Patented Pot vs. the Herbal Gold Standard

This is the longer version of an article that appeared in the 35th anniversary issue of High Times magazine – Lester and I were told that the original version would be put up on their website but so far they haven’t done so and we both felt the information was too important to keep to ourselves any longer so here it is!

Patented Pot vs. the Herbal Gold Standard

How patented marijuana strains and medicines may threaten the re-legalization movement, curb information sharing, set up a monopoly for certain breeders and medicine producers and limit users to a more expensive and inferior product. Their economic value to the pharmaceutical houses which produce them will be directly proportional to the severity of the prohibition against the use of cannabis.

By Lester Grinspoon and David Malmo-Levine

“Moreover the riches of the earth are for all …”
Ecclesiastes 5:9, the Peshitta (Aramaic Bible)

“That we may work in righteousness, and lay the Foundation of making the Earth a Common Treasury for All, both Rich and Poor …”
– Gerrard Winstanley; The True Levellers Standard Advanced, April 20, 1649

“There is no patent. Could you patent the sun?”
– Jonas Salk on why he would not patent the polio vaccine

A split in the marijuana community

During the last decade a split has developed within the marijuana community. One group is comprised of those who believe that the community’s interests are best served by patenting marijuana strains and marijuana medicines in order to make them safer, more effective, more legitimate, more understood or, perhaps most importantly, more readily accessible since they will be legally available. The other group consists of those who believe that smoked cannabis is the “gold standard” ; the safest, cheapest and, largely because of the ease with which it can be titrated, the most effective form cannabis medicine will take. This second group denies any real advantage of marijuana patents to the consumer, challenges any claim of exclusive rights of the first group to sell a particular strain and opposes the exploitation of a combination of patents and prohibition to force consumers to settle for an inferior product.

Within the first group we find those such as Britain’s GW Pharmaceutical, who (with the help of pharmaceutical-giant Bayer) is now selling their whole-plant cannabis spray Sativex. This group also includes the Toronto-based Cannasat Therapeutics, The Nevada-based Dynamic Alert Ltd and various other smaller operations. These companies are looking to patent cannabis medicines, strains of cannabis or both – if they haven’t already done so.

Even the US government has gotten in on the action. Patent #6,630,507 was awarded to the US Department of Health and Human Services in 2003, and states that cannabinoids are neuroprotectants and anti-inflammitory agents, useful in the prevention and treatment of stroke, trauma, auto-immune disorders, Parkinson’s, Alzheimer’s and HIV dementia as well as many other diseases.

GW Pharmaceutical was granted a license to grow cannabis for medical research in 1998 and it’s partner Bayer was granted a patent for Sativex in 2006. Sativex is a cannabis tincture mouth-spray with a THC/CBD ratio of approximately 1:1. The tincture takes 15 to 40 minutes to take effect. Sativex comes in a 5.5 ml spray bottle for $125 dollars Canadian (currently around $102 dollars US), which supplies about 51 sprays – enough for an average ten day supply. It is now available in Canada for MS and cancer pain, and has most recently become available in Britain and parts of Spain for use in the treatment of some other symptoms and syndromes.

GW Pharmaceutical has even patented a strain of cannabis – “Grace” – in Canada. It was patented in 2005 under the Plant Breeders’ Rights Act. Under this 1994 Act, all plant species (except algae, bacteria, and fungi) are eligible for “protection” (exclusive rights to sell) for 18 years. Medicine patents last between ten to twenty years depending on the country – it’s usually closer to twenty, as it is presently in the United States.

In the August 1st, 1998 issue of the British based Pharmaceutical Journal, GW’s Executive Chairman Dr. Geoffrey Guy mentioned the fact that “at some stage a comparison of new delivery routes and smoking cannabis might have to be performed, although this would obviously be controversial.” When asked about such comparative studies in early 2004, GW Senior Medical Advisor Dr. Ethan Russo stated that none were planned.

Safety and efficacy – synthetics vs. botanicals

Proponents of plant and medicine patents contend that there’s no controversy, that patents encourage innovation as it covers the costs of research and development, that standardization and research are impossible without patents, that patents create products superior to traditional botanical medicines, that crude plant drugs are more dangerous and less effective than patented plant products and that patenting cannabis medicines will speed up their legalization – or at the very least expand the number of people who have access to cannabis medicine. The evidence proves otherwise.

Pharmaceutical giants like Parke-Davis & Co, Merck, Eli Lilly, Upjohn, Wyeth, and Sharp & Dohme all made lots of money and undertook considerable research with unpatented botanical medicines – including cannabis, opium and coca medicines. The expensive “safety and efficacy” protocols that synthetic medicines currently must go through in order to get approved were instituted as a result of sales of untested toxic synthetics such as Elixir of Sulfanilimide in 1936 and the deformed-baby-causing Thalidomide in 1960. Herbs had nothing to do with the creation of these protocols.

Herbal marihuana has, through the massive numbers of testimonials written about it by both patients and doctors, in effect, been thoroughly clinically tested over centuries. Consequently it does not require require the same testing as new compounds any more than does aspirin which since the beginning of the 20th century has become well known as an efficacious and safe medicine, but has never been put to the same risk-benefit analysis required of new synthetics. As the patentable synthetics began to compete with the unpatentable botanicals, the botanicals were abandoned – sometimes because of Western ignorance surrounding the proper cultivation and use of these botanicals, but mostly because the profit margins were not as high as those for the patentables. In the particular case of marijuana, the 1937 Marijuana Tax Act sealed its demise as a botanical medicine.

Herbs are the number one source of medicine for 80% of the world’s population according to the World Trade Organization. According to former United States Department Of Agriculture botanical expert James Duke, drugs kill over 100,000 people every year in the US, while herbs kill less than 50. Given all the recalled synthetics up to the present day – Baycol, Bextra and Vioxx (to name three of many) – one has to wonder about the reliability of the current system of drug testing.

The “scientific method” that isn’t

Ethan Russo, an employee of GW Pharmaceuticals , writing for the on-line journal “Cannabinoids”, listed the benefits of pharmaceuticalized cannabis medicines in his article “Cannabinoid Medicine and the Need for the Scientific Method”. They are; 1) pharmaceuticalized cannabis products will gain widespread trust of physicians and medical consumers, 2) crude herbal materials can’t be standardized, 3) smoked cannabis causes coughing and “cytological alterations”, 4) sharing joints can lead to sharing diseases, 5) even vaporization is inefficient, unpredictable and unsafe, 6) there’s not enough evidence of smoked cannabis working, 7) the FDA will not accept the type of evidence that exists regarding the efficacy of smoked cannabis, 8) it is difficult to establish the dose of smoked cannabis, 9) crude herbal materials are full of micro-organisms and 10) most of the non-GW Pharmaceuticals strains of cannabis have no CBD in them.

In our view none of Russo’s claims are accurate; 1) the pharmaceutical industry is currently losing the trust of consumers as herbal medicines make a comeback, 2) “crude herbal materials” can easily be standardized without patents if the herb is legal and regulated , 3) more potent products such as bubblehash and devices such as water-pipes and vaporizers reduce coughing – there’s no evidence that the “cytological alterations” are anything other than a slight color alteration, a manifestation of bronchial irritation , 4) there are devices such as chillums and techniques for holding joints that can eliminate the spread of disease through preventing the spread of saliva, 5) there’s no evidence that smoke and/or vaporization is inferior to oral sprays because GW and Bayer will not do comparative studies, 6) US and Canadian governments have suppressed most studies on smoked marijuana but there are thousands of anecdotal accounts, and those thousands of stories collectively comprise a clinical bibliography more comprehensive than that of any synthetic, 7) the FDA has never required controlled experiments to recognize the therapeutic potential of chloral hydrate, barbiturates, aspirin, curare, insulin, or penicillin, 8) it is much easier to control the dose of smoked cannabis than oral sprays because the effects of smoked cannabis take 1 to 5 minutes to work and sprays take 15 to 40 minutes to work, 9) properly grown organic cannabis is relatively free of microbes and metals, and 10) if cannabis were legal, those high CBD strains would be more easily circulated among all breeders.

Protecting extensive investments

“To protect our extensive investment, we have sought to identify and patent certain inventions throughout the growing, extraction and manufacturing process. My comments to Mr. Lucas were made as a friendly and, hopefully, helpful gesture as I did not wish him to invest a great amount of effort into obtaining approval for a product as a prescription medicine only to find that he did not have the freedom to operate in the first place.”
– Dr. Geoffrey Guy to Author Brian Preston, published in The Walrus, 2005

Even before GW and Bayer had secured their patent on Sativex, Dr. Guy was already threatening to sue Philippe Lucas of the Vancouver Island Compassion Society for infringing Sativex’s imminent patent with VICS’s “Canna-Mist” spray. Just type “Bayer” and “patent” into Google (over two million sites) if you want evidence of Bayer’s habit of suing at the drop of a hat for all sorts of patent-related matters.

Evidence of an attempted Canadian medical marijuana monopoly began back in 2000, with a leaked, unpublished document entitled “Draft Statement of Work for The Development of a Comprehensive Operation for the Cultivation and Fabrication of Marijuana in Canada”. The plan called for a seed monopoly – “a licit source” only – and the eventual phase-out of all but a pharmaceutical “inhaler” device. According to the anonymous source who leaked the document, the first version of the plan also called for cannabis strains to be patented “as if they had been genetically modified”. It appears that GW Pharmaceutical and Bayer have now done so … with “Grace”.

There is a story going around that a certain researcher for the big pharmaceutical companies knows about the connection between the corn-shrinking cannabis medicines of the past and the tumor-shrinking effects of cannabis – but the corporation won’t let the researcher publish this information because it’s “proprietary”.

There are many herbal medicines that have successfully fought off attempted patents and monopolies. The anti-bacterial neem tree and even the vision-producing ayahuasca have all been subjects of patent attempts. Neem tree activists have used defenses such as “traditional knowledge” and “prior art” and “community heritage” in order to legally protect their healing tree from monopoly. Unfortunately, the patent on a strain of ayahuasca remains in effect to this day.

From cannabis monopolies come cannabis prohibitions

Cannabis monopolies are nothing new. One can argue that the prohibition of Moses’s holy kanneh-bosm annointing oil – found in Exodus 30:32 – a prohibition for people other than priests and kings – was a type of cannabis monopoly. When botanical medicine became popular again in the fourteen hundreds, women healers were first called “unschooled” and later called “witches” to prevent them from competing with the newly emerging male pharmacists. The same thing happened in the mid eighteen hundreds, except this time instead of “witches”, these botanical healers were called “quacks”.

The modern version of this monopoly began in 1910 with the Flexner Report – a report that succeeded in closing down all the naturopathic and herbal medicine schools by the 1930’s. This report was partially engineered by the Rockefeller Foundation. The removal of these schools would assist the Rockefeller family in protecting their investments in pharmaceuticals from botanical competition. The Rockefeller Institute and Rockefeller Foundation were also key players in the development of the sciences of genetics and molecular biology – the fields in which the concepts of patenting of life-forms originated. Standard Oil – now Exxon/Mobil and a host of other oil companies – was the Rockefeller Foundation’s source of income. Interestingly, in 1927 Standard Oil became business partners with Bayer – the marketer and distributor of Sativex in Canada.

Bayer had much to do with the development of the Codex global anti-herbs and anti-vitamin regulations. This was instituted in 1961, coincidentally (or perhaps not) around the same time as the Single Convention on Narcotic Drugs was instituted and the first Plant Patent Act was created.

What we know for certain is that nobody should have a monopoly on the emerging herbal health-care economy – especially corporations like Bayer and Exxon, who have had questions raised about the amount of influence they have welded in geopolitics, and what they’ve done with that influence.

When the modern patent was issued in the 1400’s in Italy, they were for “new and inventive devices”. This soon turned into a big money maker for kings and queens, who would issue patents for such things as salt. After a public outcry, James the first of England was forced to revoke all existing monopolies and declare that they were only to be used for ‘projects of new invention’. It can be argued that a similar reform is due again today.

Perhaps lessons can be learned from those within the medical profession who have tried to pass off discoveries as inventions, and those who have not. Jonas Salk, discoverer of the polio vaccine, famously rejected attempting a patent, explaining that it was like attempting to patent the sun. This is seen by some to be his most “winning story” – what he lost in potential revenue he gained in reputation and positive influence on the world.

Joseph Lister was an English professor of surgery who discovered – or popularized – “antiseptic” surgery. He invented a carbolic acid spray as a method of preventing infection, but considering the fact that he didn’t invent the spray bottle nor carbolic acid, he didn’t bother attempting to patent his spray. He alerted the world to his discovery in the British medical journal The Lancet in 1867, and was eventually made a Baron – the first doctor so honored. They even named the first mouthwash after him – Listerine.

William Thomas Green Morton was a dentist from Boston. He discovered – or popularized – the fact that ether was a good anesthetic. He was successful in patenting his technique – on November 12th, 1846 he was granted U.S. Patent No. 4848. But he could not collect any money as it was merely the use of an agent already well known. His apparatus was not essential to anesthesia – fabric soaked in ether was all that was necessary. He died broke and his reputation suffered for “nostrum mongering” – for being a huckster and an opportunist.

George Washington Carver refused to patent any of his discoveries, saying, “God gave them to me, how can I sell them to someone else?” Ten years after his death, the United States government acquired the Missouri farm which was Carver’s birthplace and dedicated it as a national shrine. The Carver epitaph reads: “He could have added fortune to fame, but, caring for neither, he found happiness and honor in being helpful to the world.”

Perhaps one day those who are currently attempting to patent cannabis medicines and cannabis strains will wake up to the fact that a good reputation is worth much more than a patent, and the gift of a new strain or new technique given to the world will return the most precious form of good karma upon the giver, while the person who attempts to “patent the sun” – patent a gift from nature or a traditional medicine bred and developed over thousands of years – will eventually suffer the worst forms of infamy. It is up to the entire cannabis community – especially the activist community, to see that sharing is rewarded and hoarding punished.

Additional information:

GW’s position on intellectual property:

GW adopts an aggressive approach to securing intellectual property rights to protect techniques and technologies involved in the development programme. Protection is sought in the areas listed below:

• Plant variety rights
• Methods of extraction patents
• Drug delivery patents
• Patents on compositions of matter for delivery of cannabis
• Methods of use patents
• Design copyright on devices
• Trademarks

In the last few years our intellectual property portfolio has developed considerably. The patent portfolio has more than doubled in size and comprises 42 patent families, within these families there are numerous granted patents both in the UK and in various territories around the world. GW has also developed a trademark portfolio of 21 UK registered trademarks with equivalent marks registered in many other territories around the world. GW also holds nine registered design rights and nine plant variety rights.

http://www.gwpharm.com/research_property.asp

It appears that “Patents on compositions of matter for delivery of cannabis” means “Patents on cannabinoid ratios”.

Their ratio is 51% CBD and 49% THC:

Guy’s publicly-traded company has developed three types of medicine made from cannabis extracts: a high-THC extract called Tetranabinex, a mostly-CBD extract called Nabidiolex, and the 51-49% mixture of CBD and THC, called Sativex.

http://www.medicalmarihuana.ca/sativex.html

CBD began to be studied in the 1960’s. Research into it’s anti-psychotic (or anti-THC overdose) qualities go back to the 1980’s.

http://www.scielo.br/pdf/bjmbr/v39n4/6164.pdf

Sativex was patented in 2006:

In most cases, patents are issued before the drug comes to market. In this case, the first patent pertaining to Sativex was issued on April 25, 2006 and it came under the PMPRB’s jurisdiction at that time.

http://209.85.173.132/search?q=cache:xND…clnk&cd=2&gl=ca

Sativex was released for MS patents:

http://www.gwpharm.com/news_press_releases.asp?id=/gwp/pressreleases/currentpress/2006-09-05/

Research into cannabis and MS has been going on for quite some time – this review of research is from 1996, and it indicates studies on cannabis and MS date from 1994 and studies on CBD date from the early 1980’s:

http://norml.org/pdf_files/ReviewofHumanStudies.pdf

Neem court challenge data:

* Patent No. 5,124,349 Is Obvious in Light of Prior Art:

The issuance of a patent is prohibited if the patent would have been ‘obvious’ in light of prior art. The standard for patentability requires that the differences between a patentable invention and its prior art must be great enough so that a person with ordinary skill in the art would not consider the invention to be obvious at the time of patenting. Patent No. 5,124,349 does not meet this standard.

W R Grace claims that Patent No. 5,124,349 is non-obvious in the light of prior art because in contrast to the traditional chemical extraction techniques, the company’s processes obtain storage-stable azadirachtin formulations. There are several reasons why this argument lacks merit.

First, several Indian scientists had developed stabilisation techniques prior to W R Grace’s patent application. Stabilisation research occurred within India in the 1960s and 1970s. This pre-existing body of work alone should invalidate Patent No. 5,124,349.

Second, in determining whether an invention is obvious, it is necessary to consider the possibilities and capabilities of pre-existing technologies. Inventions are unpatentable if the possibilities raised by prior technologies would make the patent obvious to a person with ordinary skill in the art. This standard disqualifies the validity of Patent No. 5,124,349. Because Indian researchers had already developed the knowledge and technology necessary to make storage-stable azadirachtin formulations possible, this pre-existing knowledge subsumes Grace’s patent claims. Patents may not be granted for trivial changes to known products and processes.

http://www.twnside.org.sg/title/neem-ch.htm

An Indian government challenge in the United States led to the revocation of a patent on another Indian plant, turmeric, whose medicinal qualities have been known for centuries. That challenge was accepted as a result of India showing that the knowledge had been found in the Indian pharmacopoeia.

In the United States, prior existing knowledge to deny a patent is accepted in terms of publication in any journal, but not of knowledge known and available in oral or folk traditions.

This narrow view of prior knowledge has been responsible for any number of patents for processes and products derived from biological material, or their synthesis into purer crystalline forms.

In the United States, neem seeds and their potent insecticidal extract, azadirachtin, have been the subject of continuing biotech research and grant of patents.

The US funds and grants have been made available also for tissue culture of the azadirchtin, to obviate the need for extracting it from the neem seeds, which are seasonal.

An US Company, AgriDyne has received two US patents for bioprocessing of neem for bioinsecticidal products. The first patent is for a refining process that removes fungal contaminants found in extracts from the neem seed, and is used in the manufacture of technical-grade azadirachtin, and in the production of AgriDyne’s neem-based bioinsecticides. The second patent is for a method of producing stable insecticide formulations containing high concentrations of azadirachtin.

The US TNC, W.R. Grace has patents for neem-based biopesticides, including Neemix for use on food crops. Neemix suppresses insect feeding behaviour and growth in more than 200 species of insects.

In New Delhi, the Indian Minister for Science and Technology, Dr.Murli Manohar Joshi welcomed the EPO decision and said that the revocation of patent had been on the issue of bio-piracy and this should lead to a better protection of India’s heritage of traditional knowledge.

A Third World Network expert group on Implementing TRIPS, recommended in 1998 that developing countries to apply a broad concept of ‘prior art’ to ensure that patents are granted to actually ‘new’ inventions, and to stick to the need of novelty of the process itself as a condition of granting a patent. The developing countries were also advised to deny patents for new uses of a known product or process, including second use of a medicine or for incremental additions to get a new patent on a prior one.

The expert group advised developing countries to define and interpret ‘novelty’ according to generally accepted concepts, namely, any prior disclosure whether written or not destroys novelty. Knowledge like use of medicinal plants diffused within a local or indigenous community should also be deemed prior art and patent denied.

And writing such a rule into their legislation would prevent patenting of knowledge or materials developed by and diffused within local or indigenous communities.

http://www.twnside.org.sg/title/revoked.htm

Abstract A recent United States patent covering an improvement to the naturally-occurring pesticide in neem tree seed oil might have been rejected as ”obvious” if United States patent law recognized certain forms of prior inventive activity on a par with similar activity occurring within the United States” borders. But the US only recognizes prior ”knowledge, use or invention” as blocking a claim to a patent when those activities take place within US borders, or are evidenced by publications accessible in the US, or, more commonly, by foreign patents. Neither of these last forms of tangible ”prior art” is likely to be available to block patents on biodiversity inventions – most notably because of the fact that most developing nations do not allow patents on pharmaceutical or agricultural inventions, categories subsuming most biodiversity-related advances. Although the United States patent only has direct force within the United States, it is nonetheless highly significant to this global dispute, since the United States and other developed nations stand to be the major markets for the end-products of neem. This paper argues that the border-drawing distinctions in US patent law are archaic, counter to stated policy directives and are disproportionately influencing the developing world”s stance towards GATT and its intellectual property rights provisions.

http://www.springerlink.com/content/nx58468m7023r452/

In its Request for Re­examination, the coalition states that there is enough evidence to the claim of ‘prior art’ outside the US (in India). It also claims prior art inside the US. In its request, the coalition sums up proof for ‘prior art’ in an attempt to get the patent revoked.
Firstly, the coalition claims the patented process has already been used by Indian farmers for many centuries. However, when Grace states that their method differs substantially from the method used by Indian farmers, they may have a point. Traditionally, the farmers have used water as solvent for the extracted oil from the neem seeds. The protic solvent cannot stabilize the azadirachtin for a long time. This is not a problem because the product is used within a few days of production. Therefore there is no immediate need for a process of stabilizing the extract. The need for extract preservation only arises in case of mass production for broader and distant export markets.
Secondly, the coalition claims the knowledge for the process patented was already available in India and elsewhere. The properties of the neem tree as pesticide and insecticide were discovered by Indian scientists decades ago. “The treatment of neem seeds with aprotic solvents has been used since the 1950’s, and scientists had prepared neem seed extracts with the same solvents that W.R. Grace used in its patent, and solvents similar to those identified by W.R. Grace, years before the company’s earliest efforts”. The coalition points out that much of the research and experimentation has been conducted by small­scale organizations which have no interest in or capability of using foreign patents. This foreign knowledge as prior art is supported by several letters from foreign scientists.
Thirdly, the coalition claims that the process patented was not new and novel from a domestic point of view. In their request, they presented many scientific publications to prove that the knowledge of the use of protic solvents in stabilizing organic material was publicly accessible. They also presented letters from US­based scientists who state that ‘no new novel chemistry was discovered’ and that the process patented makes ‘only trivial changes to known products and processes’.

http://www.biotech-monitor.nl/3004.htm

David Malmo-Levine

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