Patent Cases, GEORGE PIECZENIK, Plaintiff, -against- CAMBRIDGE ANTIBODY TECHNOLOGY GROUP, DOMANTIS, MEDICAL RESEARCH COUNCIL-LABORATORY OF MOLECULAR BIOLOGY, THE COMMISSIONER OF PATENTS AND TRADEMARKS OF THE UNITED STATES PATENT OFFICE, AN AGENCY OF THE DEPARTMENT OF COMMERCE, and THE COMMISSIONER OF FOOD AND DRUGS, Defendants, U.S. District Court, S.D. New York, (May 14, 2004)

SHIRA SCHEINDLIN, District Judge

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 [1] and Racketeer Influenced and Corrupt Organizations Act (“RICO”). [2] Defendants move to dismiss the action against them for lack of subject-matter jurisdiction. [3] Pieczenik cross-moves for: (1) dismissal of defendants' motion [4] 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].” [5] For the following reasons, defendants' motion to dismiss for lack of subject-matter jurisdiction is granted and Pieczenik's cross-motions are denied.

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.” [6] 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. [7] 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.” [8] 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. [9]

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,” [10] 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:

“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… . [11] ”

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. [12] 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. [13] 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. [14]

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.” [15] “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.’ ” [16] Pieczenik avers that the approval of Erbitux required “filling out this form,” [17] suggesting that the FDA has authority to reexamine patents listed or omitted for purposes of this application.

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.” [18] 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.” [19] 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.” [20] Fourth, the PTO engaged in wire fraud through its communications with Medical Research Council-Laboratory of Molecular Biology, CAT, Dyax Corp., and Domantis. [21]

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.” [22] 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. [23] However, “where evidence relevant to the jurisdictional question is before the court, ‘the district court … may refer to [that] evidence.’ ” [24] 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.” [25] The consideration of materials extrinsic to the pleadings does not convert the motion into one for summary judgment. [26]

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.” [27] This is so because the United States (“United States” or “Government”) is immune from suit except “as it consents to be sued.” [28] 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. [29] This waiver “is a prerequisite to subject-matter jurisdiction but the issues of subject-matter jurisdiction and sovereign immunity are nonetheless ‘wholly distinct.’ ” [30]

“An action against a federal agency or federal officers in their official capacities is essentially a suit against the United States.” [31] 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.” [32] 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. [33]

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.” [34] “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.’ ” [35] Accordingly, mandamus is not granted lightly — it “is a drastic remedy available only in extraordinary situations.” [36] 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.” [37]

Courts have held that section 1361 does not by itself operate as a waiver of sovereign immunity. [38] 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.” [39] The Supreme Court has explained:

“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. [40] ”

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. [41] Section 302, which provides for ex parte reexamination, states in relevant part:

“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. [42] 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… . [43] ”

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. [44]

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.” [45] 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. [46] 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.” [47]

2. Reexamination of BLAs

The FDA's regulation of biological products is governed by the Public Health Service Act (“PHSA”), [48] 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. [49] Pursuant to the PHSA, the Secretary of Health and Human Services must establish regulations for the approval, suspension, and revocation of biologies licenses. [50]

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.” [51] 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. [52]

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.” [53] 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.” [54]

“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.” [55] The Second Circuit has explained:

“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. [56] ”

“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.” [57] 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.” [58]

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. [59] Neither the United States nor any federal agency is named as a party defendant. [60] Rather, this action is brought against the Commissioners of the PTO and the PDA. Pieczenik also purports to sue defendants in their “individual capacities.” [61]

The “denomination of the defendant is not dispositive of the question of whether the suit is, in reality, one against the United States.” [62] Although Pieczenik purports to sue defendants in their individual capacities, the requested relief is predicated on their authority as Government officials. [63] 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. [64] 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. [65] 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” [66] and (2) to compel the Government to file a Motion of Substitution are denied. [67]

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).” [68] 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. [69]

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. [70] 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. [71] 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.

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. [72] 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. [73] But this argument fails because the fee schedule is not in contravention of, but based on, statutory authority. [74] 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.” [75] Accordingly, the Commissioner of the PTO is shielded from this action by the doctrine of sovereign immunity. [76]

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.” [77] 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. [78]

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)).” [79] 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.” [80] 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. [81] 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. [82]

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. [83] 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. [84] Accordingly, the RICO claims against defendants must be dismissed.

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.