In maintaining with very last week’s cannabis patent litigation update, it is critical to examine a landmark determination that was built by the U.S. Patent and Trademark Business office (“USPTO”) Patent Trial and Attractiveness Board (“PTAB”) on statements involving a cannabis patent just two months ago. On January three, 2019, the PTAB revealed its Closing Prepared Decision in the case, Insys Progress Co, Inc. v. GW Pharma Ltd., et al. (IPR 2017-00503). SPOILER Alert: the PTAB observed two claims to be unpatentable as clear, and the remaining eleven statements to be valid (and perhaps enforceable in litigation).
In this case, the subject patent was U.S. Patent No. 9,066,920 – “Use of a person or a mixture of phyto-cannabinoids in the treatment of epilepsy” (“the 920 Patent”). The 920 Patent was originally assigned to GW Pharma Ltd. (“GW Pharma”) and Otsuka Prescribed drugs Co., Ltd. Some track record on GW Pharma: it owns an comprehensive patent portfolio, many of which are directed to deal with disorder making use of cannabis-dependent formulations. Notably, GW Pharma created historical past by turning into the initial entity to get Fda approval of the drug, Epidiolex, which is made up of CBD. Epidiolex was authorized to take care of two scarce forms of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome.
Insys Progress Firm, Inc. (“Insys Development”) is a pharmaceutical enterprise that focuses on cannabinoids and drug shipping and delivery devices. Insys Improvement petitioned the USPTO for an inter partes critique (“IPR”) in December 2016 to cancel all 13 promises of the 920 Patent as obvious primarily based on scientific articles or blog posts as perfectly as just one of GW Pharma’s own posted PCT applications.
The two patent promises that were being invalidated relevant to dosing. While the day by day CBD dose provided to epileptic clients in the scientific tests was much less than the 400 milligrams explained in the 920 Patent, the PTAB reported it was “logical to think” a higher dose could “increase the anticonvulsant impact.” The PTAB ongoing, “We discover on this history that petitioner has demonstrated adequately that a [man or woman of ability in the art] would have a reason to, and a reasonable expectation of accomplishment in, raising the dosage of CBD to at least four hundred mg/working day to handle partial seizure.”
The remaining eleven statements that survived PTAB overview define more demands for administering CBD to handle epilepsy. The PTAB disagreed with Insys Development that these claims were being noticeable. Just one assert necessitates that the CBD be current as a plant extract. A different assert necessitates the CBD be administered with the cannabinoid THCV. In sum, the PTAB concluded that “[it] locate[s] that [Insys Improvement] has not shown sufficiently exactly where each of the limitations of [these] statements is taught or why a [person of ability in the art] would have combined the teachings of the a variety of references to arrive at the claimed invention with a affordable expectation of success.”
Consistent with the UCANN scenario, a important matter to note is that the PTAB dealt with this hashish patent IPR challenge as any other, and the fact that hashish continues to be a Routine I drug was not raised as an issue. Coming complete circle, it’s very likely that IPR issues of cannabis patents are heading to be a part of the general developing trend of cannabis patent purposes and cannabis lawsuits filed.
We’ll know regardless of whether both aspect appeals the Ultimate Penned Decision by March eight, 2019. If an appeal does transpire, the circumstance can go by means of a panel rehearing and then the Federal Circuit, or straight to the Federal Circuit. Both way, we will maintain you posted.