Only The Law Is Hazy For CBD Patent Eligible Under Section 101

29 April 2019 PharmaPatents Blog
Authors: Courtenay C. Brinckerhoff

In United Cannabis Corp. v. Pure Hemp Collective, Inc., Judge Martinez of the U.S. District Court for the District of Colorado determined that UCANN's CBD patent was not invalid under 35 USC § 101. The court reached its conclusion at step one of the Alice/Mayo framework, in an analysis that draws a line between products of nature and nature-based products. The decision was rendered on Pure Hemp's motion for partial summary judgment, and so may not be immediately appealable.

The CBD Patent At Issue

The patent at issue was UCANN's U.S. Patent No. 9,730,911, entitled "Cannabis extracts and methods of preparing and using same." The court generally considered all asserted claims (claims 10, 12, 14, 20–22, 25, 27, 28, 31, and 33). Claim 10 recites:

10. A liquid cannabinoid formulation, wherein at least 95% of the total cannabinoids is cannabidiol (CBD).

As summarized by the district court, "the obvious thrust of the patent is a supposedly new means by which humans can consume cannabinoids so that those cannabinoids can produce the pharmacological effects they are known to have, thus  (hopefully) treating or ameliorating various diseases and symptoms.

The Hazy State Of The Law

The district court reviewed Supreme Court decisions from Funk Brothers to Chakrabarty to Mayo, and the Federal Circuit decision in Ariosa, and concluded:

As the foregoing summary of case law suggests, the proper application of the Supreme Court’s Alice standard is an evolving and sometimes hazy area of law. Deciding whether a patent claim is “directed to” a law of nature is not as straightforward as the Supreme Court makes it sound in Alice itself. Moreover, the Federal Circuit itself has remarked on the difficulty, at times, of distinguishing the first Alice inquiry from the second.

What Are The Claims Directed To?

The first step of the Alice/Mayo analytical framework asks whether the claimed are "directed to" a judicial exception. Pure Hemp argued that the claims were “directed to” the natural products (e.g., the "cannabinoids, terpenes, and flavonoids" recited in the claims), while UCANN argued that “the claims are not directed to laws of nature or natural phenomena because they claim human-modified liquid formulations that require converting solid cannabinoids into a different state with markedly different  physiological characteristics.”

The district court made the following findings favorable to UCANN

  • Pure Hemp has failed to establish beyond genuine dispute that a liquefied version of cannabinoids and related chemicals at the concentrations specified in the 911 Patent is anything like a natural phenomenon.
  • [T]he 911 Patent specifies threshold concentrations of cannabinoids and related chemicals. Pure Hemp nowhere claims that these precise concentrations, or anything close to them, occur in liquid form in nature

Thus, the court determined that the claims are not "directed to" a natural product, and are not invalid under 35 USC § 101.

Not Just Blowing Smoke

All joking aside, this decision illustrates how a practical reading of the claims can support a finding that a "nature-based product" is not a patent ineligible product of nature. Instead of focusing on the gist of the invention or individual compounds present in the claimed compositions, the court considered the claimed compositions as a whole.  Interestingly, the USPTO Examiner originally rejected the claims under 35 USC § 101, but withdrew the rejection after the Applicant argued that the liquid state of the claimed compositions distinguish them from naturally occurring cannabinoids which exist in a resinous (solid) form. The Applicant cited Example 30, Claim 4, of the USPTO's 2016 Subject Matter Eligibility Examples as supporting eligibility.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services