United States: The Machine-Or-Transformation Test Reaffirmed As Useful And Important

In Prometheus v. Mayo Collaborative (2008-1403, Fed. Cir., Dec. 17, 2010)("Prometheus II"), the Federal Circuit has, on remand from the Supreme Court, again found Prometheus' claims directed to methods of treating the human body with medication to be patent-eligible subject matter. In August, the Federal Circuit noted that the Supreme Court had rejected the exclusive nature of the Machine-or-Transformation test, but not the wisdom behind it. King Pharms. v. Eon Labs, 616 F.3d 1267 (Fed. Cir., Aug. 2, 2010)(citing Bilski v. Kappos, 130 S. Ct. 3218 (U.S. 2010)("Bilski II")). Referencing its earlier decision in Prometheus v. Mayo Collaborative, 581 F.3d 1336 (Fed. Cir. 2009)("Prometheus I"), vacated and remanded, 130 S. Ct. 3543 (2010), the Federal Circuit noted in King Pharmaceuticals that "methods of treatment 'are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition,' because such methods transform the human body." King, 616 F.3d at 1277. Thus, Prometheus II was almost a foregone conclusion. Though the result comes as no surprise to those who watch the Federal Circuit closely, the way the Federal Circuit reached its result does hold some interest.


Prometheus, the sole and exclusive licensee of the litigated patents, claiming "a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder," marketed a test package covered by the patents-in-suit. Mayo formerly purchased and used Prometheus' package but, in 2004, decided to venture out on its own, i.e., to infringe the patents. Prometheus filed suit in 2004, and in 2008 the district court granted Mayo summary judgment of invalidity based on a conclusion that the claims were directed to ineligible subject matter. On appeal, the Federal Circuit reversed and upheld validity under the Machine-or-Transformation test because, as indicated, the Court concluded that all methods of treatment of the human body are transformative. The Supreme Court issued its Bilski decision on June 28 and vacated and remanded Prometheus I on June 29.

The Machine-or-Transformation Test Remains Useful and Important

In taking another look at the facts in view of the Supreme Court's Bilski II decision, the Federal Circuit noted that patent eligibility turns on whether "asserted claims are drawn to a natural phenomenon, the patenting of which would entirely preempt its use as in Benson or Flook, or whether the claims are drawn only to a particular application of that phenomenon as in Diehr." (Slip op. at 13.) This is because "laws of nature, physical phenomena, and abstract ideas" are not patent eligible. Regarding the usefulness of the Machine-or-Transformation test, however, the Federal Circuit noted, as it had in King, that Bilski "did not disavow the Machine-or-Transformation test." Rather, the Machine-or-Transformation test remains a "useful and important clue, an investigative tool" in the analysis as to whether claimed subject matter is patent eligible.

Claims Directed to a Medical Treatment Are Transformative

In Prometheus II, the Federal Circuit determined that "neither the Supreme Court's Bilski decision nor the Court's GVR Order [vacating and remanding Prometheus I] compels a different outcome on remand, and [we therefore again] reverse the district court's judgment of invalidity under § 101." As applied to the claims at issue, the Federal Circuit found that the Machine-or-Transformation test "leads to a clear and compelling conclusion, viz., that the present claims pass muster under § 101." The Court determined that the claims "do not encompass laws of nature or preempt natural correlations," because the claims are directed to a specific method of treatment, where the claimed steps "involve a particular application of the natural correlations: the treatment of a specific disease by administering specific drugs..." The claimed transformation was found to satisfy the Machine-or-Transformation test because "[t]he transformation is of the human body and of its components following the administration of a specific class of drugs and the various chemical and physical changes" of the drugs. Stated another way, the Court found that what "is clearly a transformation" is that "at the end of the process, the human blood sample is no longer human blood; human tissue is no longer human tissue." Even more generally, the Court quoted its own decision in In re Bilski, 545 F.3d 943, 962 (Fed. Cir. 2008)("Bilski I")(affirmed by Bilski II), by asserting that "[i]t is virtually self-evident that a process for a chemical or physical transformation of physical objects or substances is patent-eligible subject matter."

Reference to In re Abele

You may recall that the Federal Circuit held in Bilski I that the so-called Freeman-Walter-Abele test for determining patent eligibility was inadequate. In a footnote, Bilski I stated that "portions [of prior decisions] relying solely on the Freeman-Walter-Abele test should no longer be relied on." Therefore, it came as a bit of a surprise that the Federal Circuit in Prometheus II compared the facts before it with those in In re Abele, 684 F.2d 902 (CCPA 1982), which held that a method of displaying X-ray attenuation data was patent eligible. The point of the comparison, however, is that a claim as a whole should be considered for patent eligibility; the recitation of algorithms and mental thoughts in a claim does not render ineligible an otherwise eligible claim. In holding the claims in Prometheus II patent eligible, the Federal Circuit determined that its current analysis "is consistent with In re Abele."

What This Means to You

Less than six months after Bilski II, it seems clear, as most predicted immediately in its wake, that the Supreme Court's decision was hardly seismic in its effects. Prometheus II now makes clear that even Bilski I and Bilski II, taken together, have hardly altered the basic modes of analysis of claims for patent eligibility. The determination of whether a claim is directed to patent-eligible subject matter questions whether a natural phenomenon is claimed, "the patenting of which would entirely preempt its use as in Benson or Flook, or whether the claims are drawn only to a particular application of that phenomenon as in Diehr." While not an exclusive test, the Machine-or-Transformation test remains important in making such a determination. Similarly, while it is improper to rely solely on the Freeman-Walter-Abele test, those cases, too, remain relevant touchstones.

More practically - and of particular interest to the pharmaceutical industry - Prometheus II makes crystal clear that methods of treatment of the human body with medication are indeed patent eligible. Whether you are a patent owner seeking to enforce your rights or a party accused of infringing the rights of others, we can help you assess the strength of the intellectual property at stake in view of this ever-developing body of law.


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.

In association with
Related Topics
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