The Pennsylvania Medical Marijuana Act uniquely provides for a special class of licenses for growers and dispensaries to partner with medical schools to undertake real clinical research on medical marijuana.
On January 3, 2018, the Pennsylvania Department of Health (DOH) published for comment the final clinical registrant regulations. The process of issuing these licenses will be underway shortly. While other states are focused on increasing the availability of nonmedical adult-use marijuana, Pennsylvania seeks to become the leader in clinical research on the medical benefits of cannabis.
When most people think of patented technologies, they think of cell phones, computers, and pharmaceuticals. What entrepreneurs in the cannabis industry may not know is that cannabis and cannabis-related products are also patentable. Patents are important for any business, but are particularly important for an emerging industry such as the cannabis industry. The evolving legal and regulatory framework in the industry and the development of new technologies means that those businesses taking early steps to protect their intellectual property are likely to be at a competitive advantage as the industry matures and consolidates.
How do patents fit into the current state and federal cannabis regulations?
Currently, 29 U.S. states and the District of Columbia have legalized medical marijuana and eight states also permit recreational use. Under federal law, cannabis remains a Schedule I controlled substance under the Controlled Substances Act meaning that cannabis possession is illegal. However, the United States Patent and Trademark Office (USPTO), the federal agency responsible for granting patents, has traditionally taken a hands-off approach to barring particular kinds of inventions from patentability. The only kinds of inventions that are legally not patentable are inventions covering human life forms or whose sole purpose is use in atomic weapons. Otherwise, assuming that a patent application covering cannabis or cannabis-related products meets the legal standards for patentability, explained in more detail below, the USPTO presently grants patents to cannabis and cannabis-related inventions.
Articles appearing this week in the LA Times and the Philadelphia Inquirer, among other recent articles, highlight the horrors of the opioid crisis and the need for research into cannabis as a possible solution. While the federal government warns about the spiraling toll of the opioid epidemic, it refuses to grant the applications of world-renowned scientists at major universities and research centers seeking to explore the ways in which the well-documented therapeutic properties of cannabis can alleviate the pain and suffering – physical, emotional and financial – being caused by opioid abuse. There is no shortage of deep pockets willing to fund the research, and US-based scientists are ready, willing and able to get to work, yet the federal government refuses to depart from its antiquated “reefer madness” established in the early 20th Century. 2018 should be the year the federal government stops blocking cannabis research so that scientists can determine if and how cannabis can stem the opioid crisis. Fingers crossed!
Patents are an important tool for businesses to secure a competitive advantage, particularly for companies in an emerging industry such as the cannabis industry. Contrary to popular belief, cannabis and cannabis-related inventions are not only are patentable, but the number of patents and applications being filed in this area is growing steadily. The evolving legal and regulatory framework and the development of new technologies as the industry matures and consolidates means that those businesses that have taken steps to patent protect their technologies early on are likely to be at a competitive advantage.
How do patents fit into the current state and federal cannabis regulations?
As of this writing, twenty-nine U.S. states and the District of Columbia have legalized medical marijuana. and eight states permit recreational use. Under federal law, cannabis remains a Schedule I controlled substance under the Controlled Substances Act. However, the United States Patent and Trademark Office (USPTO), an agency of the United States Department of Commerce, has issued, and continues to issue patents to cannabis and cannabis-related inventions. The USPTO has traditionally taken a hands-off approach to barring particular kinds of inventions from patentability. Congress has determined that two kinds of inventions are categorically not patentable: those encompassing human organisms (The Leahy-Smith America Invents Act (AIA) (Public Law 112-29, sec. 33(a), 125 Stat. 284), and those having as their sole purpose use in atomic weapons (The Atomic Energy Act of 1954, See 42 U.S.C. 2181(a)). Otherwise, assuming that a patent application covering cannabis or cannabis-related products meets the legal standards for patentability, the USPTO is presently granting such patents.
On December 15, 2017, the California Bureau of Cannabis Control granted the first license for the sale of adult use marijuana in California to a San Diego dispensary. Torrey Holistics, located in Sorrento Valley, has sold medicinal marijuana since 2015. The dispensary also received a new license to continue the sale of medicinal marijuana.
The adult use retailer license received by Torrey Holistics is one of ten licenses, including one to another San Diego dispensary, Urbn Leaf in Linda Vista, for the sale of adult use marijuana granted by the California Bureau of Cannabis Control since the agency launched its online licensing system earlier in December. The licenses received by Torrey Holistics and the other medicinal and adult use retailers are temporary though. After 120 days, a permanent license must be obtained by the businesses. The licenses also do not go into effect until January 1, 2018.
For more information or questions on licensing of retailers of medicinal and adult use in California, please contact Joe Machi in our San Diego office or another member of the Duane Morris Cannabis Group.
While most of us were hitting the beaches over the summer, California lawmakers updated California’s regulations for the cannabis industry when they passed California Senate Bill 94, or the Medicinal and Adult-Use Cannabis Regulation and Safety Act (“MAUCRSA” or “the Act”). MAUCRSA repeals the Medical Cannabis Regulation and Safety Act and amends the Adult Use of Marijuana Act, resulting in MAUCRSA regulating both adult use (i.e. recreational) cannabis businesses and medicinal cannabis businesses. For purposes of the Act, an adult is considered to be anyone 21 years of age or older. Bus. & Prof. Code § 26001.
While the Act provides a comprehensive regulatory framework for key segments of the cannabis industry, it also raises new questions and concerns that will require further clarification from, and coordination with, California lawmakers and agencies. The discussion below addresses some of the key provisions of the Act.
For his monthly column “Nev’s Health Law” in Chicago Lawyer magazine, Duane Morris partner Neville Bilimoria has written a two-part article focusing on different aspects of law related to the cannabis industry.
California took the next big step in establishing its legal cannabis market. It officially launched its online licensing system and is now accepting applications for commercial cannabis licenses for retailers, distributors, microbusinesses, testing laboratories and cannabis events. The online system can be used by applicants to easily apply for a temporary and annual commercial cannabis license, submit payments and track the status of an existing application.
All business owners applying for a medical and/or adult use cannabis business license must be registered and have an active account on the licensing system. In addition, those individuals or companies that are considered “owners” of the applicant business will need to register as well in order to submit the necessary information that is required to be disclosed by each “owner.”
Cultivators must apply for a cultivation license with the California Department of Food and Agriculture’s CalCannabis Cultivation Licensing program. CalCannabis expects to launch its online application process later this month. The California Department of Public Health is currently accepting paper applications by mail or email for manufacturing licenses.
Although a member of the family of cannabis sativa that includes marijuana, hemp does not contain levels of THC that produce psychoactive effects, so it is regulated differently than marijuana. Whereas growing, processing, distributing and consuming marijuana are still federally prohibited under the Controlled Substances Act, industrial hemp has seen a revival around the U.S. because its growth, processing and distribution for research purposes is permitted under the 2014 Federal Farm Bill.
Importantly, the expansion of Pennsylvania’s industrial hemp program, and the industrial hemp programs in other states that traditionally raised large tobacco crops, may be helpful to local economies that have been impacted by declines in tobacco growth.
There are more than 25,000 products and/or uses derived from industrial hemp. Research under the PA program includes, among other things, planting methods, such as seed variety trials, fiber or seed yields, optimum fertility levels, pest management; harvesting techniques or product marketing options; or conservation, remediation or biofuel.
On November 16, 2017, the California Bureau of Cannabis Control published emergency regulations governing both the medical and the adult-use cannabis industries in California. Below are the highlights of the emergency regulations and how they may impact distributors of cannabis products.
For his monthly column “Nev’s Health Law” in Chicago Lawyer magazine, Duane Morris partner 