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Methods of Cell Cryopreservation are Patent Eligible: Federal Circuit
Practical Law Legal Update w-002-7560 (Approx. 5 pages)
Methods of Cell Cryopreservation are Patent Eligible: Federal Circuit
by Practical Law Intellectual Property & Technology
| Published on 07 Jul 2016 • USA (National/Federal) |
In Rapid Litigation Management Ltd. v. Cellzdirect, Inc., the US Court of Appeals for the Federal Circuit vacated and remanded the district court's grant of summary judgment, holding that a methods of preserving and pooling liver cells through multiple-cycle freeze-thawing were not patent ineligible under 35 U.S.C. Section 101.
On July 5, 2016, in Rapid Litigation Management Ltd. v. Cellzdirect, Inc., the US Court of Appeals for the Federal Circuit vacated and remanded the US District Court for the Northern District of Illinois' grant of summary judgment, holding that a process for multiple-cycle freeze-thawing of hepatocytes was not patent ineligible under 35 U.S.C. Section 101 ( (Fed. Cir. Jul. 5, 2016)).
This case involves US Patent No. 7,604,929 ('929 patent), directed to an improved process of preserving hepatocytes—a type of liver cell with a number of attributes useful for testing, diagnostic, and treatment purposes. The process takes advantage of the fact that a fraction of hepatocytes are capable of surviving multiple freeze-thaw cycles and behaving like cells that were only frozen once. The process involves:
- Subjecting previously frozen and thawed cells to density gradient fractionation to separate viable cells from non-viable ones.
- Recovering the viable cells.
- Refreezing the viable cells.
A suit was originally brought by Celsis In Vitro, Inc. against CellzDirect, Inc. and Invitrogen Corp. alleging infringement of the '929 patent. Currently, the named Plaintiffs-Appellants to the suit are Rapid Litigation Management Ltd. and In Vitro, Inc. (collectively RLM), and Defendants-Appellees, Cellzdirect, Inc. and Invitrogen Corp. (collectively Cellzdirect).
Cellzdirect responded to the suit by filing a motion for summary judgment of patent invalidity. The district court granted summary judgment, holding that the subject matter of the patent was patent ineligible and invalid under 35 U.S.C. Section 101. The court:
- Held that under the US Supreme Court's Alice/Mayo two-step framework for determining patent eligibility, the '929 patent's method claims at issue are:
- directed to an ineligible law of nature, namely the discovery that certain hepatocytes are capable of surviving multiple freeze-thaw cycles; and
- the patented process lacks the requisite inventive concept to make it patent eligible because the inventors simply reapplied a well-understood freezing process.
- Dismissed the action with prejudice without addressing Cellzdirect's 35 U.S.C. Section 112 arguments.
On appeal, the Federal Circuit vacated and remanded the district court's decision. With respect to Section 101, the court explained:
- The Supreme Court articulated the two-step framework to distinguish patents that claim one of the patent ineligible exceptions under Section 101—laws of nature, natural phenomena, and abstract ideas—from those that claim patent-eligible applications of those concepts.
- Under step one of the analysis, the '929 patent claims are not directed to a patent ineligible concept because:
- the claims are not directed to the ability of hepatocytes to survive multiple freeze-thaw cycles;
- they are directed to a new and useful laboratory technique for preserving hepatocytes, and the resulting preparation and the process for creating it achieved a notable advance over prior art techniques for preserving hepatocytes;
- although the inventors discovered the cells' ability to survive multiple freeze-thaw cycles, they did not stop there, and that is not what they patented;
- unlike in other cases where patents were found patent ineligible, the process claims here do not simply involve an observation or detection of a natural process or law of nature; and
- the fact that one way of describing the process is to describe the natural ability of the subject matter to undergo the process does not make the claim directed to that natural ability.
- Even if the claims are assumed to be directed to a natural phenomenon, the '929 patent claims describe a process sufficient to transform the patent-ineligible concept into an inventive application under step two because:
- the benefits of the improved process over the prior art methods are significant;
- although the individual steps of freezing and thawing were well known, the claimed process of preserving hepatocytes by repeating those steps was itself far from routine and conventional;
- that each of the claims' individual steps (freezing, thawing, and separating) were known independently in the art does not make the claim unpatentable; and
- the prior art taught that cells could be frozen only once and then had to be used or discarded, and repeating a step that the art taught should be performed only once can hardly be considered routine or conventional.
- Even if it was a simple task to repeat the known freeze-thaw process to arrive at the claimed invention, patent eligibility does not turn on ease of execution or obviousness of application.
- While fear of pre-emption is not the test for determining patent eligibility, here the '929 patent does not lock up the natural law in its entirety, and Cellzdirect has already managed to engineer around the patent.
Like the Federal Circuit's recent decision in Enfish, LLC v. Microsoft Corp., this decision shows that in some cases method claims may survive a Section 101 challenge even where a patent ineligible concept underlies them ( (Fed. Cir. May 12, 2016)). Courts must instead carefully consider what the claim is actually directed to, such as a new and improved technique for producing a tangible and useful result that goes beyond the underlying ineligible concept. As noted by the Federal Circuit, however, such claims may be susceptible to novelty and obviousness challenges.