Order in the Court – “Ordered Combination” of Method Elements Makes Liver Cell Preservation Invention Patent-Eligible

In recent articles, we have written about Federal Circuit reversals of invalidity decisions from district courts, based on patent-ineligibility under 35 U.S.C. § 101, in Enfish[1] and BASCOM.[2]

During oral argument in BASCOM, some Federal Circuit judges intimated that, after BASCOM, there might be other similar decisions waiting in the wings.  Rapid Litigation Management, Ltd. v. Cellzdirect, Inc.[3] (RLM) appears to be one of those decisions, this time upholding patent-eligibility of a patent in the life sciences area.

Reversing the district court, the Federal Circuit found that the claims recited more than just an observation or identification of properties of naturally-occurring cells.  That the underlying material was naturally-occurring did not make the method claims automatically patent-ineligible.

The invention in RLM involves hepatocytes, which are liver cells that are useful for testing the effects of drugs on patients.  Because people are different, and have different livers, pooling of liver cells from different patients, and performing testing on the pooled cells, can help in studying a drug’s effect on a larger, more representative population.  But availability of hepatocytes depends on availability of donor livers.  Also, hepatocytes do not live very long.  Consequently, freezing of hepatocytes from different donors, and then thawing and combining those hepatocytes into pools, came into use.

Until the discovery that gave rise to the patent at issue in RLM, scientists believed that it was possible to freeze and thaw hepatocytes only once.  The inventors of the patent discovered that it was possible to put hepatocytes through multiple freeze-thaw cycles and keep a significant percentage (70 percent-plus) of the cells alive.  The inventors took advantage of that discovery, and patented a “method of producing a desired preparation of multi-cryopreserved hepatocytes”.

The district court granted a motion for summary judgment for invalidity under 35 U.S.C. § 101 (patent-eligibility).  Going through both steps of the two-step process that the US Supreme Court has set forth in several recent cases, the court found first that the patent claims were directed to an exception to patent-eligibility, as the claims involved no more than a natural law – capability of surviving multiple freeze-thaw cycles.  In the second step, the court found that patent claims recited no more than the reapplication of a well-understood freezing process.[4]

The Federal Circuit disagreed with the district court.  Starting at step one, the Federal Circuit held that the patent claims were not directed to a mere natural law.  While the inventors discovered the multiple freeze cycle survivability of these liver cells, the inventors did not stop there.  Rather, the inventors claimed an application of that discovery to a new and improved way of preserving hepatocytes for later use.[5]  Thus, the Federal Circuit found the patent claims here “immediately distinguishable” from claims amounting to “nothing more than observing or identifying the ineligible concept itself”.[6]

Explaining further, the court compared the patent claims at issue to thousands of others that recite processes to achieve a desired outcome, such as methods of producing things, or methods of treating disease, going on to say, “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.”[7]

The court noted that if the patent-eligibility of the underlying material were determinative, “[N]o one could ever get a patent on cryopreservation, or on any other innovative method that acts on something that is naturally occurring, simply because of the nature of the underlying subject matter,” stating further, “Section 101 is not so narrow.”[8]

Having concluded, under step one of the analysis, that the claims were directed to patent-eligible subject matter, the Federal Circuit did not have to proceed to step two.  However, the court held that, if it did have to proceed to step two, the claims would be patent-eligible at that point as well.  The court noted first that patent claims that improve an existing technological process, transform the process into an inventive application of a patent-ineligible concept.  The court then found that the patent claims at issue did precisely that, stating, “The claimed method is patent eligible because it applies the discovery that hepatocytes can be twice frozen to achieve a new and useful preservation process.”[9]

Going further, the Federal Circuit looked at the steps of the claims, noting that, though individual steps of freezing and thawing may have been well known, a process of preserving hepatocytes by repeating those steps was itself far from routine and conventional.[10]  Importantly, the court referred to statements that the Patent and Trademark Office examiner made both during the original prosecution, and during reexamination, finding the concept of multiple freeze-thaw cycles to be absent from the prior art.  “Repeating a step that the art taught should be performed only once can hardly be considered routine or conventional. This is true even though it was the inventor’s discovery of something natural that led them to do so.”[11]

Finally, the Federal Circuit made a couple of interesting observations.  The first was that “patent-eligibility does not turn on ease of execution or obviousness of application,” noting that such questions are addressed elsewhere in the Patent Act.[12]  The court thus addressed the all-too-frequent conflation of sections 101 (patent-eligibility) and 103 (obviousness) and, importantly, differentiated between the two.

Second, the Federal Circuit used the district court’s own finding of the limited nature of the preemption of subject matter in the patented claims to support the conclusion the patent is not “directed to” a patent-ineligible building block of human ingenuity.

The closeness in time of the Federal Circuit’s three pro-patent-eligibility decisions in Enfish, BASCOM, and RLM may portend merely greater selectiveness by patent owners in taking 101 issues up on appeal.  However, it is more likely that these decisions represent helpful sophisticated analysis from the Federal Circuit, dissecting the Supreme Court’s reasoning in Alice, Myriad, and Mayo and forging a path for patent owners to follow to ward off future 101 challenges.

[1]           http://www.ipsingularity.com/improvements-in-computer-functioning-concretize-the-abstract-a-new-way-to-look-at-alice-but-is-it-really-helping/.

[2]           http://www.ipsingularity.com/not-dead-yet-bascom-gives-alice-a-different-view-through-the-looking-glass/.

[3]           2016 U.S. App. LEXIS 12352 (Fed. Cir., July 5, 2016).

[4]           Celsis In Vitro, Inc. v. CellzDirect, Inc., 83 F. Supp. 3d 774, 783-784 (N.D. Ill. 2015).

[5]           RLM, 2016 U.S. App. LEXIS 12352, *10-11.

[6]           Id. at *11.

[7]           Id. at *12.

[8]           Id. at *15.

[9]           Id. at *18.

[10]         Id. at *19.

[11]         Id. at *20.

[12]         Id. at *21.

Start typing and press Enter to search