Eleven of thirteen cannabis patent claims survive PTAB challenge.

Insys Development Company, Inc. filed a petition requesting inter partes review of claims 1-13 of GW Pharmaceutical Ltd.’s patent directed to the use of cannabinoids, including cannabidiol (“CBD”), in the treatment of certain types of epilepsy. After a trial on the prior art challenges raised by Insys, the PTAB concluded[i] that while claims 1 and 2 were obvious, the remaining claims, claims 3-13, were not. The prior art asserted was clinical literature involving administration of CBD or tetrahydrocannabinol (“THC”). The level of ordinary skill was defined as an M.D. or Ph.D. in pharmacology, chemistry, biochemistry, neurology, or a related field.

The patent at issue in this IPR is notable because it is associated with the first FDA-approved drug comprised of an active ingredient derived from cannabis: Epidiolex, which is indicated to treat rare, severe forms of epilepsy in patients two years of age and older. The PTAB’s decision is notable because, notwithstanding the unique subject matter, it analyzed the issues in largely the same way that one would expect to see in a typical biopharmaceutical case involving the obviousness of dose ranges. As the first post-grant trial on medicinal cannabis, this decision thus removes a few unknowns for those who own or are seeking patents in this space.

[i] Insys Development Company, Inc. v. GW Pharma Limited and Otsuka Pharmaceutical Co., Ltd., IPR2017-00503, Paper No. 36 (P.T.A.B. Jan. 3, 2019)

This article appeared in the January 2019 issue of PTAB Strategies and Insights. To view our past issues, as well as other firm newsletters, please click here.