Case Law Ass'n For Molecular Pathology v. United States Patent

Ass'n For Molecular Pathology v. United States Patent

Document Cited Authorities (52) Cited in (36) Related (5)

702 F.Supp.2d 181

ASSOCIATION FOR MOLECULAR PATHOLOGY, et al., Plaintiffs,

v.UNITED STATES PATENT AND TRADEMARK OFFICE, et al., Defendants.

No. 09 Civ. 4515.

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

March 29, 2010.

As Amended April 5, 2010.

OPINION TEXT STARTS HERE

COPYRIGHT MATERIAL OMITTED.

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.

OPINION

SWEET, District Judge. 

+-----------------+
¦TABLE OF CONTENTS¦
+-----------------¦
+-----------------+
 
+-------------------------------+
¦I.  ¦PRIOR PROCEEDINGS     ¦186¦
+----+----------------------+---¦
+----+----------------------+---¦
¦II. ¦THE PARTIES AND AMICI ¦186¦
+----+----------------------+---¦
+----+----------------------+---¦
¦III.¦THE FACTS             ¦192¦
+-------------------------------+
 
+------------------------------------------------------------+
¦¦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¦207¦
¦¦¦  ¦treatment                                                           ¦   ¦
+++--+--------------------------------------------------------------------+---¦
+-----------------------------------------------------------------------------+
 
+--------------------+
¦IV.¦THE PATENTS ¦211¦
+--------------------+
 
+----------------------------------+
¦¦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¦
++++--+-------------------------+---¦
+-----------------------------------+
 
+--------------------------+
¦V.¦CONCLUSIONS OF LAW ¦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       ¦222¦
¦¦¦  ¦product of nature                                                   ¦   ¦
+++--+--------------------------------------------------------------------+---¦
¦¦¦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¦233¦
¦¦¦  ¦under § 101                                                         ¦   ¦
+++--+--------------------------------------------------------------------+---¦
¦¦¦2.¦The claim for “comparing” the growth rate of cells is invalid under ¦237¦
¦¦¦  ¦§ 101                                                               ¦   ¦
+-----------------------------------------------------------------------------+
 
+-----------------------------------------------------------------+
¦¦E.¦The Constitutional Claims Against the USPTO Are Dismissed¦237¦
++--+---------------------------------------------------------+---¦
+-----------------------------------------------------------------+
 
+---------------------+
¦VIII.¦CONCLUSION ¦238¦
+---------------------+

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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5 cases
Document | U.S. Court of Appeals — Federal Circuit – 2011
The Ass'n For Molecular Pathology v. United States Patent
"...the challenged claims are drawn to non-patentable subject matter under 35 U.S.C. § 101. Assoc. for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F.Supp.2d 181 (S.D.N.Y.2010) (“ SJ Op.”). We affirm in part and reverse in part. On the threshold issue of jurisdiction, we affirm th..."
Document | U.S. Court of Appeals — Federal Circuit – 2012
Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office
"...of the challenged claims are drawn to non-patentable subject matter under 35 U.S.C. § 101. Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F.Supp.2d 181 (S.D.N.Y.2010) (“SJ Op.”). We affirm in part and reverse in part. This appeal has returned to us as, a petition for c..."
Document | U.S. District Court — District of Utah – 2014
Univ. of Utah Research Found. v. Ambry Genetics Corp. (In re Brca1 & Brca2-Based Hereditary Cancer Test Patent Litig.)
"...and mental processes—subjects that are patent ineligible under 35 U.S.C. § 101. Association for Molecular Pathology v. United States Patent and Trademark Office, 702 F.Supp.2d 181, 186 (S.D.N.Y.2010).12 These patents were drawn to “(1) isolated DNA containing all or portions of the BRCA1 an..."
Document | U.S. Supreme Court – 2013
Ass'n for Molecular Pathology v. Myriad Genetics, Inc.
"...form the basis for hereditary traits in living organisms. See generally Association for Molecular Pathology v. United States Patent and Trademark Office, 702 F.Supp.2d 181, 192–211 (S.D.N.Y.2010). The human genome consists of approximately 22,000 genes packed into 23 pairs of chromosomes. E..."
Document | Minnesota Supreme Court – 2011
Bearder v. State
"...(Fed.Cir.2003) (referring to “genetic information contained in a DNA nucleotide sequence”); Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F.Supp.2d 181, 194 (S.D.N.Y.2010) (noting that genes, which are composed of segments of DNA, “contain[ ] the information used by t..."

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5 books and journal articles
Document | Núm. 98-4, May 2013 – 2013
Exclusivity Without Patents: The New Frontier of FDA Regulation for Genetic Materials
"...court decision that the Federal Circuit reversed. See Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office ( Myriad I ), 702 F. Supp. 2d 181, 222–32 (S.D.N.Y. 2010), aff’d in part, rev’d in part , 653 F.3d 1329 (Fed. Cir. 2011), vacated sub nom. Ass’n for Molecular Pathology v. M..."
Document | The technology transfer law handbook – 2014
Patenting Diagnostic Tests Post-Myriad and Post-Prometheus
"...ruled. 5. J.E.M. Ag Supply, Inc. v. Pioneer Hi‑Bred Int’l, Inc., 534 U.S. 124 (2001). 6. Ass’n for Molecular Pathology v. U.S. Patent & Trademark Ofice, 702 F. Supp. 2d 181 (S.D.N.Y. Mar. 29, 2010); Ass’n for Molecular Pathology v. Myriad Genetics, Inc.,689 F.3d 1303 (Fed. Cir. 2011). 7. Ma..."
Document | Vol. 75 Núm. 2, December 2011 – 2011
New York intellectual property law review.
"...(189) See id. at 106-07. (190) See id. at 109. (191) Id. (192) Ass'n For Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010), aff'd in part, rev'd in part, 653 F.3d. 1329 (Fed. Cir. (193) Biotechnology Indus. Org. v. District of Columbia, 496 F.3d ..."
Document | Vol. 76 Núm. 3, June 2011 – 2011
Unpredictability in patent law and its effect on pharmaceutical innovation.
"...Guidelines Notice, 66 Fed. Reg. 1092, 1093 (Jan. 5, 2001). (210.) Holman, Gene Patents Under Fire, supra note 208, at 4. (211.) 702 F. Supp. 2d 181 (S.D.N.Y. (212.) Id. at 185. (213.) Christopher M. Holman, Maintaining Incentives for Healthcare Innovation: A Response to the FTC's Report on ..."
Document | Núm. 41-3, June 2013 – 2013
The Reexamination Power of Patent Infringers and the Forgotten Inventor
"...2011 WL 6742516, at *2. 165 Prometheus , 132 S. Ct. at 1294. 166 Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181, 229 (S.D.N.Y. 2010) rev’d , 653 F.3d 1329 (Fed. Cir. 2011) vacated sub nom. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 132 S. C..."

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5 firm's commentaries
Document | JD Supra United States – 2013
Supreme Court Ruling that Human Genes May Not Be Patented
"...I A Genes form the basis for hereditary traits in livingorganisms. See generally Association for Molecular Pathology v. United States Patent and Trademark Office, 702 F. Supp. 2d 181, 192–211 (SDNY 2010). The human genome consists of approximately 22,000 genes packed into23 pairs of chromos..."
Document | JD Supra United States – 2011
IP Insight - September 2011
"...policy, social policy, medical ethics, economic policy, and the ownership of what some view as our common heritage.” 702 F. Supp. 2d 181, 193 (S.D.N.Y. 2009); Three of the asserted patents included composition claims for “isolated DNA”: U.S. 5,693,473 (‘473) claim 1, U.S. 5,747,282 (‘282), ..."
Document | Mondaq United States – 2012
Federal Circuit Reaffirms Patentability Of Isolated DNA Molecules In View Of Supreme Court's Mayo v. Prometheus Decision
"...invalidating all of these claims under 35 U.S.C. § 101. See Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010). Before reaching the § 101 issue, the district court held that Article III standing existed under the Supreme Court's "all the..."
Document | Mondaq United States – 2011
Federal Circuit's Myriad Decision Reaffirms Patentability Of Isolated DNA Sequences
"...as well as all of the method claims, under 35 U.S.C. § 101. See Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. As to the threshold question of jurisdiction, the district court held that Plaintiffs, including several doctors and scientists ..."
Document | Mondaq United States – 2013
Are Human Genes Patentable?
"...Sweet ruled that the "isolated" DNA sequences were unpatentable "products of nature." Ass'n for Molecular Pathology v. U.S.P.T.O., 702 F. Supp. 2d 181 (S.D.N.Y. 2010). Myriad appealed to the Federal Circuit, arguing, inter alia, that DNA isolated from the human body "differs markedly" from ..."

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5 books and journal articles
Document | Núm. 98-4, May 2013 – 2013
Exclusivity Without Patents: The New Frontier of FDA Regulation for Genetic Materials
"...court decision that the Federal Circuit reversed. See Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office ( Myriad I ), 702 F. Supp. 2d 181, 222–32 (S.D.N.Y. 2010), aff’d in part, rev’d in part , 653 F.3d 1329 (Fed. Cir. 2011), vacated sub nom. Ass’n for Molecular Pathology v. M..."
Document | The technology transfer law handbook – 2014
Patenting Diagnostic Tests Post-Myriad and Post-Prometheus
"...ruled. 5. J.E.M. Ag Supply, Inc. v. Pioneer Hi‑Bred Int’l, Inc., 534 U.S. 124 (2001). 6. Ass’n for Molecular Pathology v. U.S. Patent & Trademark Ofice, 702 F. Supp. 2d 181 (S.D.N.Y. Mar. 29, 2010); Ass’n for Molecular Pathology v. Myriad Genetics, Inc.,689 F.3d 1303 (Fed. Cir. 2011). 7. Ma..."
Document | Vol. 75 Núm. 2, December 2011 – 2011
New York intellectual property law review.
"...(189) See id. at 106-07. (190) See id. at 109. (191) Id. (192) Ass'n For Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010), aff'd in part, rev'd in part, 653 F.3d. 1329 (Fed. Cir. (193) Biotechnology Indus. Org. v. District of Columbia, 496 F.3d ..."
Document | Vol. 76 Núm. 3, June 2011 – 2011
Unpredictability in patent law and its effect on pharmaceutical innovation.
"...Guidelines Notice, 66 Fed. Reg. 1092, 1093 (Jan. 5, 2001). (210.) Holman, Gene Patents Under Fire, supra note 208, at 4. (211.) 702 F. Supp. 2d 181 (S.D.N.Y. (212.) Id. at 185. (213.) Christopher M. Holman, Maintaining Incentives for Healthcare Innovation: A Response to the FTC's Report on ..."
Document | Núm. 41-3, June 2013 – 2013
The Reexamination Power of Patent Infringers and the Forgotten Inventor
"...2011 WL 6742516, at *2. 165 Prometheus , 132 S. Ct. at 1294. 166 Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181, 229 (S.D.N.Y. 2010) rev’d , 653 F.3d 1329 (Fed. Cir. 2011) vacated sub nom. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 132 S. C..."

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5 cases
Document | U.S. Court of Appeals — Federal Circuit – 2011
The Ass'n For Molecular Pathology v. United States Patent
"...the challenged claims are drawn to non-patentable subject matter under 35 U.S.C. § 101. Assoc. for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F.Supp.2d 181 (S.D.N.Y.2010) (“ SJ Op.”). We affirm in part and reverse in part. On the threshold issue of jurisdiction, we affirm th..."
Document | U.S. Court of Appeals — Federal Circuit – 2012
Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office
"...of the challenged claims are drawn to non-patentable subject matter under 35 U.S.C. § 101. Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F.Supp.2d 181 (S.D.N.Y.2010) (“SJ Op.”). We affirm in part and reverse in part. This appeal has returned to us as, a petition for c..."
Document | U.S. District Court — District of Utah – 2014
Univ. of Utah Research Found. v. Ambry Genetics Corp. (In re Brca1 & Brca2-Based Hereditary Cancer Test Patent Litig.)
"...and mental processes—subjects that are patent ineligible under 35 U.S.C. § 101. Association for Molecular Pathology v. United States Patent and Trademark Office, 702 F.Supp.2d 181, 186 (S.D.N.Y.2010).12 These patents were drawn to “(1) isolated DNA containing all or portions of the BRCA1 an..."
Document | U.S. Supreme Court – 2013
Ass'n for Molecular Pathology v. Myriad Genetics, Inc.
"...form the basis for hereditary traits in living organisms. See generally Association for Molecular Pathology v. United States Patent and Trademark Office, 702 F.Supp.2d 181, 192–211 (S.D.N.Y.2010). The human genome consists of approximately 22,000 genes packed into 23 pairs of chromosomes. E..."
Document | Minnesota Supreme Court – 2011
Bearder v. State
"...(Fed.Cir.2003) (referring to “genetic information contained in a DNA nucleotide sequence”); Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F.Supp.2d 181, 194 (S.D.N.Y.2010) (noting that genes, which are composed of segments of DNA, “contain[ ] the information used by t..."

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5 firm's commentaries
Document | JD Supra United States – 2013
Supreme Court Ruling that Human Genes May Not Be Patented
"...I A Genes form the basis for hereditary traits in livingorganisms. See generally Association for Molecular Pathology v. United States Patent and Trademark Office, 702 F. Supp. 2d 181, 192–211 (SDNY 2010). The human genome consists of approximately 22,000 genes packed into23 pairs of chromos..."
Document | JD Supra United States – 2011
IP Insight - September 2011
"...policy, social policy, medical ethics, economic policy, and the ownership of what some view as our common heritage.” 702 F. Supp. 2d 181, 193 (S.D.N.Y. 2009); Three of the asserted patents included composition claims for “isolated DNA”: U.S. 5,693,473 (‘473) claim 1, U.S. 5,747,282 (‘282), ..."
Document | Mondaq United States – 2012
Federal Circuit Reaffirms Patentability Of Isolated DNA Molecules In View Of Supreme Court's Mayo v. Prometheus Decision
"...invalidating all of these claims under 35 U.S.C. § 101. See Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010). Before reaching the § 101 issue, the district court held that Article III standing existed under the Supreme Court's "all the..."
Document | Mondaq United States – 2011
Federal Circuit's Myriad Decision Reaffirms Patentability Of Isolated DNA Sequences
"...as well as all of the method claims, under 35 U.S.C. § 101. See Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. As to the threshold question of jurisdiction, the district court held that Plaintiffs, including several doctors and scientists ..."
Document | Mondaq United States – 2013
Are Human Genes Patentable?
"...Sweet ruled that the "isolated" DNA sequences were unpatentable "products of nature." Ass'n for Molecular Pathology v. U.S.P.T.O., 702 F. Supp. 2d 181 (S.D.N.Y. 2010). Myriad appealed to the Federal Circuit, arguing, inter alia, that DNA isolated from the human body "differs markedly" from ..."

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