United States: Federal Circuit Agrees Genotyping Method Is Not Eligible For Patenting

In Genetic Veterinary Sciences, Inc. v. Laboklin GMBH& Co., the Federal Circuit upheld the district court decision that held claims directed to methods for genotyping a Labrador Retriever invalid under 35 USC § 101 at the JMOL stage. Sadly, the court’s discussion of personal jurisdiction issues may be more interesting than the all-to familiar explanation of why diagnostic methods are not eligible for patenting under the Supreme Court’s Alice/Mayo framework.

The Patent At Issue 

The patent at issue was U.S. Patent No. 9,157,114, entitled “Method of determining the genotype relating to hereditary nasal parakeratosis (HNPK) and nucleic acids usable in said method.” The Federal Circuit considered claims 1-3:

1. An in vitro method for genotyping a Labrador Retriever comprising: a) obtaining a biological sample from the Labrador Retriever; b) genotyping a SUV39H3 gene encoding the polypeptide of SEQ ID NO: 1 and c) detecting the presence of a replacement of a nucleotide T with a nucleotide G at position 972 of SEQ ID NO: 2.

2. The method according to claim 1, wherein the genotyping is achieved by PCR, real-time PCR, melting point analysis of double-stranded DNA, mass spectroscopy, direct DNA sequencing, restriction fragment length polymorphism (RFLP), single strand conformation polymorphism (SSCP), high performance liquid chromatography (HPLC), or single base primer extension.

3. The method of claim 1, wherein the genotyping utilizes a primer pair comprising a first primer and a second primer, each comprising a contiguous span of at least 14 nucleotides of the sequence SEQ ID NO: 2 or a sequence complementary thereto, wherein: a) said first primer hybridizes to a first DNA strand of the SUV39H3 gene; b) said second primer hybridizes to the strand complementary to said first DNA strand of the SUV39H3 gene; and c) the 3' ends of said first and second primers are located on regions flanking the position 972 of SEQ ID NO: 2, or of nucleotide positions complementary thereto.

While not recited in the claims, the patent explains that the recited mutation is associated with hereditary nasal parakeratosis (HNPK) which occurs in Labrador Retrievers.According to the patent, the invention permits breeders to genotype Labrador Retrievers and “eliminate carriers from breeding programs.”

The Personal Jurisdiction Issues 

The patent is owned by the University of Bern (a Swiss entity) and exclusively licensed to Laboklin (a German company), each of which challenged the district court’s personal jurisdiction.

The Federal Circuit evaluated personal jurisdiction over Laboklin under Federal Rule of Civil Procedure 4(k)(2), focusing on the Constitutional due process requirement. As noted by the court, the test for compliance with due process is whether the “nonresident defendant” has “certain minimum contacts with [the forum] such that the maintenance of the suit does not offend traditional notions of fair play and substantial justice.” Here, the relevant “forum” for assessing “minimum contacts” is the U.S. as a whole, not just “the state in which the district court sits.”

The Federal Circuit explained the personal jurisdiction question as a three-part test:

  1. whether the defendant purposefully directed its activities at residents of the forum;
  2. whether the claim arises out of or relates to the defendant’s activities with the forum; and
  3. whether assertion of personal jurisdiction is reasonable and fair.

As to Laboklin, the Federal Circuit found that its sending of a cease-and-desist letter to PPG in the U.S. and commercial licensing activities with regard to the patent at issue satisfied prongs (1) and (2) and supported personal jurisdiction. The court found prong (3) satisfied because Laboklin had “purposefully availed itself of the benefits and protections of U.S. laws through its commercial sublicensing as well as its enforcement of a U.S. patent.”

The Federal Circuit evaluated personal jurisdiction over the University under the Foreign Sovereign Immunities Act (FISA). The court noted that, under FISA, engaging in commercial activity can give rise to an exception to sovereign immunity:

The University cannot claim immunity in the District Court because it obtained a U.S. patent and then participated in licensing and enforcing the ’114 patent, which constitutes “commercial activity” under the FSIA.

In this regard, the Federal Circuit noted that, consistent with the license agreement with Laboklin, the University had consented to the cease-and-desist letter and “ultimately controlled enforcement of the ’114 patent.”

The Patent Eligibility Issue

The Federal Circuit approached the patent eligibility analysis by comparing its previous decisions in Arisosa v. Sequenom and CellzDirect.Unfortunately for the patent holder, it found the claims at issue to be more akin to those invalidated in Ariosa than those upheld in CellzDirect:

Taken together, the plain language of claim 1 demonstrates that it is directed to nothing more than “observing or identifying” the natural phenomenon of a mutation in the SUV39H3 gene. …. Claims 2 and 3 depend from independent claim 1 and add only generic methods of detecting the natural phenomenon. Thus, the Asserted Claims are directed to natural phenomenon at Alice step one.


The Asserted Claims do not recite an inventive concept that transforms the observation of a natural phenomenon into a patentable invention. Nothing in claim 1’s language suggests the invention of a new method for genotyping.


[A]ny reliance on CellzDirect is misguided. As we stated above, the claims at issue in CellzDirect were directed to a “new and improved technique[] for producing a tangible and useful result,” i.e., preserving those cells for later use. …. Here, the Asserted Claims provide no tangible result save the observation and detection of a mutation in a dog’s DNA. While a positive and valuable contribution, these claims fall short of statutory patentable subject matter.

Thus, the Federal Circuit affirmed the district court decision holding the claims invalid under § 101.

Will Congress Act To Provide Patentability For Diagnostics?

The last sentences of the court’s analysis drives home the need for Congressional action in order to make patent protection available to promote investment in the development and validation of diagnostic methods.

While a positive and valuable contribution, these claims fall short of statutory patentable subject matter.

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.

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
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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.


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.


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