By
Kevin E. Noonan —

Myriad
is facing yet another challenge to its remaining BRCA gene testing franchise,
this time from Quest Diagnostics joined by its R&D arm, Nichols Institute.  Quest is "the world's leading provider
of diagnostic information services, and is a pioneer in developing innovative
diagnostic tests and advanced healthcare information technology solutions that
help improve patient care" according to its complaint, having operations
in the U.S., the U.K., Mexico, Brazil, Puerto Rico, and India, and 43,000
employees worldwide.  This company is
thus very different from the more traditional genomics companies like Ambry
Genetics, Gene-by-Gene, and Counsyl that are currently in litigation with Myriad over the BRCA gene patents.

Quest
filed suit in the Central District of California seeking a declaratory judgment
of invalidity and non-infringement for the following Myriad patents:  U.S.
Patent Nos. 5,654,155; 5,693,473; 5,709,999; 5,710,001; 5,747,282;
5,750,400; 5,753,441; 5,837,492; 6,033,857; 6,051,379; 6,083,698; 6,492,109; 6,951,721; and 7,250,497 (all of the patents asserted against Ambry Genetics
and Gene-by-Gene as well as four additional ones indicated in bold).

The
Background section of Quest's complaint focuses on Myriad's behavior, including
its assertions of exclusivity in the BRCA gene diagnostics market based on its
patents and its aggressive assertion of them (albeit spanning its "cease
and desist" letters to the University of Pennsylvania and other academic
medical centers in the late 1990's to the recent lawsuits Myriad filed against
Ambry Genetics and Gene-by-Gene).  The
complaint mentions (irrelevantly) that some of these centers offered nascent
BRCA gene testing prior to Myriad's entry into the marketplace (and assertion
of its patents), as well as the AMP v.
Myriad case.  But the focus of Quest's
argument is set forth succinctly in Paragraph 53 of the complaint, wherein:

Myriad's aggressive conduct has deterred other competitors from entering the
BRCA1/BRCA2 genetic testing market for fear of being sued.  For example, on June
13, 2013, Pathway Genomics announced plans to offer testing for BRCA1 and
BRCA2.  However, after Myriad filed suits against Ambry Genetics Corp. and Gene
by Gene limited, Pathway Genomics stated that it is delaying launch of those
tests.

Quest
asserts that it has developed a commercial offering for BRCA gene testing, "[a]fter
years of research and development, and a financial commitment of millions of
dollars."  Further, [t]he types of
hereditary alterations detected by Quest's BRCA Assay include alterations in
DNA copy number, deletions, duplications or rearrangements in BRCA1 and BRCA"
and none of its methods "make or use cloned DNA, replicative cloning
vectors, expression systems or host cells comprising BRCA1 or BRCA2 DNA"
or BRCA polypeptides or primers.  Despite
these distinctions, Quest asserts that it is at risk of suit from Myriad, thus
justifying its complaint for declaratory judgment.  In this regard the complaint has a specific
allegation regarding representations from Myriad relating to the likelihood of
suit.  According to Quest:

[O]nly one day after Myriad sued Ambry and the same day it sued Gene by Gene Nicolas
J. Conti, PhD, Vice President Licensing and Alliances for Quest, conferred with
Sam LaBrie, Vice President of Corporate Development of Myriad RBM.

62.
Mr. LaBrie knew that Dr. Conti was a representative of Quest.  He knew that,
unless told otherwise, his comments would be perceived by Dr. Conti and Quest
as representative of the positions of Myriad.

63.
Mr. LaBrie explained Myriad's business tactics and strategy.  His detailed
discussion about Myriad's tactics and strategy, including marketing and pricing
strategy, made it clear to Dr. Conti that Mr. LaBrie was fully aware of Myriad's
positions regarding any laboratories that would offer tests for BRCA1 or BRCA2.  It was also clear to Dr. Conti that Mr. LaBrie knew Myriad's strategy for responding
to any companies that offered BRCA1 and BRCA2 tests without first seeking
permission from Myriad.

64.
Mr. LaBrie specifically discussed with Dr. Conti the status of the Myriad patents
after the Supreme Court invalidated some of those claims.  In that conversation,
Mr. LaBrie indicated that the public does not understand how strong Myriad's
patent claims are.  He further stated that the notion that Quest would enter the
market "scared the [Myriad] team" and he confirmed that Myriad would
be "sending letters" to any labs who offered BRCA1 or BRCA2 tests.  When making that statement, Mr. LaBrie knew that Quest was planning to offer
some sort of BRCA testing.  Therefore, upon information and belief, he intended
to advise that Quest would also receive a letter from Myriad objecting to Quest's
offer of those tests.  Moreover, the above statements applied to any BRCA1 and
BRCA2 testing and related services.  When making the above statements, Mr.
LaBrie did not concede that any BRCA1 or BRCA2 tests would not infringe.

65.
Upon information and belief, when Mr. LaBrie made the above statements directly
to Dr. Conti, he knew that Dr. Conti, as a representative of Quest, would
understand that Myriad would promptly assert its patents against Quest in
conjunction with the launch of Quest's BRCA 1 and BRCA2 tests and related
services.

These
specific allegations thus support Quest's declaratory judgment action here.

The
complaint contains Counts I through XXVIII alleging invalidity and
non-infringement for each of the recited patents.  As in the complaint filed by Counsyl (see "Bay Area Genetic Diagnostics Company Files Declaratory Judgment Action against Myriad Genetics"),
these counts are nothing more than the bare recitation of the patent numbers (the counts do not recite particular claims), and the allegations of
non-infringement or invalidity for failing to meet at least one of the
statutory requirements for patentability.

Quest's prayer for relief includes a declaration of invalidity or non-infringement for
the recited claims of each of the recited patents, and that the case be
declared exceptional and Quest be awarded attorneys fees under 35 U.S.C. § 285.