Rapid Litigation Management Ltd. v. CellzDirect, Inc.
827 F.3d 1042
| Fed. Cir. | 2016Background
- Hepatocytes are valuable but scarce liver cells; prior cryopreservation methods damaged cells and allowed only one freeze-thaw, preventing practical multi-donor pooled preparations.
- Inventors discovered some hepatocytes can survive multiple freeze-thaw cycles and claimed a method: (A) density-gradient fractionation of previously frozen/thawed cells to separate viable cells, (B) recover viable cells, and (C) re-cryopreserve them to produce multi-cryopreserved preparations (≥70% viability after final thaw); claim 5 adds pooling from multiple donors.
- IVT (plaintiff) sued LTC (defendants) for infringement of U.S. Patent No. 7,604,929; LTC moved for summary judgment alleging the claims are patent-ineligible under 35 U.S.C. § 101.
- The district court granted summary judgment, holding the patent was directed to a natural law (cells’ ability to survive multiple freeze-thaw cycles) and lacked an inventive concept under Alice/Mayo.
- The Federal Circuit reversed: it concluded the claims are directed to a new laboratory process for preserving hepatocytes (not merely the natural ability) and, alternatively, that the claimed combination of steps supplies the inventive concept.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are the ’929 claims "directed to" a patent-ineligible natural law under § 101? | Claims recite a concrete method producing multi-cryopreserved hepatocytes; therefore not directed to a natural law. | Claims are effectively directed to the natural discovery that hepatocytes survive multiple freeze-thaw cycles. | Federal Circuit: Not directed to a natural law; claims target a new and useful preservation process. |
| If directed to a natural law, do the claims contain an "inventive concept" under Alice step two? | The claimed combination (separation of viable cells and re-cryopreservation, including pooling) improves technological process and is inventive. | The claim elements are routine (freeze/thaw/separate) and merely apply the natural law. | Federal Circuit: As an ordered combination the steps are non-routine given prior art taught away from multi-freezing; claim passes step two. |
| Do Myriad/Funk Bros./Ariosa analogies render the claims ineligible? | Distinguishable: those cases claimed natural phenomena or products themselves; here the patent claims a method of manipulation producing a new useful preparation. | Similarity asserted: claiming natural capability or pooling is like claiming a natural product or mixture. | Federal Circuit: Distinguishable—this is a process claim directed to an improved method, not the natural product itself. |
| Does pre-emption or overbroad exclusion of natural laws make claim invalid? | Claim does not preempt the natural law in entirety and district court found others could engineer around it. | Argued that allowing such process claims would effectively patent natural products. | Federal Circuit: No pre-emption concern found; § 101 does not bar process claims that apply natural discoveries to achieve new useful ends. |
Key Cases Cited
- Alice Corp. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014) (articulates two-step test for patent-eligibility and inquiry into whether claims are "directed to" an ineligible concept and whether they add an inventive concept)
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) (explains limitations on patenting laws of nature and the requirement that added steps be more than conventional activity)
- Diamond v. Diehr, 450 U.S. 175 (1981) (a process applying a law of nature to achieve a technological improvement can be patentable)
- Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (distinguishes composition claims to natural products from potentially patentable method claims that manipulate natural materials)
- Funk Bros. Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948) (product mixture of natural bacterial species held unpatentable where no new function arises)
- Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) (process claims held directed to natural phenomenon where claimed steps were routine applications)
- Genetic Techs., Ltd. v. Merial L.L.C., 818 F.3d 1369 (Fed. Cir. 2016) (claims directed to natural relationships in DNA held patent-ineligible)
- In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litig., 774 F.3d 755 (Fed. Cir. 2014) (claims that were essentially abstract comparison methods held ineligible)