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.

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