CannabIP: FDA Approves First Drug with CBD Active Ingredient

On June 25, 2018, the Food & Drug Administration (FDA) issued a press release in which it approved EPIDIOLEX® for treatment of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome.  Lennox-Gastaut syndrome (LGS) is specific type of epilepsy characterized by multiple seizures and affects intellectual development in children.  Dravet syndrome is a severe form of epilepsy, a rare genetic encephalopathy that affects infants.  The manufacturer is GW Pharmaceuticals, plc, of Cambridge, Great Britain, which issued its own press release on Epidiolex’s FDA approval.  This is a significant development because the active ingredient in Epidiolex is cannabidiol (CBD), one of the non-psychoactive compounds of the C. sativa plant, and represents the first FDA-approved drug which contains a purified drug substance from cannabis.

In order to get the approval, the GW had to first file a priority review application.  Then, the FDA granted, separately, a fast-track designation for the Dravet syndrome indication, and then an orphan drug designation for both the Dravet syndrome and LGS indications.  Orphan drug status is a special status for a drug which treats a rare disease.

The FDA was careful to include a disclaimer in its press release on the reclassification of the CBD from Schedule I for Epidiolex:

This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.

Several patents were issued by the USPTO to GW Pharma Ltd., the patent holding subsidiary of GW, including U.S. Patent Nos. 9,949,936, 9,949,937, 9,956,183, 9,956,184, 9,956,185, 9,956,186, which are all entitled “Use of cannabinoids in treatment of epilepsy,” and are directed to method claims for therapeutic use of CBD to treat epilepsy and its two rarer syndromic relatives.

In addition, the USPTO registered two trademarks for EPIDIOLEX®, U.S. Trademark Registration No. 4,484,943 and 4,838,876.  The ‘943 registration’s identification of goods specifies goods in International Class 5 for “pharmaceutical and veterinary preparations and substances for the treatment of epilepsy, convulsions, seizures, Dravet syndrome, and Lennox-Gastaut syndrome” among others.  The ‘876 registration’s identification of goods specifies goods in International Class 31 for “agricultural and horticultural products, namely, fruit seeds, flowers and live plants.”  In the prosecution of both applications, the proposed identifications were refused in office actions (‘943 and ‘876) as unclear (TMEP 1402.01), and there was some creative legal work done to get around the fact that cannabis or any other related wording could not be used.  Amendments were made in the responses (‘943 and ‘876) which were able to have the refusals removed and the applications proceed to publication.

It is interesting that in the ‘876 prosecution, the Trademark Examining Attorney in his office action requested, among other things, “whether EPIDIOLEX has ever been used in connection with a plant patent, utility patent, or certificate for plant-variety protection.”  GW’s attorney in her response indicated that:

The Examining Attorney is advised that EPIDIOLEX has never been used as a varietal or cultivar name.  EPIDIOLEX has also never been used in connection with a plant patent, utility patent, or certificate for plant-variety protection.

The response was filed June 18, 2015; the parent patent application for all of the above-issued patents was U.S. Patent No. 9,474,726, which was filed June 17, 2015, or one day earlier.  The ‘726 specification does not contain references to Epidiolex, but references cited in an IDS clearly indicate Epidiolex in the titles.  GW’s trademark attorney and patent attorneys were not the same, so this lapse could be entirely honest, but the client GW should have known that patent applications directed to Epidiolex were or about to be filed, and that information would have been circulated to its external counsel.  And, if the Trademark Examiner had actually known that a patent application was filed the day before, he would have been easily able to check the ‘726 file wrapper and know that it was directed to a cannabis compound.  This might raise inequitable conduct issues downstream (see TMEP 720, MPEP 2016).  This is especially problematic for GW since it is already involved in an IPR on another epilepsy patent, U.S. Patent No. 9,066,020, filed by Insys Development Co. on December 16, 2016, as IPR2017-00503, and recently began trial proceedings in April 2018.

Notwithstanding this detail in the prosecutions of the trademark and patent applications, the FDA approval of Epidiolex is important for cannabis-related pharmaceutical products because it represents a change in policy within a federal agency that will permissively allow the marketing and sale of a drug with a known cannabis compound, even though cannabis remains on the CSA Schedule I list.  While the FDA only handles drug administration and the DEA handles the CSA scheduling, the fact that the FDA actually made changes to its approval process to disregard CBD’s Schedule I classification in order to approve Epidiolex for the U.S. market is significant.  It may further signify a possibly shift by the DEA for Schedule I reclassification, but more definitive information has not be disclosed by the DEA.

For more information on patent and trademark processes for cannabis-related products, please contact Yonaxis if you have any questions.