British firm GW Pharmaceuticals is licking its wounds after US judges tossed out its attempt to patent multiple cannabinoids for epilepsy treatment following an eight-year battle.
The US Patent Trial and Appeal Board, an administrative law body of the national patent office, denied patent US9066920B2 on January 3, siding with petitioner Insys, a rival biotech firm.
The patent, which has been embroiled in dispute since 2010, is for “the use of one or more cannabinoids in the treatment of epilepsy”. More particularly, to the use of one or a combination of cannabinoids, CBD oil, in the treatment of generalized or partial seizures.
The invention covers 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.
Administrative patent judges Erica Franklin, Susan Mitchell, and Zhenyu Yang, said claims 1 and 2 were “unpatentable” under US law, however the remaining 11 claims that were challenged survived and remain valid, and potentially enforceable should GW decide to appeal.
GW declined to offer comment when contacted by Cannabis Law Report, and declined to confirm or deny it would appeal.
GW’s patent portfolio is extensive, running into the several hundreds, with many aimed at using cannabis to fight diseases.
Last year, the British company successfully lobbied the US Food and Drug Administration (FDA) to approve Epidiolex, it’s landmark cannabinoid-based oral solution for the treatment of seizures, becoming the first company in the world to gain FDA backing for a cannabis product.
According to the company’s annual report, it spent more than £110m ($141m) on Epidolex research and development in 2017 alone, as it invested heavily in attempts to have the drug approved in the US and push through it in Europe. It spent more than $100m on the drug in 2016.
Campaigners said the firm had overstepped the mark in attempting a widespread land-grab of cannabis-related IP, and having the patent exclusivity in its arsenal would lock out almost everyone else from the market.
“Having this patent denied does not stop them from helping sick kids,” said Bill and Jeff Levers, of top West Coast cultivators Beard Bros. Pharms. “It stops them from stopping others from helping sick kids. Thank you to the US Patent Office for seeing it that way.”
The Levers brothers said GW Pharma, with their exclusive blessing from the federal government, is in a wholly unique position to really do some good, and called on the firm to help preserve the cannabis culture and “regain some respect from the grassroots”.
Insys also focuses on cannabinoids and drug delivery systems, and it fought to wipe out all thirteen claims of the ‘920 Patent as obvious based on a trio of different combinations of references that included scientific articles as well as one of GW Pharma’s own published PCT applications.
“One key takeaway from this decision is that the PTAB seemed to treat this cannabis patent just like any other patent subject to an IPR challenge (the fact that cannabis remains a Schedule I drug was not an issue),” said litigation and IP lawyers from McDonnell Boehnen Hulbert & Berghoff. Therefore, this decision may provide some clarity (or at least hope) to canna-patent owners and third-party challengers that inter-party review proceedings (and likely other USPTO post-grant proceedings) are at least one option for challenging cannabis patents.”
The lawyers said as canna-patents continue to make their way through the federal courts, the industry may expect to see even more challenges of cannabis patents, as well as more frequent patent application filings, following the legitimization of canna-patent infringement cases in district courts.
One of the first cannabis patent infringement lawsuit underway in the US District Court for the District of Colorado; United Cannabis Corp. v. Pure Hemp Collective Inc. (1:18-cv-01922), is due before court later this year.
“At bottom, in light of these decisions and others, the message to canna-patent owners and applicants seeking to protect their innovations is what it has always been—obtaining canna-patents is highly valuable for companies in this industry, as these canna-patents will serve as irreplaceable stakeholders as the market continues to normalize and expand,” the lawyers said. And the stakes will continue to increase as courts and federal agencies take note.”
Litigation lawyer David B. Feder, esq said the GW-Insys rumble was likely to be the first of many examples of “big pharma vs big pharma duking it out in the cannabis arena”.
“Insys successfully invalidated GW Pharma’s ’920 Patent involving the use of cannabinoids in the treatment of epilepsy, and more particularly, generalized or partial seizures,” he said. “It’s important to remember that Insys claim to fame is fentanyl, a very strong opioid that’s delivered via a spray.
He said Fentanyl sales have rapidly declined as the opioid crisis has caused doctors to crack down on prescribing the drug and other opioids, especially outside its approved purpose.
“So, it’s not surprising to see Insys muscling itself into the cannabis industry, while muscling out the competition,” he said.
The number of global cannabis patent applications has doubled since 2008, according to figures obtained by Cannabis Law Report.
The World Intellectual Property Organization said approximately 10,246 cannabis-related applications have been filed since 1978 under the Patent Cooperation Treaty (PCT), with 6,137 applications coming after 2008.
Experts say the number could potentially be even higher as firms exploit loopholes to snatch patents related to cannabis such as growing or treating addictions, without expressly referring to marijuana in their application.