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Cannabis Patents are Approaching the Patent Trial and Appeal Board

Last week's cannabis litigation makes it important to discuss the important decision made by the United States Patent and Trademark Office ("USPTO") on patent litigation and appeal ("PTAB"). ) requirements for a cannabis patent just two months ago. On 3 January 2019, PTAB published the final written decision in Insys Development Co, Inc. v GW Pharma Ltd. et al. (IPR 2017-00503). SPOILER ALERT: PTAB found two claims to be patentable so obvious and the rest eleven claim to be qualified (and possibly enforceable in litigation)

In this case, the subject patent was U.S. Patent No. 9,066,920 to "Use of one or a combination of Fito cannabinoids in the treatment of epilepsy" ("920 patent"). The 920 patent was originally addressed to GW Pharma Oy ("GW Pharma") and Otsuka Pharmaceuticals Co., Ltd.. Background from GW Pharma: It has a wide patent application, many of which are for the treatment of cannabis-based disease. formulations. In particular, GW Pharma made history to become the first entity to receive FDA approval for the drug, Epidiolex containing CBD. Epidiolex was approved for the treatment of two rare epilepsy devices: Dravet's Syndrome and Lennox-Gastaut Syndrome.

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<p> Insys Development Company, Inc. ("Insys Development") is a pharmaceutical company focusing on cannabinoids and drug delivery systems. In December 2016, Insys Development asked the USPTO for an inter partes assessment (“IPR”) to cancel all 920 patent claims based on scientific articles and GW Pharma's own PCT applications. </p>
<p> Two claims which were void for administration. Although the daily dose of CBD given to epileptic patients in studies was less than 400 milligrams described in the 920 patent, PTAB said that "it is logical to think that a higher dose could" increase the anticonvulsant effect. " This document states that the petitioner has sufficiently demonstrated that [person of skill in the art] could reasonably expect success and increase the dose of CBD to at least 400 mg / day for partial seizure treatment. "</p>
<p> The remaining 11 claims that retained the PTAB review describe additional requirements for the administration of CBD for the treatment of epilepsy. PTAB disagreed with Insys Development that these allegations were obvious. One claim requires CBD to be present as a plant extract. The second claim requires the administration of CBD with cannabinoid THCV. To sum up, PTAB stated that "[it] finds [s] that [Insys Development] has not sufficiently demonstrated where each of the limitations of the [these] requirements is taught or why [person of skill in the art] would have combined the teachings of different references to achieve the required invention with reasonable expectation of success. ”</p>
<p> According to the UCANN case, it is worth noting that PTAB dealt with the IPR challenge of the cannabis patent and that the fact that cannabis remains in List I is not a problem. With a full circle, the IPR challenges of cannabis patents are likely to be related to the increasing trend in cannabis patent applications and cannabis trials </p>
<p> We know if either party invokes the final written decision on March 8, 2019. If the complaint is made, the matter may go through the panel review and then the federal district or directly to the Federal Circuit. Either way, we'll keep you posted. </p>
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