Association for Molecular Pathology v. Uspto
| Decision Date | 02 November 2009 |
| Docket Number | No. 09 Civ. 4515.,09 Civ. 4515. |
| Citation | 669 F.Supp.2d 365 |
| Parties | ASSOCIATION FOR MOLECULAR PATHOLOGY, et al., Plaintiffs, v. UNITED STATES PATENT AND TRADEMARK OFFICE, et al., Defendants. |
| Court | U.S. District Court — Southern District of New York |
American Civil Liberties Union Foundation, by Christopher A. Hansen, Esq., Aden Fine, Esq., Lenora M. Lapidus, Esq., Sandra S. Park, Esq., Public Patent Foundation, Benjamin N. Cardozo School of Law, by Daniel B. Ravicher, Esq., New York, NY, for Plaintiffs.
Preet Bharara, United States Attorney for the Southern District of New York, by Beth E. Goldman, Esq., New York, NY, for Defendant USPTO.
Jones Day, by Brian M. Poissant, Esq., Barry R. Satine, Esq., Laura A. Coruzzi, Esq., New York, NY, for Defendants Myriad Genetics and Directors of the University of Utah Research Foundation.
I. PRIOR PROCEEDINGS .............................................. 370
II. THE COMPLAINT AND THE AFFIDAVITS ................................ 370
A. The Plaintiffs ............................................... 370
B. The Defendants ............................................... 376
C. BRCA1 and BRCA2 .............................................. 377
D. Enforcement of the Patents-in-Suit ........................... 378
III. THE PARTIES' CONTENTIONS ........................................ 380
IV. THERE IS SUBJECT MATTER JURISDICTION OVER THE CLAIMS
AGAINST THE USPTO ............................................... 381
V. THERE IS STANDING ............................................... 383
A. The Plaintiffs Have Standing to Sue the USPTO for Constitutional
Violations ................................................... 383
B. The Plaintiffs Have Established Standing to Sue Myriad and the
Directors .................................................... 385
1. Affirmative Acts by the Defendants ........................ 387
2. Meaningful Preparations for Infringing Action ............. 390
VI. JURISDICTION EXISTS OVER THE DIRECTORS .......................... 392
VII. THE ALLEGATIONS OF CONSTITUTIONAL VIOLATIONS ARE
ADEQUATE ....................................................... 397
VIII. CONCLUSION ...................................................... 398
In this action the Plaintiffs challenge certain patent claims granted to defendants Myriad Genetics and the Directors1 of the University of Utah Research Foundation ("UURF") (collectively, "Myriad") by defendant United States Patent and Trademark Office ("USPTO") (collectively, the "Defendants"). The identified patent claims (the "patents-in-suit" or the "claims-in-suit") cover two human genes known as BRCA1 and BRCA2 (). Compl. ¶¶ 37, 55-80. The claims-in-suit also cover certain mutations in those genes, the mental act of comparing different forms of the BRCA genes, and the correlations between certain genetic mutations and an increased risk of breast and/or ovarian cancer. Id.
The Plaintiffs allege that these patents are unlawful under each of (1) the Patent Act, 35 U.S.C. § 101 (1952), (2) Article I, Section 8, Clause 8 of the United States Constitution, and (3) the First and Fourteenth Amendments because they cover products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought. Compl. ¶ 102.
The Defendants now move, pursuant to Rules 12(b)(1), (b)(2), and (b)(6), Fed. R.Civ.P., to dismiss Plaintiffs' complaint (the "Complaint") for lack of subject matter jurisdiction, lack of personal jurisdiction, and failure to state a claim.
This action is unique in the identity of the parties, the scope and significance of the issues presented, and the consequences of the remedy sought. The Plaintiffs in this action comprise a broad range of parties, including researchers, genetic counselors, medical and/or advocacy organizations, and women facing the threat of breast cancer or who are in the midst of their struggle with the illness. The challenges to the patents-in-suit raise questions of difficult legal dimensions concerning constitutional protections over the information that serves as our genetic identities and the need to adopt policies that promote scientific innovation in biomedical research. The widespread use of gene sequence information as the foundation for biomedical research means that resolution of these issues will have far-reaching implications, not only for gene-based health care and the health of millions of women facing the specter of breast cancer, but also for the future course of biomedical research.
Based on the conclusions set forth below, the motions to dismiss are denied.
The Complaint in this action was filed on May 12, 2009.
The Plaintiffs moved for summary judgment pursuant to Rule 56, Fed.R.Civ.P., on August 26, 2009.
Defendants' motion to dismiss and Plaintiffs' motion for jurisdictional discovery2 were heard and marked fully submitted on September 30, 2009, and Plaintiffs' motion for summary judgment was stayed pending resolution of Defendants' motion to dismiss.
The following allegations, taken from the Complaint and the affidavits submitted by the parties in connection with Defendants' motion to dismiss, are accepted as true for the purpose of resolving the motions to dismiss.
Plaintiff the Association for Molecular Pathology ("AMP") is a not-for profit scientific society dedicated to the advancement, practice, and science of clinical molecular laboratory medicine and translational research based on the applications of genomics and proteomics. AMP members participate in basic and translational research aimed at broadening the understanding of gene/protein structure and function, disease processes, and molecular diagnostics, and provide clinical medical services for patients, including diagnosis of breast cancer. Compl. ¶ 7.
Plaintiff the American College of Medical Genetics ("ACMG") is a non-profit organization of clinical and laboratory geneticists seeking to improve health through the practice of medical genetics. AMCG strives to 1) promote excellence in medical genetics practice and the integration of translational research into practice; 2) promote and provide medical genetics education; 3) increase access to medical genetics services and integrate genetics into patient care; and 4) advocate for and represent providers of medical genetics services and their patients. Compl. ¶ 8.
Plaintiff the American Society for Clinical Pathology ("ASCP") is the largest and oldest organization representing pathologists and laboratory professionals. ASCP members design and interpret the tests that detect disease, predict outcome, and determine the appropriate therapy for the patient. Compl. ¶ 9.
Plaintiff the College of American Pathologists ("CAP") is a national medical society representing board-certified pathologists and pathologists in training who practice anatomic pathology and laboratory medicine worldwide. The CAP is an advocate of high-quality and cost-effective medical care. Compl. ¶ 10.
The affidavits submitted by the Plaintiffs state that members of AMP, ACMG, ASCP, and CAP are ready, willing, and able to engage in research and clinical practice involving the BRCA1/2 genes if the patents-in-suit were to be invalidated. For example, Madhuri Hegde, Ph.D. ("Dr. Hegde"), is a member of AMP and ACMG and serves as an Associate Professor in the Department of Human Genetics at Emory University School of Medicine, Adjunct Assistant Professor at the University of Texas M.D. Anderson Cancer Center, and Senior Laboratory Director at the Emory Genetics Laboratory. He currently conducts research on human genes in addition to supervising one of the largest and most technologically advanced clinical laboratories in the country. The laboratory sequences and analyzes approximately sixty genes every day for sequence variants and their clinical significance. Dr. Hegde has personally sequenced the BRCA1/2 genes while at the Auckland Hospital in New Zealand, and his lab would begin sequencing an analyzing BRCA1/2 genes for clinically significant variants within weeks if the patents-in-suit were invalidated. Hegde Decl. ¶¶ 3-12.3
Roger Hubbard, Ph.D. ("Dr. Hubbard"), a member of ASCP, is the President and Chief Executive Officer, Molecular Pathology Laboratory Network, Inc. ("MPLN"), and an Adjunct Associate Professor at the University of Tennessee Medical Center/Knoxville, Department of Pathology. MPLN offers molecular diagnostics and cytogenetic testing services that target hematological malignancies, oncology, and medical diseases. MPLN currently sequences genes and has the personnel, experience and equipment to analyze the BRCA genes. They currently receive inquiries every few weeks from a hospital or laboratory asking them to analyze the BRCA genes, but they do not do so as solely because of the patents-in-suit. If the patents-in-suit were to be invalidated, Dr. Hubbard and MPLN would immediately consider doing BRCA1/2 testing in their laboratory. Hubbard ¶¶ 1-4, 6, 8-9.
Jeffrey Kant, M.D., Ph.D. ("Dr. Kant"), a member of AMP and CAP, is the Director of the Division of Molecular Diagnostics in the Department of Pathology at the University of Pittsburgh Medical Center and a Professor Pathology and Human Genetics at the University of Pittsburgh. As part of his responsibilities, he supervises a clinical laboratory that analyzes human genes and is experienced in sequencing and analyzing genes for inherited diseases. His laboratory currently tests nine genes, including five related to hereditary predisposition for cancer. His laboratory was asked in the late 1990s to engage in the sequencing and analysis of BRCA1/2, but declined to do so because of...
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