Myriad Genetics Sues LabCorp over BRCA Gene Testing

by McDonnell Boehnen Hulbert & Berghoff LLP
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MyriadThe very latest company targeted by Myriad Genetics for offering a genetic diagnostic test encompassing the human BRCA 1 and BRCA 2 genes is LabCorp (Laboratory Corporation of America), located in Burlington, North Carolina.  Myriad sued LabCorp on Tuesday in the District of Utah, Central Divisions (Case No. 2:13-cv-01069-BCW; complaint).  Myriad's complaint in this case is similar to Myriad's complaints against other defendants, albeit being limited solely to BRCA gene claims, and once again, Myriad is joined by the University of Utah Research Foundation, the Trustees of the University of Pennsylvania, HSC Research and Development Limited Partnership, and Endorecherche Inc.

This Complaint alleges that:

With knowledge of Plaintiffs' patents, Defendant began offering its BRCA1 and BRCA2 testing as part of its cancer-testing menu on December 2, 2013.  On information and belief, Defendant offers stand-alone tests comprising full gene sequencing and deletion/duplication analyses for the BRCA 1 and BRCA 2 genes.

LabCorpMyriad alleges infringement by Labcorp's "making, manufacturing, promoting, marketing, advertising, distributing, offering for sale and selling and/or causing to be offered or sold at least certain BRCA1/2 Comprehensive Analysis (BRCAssureSM ) products."  The specific claims Myriad alleges are infringed include the following:  claim 6 of U.S. Patent No. 5,709,999; claim 6, 16 and 17 of U.S. Patent No. 5,747,282; claims 7, 8, 12, 23, and 26 of U.S. Patent No. 5,753,441; claims 29 and 30 of U.S. Patent No. 5,837,492; claim 4 of U.S. Patent No. 6,033,857; claims 2, 3 and 4 of U.S. Patent No. 5,654,155; claims 2, 3, 4, 5, 6, and 7 of U.S. Patent No. 5,750,400; claims 32 and 33 of U.S. Patent No. 6,051,379; claim 5 of U.S. Patent No. 6,951,721; claims 3, 4, 5, 6, 7, 8, 11, 14, 17, 18, 19 of U.S. Patent No. 7,250,497; and claims 1, 5, 6, 8, 11, 14, 17, 20, 23, 26, 27, 32, 33, 35, 38, 39, 41, 44, 45, and 82 from U.S. Patent No. 6,083,698.

This complaint is unlike several of Myriad's earlier complaints, particularly with regard to the claims asserted from the '698 patent.  In particular, claim 73 from the '698 patent (set forth below) is not asserted here:

73.  A chip array having "n" elements for performing allele specific sequence-based techniques comprising:
    a solid phase chip and
    oligonucleotides having "n" different nucleotide sequences,
    wherein "n" is an integer greater than one, p1 wherein said oligonucleotides are bound to said solid phase chip in a manner which permits said oligonucleotides to effectively hybridize to complementary oligonucleotides or polynucleotides,
    wherein oligonucleotides having different nucleotide sequence are bound to said solid phase chip at different locations so that a particular location on said solid phase chip exclusively binds oligonucleotides having a specific nucleotide sequence, and
    wherein at least one oligonucleotide is an oligonucleotide that is an isolated nucleotide that hybridizes to either a normal or a mutant BRCA1 gene selected from the group consisting of:
    a first oligonucleotide for detecting a deletion of a nucleotide in intron 6 at nucleotide number 421-2 of a BRCA1 gene sequence, wherein said first oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 421-2 of the BRCA1 gene,
    a second oligonucleotide for detecting a deletion of two nucleotides at nucleotide number 815 of a BRCA1 gene sequence, wherein said second oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 815 of the BRCA1 gene,
    a third oligonucleotide for detecting an insertion of 10 nucleotides at nucleotide number 926 of a BRCA1 gene sequence, wherein said third oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 926 of the BRCA1 gene,
    a fourth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 1506 of a BRCA1 gene sequence, wherein said fourth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 1506 of the BRCA1 gene,
    a fifth oligonucleotide for detecting a mutation of one nucleotide at nucleotide number 2034 of a BRCA1 gene sequence, wherein said fifth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 2034 of the BRCA1 gene,
    a sixth oligonucleotide for detecting an amino acid change from serine to a stop codon at codon 770 of a BRCA1 gene sequence, wherein said sixth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 2428 of the BRCA1 gene,
    a seventh oligonucleotide for detecting an amino acid change from tryptophan to a stop codon at codon 1508 of a BRCA1 gene sequence, wherein said seventh oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 4643 of the BRCA1 gene,
    an eighth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5053 of a BRCA1 gene sequence, wherein said eighth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5053 of the BRCA1 gene,
    an ninth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5210 of a BRCA1 gene sequence, wherein said ninth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5210 of the BRCA1 gene,
    a tenth oligonucleotide for detecting an insertion of 12 nucleotides at nucleotide number 5396+40 in intron 20 of a BRCA1 gene sequence, wherein said tenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5396+40 of the BRCA1 gene,
    an eleventh oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5150 of a BRCA1 gene sequence, wherein said eleventh oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5150 of the BRCA1 gene,
    a twelfth oligonucleotide for detecting an amino acid change from serine to a stop codon at codon 1262 of a BRCA1 gene sequence, wherein said twelfth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 3904 of the BRCA1 gene,
    a thirteenth oligonucleotide for detecting an amino acid change from tyrosine to stop at nucleotide number 903 of a BRCA1 gene sequence, wherein said thirteenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 903 of the BRCA1 gene, and
    a fourteenth oligonucleotide for detecting a detecting an amino acid change from threonine to proline at nucleotide number 4164 of a BRCA1 gene sequence, wherein said fourteenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 4164 of the BRCA1 gene.

While the following '698 claims are asserted here (and not in cases against other defendants):

1.  An isolated oligonucleotide that hybridizes to either a normal or a mutant BRCA1 gene selected from the group consisting of:
    a first oligonucleotide for detecting a deletion of a nucleotide in intron 6 at nucleotide number 421-2 of a BRCA1 gene sequence, wherein said first oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 421-2 of the BRCA1 gene,
    a second oligonucleotide for detecting a deletion of two nucleotides at nucleotide number 815 of a BRCA1 gene sequence, wherein said second oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 815 of the BRCA1 gene,
    a third oligonucleotide for detecting an insertion of 10 nucleotides at nucleotide number 926 of a BRCA1 gene sequence, wherein said third oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 926 of the BRCA1 gene,
    a fourth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 1506 of a BRCA1 gene sequence, wherein said fourth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 1506 of the BRCA1 gene,
    a fifth oligonucleotide for detecting a mutation of one nucleotide at nucleotide number 2034 of a BRCA1 gene sequence, wherein said fifth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 2034 of the BRCA1 gene,
    a sixth oligonucleotide for detecting an amino acid change from serine to a stop codon at codon 770 of a BRCA1 gene sequence, wherein said sixth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 2428 of the BRCA1 gene,
    a seventh oligonucleotide for detecting an amino acid change from tryptophan to a stop codon at codon 1508 of a BRCA1 gene sequence, wherein said seventh oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 4643 of the BRCA1 gene,
    an eighth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5053 of a BRCA1 gene sequence, wherein said eighth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5053 of the BRCA1 gene,
    an ninth oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5210 of a BRCA1 gene sequence, wherein said ninth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5210 of the BRCA1 gene,
    a tenth oligonucleotide for detecting an insertion of 12 nucleotides at nucleotide number 5396+40 in intron 20 of a BRCA1 gene sequence, wherein said tenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5396+40 of the BRCA1 gene,
    an eleventh oligonucleotide for detecting a deletion of one nucleotide at nucleotide number 5150 of a BRCA1 gene sequence, wherein said eleventh oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 5150 of the BRCA1 gene,
    a twelfth oligonucleotide for detecting an amino acid change from serine to a stop codon at codon 1262 of a BRCA1 gene sequence, wherein said twelfth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 3904 of the BRCA1 gene,
    a thirteenth oligonucleotide for detecting an amino acid change from tyrosine to stop at nucleotide number 903 of a BRCA1 gene sequence, wherein said thirteenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 903 of the BRCA1 gene, and
    a fourteenth oligonucleotide for detecting a detecting an amino acid change from threonine to proline at nucleotide number 4164 of a BRCA1 gene sequence, wherein said fourteenth oligonucleotide specifically hybridizes to a region encompassing the nucleotide number 4164 of the BRCA1 gene.

5.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a TG at nucleotide number 815 by specifically hybridizing to the region encompassing the nucleotide number 815 of the BRCA1 gene.

6.  An isolated wild type allele specific oligonucleotide according to claim 5 having the sequence 5'GAC GGA TGT AAC AAA TA 3', SEQ ID NO:7, or the sequence complementary thereto.

8.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of an insertion at nucleotide number 926 by specifically hybridizing to the region encompassing the nucleotide number 926 of the BRCA1 gene.

11.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of an A at nucleotide number 1506 by specifically hybridizing to the region encompassing the nucleotide number 1506 of the BRCA1 gene.

14.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a nucleotide change at nucleotide number 2034 by specifically hybridizing to the region encompassing the nucleotide number 2034 of the BRCA1 gene.

17.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a nucleotide change at nucleotide number 2428 by specifically hybridizing to the region encompassing the nucleotide number 2428 of the BRCA1 gene.

20.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a nucleotide change at nucleotide number 4643 by specifically hybridizing to the region encompassing the nucleotide number 4643 of the BRCA1 gene.

23.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a G at nucleotide number 5053 by specifically hybridizing to the region encompassing the nucleotide number 5053 of the BRCA1 gene.

26.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a T at nucleotide number 5210 by specifically hybridizing to the region encompassing the nucleotide number 5210 of the BRCA1 gene.

27.  An isolated wild type allele specific oligonucleotide according to claim 26 having the sequence SEQ ID NO:32, or the sequence complementary thereto.

32.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a deletion at nucleotide number 5150 by specifically hybridizing to the region encompassing the nucleotide number 5150 of the BRCA1 gene.

33.  An isolated wild type allele specific oligonucleotide according to claim 32 having the sequence SEQ ID NO:40, or the sequence complementary thereto.

35.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a deletion at nucleotide number 3904 by specifically hybridizing to the region encompassing the nucleotide number 3904 of the BRCA1 gene.

38.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a G at nucleotide number 903 by specifically hybridizing to the region encompassing the nucleotide number 903 of the BRCA1 gene.

39.  An isolated wild type allele specific oligonucleotide according to claim 38 having the sequence SEQ ID NO:50, or the sequence complementary thereto.

41.  The isolated oligonucleotide according to claim 1 wherein the oligonucleotide detects the presence or absence of a C at nucleotide number 4164 by specifically hybridizing to the region encompassing the nucleotide number 4164 of the BRCA1 gene.

44.  The isolated oligonucleotide according to claim 1 further comprising a label bound thereto.

45.  The isolated oligonucleotide according to claim 44 wherein the label is selected from the group consisting of a radiolabel, a fluorescent label a bioluminescent label, a chemiluminescent label, an enzyme label and a ligand label.

82.  A kit comprising a carrier means being compartmentalized to receive in close confinement one or more container means, and at least one container means,
    wherein at least one container means contains the oligonucleotide of claim 1.

Myriad and its co-plaintiffs demand a jury trial, and request judgment of patent infringement, a preliminary and permanent injunction, an accounting and damages, delivery for destruction of all "products" that infringe any of the asserted claims, a finding of willful infringement, and a request for attorneys' fees, enhanced damages, and costs of suit.

The scorecard now stands at six patent infringement lawsuits pending in the District of Utah, against Ambry Genetics, Gene-by-Gene, Quest, GeneDx, Invitae, and LabCorp, and three declaratory judgment actions by Quest, Invitae, and Counsyl, pending in various California district courts (see links below).

For additional information regarding this and other related topics, please see:

• "Myriad Genetics Sues Invitae over BRCA Gene Testing and Invitae Sues Right Back," November 27, 2013
• "Where Do We Stand?" October 31, 2013
• "Defendants' Oppose Myriad's Motions to Dismiss Antitrust Counterclaims," October 28, 2013
• "Myriad Genetics Files Amended Complaint Relating to Colon Cancer Genetic Diagnostic Testing," October 23, 2013
• "Myriad Genetics Sues Quest for Patent Infringement," October 22, 2013
• "Myriad Sues GeneDx on BRCA and Other Genetic Diagnostic Patents," October 21, 2013
• "Diagnostics Giant Quest Files Declaratory Judgment Action against Myriad Genetics," October 13, 2013
• "Bay Area Genetic Diagnostics Company Files Declaratory Judgment Action against Myriad Genetics," October 10, 2013
• "Preliminary Injunction in Myriad v. Ambry and Gene-by Gene: Myriad Replies," October 9, 2013
• "Defendants' Response to Myriad's Preliminary Injunction Motions," September 19, 2013
• "Myriad Moves to Dismiss Ambry's Antitrust Counterclaims on Noerr-Pennington Doctrine," August 28, 2013
• "Amici Submit Brief in Support of Ambry Genetics and Gene by Gene," August 27, 2013
• "Ambry Responds to Myriad Lawsuit," August 7, 2013
• "Why Does Myriad Think It Can Win BRCA Gene Lawsuits?" July 30, 2013
• "Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test," July 17, 2013
• "Myriad Genetics Files Infringement Suit Against Gene by Gene for Genetic Diagnostic Testing of BRCA Genes," July 10, 2013
• "Myriad Genetics Files Suit Against Ambry Genetics for Genetic Diagnostic Testing of BRCA Genes," July 9, 2013

 

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McDonnell Boehnen Hulbert & Berghoff LLP
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