California’s three cannabis licensing authorities, the Bureau of Cannabis Control, California Department of Public Health and California Department of Food and Agriculture, have proposed readopting their emergency regulations currently in effect for another 180 days. Since the original regulations were released in November 2017, representatives from the three agencies have been soliciting feedback from stakeholders and the public. As a result of that process, some changes are being made to the emergency regulations. Continue reading “California Cannabis Licensing Authorities To Readopt Emergency Regulations with Proposed Changes”
Cannabis Law Summit
Duane Morris will host the Cannabis Law Summit, to be held on May 17-18, 2018 at the firm’s New York office. Duane Morris attorney Patricia Heer will be a member of the panel discussion “Introduction to Cannabis & Tri-state Medical Programs” on Thursday, May 17, at 10:00 a.m.
For more information or to register, please visit the Cannabis Law Summit website.
“Cannabis 104” Webinar Replay Available
A video replay of the webinar “Cannabis 104: Marijuana in the Workplace – What Employers Need to Know” is available to view.
FDA to Consider Approval of Botanical (not synthetic) CBD Drug
Authored by Robert Prince, Ph.D, https://www.duanemorris.com/attorneys/robertwprince.html
On Thursday April 18, 2018, at 8:00AM-12:30PM EST, an FDA advisory panel will consider whether to recommend or not recommend approval of GW Pharmaceutical’s cannabis-based drug Epidiolex ® for use in treating two rare types of epilepsy in children- Dravet syndrome and Lennox-Gastaut syndrome. Epidiolex is an oral formulation of a purified form of cannabidiol (CBD) a component found in cannabis. CBD does not have any psychoactive effects as compared to another component of cannabis tetrahydocannabinol (THC). Epidiolex has less than 0.1 percent of THC.
If approved, Epidiolex would be the first botanical cannabis product approved in the U.S. for any indication. The FDA has approved Marinol® and Syndros® for uses in the U.S. for the treatment of anorexia associated with weight loss in AIDS patients. Both products contain dronabinol, a synthetic delta-9-tetrahydrocannabinol. Another FDA approved drug Cesamet® contains nabilone, which is a synthetic drug with a structure similar to THC that is used to treat nausea and vomiting.
The FDA released briefing documents on April 17, 2018, which did not seem to raise any major issues with Epidiolex, resulting in the share price of GW Pharmaceuticals to rise sharply- up 2.27%. The Center for Drug for Drug Evaluation and Research (CDER) indicates that it plans to provide a free of charge, live webcast of the April 19, 2018 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. Information regarding the webcast, including the web address for the webcast, will be made available at the following website: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. At the time of writing this note, the FDA has not provided any login information for the webcast.
IP Protection and the Cannabis Industry: Strategies and Trends
Protection of intellectual property is a key element in any company’s efforts to secure a competitive advantage. For companies in the cannabis space, efforts to secure intellectual property protection play out against a background of conflicting federal and state regulations. Cannabis continues to be a Schedule I drug under the Controlled Substances Act, and possession of cannabis is prohibited by federal law. However, 29 U.S. states and the District of Columbia have legalized medical cannabis, and eight U.S. states have legalized recreational cannabis. This article will address various IP strategies, including trademarks and branding, patents and trade secrets, for protection of cannabis and cannabis-related products and services. The article will also discuss trends in the industry as well as contrasting protections available on the state and federal levels.
To read the full text of this article by Duane Morris attorneys Gretchen Temeles, Christiane Campbell and Vicki Norton, please visit the Duane Morris website.
Interview with Seth Goldberg: Is NJ About To Fire Up The East Coast Regulation Rush? And Hemp vs Cannabis
You may have read a piece by CLR on Duane Morris’ approach to the national cannabis market late last year.
They are running ahead of their competitors and continue to do so.
They are one of the few firms in the Am Law 200 to have taken up the challenge presented by this de-centralized and sometime rather chaotic corner of the American economy.
Seth Goldberg, based in Philadelphia, practices in business and litigation with a particular emphasis in highly regulated industries such as healthcare and Pharma, saw the opportunities in cannabis and hemp early on in the game and has developed a multidisciplinary cannabis practice drawing across a wealth of experience in the firm.
The practice now comprises 48 attorneys, of whom a good 30 or so are partners.
They are taking the sector seriously and here at CLR we’re surprised that more in the top echelons still aren’t doing the same. …
It’s a question we posed to Seth during our hour long conversation and he concurred that he was equally surprised at the lack of cannabis / hemp practice development at the larger firms on the eastern seaboard.
To read the full text of this article, please visit the Cannabis Law Report website.
Pennsylvania Medical Marijuana Program to Begin Phase II Permitting
On April 5, 2018, Phase 2 of the PA Department of Health’s permitting for commercial medical marijuana cultivation and dispensary operations will begin.
13 Grower/Processor permits will be available, two in each of the six DOH regions, and the 13th going to the highest scorer. 23 Dispensary permits will be available, nine in Region 1, three in Regions 2 and 3, two in Regions 4 and 6, and four in Region 5. Applications will be available online at www.medicalmarijuana.pa.gov on April 5, and the submission deadline will be May 17.
In June 2017, 12 Grower/Processor and 27 Dispensary permits were granted. According to April Hutcheson of DOH:
- 25,573 patients have registered to participate in the PA program;
- 9,020 patient certifications have issued;
- 7,000 of those patients have purchased their ID cards;
- 6,683 patients have bought medical marijuana in a PA dispensary;
- 866 physicians have been registered to participate in the program; and
- 473 of the registered physicians have been approved.
Given the very real possibility that PA will approve the use of dry flower products, i.e., smoking and edibles, this summer, the PA market is positioned for strong performance over the next few years.
Medical Marijuana Business Banking Remains Difficult
Duane Morris partner Seth Goldberg is quoted in the New York Law Journal article, “Medical Marijuana Business Banking Remains Difficult.” Mr. Goldberg discusses how banking is a major hurdle for the legal medical marijuana business.
To read the article, visit the Duane Morris website.
Sessions Draws Lines for US Attorneys in Terms of Marijuana Prosecution
In speaking at the Georgetown Law Center on March 10, 2018, AG Sessions said the following: “We’re not going to be able, even if we desire, to take over state enforcement of routine cases that might occur. Federal agents are highly paid, highly trained. They work on cases involving cartels, international organizations, major distribution networks, large amounts of cash. They deal with criminal organizations, RICO type cases, and we’re not out there prosecuting those types of cases everyday.”
Although, in making the above comments, Sessions was clear that marijuana was still illegal in the U.S., he appears to have drawn a box around those types of marijuana-related criminal activities on which federal prosecutors are focused. The above comments are not inconsistent with the Sessions memo of January 4, 2018, and may help clarify what prosecutorial discretion looks like under that memo. Based on the above comments, it would seem that activities conducted pursuant to state marijuana programs are not the types of activities on which federal prosecutors are focused.
Cannabis Trading on Major U.S. Stock Exchange
Another breakthrough for the cannabis space occurred on Tuesday, February 27, 2018, when Toronto-based Cronos Group Inc. began trading on the Nasdaq Stock Market. (MJN:CN). This marks the first listing of a company focused purely on cannabis on a major U.S. stock exchange. The listing of Cronos comes within two months of the memorandum issued by Attorney General Sessions that rescinded the federal government’s previous guidance regarding enforcement of state-lawful cannabis activities under the Cole Memorandum. That earlier guidance is credited with providing the cannabis space with a window of opportunity for the warp-speed growth the space has seen in recent years. The Sessions memo was intended to slow the growth of the cannabis space, especially with respect to the capital markets. The Nasdaq listing of Cronos suggests that 2018 could be another strong year for cannabis-related investments; 2017 was believed to have resulted in approximately $2 billion in cannabis-related investments in the U.S.