Thursday, July 7 2016

In Vitro Inc.’s Method of Refreezing Viable Hepatocytes Confirmed Patentable

James Watson

On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit reversed the grant of a motion for summary judgment, finding the subject matter of the asserted claims patent-eligible under 35 U.S.C. § 101. The U.S. District Court for the Northern District of Illinois had held that the asserted claims were invalid because they were directed to a law of nature. The claims are generally drawn to methods of aggregating certain liver cells for testing by freezing a sample of the cells, thawing them, separating viable thawed cells from unviable ones, and refreezing the viable cells for storage until a sufficiently large pool of viable cells has been produced. The general wisdom in the field was that the cells should only be frozen once, then thawed and used or discarded, because it was thought that refreezing would damage the cells. The inventors had discovered that twice-frozen cells did not experience significantly more damage than once-frozen cells. Accordingly, they developed the claimed methods to select viable cells for refreezing, enabling verified viable cells to be pooled and stored for subsequent use.

The patent challenger, CellzDirect, Inc. had convinced the District Court to view the claims as being directed to the ability of hepatocytes to survive multiple freeze-thaw cycles. Rejecting that high-level analytical framework, the Court concluded that the claims are directed to “a new and useful laboratory technique for preserving hepatocytes.” The Court emphasized that the claimed methods required the performance of several concrete actions, including separating out viable cells from a previously frozen and thawed sample, recovering the viable cells, and cryopreserving the recovered cells. That process resulted from the inventors’ discovery that the cells could survive multiple freeze-thaw cycles, and constituted a practical application of the underlying discovery. Criticizing the approach proposed by the patent challenger, the Court stated that “it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is ‘directed to.’” Accordingly, the Court held that the claims were not directed to a law of nature.

The Court went on to state that the claims would be patent-eligible even if they could be properly construed as being directed to a law of nature. Although the individual acts of freezing, thawing, and separating were all well known in the art, the Court highlighted the fact that repeating the freezing and thawing steps was neither routine nor conventional. The Court reasoned that requiring more than the practical application of a natural discovery to achieve a new and useful end would discount the human ingenuity required to do so, even when the application is straightforward once the discovery has been made. Finally, the Court noted that the claims do not lock up the natural law in its entirety, specifically pointing out that the patent challenger had already designed around the claimed invention.

Unlike the claims invalidated in the Mayo, Genetic Techs., Ariosa, and Myriad, the claims confirmed to be patent-eligible in Rapid Litig. Mgmt. required more than merely detecting the presence of a naturally occurring phenomenon. Rather, they required that the naturally occurring phenomenon be utilized as part of an unconventional process for pooling cells. The Court held up “methods of, say, producing a new compound (as directed to the individual components’ ability to combine to form the new compound), treating cancer with chemotherapy (as directed to cancer cells’ inability to survive chemotherapy), or treating headaches with aspirin (as directed to the human body’s natural response to aspirin)” as examples of claims that would be found patent eligible. It remains to be seen whether claims to diagnostic tests, such as those presented in Mayo, Genetic Techs., Ariosa, and Myriad, would be found patent-eligible if they required a treatment step, or whether the step of treatment would be considered insignificant post-solution activity. Without any specific standards governing the process for identifying what a claim is directed to, the Court in Rapid Litig. Mgmt. could have equally found that the claims were directed to the ability of cells to survive multiple freeze-thaw cycles and construed the process of separating out viable cells for refreezing as insignificant post-solution activity. While Rapid Litig. Mgmt. offers hope to innovators in the bio-medical space, it does not do enough to bring clarity to the shifting standards for subject-matter eligibility.

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