Diagnostics Giant Quest Files Declaratory Judgment Action against Myriad Genetics

by McDonnell Boehnen Hulbert & Berghoff LLP

Quest DiagnosticsMyriad 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.

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.


Written by:

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.