United States: The Federal Circuit Clarifies The Scope Of § 101 In Pharmaceutical Related Patents

In Rapid Litigation Management v. CellzDirect, Inc., the Federal Circuit vacated and remanded a decision from the Northern District of Illinois invalidating U.S. Patent No. 7,604,929 under 35 U.S.C. § 101 as a patent-ineligible law of nature and lacking an inventive step.1 This appears to be the first post-Alice decision where the Federal Circuit has vacated and remanded based on § 101 a pharmaceutical related patent. The claims recite a method of "cryopreservation" for preserving hepatocytes, which generally involves freezing the hepatocytes, using density gradient fractionation on thawed cells to recover viable cells, and refreezing the viable cells. The claims also recite a method for preparing multi-donor cryopreserved hepatocytes, resulting in greater than 70% viable hepatocytes after the final thaw.

The district court applied the Supreme Court's two-step test for patent eligibility, derived from Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014) and Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012). In doing so, the district court determined that (1) the patent was directed to an ineligible law of nature, "the discovery that hepatocytes are capable of surviving multiple freeze-thaw cycles," and (2) the process did not contain an inventive concept, as the inventors "reapplied a well-understood freezing process." 2

The Federal Circuit undertook the same analysis with the two-step framework from Alice and Mayo. Under the first inquiry, the court rejected the district court's conclusion that the patent was drawn to a law of nature, finding that the patent was directed to a "new and useful laboratory technique for preserving hepatocytes." 3 The Federal Circuit declined to decide whether the "cells' capability of surviving multiple freeze-thaw cycles" constituted a "natural law," as had been determined by the district court. Instead, the court concluded that the plain language of the claims showed that they are not directed to the hepatocytes' ability to survive multiple freeze-thaw cycles, but to a multi-step "method of producing a desired preparation of the multi-cryopreserved hepatocytes." 4 Given that the claim "employed their natural discovery to create a new and improved way of preserving hepatocyte cells," the court determined that this constitutes "precisely the type of claim that is eligible for patenting." 5

The court distinguished several recent cases where claims were found patent ineligible under § 101, including Genetic Technologies, Ltd. v. Merial, Ariosa Diagnostics, Inc. v. Sequenom, Inc., 7 and In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation. 8 In these cases, the claims "amounted to nothing more than observing or identifying the ineligible concept itself." 9 In Genetic Technologies, the claims pertained to methods regarding the relationship between coding and non-coding DNA sequences, amounting to a claim which simply identified information about a patient's natural genetics. 10 In Ariosa, the claims recited methods for detecting paternally inherited cffDNA, and a claim identifying its presence "was merely claiming the natural phenomena itself." 11 In In re BRCA, claims directed to methods for screening human germline by comparing two sequences were patent-ineligible as an abstract mental process. 12 The Federal Circuit explained that "[a]lthough the claims in each of these cases employed method steps, the end result of the process, the essence of the whole, was a patent-ineligible concept." 13

In Rapid Litigation Management, the Federal Circuit concluded that "it is the process of preservation that is patent eligible here, not necessarily the end product." 14 In other words, the claims do not amount to simply an observation or identification of a law of nature, but recite a "new and useful method." 15 This particularly applies to dependent claim 5, which requires the pooling of hepatocytes from multiple donors, an impossible task under conventional preparation methods. In addition, "regardless of whether the individual hepatocytes in the pool of multi-cryopreserved hepatocytes have the same effect that they always had," the court explained that "the claims are directed to the new and useful process of creating that pool, not to the pool itself." 16

Although unnecessary to proceed to the second step of the test, the Federal Circuit noted that it would find the claims patent eligible under that inquiry as well. 17 The court first explained that claims which "improve[] an existing technological process" are sufficient to "transform[] the process into an inventive application." 18 It then highlighted the benefits of the process over the prior-art methods. For example, the prior-art method damaged the hepatocytes such that the conventional wisdom was that they could only be frozen once. Using the new method, the hepatocytes "no longer exhibit unacceptable loss of viability." 19 In addition, instead of waiting for enough single samples to be pooled and used immediately, the method allows researches to pool samples together in advance and to then preserve them for later use. The court determined that to require anything additional in this step "would be to discount the human ingenuity that comes from applying a natural discovery in a way that achieves a 'new and useful end.'" 20 The court quickly dismissed Life Technologies Corp.'s argument that it was a simple task to merely repeat the known process of freezing, explaining that ease of execution or obviousness does not have any impact on patent eligibility under § 101. 21

The Federal Circuit refined the inquiry for patent eligibility under § 101 in rejecting the district court's reasoning and rendering the method patent eligible. The decision provided constructive guidance to the life-science industry, which has been grappling with the boundaries of patent eligibility. The court explained that the inquiry is not simply whether an invention involves a patent-ineligible concept, and further clarified that the "natural ability of the subject matter to undergo the process does not make the claim 'directed to' that natural ability." 22 Claims drawn to "laws of nature," including methods for treatment and diagnostic purposes, may be patent eligible provided that the claims are directed to more than the law of nature itself. The court specifically noted that if the method for preparing hepatocytes was found to be patent ineligible as drawn to a law of nature, the reasoning would extend patent ineligibility to a large majority of methods of producing things or methods of treating disease. "Section 101 is not so narrow" as to prevent the patenting of any innovative method that acts on something naturally occurring. 23 Patent practitioners and life-science professionals should look to see whether their claims, even method claims, amount to merely a law of nature, or are further directed to a new and useful application of the law.

To view the Court's Opinion, please click here.


1 Rapid Litig. Mgmt. v. CellzDirect, Inc., 2016 U.S. App. LEXIS 12352 (Fed. Cir. 2016).

2 Celsis in Vitro, Inc. v. CellzDirect, Inc., 83 F. Supp. 3d 774, 783-84 (N.D. Ill. 2015).

3 Rapid Litig. Mgmt., 2016 U.S. App. LEXIS 12352, at *10.

4 Id. at *12.

5 Id. at *10.

6 Genetic Techs., Ltd. v. Merial L.L.C., 818 F.3d 1369 (Fed. Cir. 2016).

7 Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).

8 In re BRCA1 & BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755 (Fed. Cir. 2014).

9 Rapid Litig. Mgmt., 2016 U.S. App. LEXIS 12352, at *11.

10 Id. (citing Genetic Techs., Ltd. v. Merial L.L.C., 818 F.3d 1369, 1373-74 (Fed. Cir. 2016)).

11 Id. (citing Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1373-74 (Fed. Cir. 2015), cert. denied, 2016 U.S. LEXIS 4087 (June 27, 2016)).

12 Id. (citing In re BRCA1 & BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755, 761-62 (Fed. Cir. 2014)).

13 Id. at *12.

14 Id. at *

15. 15 Id. at *12.

16 Id. at *14.

17 Id. at *17.

18 Id. (citing Alice Corp. v. CLS Bank Int'l, 134 S. Ct. 2347, 2358 (2014) (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1299 (2012))).

19 Id.

20 Id. at *20.

21 The original suit was brought against Defendants-Appellees, CellzDirect, Inc. and Invitrogen Corporation, which has since merged with another corporation to form Life Technologies Corporation. Id. at *6 n.1.

22 Id. at *12.

23 Id. at *15.

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 Video
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
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.


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.


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.


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.


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.


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.


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.