United States: District Court Finds Genetic Technologies Patent Invalid Under 101 On Motion to Dismiss

Judge Stark of the U.S. District Court for the District of Delaware granted defendants' motion to dismiss Genetic Technologies, Ltd.'s patent infringement suit with regard to claim 1 of U.S. Patent 5,612,179 on the basis that the claimed sequence analysis method is invalid under 35 USC § 101 because it merely applies conventional methods to a natural phenomenon. Judge Stark's opinion draws on recent Supreme Court and Federal Circuit decisions, and shines a light on the difficulties biotechnology patents can face under Mayo, Myriad and Alice. If this case is appealed to the Federal Circuit, will it find that Judge Stark when astray in the analysis that led to the finding of ineligibility?

The Patents at Issue

Genetic Technologies, Ltd. had asserted two patents relating to intron sequence analysis methods against multiple defendants including Bristol-Meyers Squibb Co. and Meriall LLC: U.S. 5,612,179 and U.S. 5,851,762.

The district court granted the motion to dismiss with regard to the '179 patent. The court's analysis focused on claim 1:

1. A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising:
a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and
b) analyzing the amplified DNA sequence to detect the allele.

The district court denied the motion to dismiss without prejudice with regard to the '762 patent, because the parties only had provided a "limited analysis" of that patent, which recites a 10-step method.

The Burden of Proof

The district court turned to the Federal Circuit's 2013 decision in Ultramercial, Inc. v. Hulu, LLC, for the appropriate burden of proof, even though the Ultramercial decision was vacated by the Supreme Court.

The ... Federal Circuit has stated that to grant dismissal of a patent infringement suit at the pleading stage for lack of patentable subject matter, "the only plausible reading of the patent must be that there is clear and convincing evidence of ineligibility."

According to the court, "the Federal Circuit made clear in Ultramercial that it will be 'rare' that patent ineligibility is evident at the pleading stage such that a patent suit can be dismissed on this basis ... the instant matter presents such a rare case."

The Legal Principles Applied by the District Court

The district court began its analysis with this statement of the holding of Mayo v. Prometheus:

A claim is unpatentable if it merely informs a relevant audience about certain laws of nature, even newly-discovered ones, and any additional steps collectively consist only of well-understood, routine, conventional activity already engaged in by the scientific community.

The court also cited the Supreme Court's decision in Alice Corp. v. CLS Bank for "reiterating that courts are to apply the two-step framework set out in Mayo":

A court first determines "whether the claims at issue are directed to one of those patent-ineligible concepts." .... If so, a court then "consider[s] the elements of each claim both individually and as 'an ordered combination' to determine whether the additional elements 'transform the nature of the claim' into a patent-eligible application." .... At this second step, courts examine whether "a process that focuses upon the use of a natural law also contain[ s] other elements or a combination of elements, sometimes referred to as an 'inventive concept,' sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself."

The district court cited the Federal Circuit decision in buySAFE, Inc. v. Google, Inc., for the proposition that "if '"the additional elements" do not supply an "inventive concept" in the physical realm of things and acts—a "new and useful application" of the ineligible matter in the physical realm—that ensures that the patent is on something "significantly more than" the ineligible matter itself,' the claim is outside the scope of § 101."

The Patent Subject Matter Eligibility Analysis

Turning to claim 1 of the '179 patent, the district court made the following findings:

The Claim Recites A Natural Phenomenon: The correlations between variations in non-coding regions of DNA – formerly known as "junk DNA" – and variations in coding regions of DNA – specifically, alleles – are natural phenomena. A correlation that preexists in the human body is an unpatentable phenomenon.

The Claim's Additional Steps Do Not Give Rise to an "Inventive Concept": The asserted claim recites a series of steps to manifest the natural law – that is, to detect the natural correlations between coding and noncoding sequences. The added steps used to discern these correlations consist only of routine and conventional techniques. The patent specification states this outright ....

The court also noted that because the claim "stops" "once the correlation is detected," it does not recite a specific application of the natural phenomenon.

The district court rejected GTG's arguments that the claim recites "unconventional methods" because they recite the use of a primer pair with a novel property, e.g., a primer pair that "spans an intron sequence and defines a DNA sequence in genetic linkage with an allele to be detected." In so doing, the court cited Mayo for the proposition that "when 'the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field,' the subject matter is ineligible without more." (emphasis added in district court opinion). According to the district court:

Mayo requires that the additional steps be viewed apart from the natural law. Otherwise, whenever a natural law is newly discovered, any "additional step" – no matter how routine or conventional in that field – could be tacked onto it and become patent eligible by virtue of the fact it takes advantage of the naturally occurring phenomenon.

Digging further into the claims, the court stated:

The primer pair must define a DNA sequence that has enough non-coding region sequence nucleotides in "genetic linkage" with the allele such that when amplified, the sequence is characteristic of the allele. In short, the DNA sequence must contain the correlation. The limitation sets forth a condition that is inherently required in order to implement the natural law and, therefore, does nothing to impart an "inventive concept."

(emphasis added)

The district court also rejected GTG's arguments that the claim should be found eligible under the machine-or-transformation test. The court noted that the "claims do not tie amplification to a 'particular machine,'" and so cannot be eligible on that basis. With regard to "transformation," the court disagreed that the fact that the amplified DNA was "man-made" carries any weight where the claim does not recite any features of the amplified DNA that distinguish it from naturally occurring DNA. The court cited the Federal Circuit decision in In re Roslin Institute for the proposition that unclaimed differences do not support patent eligibility.

Thus, the court granted the motion to dismiss as to the '179 patent.

Where Did Judge Stark Go Astray?

If the Federal Circuit disagrees with this decision, where will it find that Judge Stark went astray?

In finding that "the DNA sequence must contain the correlation," did Judge Stark confound the natural phenomenon at issue—the fact that a non-coding region can be correlated with an allele—with physical structures relevant to a specific application of the phenomenon—a primer pair useful for amplifying non-coding region DNA to detect a coding region allele?

Did Judge Stark lose sight of the method as a whole? Is a method for detecting a coding region allele by amplifying genomic DNA using the recited (novel) primer pair a specific application of the natural phenomenon that should be patent eligible under Mayo?

In dismissing GTG's "transformation" arguments, did Judge Stark confuse the principles to be applied when the claimed subject matter is a product, as it was in Myriad and Roslin, with principles to be applied when the claimed subject matter is a method that involves the manipulation and transformation of a product?

Judge Stark worries that a liberal application of the machine or transformation test would "eviscerate the holding in Mayo" but did he forget the Supreme Court's warning in Myriad that an overly broad application of the judicially-created patent subject matter eligibility exceptions to will "eviscerate patent law"?

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
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
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
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions