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As the path to legality of cannabis and cannabis-related products progresses, the formerly illegal world of marijuana now confronts legal principles beyond law enforcement. And the patent laws are no exception. On April 17, 2019, in the case of United Cannabis Corp. v. Pure Hemp Collective, 2019 WL 1651846 (D. Col. 2019), the District Court for the District of Colorado issued an order denying a motion for summary judgment that certain claims of United Cannabis’ (“UCANN”) United States Patent No. 9,730,911 (“the ‘911 patent”) were invalid.
The ’911 patent claims cannabis extracts in the form of formulation claims (liquid cannabinoid with at least 95% of one or more particular components of cannabis, e.g., tetrahydracannabinol (Claim 4)). Dependent claims provide for the presence of other naturally occurring compounds – terpenes and flavonoids. The patent challenger, Pure Hemp, alleged that the claims are invalid as not claiming patentable subject matter because they sought to claim natural compounds and were an attempt to secure a monopoly on those compounds. UCANN responded that the claims are not directed to natural compounds, but instead are directed to human-modified liquid formulations requiring conversion of solid cannabinoids into a different state with different physiological characteristics.
The Colorado District Court agreed with UCANN. Even if the cannabinoids in nature could take the form of a highly viscous resin, which could be considered a liquid, the claim requirements as to the 95% threshold concentrations are not found in nature in liquid form. The court found this sufficient to differentiate from the Supreme Court Funk Brothers case (333 U.S. 127 (1948)), which held unpatentable the aggregation of strains of naturally occurring bacteria into one product based on the natural phenomenon that these strains of bacteria can be mixed without harming their natural qualities to assist in root nodule growth. The Supreme Court had reasoned that mixing the bacteria did not cause the bacteria species to acquire a different use, produce a new bacteria, change any of the species or enlarge their range of utility. In contrast, the district court here found that UCANN’s patent claims to the precise concentrations are based on UCANN’s handiwork and are not found in nature.
The district court then commented that having found the UCANN patent claims to pass step one of the two-step Alice inquiry as “a non-naturally occurring delivery method of naturally occurring chemicals in (as far as the record reveals) non-naturally occurring proportions and concentrations,” the court did not need to address step two.
This UCANN case presents interesting issues in the arena of patentable subject matter as it pertains to life sciences. Most of the recent life sciences cases have involved diagnostic methods or methods of treatment. Claims to compositions or formulations based on ingredients that are purified or extracted from naturally-occurring compounds could, in certain circumstances, provide a means for overcoming Section 101 patentability concerns. However, practitioners need to pay careful consideration to the holdings in Funk Bros., as well as the Federal Circuit decisions in Natural Alternatives Int’l Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019) (finding dietary sports drinks containing a combination of alanine and glycine patentable) and In re Bhagat, 726 Fed. Appx. 772 (Fed. Cir. 2018), cert. denied, 139 S.Ct. 430 (2018) (lipid containing compositions comprising omega-6 and omega-3 fatty acid mixtures from different sources not patentable as indistinct from lipid formulations derived from a single source); and the Supreme Court decision in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) (finding isolated DNA genes unpatentable, but synthetic complementary DNA patentable).