Ass'n For Molecular Pathology v. United States Patent
| Decision Date | 05 April 2010 |
| Docket Number | No. 09 Civ. 4515.,09 Civ. 4515. |
| 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 |
OPINION TEXT STARTS HERE
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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 Ross Morrison, 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.
Plaintiffs Association for Molecular Pathology, et al. (collectively “Plaintiffs”) have moved for summary judgment pursuant to Rule 56, Fed.R.Civ.P., to declare invalid fifteen claims (the “claims-in-suit”) contained in seven patents (the “patents-in-suit”) relating to the human BRCA1 and BRCA2 genes (Breast Cancer Susceptibility Genes 1 and 2) (collectively, “ BRCA1/2”) 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 of the Constitution because the patent claims cover products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought. The defendant United States Patent and Trademark Office (“USPTO”) issued the patents-in-suit which are held by defendants Myriad Genetics and the University of Utah Research Foundation (“UURF”) (collectively “Myriad” or the “Myriad Defendants”). Myriad has cross- moved under Rule 56, Fed.R.Civ.P., for summary judgment dismissing Plaintiffs' complaint, and the USPTO has cross-moved under Rule 12(c), Fed.R.Civ.P., for judgment on the pleadings. Based upon the findings and conclusions set forth below, the motion of Plaintiffs to declare the claims-in-suit invalid is granted, the cross-motion of Myriad is denied, and the motion of the USPTO is granted.
As discussed infra in greater detail, the challenged patent claims are directed to (1) isolated DNA containing all or portions of the BRCA1 and BRCA2 gene sequence and (2) methods for “comparing” or “analyzing” BRCA1 and BRCA2 gene sequences to identify the presence of mutations correlating with a predisposition to breast or ovarian cancer. Plaintiffs' challenge to the validity of these claims, and the arguments presented by the parties and amici, have presented a unique and challenging question:
Are isolated human genes and the comparison of their sequences patentable?
Two complicated areas of science and law are involved: molecular biology and patent law. The task is to seek the governing principles in each and to determine the essential elements of the claimed biological compositions and processes and their relationship to the laws of nature. The resolution of the issues presented to this Court deeply concerns breast cancer patients, medical professionals, researchers, caregivers, advocacy groups, existing gene patent holders and their investors, and those seeking to advance public health.
The claims-in-suit directed to “isolated DNA” containing human BRCA1/2 gene sequences reflect the USPTO's practice of granting patents on DNA sequences so long as those sequences are claimed in the form of “isolated DNA.” This practice is premised on the view that DNA should be treated no differently from any other chemical compound, and that its purification from the body, using well-known techniques, renders it patentable by transforming it into something distinctly different in character. Many, however, including scientists in the fields of molecular biology and genomics, have considered this practice a “lawyer's trick” 1 that circumvents the prohibitions on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result. The resolution of these motions is based upon long recognized principles of molecular biology and genetics: DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature. It is concluded that DNA's existence in an “isolated” form alters neither this fundamental quality of DNA as it exists in the body nor...
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The Ass'n For Molecular Pathology v. United States Patent
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