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Federal Circuit Decision Breathes Life into Patenting Life Science Methods

July 8, 2016


While the life sciences are typically pretty quiet when it comes to important cases, another one came out this past Tuesday. It is a positive decision that is worth sharing with the community.

The Federal Circuit's recent decision in Rapid Litigation Management Ltd. (formerly, Celsis Holdings, Inc.) v. Cellzdirect, Inc. provides hope that life science methods are patent eligible subject matter. The Federal Circuit found that the District Court erred in its finding that the claimed methods in U.S. Patent No. 7,604,929 for producing pure cultures of mature hepatocytes to be used "for testing, diagnostic, and treating purposes" were invalid under Section 101. According to the Federal Circuit opinion, the claims were not directed to a law of nature because "the claims are simply not directed to the ability of hepatocytes to survive multiple freeze-thaw cycles[; r]ather, the claims of the '929 patent are directed to a new and useful laboratory technique for preserving hepatocytes. A claim that is interpreted as being a "constructive process" directed to achieving "a new and useful end," the Court stated, "is precisely the type of claim that is eligible for patenting." The Court recognized that the inventors' discovery of the capacity for hepatocytes to undergo multiple cycles of freezing and thawing was just the beginning of their finding and was not where they stopped or what they patented, distinguishing this case from the recent decisions in Genetic Techs., Ltd. v. Merial L.L.C.; Ariosa Diagnostics, Inc. v. Sequenom, Inc., (cert. denied); and In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig.

Take-away: Patent claims in life science applications need to be carefully crafted to ensure that the end result is patentable subject matter—claims drafted to methods for producing a tangible thing have a much better chance of being found patent eligible than methods of producing diagnostic information. 

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