United States: Myriad Set For Another Round

On Monday October 6th, the U.S. Court of Appeals for the Federal Circuit will entertain oral argument in another case involving Myriad's BRCA1/BRCA2 diagnostic tests. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. In the words of Myriad "[t]his appeal ... presents this Court with one of the most basic issues under patent law: should Myriad be able to enforce its patents to enjoy its remaining exclusivity or does section 101 of the Patent Act effectively say that Myriad can patent almost nothing related to its ground-breaking discovery?" Myriad Opening Brief ("Opening") at page 4. In addition to responding to Myriad's query regarding its patent estate, the Federal Circuit's review has the potential to provide much needed clarity for diagnostic innovators and patent holders, as well as the U.S. Patent and Trademark Office, regarding the scope and reach of the U.S. Supreme Court's recent patent-eligibility decisions.

Ambry Genetics and BRCA1/2 Testing

On the same day the Supreme Court issued (Assn. for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2120 (2013)) ("AMP"), Ambry Genetics Corp. ("Ambry") announced that it would begin offering its own BRCA test at a price undercutting the price of Myriad's test. Soon thereafter, Myriad sued Ambry in the U.S. District Court for the District of Utah alleging infringement of select claims from several of Myriad's U.S. patents covering pairs of synthetic DNA strands or "primer pairs" and methods for analyzing BRCA1 and BRCA2 sequences. More specifically, Myriad's asserted claims relate to pairs of single stranded DNA primers for use in the polymerase chain reaction (PCR). Other asserted claims cover methods for screening germline mutations in the BRCA1 gene.

Myriad also moved for a preliminary injunction, arguing that the sale of Ambry's test caused Myriad irreparable harm. Ambry opposed the motion, alleging that the claims were invalid under 35 U.S.C. §§ 101, 102, 103 and 112. The district court denied Myriad's motion for preliminary injunction, finding that damages would be adequate to compensate the company for its harm should it subsequently prevail. The district court also found that Ambry had raised a substantial question that the asserted claims were invalid under 35 U.S.C. § 101 (patent-eligibility) because the method claims, as a group, were similar in form to the abstract method claims invalidated in AMP.

Myriad's Appeal

Myriad appealed, noting the district court improperly extended the reach of Mayo and AMP: "While the Supreme Court may have ruled that the isolated BRCA genes themselves were not patentable, it declined to go any further, and stated that Myriad could lawfully claim applications of that gene, including for example, BRCA cDNAs. It is thus manifestly not the case – as the district court found – that Myriad's methods of diagnosis employing BRCA-related probes and primers are "conventional" or unlawfully preempt use of the gene, and it is manifestly not the case that pairs of short, single-stranded BRCA-related DNA primers created in the lab to initiate the polymerase chain reaction ("PCR") in order to replicate portions of the BRCA genes are unpatentable "products of nature" under the Supreme Court's precedent." Opening at pages 4-5.

Myriad further argues that the Supreme Court's 2013 AMP decision does not preclude the patenting of applications of that knowledge – applications of the knowledge of the BRCA gene sequences. Opening at pages 5-6. Myriad alleges that the district court erred in its analysis of the method claims, in particular its application of the 2012 U.S. Supreme Court's Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) (Mayo) decision. As summarized by Myriad, the district court's application of the "Mayo" test for whether a claim is patent-eligible is: "'whether the Method Claims as issue set forth an 'inventive step' aside from the patent ineligible subject matter, and beyond 'well-understood, routine, conventional activity previously engaged in' by those in the field; and 2) whether allowing the Method Claims risks preempting the use of a natural law, natural phenomenon, or abstract idea." Opening at pages 21-22 (internal citations omitted).

Myriad further argues that the district court also erred in failing to review and analyze the claims as a whole in that the court improperly split the claims into pieces, ignored the BRCA gene sequence elements in the claims, and then found that the remaining claim elements were no more than conventional activities that were well-understood and uniformly employed by those working in the field. Myriad asserts that when the claims are viewed as a whole, they are patentable applications of its discovery of the BRAC sequences.

With respect to the primer pairs, Myriad alleges that the district court erred in finding them to be ineligible products of nature because they are designed and made by scientists in a laboratory and have a utility distinct from isolated DNA fragments.

The ACLU's Brief in Support of Ambry

The American Civil Liberties Union (ACLU), the Association for Molecular Pathology, the Breast Cancer Action, the Public Patent Foundation, and AARP, (collectively "ACLU"), as Amici Curie, filed a brief in support of Appellee Ambry Genetics.

The Method Claims

Interestingly but not surprisingly, the ACLU suggests a different test for the analysis of Myriad's method claims. The ACLU asserts that to apply Mayo, the court should determine whether the claimed method "is based on an inventive concept, and whether the patent ties up the use of underlying natural phenomena." ACLU Brief at page 6. Under this test the ACLU argues, Myriad's method claims do not satisfy 35 U.S.C. § 101 because the claims are only directed at whether a patient has a BRCA1 mutation, which is a law of nature. In the ACLU's view, the additional methods steps in the claims are simply routine, preparatory steps that were not invented by Myriad. In addition, Myriad's patented technology is alleged to disproportionately tie up the use of the underlying natural laws.

The Primer Claims

The primer claims also are alleged to lack patent-eligibility. The ACLU asserts that the primers sequences are the same as naturally-occurring sequences of the BRCA1 gene and they do not have markedly different characteristics from naturally-occurring DNA. The primers are noted to hybridize to complementary segments of DNA, and based on this inherent natural function, are therefore argued to be analogous to the strains of bacteria in Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948).

Patents and the First Amendment

The ACLU also argues that the patents raise constitutional problems by monopolizing areas of knowledge and inquiry and claiming thought, and thereby interfering with scientific inquiry. Myriad's patent claims, in the ACLU's opinion, give Myriad control over an entire body of knowledge that violates the Constitution.

The parties' briefs are attached. Myriad Opening Brief; Ambry Response Brief; Myriad Reply Brief; ACLU Amicus Brief

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Emails

From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.