With everybody discussing the passage of the 2018 Farm Bill and its implications for the booming cannabidiol (CBD) business, there’s a lot hypothesis as to how the legalization of commercial hemp will have an effect on the remedy of CBD by a number of authorities businesses, together with the United States Patent and Trademark Workplace. Will the legalization of commercial hemp open the door to federal trademark safety for CBD merchandise? Sadly, the reply shouldn’t be but clear.
I’ve mentioned the “legal use in commerce” requirement for federal logos at size in different posts, so I gained’t go into an excessive amount of element right here. However the gist is that so as to procure federal trademark safety on your mark, the items and/or providers for which you’re claiming trademark safety have to be authorized pursuant to federal regulation. As a result of the manufacture, distribution and dishing out of hashish is unlawful beneath the Managed Substances Act, the lawful use in commerce requirement can’t be met.
However what about CBD? If my CBD merchandise are “legal under federal law,” why can’t I acquire federal trademark safety? A part of the concern that is still, even in mild of the legalization of commercial hemp, is that the FDA nonetheless says that CBD can’t be bought for human consumption until it has undergone the company’s drug approval course of. At present, Epidiolex is the solely FDA-approved CBD-based drug, which was rescheduled to Schedule V of the Managed Substances Act (CSA) in September.
The DEA now defines CBD medicine as follows:
“Approved cannabidiol drugs. A drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol . . . derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols.”
This definition creates three circumstances for a product to be an permitted CBD drug. As such, it should:
- Be FDA authorised;
- Be derived from hashish; and
- Have lower than .1% THC.
And no less than for now, nothing in the 2018 Farm Bill modifications this. With no formal coverage change or a change to the FDA’s place, we anticipate that the USPTO will deal with CBD merchandise a lot the similar as they’ve to date, though we wouldn’t be stunned to see an excellent quantity of debate round the topic.
Probably the most informative case that helps to illustrate the USPTO’s present place on CBD logos is the Stanley Brothers case.
On December 5, 2014, Stanley Brothers Social Enterprises, LLC filed a U.S. federal trademark software for CHARLOTTE’S WEB, to be used on “plant extracts, namely, hemp oil sold as a critical component or ingredient of dietary supplements.” That software has been alive and the topic of a number of workplace actions from the analyzing lawyer since, together with a ultimate workplace motion that was issued on April 20th of this yr (harsh). This last workplace motion could be very fascinating, as a result of the refusal to register the mark was made last for illegal use in commerce on two grounds: Lack of compliance with the Managed Substances Act (CSA) and lack of compliance with the federal Meals, Drug & Beauty Act (FDCA). I’ll take every of the USPTO’s lawful use determinations in flip.
The Analyzing Lawyer used a reasonably normal argument in deeming the Applicant’s items illegal pursuant to the CSA stating:
“[i]n this case, the items or activities in the application with which the mark is used involve a per se violation of federal law. See In re Brown, 119 USPQ2d at 1352. Specifically, federal law prohibits the sale, distribution, dissemination and possession of marijuana. That is, under the [CSA] prohibits, among other things, manufacturing, distributing, dispensing, or possessing certain controlled substances, including marijuana and marijuana-based preparations.”
The Analyzing Lawyer goes on to word that the Applicant’s specimens submitted with its software present that the “goods are dietary supplements infused with or which are comprised of cannabidiol (CBD) which is derived from what applicant has called industrial hemp plants which is grown in Colorado.” The Applicant additionally offered a press release to the USPTO that the items are “comprised of CBD derived from the plant Cannabis sativa L and that applicant obtains the CBD from more than just the mature stalks and sterilized seeds of the plant. Applicant processes the entire plant including the resins, stalks, stems, buds and flowers …”. Subsequently, the Analyzing Lawyer deemed Applicant’s CBD to be derived from the parts of the hemp plant which are illegal underneath the CSA.
This argument might develop into out of date with the passage of the 2018 Farm Bill.
Nevertheless, the Analyzing Lawyer additionally decided that the Applicant’s items are usually not in compliance with the FDCA, which prohibits the introduction or supply for introduction into interstate commerce of a meals to which has been added a drug or a organic product for which substantial medical investigations have been instituted and for which the existence of such investigations has been made public. 21 U.S.C. §331(11). The U.S. Meals and Drug Administration (FDA) has said that substantial medical investigations of cannabidiol have begun and thus merchandise containing CBD is probably not bought as dietary dietary supplements. Applicant plainly signifies that its items are a dietary complement, each in its software and on its web site, and the Analyzing Lawyer analyzes why CBD doesn’t fall into any of the FDA exceptions that might permit it to be marketed as such.
In wrapping up his evaluation, the Analyzing Lawyer made a last argument entitled “The 2014 Farm Bill Did Not ‘Legalize’ Hemp on a National Level.” The Applicant right here argued that “its goods are not prohibited under either the CSA or the FDCA [because] the 2014 Farm Bill, 7 U.S.C. Section 5940, has effectively overruled the FDCA as well as the CSA by declaring that hemp is a legal product at the federal level and that all things made from hemp are, therefore, legal.” Applicant additionally argued that the omnibus regulation prohibits the expenditure of federal funds to prohibit the transportation, processing, sale or use of hemp that’s grown or cultivated beneath the 2014 Farm Bill. Right here’s the related portion of the 2014 Farm Bill:
“[N]otwithstanding the Controlled Substances Act, or any other federal law, an institution of higher education or a State department of agriculture may grow and cultivate hemp if (1) the industrial hemp is grown or cultivated for the purposes of research conducted under an agriculture pilot program or other agricultural academic research and (2) the growing or cultivating of the industrial hemp is allowed under the laws of the State in which such institution of higher education or State department of agriculture is located and such research occurs.” 7 U.S.C. Part 5940(a).
And right here is the Analyzing Lawyer’s succinct response:
“Although applicant is correct that the cited portion of the Farm Bill states that ‘industrial hemp’ is Cannabis sativa L which is less than 0.3 percent tetrahydrocannabinol (THC) on a dry weight basis, the Farm Bill did not make ‘hemp’ and everything made or extracted from hemp ‘legal’ on a nationwide basis as applicant contends. Section 7606 of the 2014 Farm Bill, 7 USC Section 5940, merely allowed universities and/or state departments of agriculture to create pilot programs to grow Cannabis sativa L with a THC content of less than 0.3 percent for purposes of conducting academic or scientific or marketing research. However, this marketing research did not extend to general commercial activity nor did it make all hemp related goods ‘lawful’ on a federal level. The 2014 Farm Bill provision, for example, did not allow those participating in a state pilot program to sell seeds or plants to consumers in other states nor did it allow for goods made under the program, such as applicant’s dietary supplements, to be sold in states which have not established similar pilot programs … The Federal Register notice goes on to state that Section 7606 of the 2014 Farm Bill, 7 USC Section 5940, did not amend the federal Food, Drug and Cosmetic Act’s requirements for obtaining FDA approval for new drug applications or the requirements for conducting clinical trials and research prior to such approval, or the FDA’s oversight of marketing claims such as those in the Warning Letter addressed to applicant. With regard to the Controlled Substances Act, the Farm Bill provision did not alter the provisions of the CSA that apply to the dispensing, distribution and manufacture of drug products containing controlled substances. ‘Manufacturers, distributors, dispensers of drug products derived from cannabis plants, as well as those conducting research with drug products, must continue to adhere to CSA requirements.’ Federal Register, Vol. 81, No. 156 (August 12, 2016). With regard to ‘marijuana,’ a Schedule I prohibited substance, this means that anything which falls within the statutory definition of marijuana, 21 USC Section 802(16), cannot be distributed or disseminated in interstate commerce. This means that if applicant is extracting CBD from all parts of the Cannabis sativa L plant, as applicant has stated, then the goods are marijuana and cannot be sold in interstate commerce under the CSA.”
Clearly, with the legalization of commercial hemp pursuant to the 2018 Farm Bill, a big portion of the Analyzing Lawyer’s argument for denying the Stanley Brothers trademark safety can be irrelevant. Nevertheless, the FDA-based causes for denial nonetheless stand, and we’ll be ready in anticipation to see how FDA’s place on CBD modifications, if in any respect. Finally, it appears that evidently the FDA holds the key when it comes to federal trademark safety for CBD merchandise.