Mark Taylor, Author at Green Market Report

Mark TaylorJanuary 15, 2019
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8min3630

British firm GW Pharmaceuticals (NASDAQ: GWPH) 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.


Mark TaylorJanuary 9, 2019
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15min240

A skeptic all his life, it was not until Martin Tindall walked around a Colorado dispensary and saw firsthand how cannabis could lengthen and save lives did he become a believer.

Now the former finance executive is on a mission to stamp out diabetes in some of the world’s worst-hit areas with a revolutionary marijuana treatment engineered by his firm, Phoenix Life Sciences International.

Tindall was helping turnaround a business using his decades of experience in financial services, and also coming to terms with the death of his own father, when he had an awakening as to what medicinal cannabis was capable of.

“I would never have thought to get into the medical cannabis industry, it always just seemed like an excuse for people to get high,” he told Cannabis Law Report. “Then I saw someone with Stage 4 breast cancer end up in remission from cannabis-based therapy, someone else with skin cancer; kid after kid with seizures all being treated. There seemed so much more to it.”

Phoenix, headquartered in Denver, distributes medicinal cannabis products around the globe to treat seven major categories of medical conditions including pain, cancer, autoimmune, metabolic, neurological, psychological and sleep disorders.

A standout project is its partnership with governments on the South Pacific islands to put cannabis-based products at the centre of their national healthcare programmes, and tapping into Tindall’s visionary spirit, the team hopes to turnaround soaring diabetes rates, which are the highest anywhere in the world.

The South Pacific epidemic is staggering, as during the past 20 years, diabetes and other non-communicable diseases (NCDs) have overtaken infectious diseases such as tuberculosis, pneumonia and malaria as the greatest causes of mortality in the region.

In at least 10 Pacific island countries, more than 50 percent (and in some, up to 90 percent) of the population is overweight according to World Health Organization surveys.

Obesity prevalence ranges from more than 30 percent in Fiji to an eye-opening 80 percent among women in American Samoa, a territory of the United States.

Almost 50 percent of the Pacific island region’s population of 10 million has been diagnosed with a noncommunicable disease, notably cardiovascular disease, diabetes and hypertension. These diseases account for 75 percent of all deaths across the Pacific archipelago and 40–60 percent of total healthcare expenditure.

“We have countries that cannot afford insulin, so the treatment for diabetes is amputation of lower limbs,” said Tindall, a member of the board of directors of the National Cannabis Chamber of Commerce.

The largest cause of death in South Pacific females is cervical cancer; as there is little or no access to chemotherapy or radiotherapy. “It’s hysterectomy or death,” said Tindall.

“The US Food and Drug Administration doesn’t care someone in Vanuatu loses a foot,” he said. “Their amputation rate is a literally foot a day. We were motivated by the passion to provide healthcare services, knowing we could manufacture down there and achieve global capacity and service so many more countries.”

Research has found cannabis can help those diagnosed with either type 1 or 2 diabetes, and those who suffer complications, and a landmark study published in the American Journal of Medicine in 2013 said marijuana compounds can also help control blood sugar.

Armed with their mission, in June 2018, Phoenix merged many of its partnership organisations together under the name Phoenix Life Sciences International Limited, placing expert botanists, biologists, industrial and organic chemists, medical doctors, researchers, packagers and distributors together under one roof.

From the outset, the firm targeted accurate dosing and delivery systems, with a botanist crafting many different formulas for treatments through varying strains.

“Government agencies want to see this consistency, that they won’t have fluctuations in botanicals,” said Tindall. “That is something that scares them. “It showed us there were ways to have formulas that were more effective for diabetes, and others for the treatment of cancers.”

The South Pacific region also has large tracts of real estate allowing Phoenix to expand and scale production. From January, the build-out of the Republic of Vanuatu is top of the Phoenix list, at an expansion of 50 acres per quarter. Tindall also hope to commence the clinical trials with Vanuatu for diabetes treatment.

The tiny Pacific island has a population of 270,000, but a diabetes rate of around 13 percent, making it a major issue for the government.

Photo: Google Maps

Phoenix are conducting short-term CBD oil studies with local patients at the country’s general hospital. Phoenix will import the cannabis from the US at first while it constructs its plant on the site of a former military base in Vanuatu, currently occupied by goats.

“It’s important to us to run local trials, so we are not relying on evidence from elsewhere,” Tindall said. “It also gives us a fast-track program. We are working with governments on single-payer healthcare systems as they are the ones who save the money, and the patients get the great end result.”

For the communities, Phoenix can roll out much faster when part of a national healthcare system with clinics and infrastructure, said Tindall.  “We want to replicate that in the South Pacific, where they have 46 countries,” he said.

Tindall cites the positive strides GW Pharmaceuticals have made on overseas markets as the regulatory playbook to follow.

GW, the world’s biggest medicinal cannabis firm, have blazed a trail in taking new drugs derived from plant extract to market, enabling them to be circumvent the scheduling as general CBD or THC and become subject to stricter enforcement.

It is Tindall’s hope Phoenix can replicate this success in the South Pacific, and other areas where some of the larger cannabis firms are not as active; if countries cannot afford to import and sell, there is little incentive for Big Pharma to get involved.

“We are positioned to pick up a good part of the global market while also preparing for bringing products back into the US, and even the UK,” he said.

Martin Tindall, CEO of Phoenix Life Sciences International.

The firm is expected to engage in M&A activity throughout 2019, and Tindall confirms he is looking at other companies to acquire that will allow Phoenix to leapfrog. “Whether a licensee in another country or securing another location for plantation sites,” he said. “We’re looking at companies with Drug Enforcement Administration licensing, so we can move the studies along.”

Also on the list of targets for 2019 is an FDA study license, which would allow Phoenix to serve universities and other clinical organisations. Tindall sees education of doctors and medical professionals as the number one aim, not just for Phoenix but the wider industry.

“No doctor is going to say to a patient ‘smoke two joints and call me in the morning’,” he said. “They want to know it’s accurate, medically delivered, and there is substantial research for them to point to. The more doctors will become aware of the treatments, the faster the market will grow, with more and more drug studies being held.”

The biggest pushback Phoenix has received until now has been the lack of data, Tindall said. The company sponsored a non-profit to build a database of medical cannabis data, putting up information on anxiety disorders and how the cannabinoids are being used in clinical trials.

“It’s all about access and education,” said Tindall. “If you have access, great, but you won’t get the programme without physicians prescribing.”

Each time the company enters a new market or country it has introduced a training programme for doctors, forming part of a strategy seeking to mature the industry and move away from the stereotypes Tindall believes hinder growth.

“By being able to provide video communications, presentations, there has to be a plethora of data pushed to the doctors, presented in a structured format so they can accept it,” he said. “It’s no good having Snoop Dogg on the front puffing a leaf.”

As the cannabis industry continues its stratospheric rise, Tindall warns firms who play up to old habits in order to gain attention they are only hurting themselves.

“At conferences, you still see the legacy of the weed industry,” he said. “It doesn’t really help. If you have a doctor in there, and the first thing he sees is potheads, it’s not going to work.”

Phoenix is strict on branding; it doesn’t use pictures of cannabis plants, and it is deliberately positioning itself as a pharmaceutical firm that happens to use marijuana in its products “If we can get a better result in the treatment of diabetes out of a fennel plant, that is what we are going to do, we’d be just as happy,” said Tindall. “It’s about finding the end solution for the patient.”



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