WASHINGTON, D.C. – Federal authorities overseeing patents and trademarks appear to be signaling a change in regulations for hemp patents.
The United States Patent and Trademark Office (USPTO) has reaffirmed its position that it is unwilling to approve patents for controlled substances in violation of federal law. For those closely following federal cannabis law over the years, this may seem like more of the same. However, the possibility of patents being approved for hemp products is now in play as hemp was removed from the Controlled Substance Act (CSA) in December. The Farm Bill’s passage also removed hemp derived products from the CSA, such as CBD, so long as the extracted material does not exceed 0.3 percent THC.
Right now, it appears only a small number of applicants are eligible for a hemp patent. Only applications submitted on or after December 20, 2018, the day the Farm Bill was signed into law, are eligible. Applications submitted before that will be turned down “due to the unlawful use or lack of bona fide intent to use in lawful commerce under the CSA,” the USPTO said in a release.
Those with submitted applications after December 19, 2018, still should not expect quick USPTO approval. In fact, the agency is suggesting final approval for a patent may actually rest with the Food and Drug Administration (FDA).
“Such applications did not have a valid basis to support registration at the time of filing because the goods violated federal law,” the USPTO said. “However, because of the enactment of the 2018 Farm Bill, the goods are now potentially lawful if they are derived from ‘hemp’ (i.e., contain less than 0.3 percent THC). Therefore, the examining attorney will provide such applicants the option of amending the filing date and filing basis of the application to overcome the CSA as a ground of refusal.”
Applicants seeking a trademark for edible products containing hemp or CBD may also be out of luck for now. The FDA has not conducted tests on hemp and CBD-infused food and has even targeted some producers of edible products.
Those seeking to patent CBD-infused alcoholic drinks find themselves in a similar position. Last month, after consulting with the FDA, the Alcohol and Tobacco Tax and Trade Bureau (TTB) announced the agency “will not approve any formulas or labels for alcohol beverage products that contain a controlled substance under federal law, including marijuana.”
TTB did not shut the door entirely, but made it sound like approving CBD cocktails may still take some time. “TTB may require formula applicants to obtain documentation from FDA indicating that the proposed use of an ingredient in an alcohol beverage would not violate the [Food, Drug, and Cosmetic Act],” the agency said in a statement last month.
The 2018 Farm Bill was passed in December, a positive development for CBD producers and merchants, but also a confusing one. The FDA will hold a public hearing on May 31 and industry members will want to pay close attention to see if any clarity is provided by the agency. Below are details of the upcoming hearing.
DATE:
May 31, 2019
TIME:
8:00 a.m. – 6:00 p.m. ET
LOCATION:
FDA’s White Oak Campus
Building 31, Room 1503 – Great Room
10903 New Hampshire Avenue
Silver Spring, Maryland 20993