Authored By Fox Rothschild LLP
August 15, 2018
John Shaeffer writes:
On July 30, 2018, United Cannabis Corporation (“UCNN”) filed a lawsuit in Federal District Court in Colorado against Pure Hemp Collective Inc. (“Pure Hemp”) alleging that Pure Hemp infringed U.S. Patent No. 9,730,911 (“the ‘911 Patent”), which is entitled Cannabis Extracts and Methods of Preparing and Using Same. The ‘911 Patent issues on August 15, 2017, based on an application filed on October 21, 2015.
As is typical in a patent case, the complaint tells us little. The ‘911 Patent, however, describes its invention as “relat[ing] to the extraction of pharmaceutically active components from plant materials, more particularly [a] botanical drug substance (BDS) … comprising cannabinoids … extracted from cannabis.” ‘911 Patent at 1:14-17. The ‘911 Patent’s claims are limited to formulations of what is extracted. For example, Claim 1 of the ‘911 patent is “[a] liquid cannabinoid formulation, wherein at least 95% of the total cannabinoids is terahydrocannabinolic acid.” ‘911 Patent at 18:29-31. For UCNN to prove that Pure Hemp infringes Claim 1 of the ‘911 Patent, UCNN must prove that Pure Hemp makes, sells, or uses a product that is or contains this specific formulation.
Now patent law does not protect anything discovered. Specifically, Section 101 of Patent Act provides:
Whoever invents or discovers any new and useful … composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
35 U.S.C. § 101. The United States Supreme Court has “long held that this provision contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable.” Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 70 (2012). (internal quotation marks and brackets omitted). In a fairly well-known case, the United States Supreme Court held that the discovery of the location and sequence of genes that dramatically increased a woman’s risk for developing breast cancer was not patentable because all that was discovered is something that already exists in nature. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 590 (2013).
While there may be something unique and inventive about the way UCNN extracts cannabinoids from cannabis, the ‘911 patent does not claim any such method, even though methods are described in the patent’s specification. During the examination of the application that matured into the ‘911 Patent, its examiner initially rejected its claims as being not patentable because all that was claimed were compounds already found in the cannabis. Counsel who prosecuted the ‘911 Patent overcame the examiner’s rejection by arguing that the ‘911 Patent claims a liquid and the compounds in the cannabis are a resin. While the examiner found this distinction significant enough to allow the ‘911 Patent to issue, we should expect that Pure Hump will argue that what the ‘911 Patent claims are simply a natural phenomena and not entitled to patent protection. Simply that the distinction between the natural resin form and a liquid is not sufficiently significant to warrant awarding a patent here. So even if UCNN can prove that Pure Hemp infringing one or more claims of the ‘911 Patent, Pure Hemp can still prove the patent invalid because it does not claim a patentable invention.
In addition to the requirement that the invention claimed in the ‘911 Patent be protectable under Patent Law, Pure Hemp has other roadblocks it can raise in an effort to stop the patent’s enforcement. Patent Law requires that the patent specification include a written description of the invention and explain how to make – enable – the invention. Pure Hemp has some strong arguments that the ‘911 Patent fails in both respects. While the specification of the ‘911 Patent describes a variety of ways to extract all cannabinoids from cannabis, each of its claims assert specific concentrations of particular cannabinoids – e.g. “[a] liquid cannabinoid formulation, wherein at least 95% of the total cannabinoids is terahydrocannabinolic acid. The specification fails to describe how to achieve any of the specific concentrations claimed. The reason for this disconnect may stem from the fact that during the prosecution of this patent, the examiner argued that the methods for extracting cannabinoids described in the patent were already well-know. The examiner rejected all the claims based on a generic composition of such extracts as being obvious and/or anticipated. To overcome, this objection, the patent’s claims were amended to claim specific concentrations of specific cannabinoids even though the specification failed to describe how to obtain such concentration. This disconnect means that the reader of the patent is not told how to make the invention and raises question as to whether the inventor could so isolate extracted cannabinoids – i.e. the invention is not enabled and lacks and adequate written description.
John Shaeffer is a partner in the firm’s Litigation Department, based in its Los Angeles office.