In step with final week’s hashish patent litigation replace, it’s necessary to debate a landmark determination that was made by the U.S. Patent and Trademark Workplace (“USPTO”) Patent Trial and Enchantment Board (“PTAB”) on claims involving a hashish patent simply two months in the past. On January three, 2019, the PTAB printed its Remaining Written Determination within the case, Insys Growth Co, Inc. v. GW Pharma Ltd., et al. (IPR 2017-00503). SPOILER ALERT: the PTAB discovered two claims to be unpatentable as apparent, and the remaining eleven claims to be legitimate (and probably enforceable in litigation).
On this case, the topic patent was U.S. Patent No. 9,066,920 – “Use of 1 or a mix of phyto-cannabinoids within the remedy of epilepsy” (“the 920 Patent”). The 920 Patent was initially assigned to GW Pharma Ltd. (“GW Pharma”) and Otsuka Prescription drugs Co., Ltd. Some background on GW Pharma: it owns an in depth patent portfolio, lots of that are directed to deal with illness utilizing cannabis-based formulations. Notably, GW Pharma made historical past by changing into the primary entity to obtain FDA approval of the drug, Epidiolex, which incorporates CBD. Epidiolex was authorized to deal with two uncommon types of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome.
Insys Growth Firm, Inc. (“Insys Growth”) is a pharmaceutical firm that focuses on cannabinoids and drug supply methods. Insys Growth petitioned the USPTO for an inter partes assessment (“IPR”) in December 2016 to cancel all 13 claims of the 920 Patent as apparent based mostly on scientific articles in addition to certainly one of GW Pharma’s personal printed PCT purposes.
The 2 patent claims that have been invalidated associated to dosing. Though the day by day CBD dose given to epileptic sufferers within the research was lower than the 400 milligrams described within the 920 Patent, the PTAB stated it was “logical to assume” a better dose might “improve the anticonvulsant impact.” The PTAB continued, “We discover on this report that petitioner has proven sufficiently [person of skill in the art] would have a motive to, and an inexpensive expectation of success in, growing the dosage of CBD to at the least 400 mg/day to deal with partial seizure.”
The remaining eleven claims that survived PTAB assessment define further necessities for administering CBD to deal with epilepsy. The PTAB disagreed with Insys Growth that these claims have been apparent. One declare requires that the CBD be current as a plant extract. One other declare requires the CBD be administered with the cannabinoid THCV. In sum, the PTAB concluded that “[it] discover[s] that [Insys Development] has not proven sufficiently the place every of the constraints of [these] claims is taught or why a [person of skill in the art] would have mixed the teachings of the varied references to reach on the claimed invention with an inexpensive expectation of success.”
In keeping with the UCANN case, a key factor to notice is that the PTAB handled this hashish patent IPR problem as some other, and the truth that hashish stays a Schedule I drug was not raised as a problem. Coming full circle, it’s seemingly that IPR challenges of hashish patents are going to affix the general rising development of hashish patent purposes and hashish lawsuits filed.
We’ll know whether or not both facet appeals the Remaining Written Determination by March eight, 2019. If an attraction does occur, the case can undergo a panel rehearing after which the Federal Circuit, or straight to the Federal Circuit. Both method, we’ll preserve you posted.