Association of Molecular Pathology v. U.S. Patent and Trademark Office
By Kevin E. Noonan --
Not surprisingly, Judge Robert W. Sweet of the Southern District of New York ruled in favor of the plaintiffs today in Association of Molecular Pathology v. U.S. Patent and Trademark Office, granting partial summary judgment that the claims of several patents on BRCA1 were invalid as encompassing non-statutory subject matter. In an extensive, 156-page opinion (which will be analyzed more thoroughly in a later post), the District Court entered a narrow ruling that was damaging to the University of Utah and its licensee Myriad Genetics, but not as far-reaching as plaintiffs and their backers, the American Civil Liberties Union and the Public Patent Foundation, undoubtedly hoped.
The Court granted summary judgment on the composition of matter claims, based on its (mis)reading of 19th century Supreme Court precedent as well as several old "product of nature" cases from several district courts and regional circuit Courts of Appeal. (Ironically, the District Court disregarded the teachings of Learned Hand in this same court, Judge Learned Hand's opinion in Parke-Davis & Co. v. H.K. Mulford Co., 189 F.2d 95 (2d. Cir. 1911)). The method claims were found invalid under the Federal Circuit's "machine or transformation" test from In re Bilski. The Supreme Court will rule on the Federal Circuit's decision and adoption of this test (representing another rigid rule like the many the Court has overturned or has voiced its disapproval of), making this portion of the opinion of questionable longevity.
As a reminder, the following U.S. Patents were at issue in this litigation: U.S. Patent Nos. 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; and 6,033,857. They are assigned to Myriad Genetics, the University of Utah Research Foundation, and the National Institutes of Health (the '282, '001 and '441 patents); Myriad Genetics, Centre de Recherche du Chul, and the Japanese Cancer Institute (the '473 and 999 patents); and Myriad Genetics, Endo Recherche, HCS R&D Ltd. Partnership, and the University of Pennsylvania (the '492 and '857 patents). All but the '492 and '857 patents claim priority to an application filed August 12, 1994; all but the '473 patent (December 2014) and the '857 patent (March 2017) will expire (upon timely payment of maintenance fees) in 2015.
The following claims have (for now) been invalidated:
For the '282 patent:
1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2.
7. An isolated DNA selected from the group consisting of:
(a) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having T at nucleotide position 4056;
(b) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having an extra C at nucleotide position 5385;
(c) a DNA having the nucleotide sequence set forth in SEQ ID NO: 1 having G at nucleotide position 5443; and, (d) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having 11 base pairs at nucleotide positions 189-199 deleted.
20. A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.
For the '492 patent:
1. An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2.
6. An isolated DNA molecule coding for a mutated form of the BRCA2 polypeptide set forth in SEQ ID NO:2, wherein said mutated form of the BRCA2 polypeptide is associated with susceptibility to cancer.
7. The isolated DNA molecule of claim 6, wherein the DNA molecule comprises a mutated nucleotide sequence set forth in SEQ ID NO:1.
For the '473 patent:
1. An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1.
For the '999 patent:
1. A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.
For the '001 patent:
1. A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises gene comparing a first sequence selected form the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.
For the '441 patent:
1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.
And for the '857 patent:
1. A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.
2. A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.
Fortunately, the District Court ignored plaintiffs' invitation to rule on several constitutional issues of questionable provenance (see "The USPTO Asks out of Gene Patenting Case (Again)"), dismissing the claims against the U.S. Patent and Trademark Office. Invoking the principle of constitutional avoidance, i.e., that "federal courts should, where possible, avoid reaching constitutional questions (Allstate Ins. Co. v. Serio, 261 F.3d 143,149-150 (2d Cir. 2001) and Spector Motor Serv. Inc. v. McLaughlin, 323 U.S. 101 (1944)), the Court answered plaintiffs' argument that deciding as it did would not reach the question of whether the Patent Office was improperly granting patents on genes by saying:
[A] decision by the Federal Circuit or the Supreme Court affirming the holding set forth above would apply to both the issued patents as well as patent applications and would be binding on all patent holders and applicants, as well as the USPTO.
We can only hope not.
As the District Court predicts, however, this case is now headed to the Federal Circuit, which may benefit from amici curiae briefs from those stakeholders, such as major patent bar groups, universities and others, who sat on the sidelines during the District Court case. The dangers and negative consequences of a ban on gene patenting have been set out before and won't be repeated here. That doesn't make the outcome any less dangerous, or the consequences any less threatening to the biotechnology industry or our society.
For information regarding this and other related topics, please see:
• "Debating Gene Patents - Round Four," February 10, 2010
• "Newsweek = Newspeak on Gene Patenting," February 8, 2010
• "Everybody Knows -- The Boston Globe Weighs in on Gene Patenting," February 1, 2010
• "The USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010
• "Top Stories of 2009: #4 to #1," January 4, 2010
• "Gene Patenting: Australian Potpourri," December 28, 2009
• "Science Progress Article Examines Impact of Gene Patents on Research," December 21, 2009
• "Gene Patenting Debate Continues - Round Three," December 17, 2009
• "BRCA Patent Suit to Continue in Southern District of New York," November 2, 2009
• "Empirical Research Fails to Support Gene Patenting Ban," October 22, 2009
• "The Tragedy of a Bad Idea," August 25, 2009
• "Gene Patenting Debate Continues - Round Two," August 4, 2009
• "The Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S. Patent and Trademark Office," May 17, 2009
• "Court Report: Special Edition," May 13, 2009