Biotechnology Patent Survives a § 101 Challenge at the Federal Circuit

Author: Meredith H. Boerschlein*
Editor: Jeff T. Watson

In Rapid Litigation Management Ltd. v. CellzDirect, Inc., No. 15-1570 (Fed. Cir. July 5, 2016), the Federal Circuit vacated and remanded the district court’s summary judgment determination that the patent-in-suit is directed to patent-ineligible subject matter and therefore invalid.

Rapid Litigation Management sued CellzDirect for infringing its patent covering a method of preserving hepatocytes (liver cells). CellzDirect moved for summary judgment alleging the patent was invalid under 35 U.S.C. § 101. The district court agreed, applying the two-part test for patent eligibility established in Mayo Collaborative Servs. v. Prometheus Labs., Inc. and confirmed in Alice Corp. v. CLS Bank International. According to the district court, the claims concerned a law of nature (hepatocytes’ ability to survive multiple freeze-thaw cycles), and the well-known freezing method did not provide the requisite “inventive concept.”

On appeal, the Federal Circuit disagreed with the district court’s application of the Mayo/Alice test. Unlike the court below, the Federal Circuit found that the patent did not concern a law of nature, but rather “a new and useful laboratory technique[.]” As the Court further articulated, even if the patent is directed to a law of nature, it is eligible under step two. The twice-frozen process provides an inventive concept.

In reaching its conclusion, the Court added two points: (1) “patent-eligibility does not turn on ease of execution or obviousness of application”; and (2) “while pre-emption is not the test for determining patent-eligibility,” the district court’s findings that the patent “does not lock up the natural law in its entirety” and that “LTC has already managed to engineer around the patent” are in accord with the Court’s conclusion that “the patent is not ‘directed to’ a patent-ineligible building block of human ingenuity.” Thus, the Court vacated and remanded the district court’s summary judgment grant.


*Meredith H. Boerschlein is a Law Clerk at Finnegan.

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