3 Analyses of this federal-register by attorneys

  1. MarkIt to Market® – September 2024: Expanding Horizons: Potential Expansion of IP Rights for High-THC Cannabis Varieties

    Sterne, Kessler, Goldstein & Fox P.L.L.C.September 30, 2024

    can save and replant seeds from their own land, on an acre-for-acre basis.Future OutlookAs marijuana’s legal status continues to evolve, the intellectual property landscape for cannabis-related plants will evolve too. The proposed reclassification of marijuana to Schedule III likely will pave the way for new developments in plant variety protection, including PVP certificates, for high-THC plants, much like the Farm Bill did for low-THC hemp plants.Understanding the availability of and interplay between the various intellectual property rights available for plants is essential for breeders, researchers, and industry stakeholders. As regulatory changes unfold, staying informed about the implications for plant protection will be crucial for navigating this dynamic field. H.R.2, 115th Cong. (2018) (later enacted). USDA, Agricultural Marketing Service Certificate Management System: https://apps.ams.usda.gov/CMS/CropSearch.aspx Schedules of Controlled Substances: Rescheduling of Marijuana (May 16, 2024), 89 FR 44597 available at https://www.federalregister.gov/documents/2024/05/21/2024-11137/schedules-of-controlled-substances-rescheduling-of-marijuana (receiving 43,564 comments at Regulations.gov by the July 22, 2024 deadline).

  2. Navigating the New Legal Landscape: The Impact of Loper Bright on Federal Marijuana Rescheduling

    Troutman PepperDascher PascoJuly 10, 2024

    o Gonzales 28 C.F.R. § 0.100 (2023); 6 Fed. Reg. 49337 (Sept. 2, 2021). 21 U.S.C. 877. 21 U.S.C. § 877. 5 U.S.C. § 706(2). 467 U.S. 837 (1984).See e.g., Alliance for Cannabis Therapeutics v. DEA, 15 F. 3d 1131, 1134 (D.C. Cir. 1994) (“On reviewing the Administrator’s decision, we found the eight-factor test for determining whether a drug had a ‘currently accepted medical use’ to be in the main acceptable. We noted the ambiguity of the phrase and the dearth of legislative history on point and deferred to the Administrator’s interpretation as reasonable.”) (internal quotations and citations omitted).)Loper Bright, at *16 David Anthony, et al., Supreme Court Overrules Chevron Doctrine in Landmark Administrative Law Decision, Troutman Pepper Consumer Services Law Monitor (June 28, 2024) https://www.consumerfinancialserviceslawmonitor.com/2024/06/supreme-court-overrules-chevron-doctrine-in-landmark-administrative-law-decision/. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. Reg. 44597 (proposed May 21, 2024) https://www.govinfo.gov/content/pkg/FR-2024-05-21/pdf/2024-11137.pdf.Id. at 44601.Id. at 44603.Id. at 44615.Id. at 44603.Id. at 44616.Id.Id. at 44617.Id. at 44616.Id. at 44619.

  3. DEA's Proposed Rule to Reschedule Marijuana Could Reduce Obstacles to Medical Research but Public Input Is Needed to Fill in Knowledge Gaps

    King & SpaldingLisa DwyerJune 25, 2024

    d state-legal cannabis businesses unanswered. Such companies still face uncertainty related to potential federal enforcement actions because cannabis remains illegal under federal law and has not been approved by the FDA for the treatment of any disease.35DEA has previously considered rescheduling marijuana, but that consideration was initiated by outside parties, and the DEA denied both petitions. Now DOJ has, for the very first time, initiated the process to reschedule marijuana. Stakeholders have the opportunity to submit comments on the proposed rule by July 22, 2024. Public input will clarify regulatory outcomes for a promising and growing industry.1Marijuana is defined as the plant Cannabis sativa L. and its parts, compounds, or products—excluding “hemp,” which is the plant and its products that are low in delta-9-tetrahydrocannibinol, one psychoactive cannabinoid in marijuana. See DEA, Notice of Proposed Rulemaking, Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. Reg. 44,597 (May 21, 2024) (Docket No. DEA–1362), available athttps://www.govinfo.gov/content/pkg/FR-2024-05-21/pdf/2024-11137.pdf [hereinafter “Proposed Marijuana Rulemaking”].2See U.S. Dep’t of Justice, Press Release, Justice Department Submits Proposed Regulation to Reschedule Marijuana (May 16, 2024), https://www.justice.gov/opa/pr/justice-department-submits-proposed-regulation-reschedule-marijuana.3See generally 21 U.S.C. § 812. The current list of scheduled substances can be found at 21 U.S.C. § 812 and 21 C.F.R. § 1308.4DEA, Drug Scheduling (last visited June 21, 2024), https://www.dea.gov/drug-information/drug-scheduling; see also 21 U.S.C. § 812(b)(1), (3).5See Proposed Marijuana Rulemaking, 89 Fed. Reg. at 44,599-600.6See generally HHS, Basis for the Recommendation to Reschedule Marijuana to Schedule III of the Controlled Substances Act (Aug. 29, 2023) (recommending to DEA “that marijuana should be placed in Schedule III”), available athttps://www.dea.gov/sites/default/files/2024-05/2016-17954-HHS.pdf [hereinafter “HHS Re