Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.


May 14, 2004.


The opinion of the court was delivered by: SHIRA SCHEINDLIN, District Judge


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*fn1 and Racketeer Influenced and Corrupt Organizations Act ("RICO").*fn2 Defendants move to dismiss the action against them for lack of subject-matter jurisdiction.*fn3 Pieczenik cross-moves for: (1) dismissal of defendants' motion*fn4 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]."*fn5 For the following reasons, defendants' motion to dismiss for lack of subject-matter jurisdiction is granted and Pieczenik's cross-motions are denied.


  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."*fn6 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.*fn7 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."*fn8 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.*fn9

  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,"*fn10 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. . . .*fn11
  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.*fn12 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.*fn13 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.*fn14

  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."*fn15 "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.'"*fn16 Pieczenik avers that the approval of Erbitux required "filling out this form,"*fn17 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."*fn18 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."*fn19 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."*fn20 Fourth, the PTO engaged in wire fraud through its communications with Medical Research Council-Laboratory of Molecular Biology, CAT, Dyax Corp., and Domantis.*fn21 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."*fn22 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.*fn23 However, "where evidence relevant to the jurisdictional question is before the court, `the district court . . . may refer to [that] evidence.'"*fn24 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 ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.