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17 January 2019Americas

PTAB issues final decision in CBD patent dispute

US-based Insys Therapeutics has succeeded in its bid to prove that two of the claims in a patent owned by British company GW Pharmaceuticals were covered by a prior invention.

On January 3, the US Patent and Trademark office’s Patent Trial and Appeal Board issued a decision that two of the challenged claims would have been obvious given the prior art.

The decision concerned GW’s ‘920 patent (US number 9,066,920) for the "use of one or a combination of phyto-cannabinoids in the treatment of epilepsy".

Phyto-cannabinoids are cannabinoids that occur naturally in the cannabis plant.

In 2017, Insys sought inter partes review - a review of the patentability of one or more claims in a patent - of all 13 claims of the ‘920 patent. It alleged the 13 claims would have been obvious based on different scientific articles and clinical trials.

PTAB ruled that Insys had been successful in proving that claims 1 and 2 of the patent were unpatentable, but the remaining 11 claims were valid.

Claim 1 of the patent was for “a method of treating partial seizure comprising administering cannabidiol (CBD), to a patient wherein the CBD is present in an amount which provides a daily dose of at least 400 mg”.

Claim 2 was for the method of claim 1, “wherein CBD is present in an amount which provides a daily dose of from 400 to 800 mg”.

In its argument, Insys referred to a 1980 study, Chronic Administration of Cannabidiol to Healthy Volunteers and Epileptic Patients by Jomar M Cunha, which it said, “teaches the use of CBD to treat partial seizures”.

Other scientific articles given as examples of prior art were Modulation of Mediotemporal and Ventrostriatal Function in Humans by Δ9-Tetrahydrocannabinol, Anticonvulsant Effect of Cannabidiol, and Seizures and Epilepsy.

Insys said that claims 1 and 2 of the ‘920 patent would have been “expected in view of Cunha” and the other scientific articles and that a person of “ordinary skill in the art would have concluded that the daily dosage of 400mg is predicted and safe”.

PTAB said the evidence presented by Insys showed that claims 1 and 2 of the ‘920 patent were obvious. It said it agreed with Insys’ analysis that a person of skill in the art would have “had a reason to increase the dose of CBD to at least 400mg per day to treat partial seizures”.

But, it concluded Insys had failed to show that claims 3-13 of ‘920 are unpatentable under given any prior art.

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