Because enforcement of patent rights in the U.S. is governed by federal law, the Schedule I status of cannabis continues to cast uncertainty over whether cannabis patent rights can actually be challenged or enforced. That uncertainty diminished with the filing of the first patent infringement case in federal court on a patent covering a cannabis-related technology on July 30, 2018 when United Cannabis Corporation (“UCANN”) sued Pure Hemp Collective, Inc. (“Pure Hemp”) in the United States District Court for the District of Colorado (United Cannabis Corporation v. Pure Hemp Collective, Inc.(Case No.: 1:18-cv-01922-NYW) for patent infringement. (https://www.duanemorris.com/articles/patent_litigation_cannabis_industry_2_cases_to_review_0319.html) UCANN alleged that Pure Hemp is selling products that are encompassed by the claims of its patent, US 9,730,911. Pure Hemp denied infringement and counterclaimed that the UCANN patent is invalid and should never have been granted because similar products were well known long before the filing date of the patent.
These proceedings have now moved to the claim construction stage, a stage specific to patent litigation, The claims in a patent specify the rights to which the patent owner is entitled, just as language in a deed to real property specifies the boundaries of the real property. But, unlike the quantitative verifiable measurements taken to define the boundaries of real property, claim language can be imperfect and open to more than one interpretation. Continue reading “Cannabis patent litigation update: construing cannabis claims”
One day after a federal judge dismissed a lawsuit challenging the U.S. Food and Drug Administration’s (FDA) regulatory authority over e-cigarettes, a published study funded by the National Institutes of Health (NIH) reported that more than 20% of High School seniors in the U.S. reported vaping THC (the psychoactive cannabinoid found in marijuana) in 2019.
According to the study, 20.8% of 12th graders reported marijuana vaping in the past 12 months, while 14% reported marijuana vaping in the past 30 days. (These figures, in 2018, were 13.1%, and 7.5%, respectively.) According to the report, the absolute increases from 2018 to 2019 in 12th graders who reported vaping marijuana within the previous 30 days were “the second largest … ever tracked by Monitoring the Future for any substance in its 45-year history[,]” only outpaced by the increase in nicotine vaping from 2017 to 2018.
Other age groups showed increases in THC vaping as well; the percentage of 10th graders who reported marijuana vaping in the past 12 months increased from 12.4% in 2018 to 19.4% in 2019 and the percentage of 10th graders who reported marijuana vaping in the past 30 days increased from 7% in 2018 to 12.6% in 2019. Moreover, the percentage of 8th graders who reported vaping marijuana in the past 12 months increased from 4.4% in 2018 to 7% in 2019; for use in the past 30 days, the percentage increased from 2.6% to 3.9% over the same time period.
Based on the results of the just-released study, Judge Guirola’s opinion–in which the court held that the delegation of authority to the FDA under the Family Smoking Prevention and Tobacco Control Act was not unconstitutional–could be afforded renewed significance. Both the federal court’s order and the NIH-funded study documenting the rise in THC vaping among adolescent come in the midst of heightened scrutiny of e-cigarette and vaping products generally, in light of the widely reported lung-related health issues stemming from use of certain vaping products.
Given the new data from the NIH-funded study and the FDA’s recently confirmed regulatory authority over the products alleged to be causing the lung-related illnesses, it appears likely that calls for regulators to scrutinize and crack down on the manufacture and sale of e-cigarettes and vaping products will only grow.
When the United States Department of Agriculture released the interim final rule for the hemp program in October 2019, many stakeholders—including businesses and state agencies—were caught off guard by certain testing-related requirements contained in the rule. Because hemp is now legal under the 2018 Farm Bill if it contains no more than 0.3 percent THC concentration, testing for THC levels is critical. However, significant questions and issues with the testing requirements must be clarified.
On November 20, 2019, Senators Ron Wyden and Jeff Merkley, both from the state of Oregon, submitted a letter to the secretary of the USDA, in which they flagged—“in no particular order”—five controversial testing-related requirements and requested modifications to those requirements. Below, we have summarized the senators’ concerns and proposed solutions to three particularly controversial testing-related requirements in the interim final rule.
With the enactment of the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill), hemp-derived CBD appeared to be on the table for marketing all across the country. However, the U.S. Food and Drug Administration’s (FDA) press release issued that same day put a hold on the jubilation, stating that FDA considered any and all cannabis-containing or cannabis-derived products as drug products and not food or dietary supplements, regardless of whether the CBD was hemp-derived.
On April 2, 2019, departing FDA Commissioner Scott Gottlieb issued a statement about FDA’s next steps to advance a regulatory pathway for cannabis-containing and cannabis-derived products. At the same time FDA updated its cannabis-containing products and cannabis-derived products Q&A. It is clear that, at this point, FDA has not changed its position.