patent unless [he] has a patent pending in the [PTO]." Compl ¶ 39. But, this argument fails — any party may request reexamination, irrespective of whether he has a patent pending in the PTO.
Pieczenik's allegations fail adequately to demonstrate either that the United States has waived sovereign immunity or that sovereign immunity does not bar his action. He has not identified an applicable statute providing for the waiver of sovereign immunity. Moreover, because Pieczenik has not shown that the Commissioner of the PTO owes him a duty to reexamine the relevant patents absent Pieczenik's submission of an application for patent review, this action does not fall within any exception to sovereign immunity. Pieczenik does not deny that he has not followed the administrative procedures governing patent reexamination, opting instead to e-mail PTO officials to request that the PTO commence reexamination proceedings. Although federal regulations permit the Director of the PTO, on his own initiative at any time, to initiate patent reexamination, he is not obligated to do so. Because no official employed by the PTO had a duty to grant Pieczenik's informal request for action, this does not qualify as an exception to sovereign immunity.
I note that the waiver of sovereign immunity contained in section 702 of the Administrative Procedure Act ("APA"), 5 U.S.C. § 702-06, is inapplicable. "It is not necessary that the suit be brought under the APA for section 702's waiver to apply." Swan v. Clinton, 100 F.3d 973, 981 n. 4 (D.C. Cir. 1996). Accordingly, although not raised by Pieczenik, it is appropriate to consider whether section 702 permits this suit to proceed. Section 702 provides:
A person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute, is entitled to judicial review thereof. An action in a court of the United States seeking relief other than money damages and stating a claim that an agency or an officer or employee thereof acted or failed to act in an official capacity or under color of legal authority shall not be dismissed nor relief therein be denied on the ground that it is against the United States or that the United States is an indispensable party.5 U.S.C. § 702. The Complaint, however, fails to satisfy the requirements set forth under the APA, because there has been no final "agency action" for which Pieczenik is seeking review. See id.; 5 U.S.C. § 704. Pieczenik does not allege that he filed an application for ex parte or inter partes reexamination with the Commissioner of the PTO, nor did he request patent review from the Commissioner of the FDA.
Finally, Pieczenik alludes to the PTO's violation of his "Constitutional rights and their own regulations," through its imposition of fees in connection with applications for reexamination. Liberally construed, this could be interpreted as an argument that the Commissioner of the PTO acted pursuant to governmental authority, but in violation of Pieczenik's clearly established constitutional or statutory rights. But this argument fails because the fee schedule is not in contravention of, but based on, statutory authority. Nor can this financial burden permit the circumvention of the PTO's administrative procedures governing reexamination requests. Courts have found that "ordinary litigation expenses which accompany administrative relief do not excuse plaintiffs from the requirement to exhaust administrative remedies, no matter how substantial and nonrecoverable are the expenses." Accordingly, the Commissioner of the PTO is shielded from this action by the doctrine of sovereign immunity.
Compl. ¶ 42.
See supra note 33 and accompanying text.
See 35 U.S.C. § 41.
Moncrief v. United States, 43 Fed. Cl. 276, 288 (1999) (citing cases). Moreover, defendants point out that the PTO has the discretion to "refund a portion of the fee if it [determines] that the requesting party [has] not raised a substantial question of patentability." Defendants' Memorandum of Law in Support of Their Motion to Dismiss ("Def. Mem.") at 9 (citing 35 U.S.C. § 303(c)).
I need not address the issue of mandamus jurisdiction. I note, however, that even if this action was not precluded by the doctrine of sovereign immunity, Pieczenik does not sufficiently allege the existence of mandamus jurisdiction, having failed to demonstrate that there is a "plainly defined and peremptory duty to perform the act in question." Morelli, 920 F. Supp. at 558. Reexamination by the Director of the PTO "on his own initiative" is obviously discretionary. Because a PTO official may not be compelled to perform a discretionary act, there is no basis for asserting mandamus jurisdiction over this action. Cf. Marquez-Ramos v. Reno, 69 F.3d 477, 479 (10th Cir. 1995) ("The `ministerial-discretionary dichotomy which permeates the jurisprudence of mandamus is merely shorthand for the well-taken rule that to the extent a statute vests discretion in a public official, his exercise of discretion should not be controlled by the judiciary. Thus, the question of whether a particular act is discretionary or ministerial rises to the jurisdictional level.").
2. Patent Reexamination by the FDA
Pieczenik argues that this Court should compel the FDA to conduct a "re examination of Erbitux's [BLA] with regard to all unexpired patents and published patent applications listed in their PDA's [Form] 356h in light of the published '973 patent application." However, Pieczenik again fails to identify either (1) an applicable statutory waiver of sovereign immunity or (2) any duty on the part of the PDA to reexamine Erbitux's BLA in light of the '973 patent application that brings this action within an exception to sovereign immunity.
Compl.f20.
Pieczenik also makes vague references to "direct infringement [of his patents] by the FDA by its purchases of NEB libraries." PL Sur-Reply at 2. Although the United States has consented to be sued for its taking of a patent license, see, e.g., Zoltek Corp. v. United States, 58 Fed. Cl. 688, 696 (2003), such a lawsuit must be brought in the U.S. Court of Federal Claims. See 28 U.S.C. § 1498. As such, Pieczenik's claims for patent infringement by the United States, if any, are not properly before this Court.
Pieczenik asserts that line 13 of PDA Form 356h imposes a duty upon the Commissioner of the PDA to order and conduct patent reexamination. Line 13 states: "This application contains the following items: ( Check all that apply) Patent information on any patent which claims the drug ( 21 U.S.C. § 355(b) or (c))." As defendants point out, this form is "an application to market a new drug, biologic, or an antibiotic drug for human use Throughout this form, PDA indicates the particular regulation or statute applicable to the information required." Section 355 is a part of the Federal Food, Drug, and Cosmetic Act, which requires an applicant to obtain pre-market approval of a drug by filing a New Drug Application ("NBA"), indicating that line 13 relates to NDAs, not BLAs. Thus, line 13 does not create an obligation for the FDA to review patents. As such, the action against the Commissioner of the FDA must be dismissed on sovereign immunity grounds.
FDA Form 356h.
Def. Mem. at 7 n. 4.
See 21 U.S.C. § 355 (describing method for new drug approval).
For the same reasons set forth in the preceding discussion, this Court also lacks mandamus jurisdiction over the FDA. See supra note 76.
C. RICO Claims
Pieczenik argues that defendants have engaged in a number of conspiracies for which they are liable under RICO, but he fails to demonstrate that this Court has jurisdiction over this claim. Because he is suing the Commissioners in their official capacities, he is essentially asserting a RICO claim against the United States. But, RICO does not define a "person" to include the United States, and as such the statute does not amount to a clear, unequivocal waiver of sovereign immunity. Accordingly, the RICO claims against defendants must be dismissed.
Moreover, Pieczenik does not allege facts sufficient for a Bivens claim. As defendants note, "[n]owhere in the complaint does plaintiff allege a constitutional claim for damages" based on their conduct. Def. Reply at 3.
See Spinale, 2004 WL 50873, at *7.
IV. CONCLUSION
For the foregoing reasons, defendants' motion to dismiss for lack of subject-matter jurisdiction is granted and Pieczenik's cross-motions are denied in their entirety. The Clerk of the Court is directed to close these motions [numbers 85 and 88 on the docket sheet] and this case.
SO ORDERED.