702 F.Supp.2d 181 (S.D.N.Y. 2010), 09 Civ. 4515, Association for Molecular Pathology v. United States Patent and Trademark Office

Docket Nº:09 Civ. 4515.
Citation:702 F.Supp.2d 181
Opinion Judge:SWEET, District Judge.
Attorney: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 ...
Case Date:March 29, 2010
Court:United States District Courts, 2nd Circuit, Southern District of New York

Page 181

702 F.Supp.2d 181 (S.D.N.Y. 2010)




No. 09 Civ. 4515.

United States District Court, S.D. New York.

March 29, 2010

As Amended April 5, 2010.

Page 182

[Copyrighted Material Omitted]

Page 183

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.


SWEET, District Judge.

A. The Development of Genetics as a Field of Knowledge. 192
B. Molecular Biology and Gene Sequencing 193
1. DNA 193
2. Extracted and purified DNA 196
3. RNA 197
4. cDNA 198
5. DNA sequencing 199
C. The Development of the Patents-in-Suit 200
D. Application of the Patents-in-Suit 203
1. Myriad's BRCA1/2 testing 203
2. Funding for Myriad's BRCA1/2 tests 203
3. Myriad's enforcement of the patents-in-suit 204
E. Disputed Issues 206
1. The impact of Myriad's patents on BRCA1/2 testing 206
2. The impact of gene patents on the advancement of science and medical treatment 207
A. Summary of the Patents 211
B. Construction of the Claims 214
1. Legal standard 214
2. Resolution of the disputed claim terms 216
a. " DNA" and " isolated DNA" 216
b. " BRCA1" and " BRCA2" 217
A. The Summary Judgment Standard 217
B. 35 U.S.C. § 101 and Its Scope 218
C. The Composition Claims Are Invalid Under 35 U.S.C. § 101 220
1. Consideration of the merits of Plaintiffs' challenge is appropriate 220
2. Patentable subject matter must be " markedly different" from a product of nature 222
3. The claimed isolated DNA is not " markedly different" from native DNA 227
D. The Method Claims are Invalid Under 35 U.S.C. § 101 232
1. The claims for " analyzing" and " comparing" DNA sequences are invalid under § 101 233
2. The claim for " comparing" the growth rate of cells is invalid under § 101 237
E. The Constitutional Claims Against the USPTO Are Dismissed 237
Page 184 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- Page 185 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 the information it encodes. Therefore, the patents at issue directed to " isolated DNA" containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. § 101. Similarly, because the claimed comparisons of DNA sequences are abstract mental processes, they also constitute unpatentable subject matter under § 101. The facts relating to molecular biology are fundamental to the patents at issue and to the conclusions reached. Consequently, in the findings which follow, the discussion of molecular biology precedes the facts concerning the development, application, and description of the patents. Following those facts are the conclusions which compel the partial grant of summary Page 186 judgment to the Plaintiffs, the denial of Myriad's cross-motion, and the grant of the USPTO's motion for judgment on the pleadings. I. PRIOR PROCEEDINGS The complaint in this action was filed on May 12, 2009, alleging violations of 35 U.S.C. § 101; Article I, Section 8, Clause 8 of the United States Constitution; and the First and Fourteenth Amendments to the Constitution. Defendants moved to dismiss the complaint which motion was denied by the opinion of November 1, 2009. See Assoc. for Molecular Pathology v. U.S. Patent and Trademark Office, 669 F.Supp.2d 365 (S.D.N.Y.2009). Plaintiffs were found to have the necessary standing to assert their declaratory judgment claims against the Myriad Defendants and the USPTO, and specific personal jurisdiction was found to exist over the Directors of the UURF by virtue of acts performed in their official capacity that were directed to the state of New York. It was also determined that this Court possessed the necessary subject matter jurisdiction to hear Plaintiffs' constitutional claims against the USPTO and that the complaint satisfied the pleading requirements set forth in Ashcroft v. Iqbal, __ U.S. __, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). Plaintiffs' motion for summary judgment and the cross-motions for summary judgment and judgment on the pleadings were heard and marked fully submitted on February 4, 2010. II. THE PARTIES AND AMICI Plaintiff 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. Sobel Decl. ¶ ¶ 2, 4-5.2 Plaintiff the American College of Medical Genetics (" ACMG" ) is a private, non-profit voluntary organization of clinical and laboratory geneticists. The Fellows of the ACMG are doctoral level medical geneticists and other physicians involved in the practice of medical genetics. With more than 1300 members, the ACMG's mission is to improve health through the practice of medical genetics. In order to fulfill this mission, the ACMG strives to define and promote excellence in medical genetics practice and the integration of translational research into practice; promote and provide medical genetics education; increase access to medical genetics services and integrate genetics into patient care; and advocate for and represent providers of medical...

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