Pharma is getting high on marijuana

“Beware, young and old people in all walks of life. This may be handed to you by a friendly stranger. It contains the killer drug marijuana — a powerful narcotic in which lurks Murder! Insanity! Death!” Thus ran a public warning issued by the US Federal Bureau of Narcotics (FBN) in a high-profile campaign against marijuana in 1930s and 1940s. The “this” in the advertisements and posters showed an image of the cannabis or marijuana plant.

Records show that the criminalisation of marijuana was strongly rooted in racism. The then FBN head Harry J Anslinger, who was openly racist, linked the weed with African Americans and Hispanics and played on the fear of crime by the minorities in his strategy to get marijuana banned at the federal level. For decades thereafter, the use of marijuana came under severe restrictions with laws that entailed stiff punishment and mandatory sentencing. Even a first-time offence for possession of cannabis meant a two- to 10-year jail term along with heavy fines, though usage in the US was rather minimal at the time.

Now, almost everyone is high on marijuana. Usage in the US is three times above the global average — more or less on par with other Western countries — but a 2022 Gallup poll indicated that Americans are for the first time smoking more marijuana than cigarettes! That is because about half of the US, 24 states, three territories, and the District of Columbia, have in the space of a few years legalised recreational marijuana; although it continues to be illegal under federal law. This column, however, is more interested in the advance that has been made in the proven medical use of marijuana that many societies, not least India, are said to have been seeing since ancient times.

Drug companies, investors and commercial entities are pouring money into the research and cultivation of cannabis to develop new therapeutics for a range of diseases and ailments. But this is a complex and rather confusing field. Medical marijuana can be termed as those products prescribed by doctors to treat specific conditions. Markets, even in India to a small extent, offer a vast array of products in the form of oils, extracts, patches and topical medication, but there is no clear definition of what constitutes medical marijuana. Yet only one drug has been approved by the US Food and Drug Authority because the rigour demanded by present-day regulation is a challenge for researchers and developers, even if cannabis has been used for centuries to treat medical conditions.

This drug is Epidiolex, which was given the green light in June 2018 and was also approved by Europe’s regulator, the European Medical Agency (EMA), in September 2019 as Epidyolex. Developed by UK company GW Pharmaceuticals, Epidiolex treats rare forms of epilepsy in children and has become a bestseller — and has sparked a patent battle involving a clutch of generic firms from global leader Teva of Israel to half-a-dozen of India’s top-rung manufacturers.

In January this year, GW Research along with GW Pharmaceuticals — both are now subsidiaries of Ireland-based Jazz Pharmaceuticals — filed a patent infringement lawsuit against more than a dozen competitors that have declared their intention of producing generic versions of the drug in what are known as Abbreviated New Drug Applications (ANDAs), in order to “commercially market generic versions of GW’s cannabidiol oral solution drug product.”

In all, GW holds 25 patents on Epidiolex, the first of which expires in September 2025 and the others in July 2027, and it says the applications filed before the expiry of the patent term is a violation of its intellectual property rights, since it is “an important part of what enables us to continue to innovate and develop new medicines for patients, including our pioneering work and industry-leading GW cannabinoid scientific platform.” It is asking the Federal Court in New Jersey to stop each of the companies from moving forward with their applications.

ANDAs and the subsequent patent infringement suits are routine in the litigation-prone world of pharmaceuticals. Sometimes the patent-holding company and their generic rivals arrive at a settlement; at other times, both parties go ahead with a legal challenge if their case is strong. This case is of special interest because it involves cannabis medications.

But legal experts believe such patent cases will increase as research into medical marijuana yields more products. Big Pharma in both the US and Europe are excited by the possibilities offered by the cannabis plant that produces a thick substance full of compounds called cannabinoids or CBD. There are more than 100 cannabinoids, the second most active ingredient of the plant, and initial studies have shown promising results in the treatment of anxiety, insomnia and more significantly in controlling pain. One animal study in the European Journal of Pain suggests that CBD could help lower arthritic pain and inflammation when applied topically. Other research, quoted by a Harvard Health Publishing paper, shows CBD may inhibit inflammatory neuropathic pain which is difficult to treat with current medications.

Both CBD and the other major compound of cannabis, tetrahydrocannabinol or THC, cause drug-like reactions in the body but it is only THC which produces the “high” that people feel when they smoke marijuana or eat foodstuffs containing it. Its usage is under strict regulation. The focus now is on CBD, which has been endorsed by the World Health Organization as safe. It says that so far there has been no evidence of public health-related problems associated with the use of pure CBD.

Purity of the product will remain a major concern with medical marijuana. How it is cultivated and processed will determine how many therapies come into the market. Cannabis-related patents are being piled on at a steady rate by Big Pharma. As of 2019, AbbVie had the largest number of patents in the US at 59, streets ahead of the second ranked company, Sanofi, which had 39 patents at that time. Following the leaders were the other giants from Merck, Bristol Myer Squibb, Roche and Pfizer. The surprise in the list of the top 10 were Hebrew University of Jerusalem (Israel), University of Connecticut and the government’s US Health and Human Service, apart from GW Pharmaceuticals.

Destigmatised and rehabilitated, marijuana promises hope and excitement as more breakthroughs are made in new fields.

A review of the cannabis patent landscape reveals that many of the intellectual property rights (IPRs) are for cancer therapies, a strong focus area being the treatment of tumours. As a drug that was widely used in parts of the world centuries ago, it appears to be coming into its own once again.

This was first published in the 1-15 December, 2023 print edition of Down To Earth

Subscribe to Daily Newsletter :

SUPPORT US

We are a voice to you; you have been a support to us. Together we build journalism that is independent, credible and fearless. You can further help us by making a donation. This will mean a lot for our ability to bring you news, perspectives and analysis from the ground so that we can make change together.