In the past few years1 we have reviewed decades of cannabis-centric2 patent data to identify and analyze U.S. patent trends in the cannabis industry. Given the increasing number of states legalizing cannabis and the passage of the Farm Bill in 2018, it was unsurprising that a record number of cannabis-centric patents granted, and patent applications published, in 20193 and again in 20204. In this piece, we will briefly examine the U.S. cannabis-centric patent data for 2021 to see if the numbers are continuing to rise at a record pace. Additionally, we will analyze certain recently granted cannabis-centric patents to give readers a sense of the subject matter applicants are inventing. We will also provide a brief overview of cannabis-centric patent litigation in the U.S. and the types of rejections cannabis-centric patent applications are facing at the U.S. Patent and Trademark Office.
Trends in 2021 and Beyond
The numbers are clear: 2021 again saw a record number of cannabis-centric patents granted and applications published. That said, the early numbers from this year suggest these numbers will decrease in 2022. Regarding cannabis-centric patents, 263 were granted in 2021, eclipsing the record 255 that granted in 2020. This 3.14% increase pales in comparison with the percent increases observed in prior years5.
The explanation for this modest percent increase in 2021 seems relatively straightforward: the COVID-19 pandemic, now in its third year, continues to create serious disruptions for applicants and the USPTO, resulting in delays6. Notably, in 2022, a paltry 22 cannabis-centric patents had been granted as of March 30. If that grant rate holds, we expect only 90 cannabis-centric patents to grant by the year’s end — a 65.77% decrease from 2021 and the first percent decrease observed in cannabis-centric patent grants in nearly a decade. The 2022 numbers appear to indicate enthusiasm for cannabis-centric innovations is waning. However, because patents can grant many years after their underlying applications are filed7, the better barometer for enthusiasm for cannabis-centric innovations is whether inventors are continuing to apply for cannabis-centric inventions at record rates.
In that regard, 702 cannabis-centric patent applications published in 2021, eclipsing the record 634 that published in 2020 — a 10.72% increase. As with cannabis-centric patents, this increase pales in comparison with the percent increases observed in prior years8. Notably, in 2022, 165 cannabis-centric patent applications had published as of March 30. If that publication rate holds, we expect only 679 cannabis-centric patent applications to publish by the year’s end — a 3.27% decrease from 2021 and the first percent decrease observed in cannabis-centric patent application publications in more than a decade. Thus, like the 2022 patent data discussed above, the slight dip in cannabis-centric patent application publications through the first three months of the year indicates, for the first time in years, that inventors are going to the USPTO less often to protect their cannabis-centric inventions. This trend is confirmed by looking at the number of cannabis-centric patent applications filed each year. Specifically, after reaching a record high 632 cannabis-centric patent applications filed in 2019, only 516 cannabis-centric patent applications were filed in 2020 — an 18.35% decrease. As cannabis-centric applications filed in 2021 and 2022 continue to publish9, it will be interesting to see how pronounced any downward trend becomes.
Cannabis-centric subject matter
The cannabis-centric subject matter inventors are attempting to patent remains diverse. Patents have granted recently with claims drawn to compositions “for delivering … cannabinoids to the skin of a subject …,”10 “chewing gum for mucosal delivery of cannabinoids,”11 “method[s] for decarboxylating and crystallizing a cannabinoid,”12 production of cannabinoids in genetically modified yeast,13 “method[s] for treating multiple myeloma comprising administering … a therapeutically effective amount of a cannabis extract …”14 and even a cannabis plant named “Happy Pineapple.”15
Patent Litigation
There has been limited cannabis-centric patent litigation in the United States. This is unsurprising, as marijuana remains a Schedule 1 substance under the Controlled Substances Act. As such, U.S. federal courts, based on hundreds of years of precedent, will almost certainly not entertain cases that, in their view, would further federally criminal activity16. That said, there has been some litigation in the space, which we summarize below.
– United Cannabis Corp. v. Pure Hemp Collective Inc.: This patent infringement case was filed in the District of Colorado in 2020. The asserted patent relates to the extraction of cannabinoids from cannabis to prepare a botanical drug substance. United Cannabis Corp. alleged Pure Hemp’s range of CBD wellness products, which contained cannabis extracts approved by the U.S. Food and Drug Administration, infringed United Cannabis Corp.’s patented cannabinoid formulations17.
After a little under two years of litigating the case and without any major case events or decisions, the parties voluntarily dismissed the action in April 2020, as a result of United Cannabis’ bankruptcy proceedings. However, in the past year, the bankruptcy proceedings have concluded, and the parties have attempted to reopen the case to no avail. Currently, Pure Hemp is appealing the district court’s denial of its motion for attorney’s fees to the Federal Circuit Court of Appeals.
– Canopy Growth Corp. v. GW Pharm. plc: This patent infringement case was filed in the Western District of Texas in 2020. The asserted patent claims a carbon dioxide-based extraction method from cannabis plant material. The plaintiff, Canopy Growth Corp., alleges GW Pharmaceuticals infringes Canopy’s patented cannabidiol extraction method when GW manufactures Epidiolex, a pharmaceutical product containing highly purified CBD18.
On November 27, 2021, the court issued an order construing (defining) the meaning of the patent claim term “CO2 in liquified form under subcritical pressure and temperature conditions.” The court held the term means “CO2 in liquified form under both subcritical pressure and temperature conditions.”19 Since this narrow construction requires that an accused infringer utilize both subcritical pressure and temperature conditions for its manufacturing process to infringe, it appeared to be a victory for GW Pharmaceuticals and other companies that utilize CO2 extraction methods for cannabis products. Indeed, on February 25, 2022, a final judgment was entered based on the parties’ stipulation that under the court’s claim construction order, Canopy Growth could not possibly prevail on infringement20. A month after the final judgment, Canopy Growth appealed the court’s claim construction order and final judgment, and the case remains pending21.
Obstacles for patentees
As cannabis-centric patent applications continue to be filed, patent attorneys specializing in this field should diligently monitor the USPTO’s approach to determining whether claimed inventions are patentable. We discuss two interesting examples of cannabis-centric patent prosecution below.
– Example 1: Recently allowed patent claims drawn to dental topical anesthetic gel containing THC22 faced numerous novelty and obviousness rejections by the USPTO. Notably, the patent applicant successfully argued its claims were inventive by demonstrating that, unlike the claimed invention, the prior art cited by the USPTO was drawn to nonintoxicating cannabis compositions, and therefore said prior art compositions could not exceed a 0.3% THC threshold like the inventive anesthetic compositions. This result is significant because it demonstrates the utility and inventiveness of patent claims that recite cannabis compositions with 0.3% or more THC, which are patentably distinguishable from nonintoxicating cannabis compositions.
– Example 2: A patent application directed to a composition for treating seizure disorders23 is currently on appeal from a final obviousness rejection. There, the patent applicant argued that the obviousness rejections should be withdrawn and the application allowed because the prior art did not teach the unexpected effects associated with a combination of a barbiturate drug, phytocannabinoid (CBD), and a blocking compound24. Specifically, the applicant argued that the blocking compound can prevent degradation of CBD by metabolic processes that would otherwise be induced by the co-administered barbiturate25. The applicant argued that this in turn allows for the administration of a lower dose of barbiturate to a subject, a higher availability of CBD to treat seizures, and a reduced likelihood of barbiturate-related side effects26. This appeal exemplifies the medicinal versatility of cannabinoids that are co-administered with other drugs and strategies patent owners may employ to demonstrate that cannabinoid compositions are patentable — meaning that cannabinoid compositions exhibit unexpected properties or synergies alone or in combination with other drugs.
Conclusion
U.S. cannabis-centric patents and patent applications were granted and published, respectively, at record numbers in 2021. The early returns in 2022 suggest that these numbers are about to dip for the first time in years. Cannabis-centric patents also continue to claim diverse and complex subject matter, and a select few have been the subject of patent litigation in the U.S. As states continue to legalize cannabis, and with federal legalization or descheduling potentially on the horizon, we expect it will not be long before cannabis-centric patent litigation becomes more prevalent in the U.S.
Footnote
- Kamps M. “The Number Of Cannabis-Centric Patents Is Getting High.” Law360. (“Kamps 2019”); Kamps M. et al. “Innovation on the Rise.” Marijuana Venture. (“Kamps 2020”); 2. A “cannabis-centric” patent or patent application was a hit for a U.S. utility or plant patent or patent application returned by the following search query using TotalPatent One®: CLM:((cannab* OR THC* OR CBD* OR marijuana OR marihuana OR tetrahydrocannab* OR hemp OR phytocannab*)) AND TA:((cannab* OR THC* OR CBD* OR marijuana OR marihuana OR tetrahydrocannab* OR hemp OR phytocannab* OR trichom* OR ((leaf* OR leav* OR plant*) NEAR5 (extrac* OR remov* OR puri* OR trim*))) ) AND DSC:(cannab* OR THC* OR CBD* OR marijuana OR marihuana OR tetrahydrocannab* OR hemp OR phytocannab*) AND PD:[2012-03-30 TO 2022-03-30]; where * represents one or more characters; 3. Kamps 2019; 4; Kamps 2020; 5. See Kamps 2019 and Kamps 2020; 6. See, e.g., https://www.uspto.gov/coronavirus (“The United States Patent and Trademark Office (USPTO) considers the effects of coronavirus to be an ‘extraordinary situation…’”); 7. https://www.uspto.gov/dashboard/patents/pendency.html; 8. See Kamps 2019 and Kamps 2020; 9. https://www.uspto.gov/web/offices/pac/mpep/s1120.html; 10. US 11213467B2; 11. US 11191720B2; 12. US 11148988B2; 13. US 11149291B2; 14. US 11065227B2; 15. US PP033332P3; 16. McNichol, William, “The New Highwayman: Enforcement of U.S. Patents on Cannabis Products.” 101 J. Pat. & Trademark Off. Soc’y 24 (2019). Rutgers Law School Research Paper. Available at: https://ssrn.com/abstract=3391803; 17. United Cannabis Corp. v. Pure Hemp Collective Inc., No. 1:18-cv-1922, Dkt. 1 at ¶¶ 3, 20-22 (July 30, 2018); 18. See Canopy Growth Corp. v. GW Pharm. plc, No. 6:20-cv-01180, Dkt. 1 at ¶¶ 11-16 (W.D. Tex. Dec. 22, 2020); 19. See Canopy Growth, Dkt. 50 (Nov. 27, 2021) (emphasis added); 20. See Canopy Growth, Dkt. 56 (Feb. 25, 2022) (emphasis added); 21. See Canopy Growth, Dkt. 58 (March 24, 2022) (emphasis added); 22. U.S. Patent Pub. 2021/0137833A1; 23. U.S. Patent Pub. 2020/0383935A1; 24. See Appellant’s Brief in Support of Appeal Under 37 CFR 41.37 at pp. 8-11 (Dec. 17, 2021); 25. Id; 26. Id.