WASHINGTON, DC – Having a patent under your name means owning an intellectual property set upon the grounds and regulations of the agency governing it.
Not all people are familiar and well-versed with the scopes of patents, this is why it is easier for some to spread misinformation regarding the importance of one patent and its general use.
This is what happened when Patent no. 6630507 trended and had been shared in multiple social media accounts with different claimants, representations, and explanations on exactly it is all about.
Some are urging the government to use the scope of the patent as a basis in legalizing the use of pot in the states. Others who understand the scope of the patent called those in the government who are still against the promulgation of marijuana legalization in some states as hypocrites.
For the many who are still baffled on the scope of the famed Patent No. 6630507 were referred to the US Department of Health and Human Services. According to the scope of the intellectual property given to the said department on 2003, this patent covers the potential use of the chemical compounds that can be found in the cannabis plant. It also includes the study on cannabis and its possibilities to protect the brain from damage or degeneration due to some diseases such as Alzheimer’s Disease and Cirrhosis.
Although they aim only to use the non-psychoactive cannabinoids component, critics are still fast to point out that if the government doesn’t believe in the potentials of marijuana as a natural medicine, why do they patent cannabis the way the scope defined it?
Sam Mendez, a public policy lawyer and currently serving as the Executive Director of the University of Washington’s Cannabis Law and Policy Project, stated that it was clearly indicated in the Federal Law that cannabis has no accepted medical use. If that’s the case, the government seemed to be hypocritical for owning a patent that contradicts the perception of the Federal Law.
So the question now lies on what could be the possible impact of the patent no. 6630507 to the pot industry? In many aspects, since the government owns all the legal rights in testing and experimenting cannabis for medical uses, other private companies can only rely on the results provided by the government. They can’t conduct their private experimentation if it goes beyond the legal boundaries of the patent owned by the government.
Marijuana advocates also stressed out that if the government applied and legally owned the patent about medical marijuana, they should have the decency to use this as a basis of the medical benefits, and as a factor in extending the criminal boundaries of marijuana. This can be a good reason for finally implementing legalization of cannabis not just in some states but all throughout the US.
Most of the states that legalized marijuana accepted the usage of the plant for recreational purposes only and subject to some prohibitions and regulations. With this patent, they should extend the usage for medical purposes as well.
On January 19, the German Parliament unanimously voted to legalize medical cannabis. “Critically ill people must be cared for in the best possible way,” federal health minister Hermann Gröhe said at the time. “The costs of using cannabis for medicinal purposes will be met by the health insurance companies if the critically ill, if no other form of treatment is effective.”
The law went into effect in March. Patients are now able to receive up to five ounces per month at a cost of $12 per ounce under public health insurance (which covers 90% of Germans). They can take their doctor’s prescription to any licensed apotheke, or pharmacy, to get it filled. Reimbursement will happen via a special fund set up by the government, with an eye to public health insurers then picking up the slack (probably after the five-year trial also mandated by the new law).
More than 1,000 patients have registered with the program. That number is expected to grow to between 5,000 and 10,000 per year for the next several years, depending on how doctors respond to government education efforts and patient demand.
There’s no list of qualifying illnesses. All patients need to do is get a doctor to write them a prescription. Therein lies the temporary catch. Even the government realizes that finding doctors willing to write such prescriptions is going to be problematic. However, a growing “cannabis doctors” community is eager to put the law into greater practice. Last summer, even before the law passed, legal sales of cannabis in pharmacies doubled—but pharmacies were charging $2,000 an ounce, paid for fully by the patient.
As mandated by a United Nations drug treaty, the Cannabis Agency has been established. By May, it had begun to recruit staff members. They will go about implementing the day-to-day details, including vetting the responses to Germany’s first applications for domestically grown medical cannabis.
Ten grow licenses are up for grabs. There are already indications that leading international cannabis firms will have a clear advantage. All they need is an office in Germany and proof they can deliver 200 kilograms of medical-grade cannabis per year by 2019. If domestic crops in the first grow trials fail, it’s possible that imports will be used to back them up.
The Canadian firm Tilray, which began to export cannabis extracts to Croatia last year will likely receive one of the licenses. The U.S. company CW Hemp, maker of the “Charlotte’s Web” strain, which already exports to Argentina, might nab another. In addition, a licensed producer from Israel might partner with a German processor.
The German government wants a steady and expandable supply of cheaper and domestically produced cannabis, probably in the form of extracts, for the majority of patients. That said, cannabis flowers will be available for patients if doctors recommend that.
The biggest uncertainty right now domestically is what the winning combination of producers will look like. With a deadline for proposals to the Cannabis Agency coming in early summer, it’s likely that Germany won’t see its first domestically grown crops harvested until 2019 or 2020. The agency will presumably take until late this year or early in 2018 to screen, test and vet applicants.
While some failures in the early testing process can be expected, deadlines are deadlines. Indoor cannabis, in particular, can be grown with a precision that comes naturally to a nation where the trains usually arrive and depart on time.
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When it comes to developing and implementing an appropriately comprehensive security plan, the pharmaceutical industry knows what it is doing. You might say that this is not their first rodeo.
That is not, however, the case with many cannabis businesses newly charged with mapping out security for the purposes of licensing and daily operations.
The pharmaceutical industry and a comprehensive approach to security
Pharmaceutical companies must be compliant with Drug Enforcement Administration (DEA) regulations in order to remain operational. But their accountability does not end there. Ultimately, companies that deal with controlled substances and other drugs are held responsible for the welfare of the American public. As such, both large and small scale pharmaceutical entities manage their security plans as a long-term proposition.
Whether they are laboratories, manufacturers or distributors, those that operate within the pharma space evaluate the here and now, but also project future facility and product needs when mapping out security. They go to great lengths to ensure full compliance with all federal, state and industry regulations; often exceeding them. And while their “toolbox” certainly includes security equipment, it is also comprised of three other critical elements: policy, procedure and people.
It all begins with culture
The cannabis business would be wise to mimic pharma efforts to establish a clear and consistent company culture. Culture does, in fact, define the character and personality of the organization. Want employees to be honest and trustworthy? It helps to begin by saying so, and emphasizing your zero tolerance culture. Ultimately, clear cultural communication helps the cannabis business owner find and keep the kind of people it seeks to employ. Of course, it is critical to back that up with…
Policy and procedures
Policy and procedures is another area where cannabis can follow the pharma lead. Upon hire, employees should be apprised of all company policy via written agreements and handbooks. And reinforcement will be critical to ensure compliance – via internal signage, written reminders and in-person communication as needed. Of course, change should be anticipated. Policy must be reassessed regularly to gauge and prevent new threats, and communicated as such.
All good policy is supported by detailed procedure. This begins with hiring and training. Employment must be contingent on background/reference checks, credit checks and drug screening in an effort to hinder diversion risk. Once hired, all employees should be required to participate in diversion training programs to prepare them for detection and appropriate response. And those with access to security equipment must be properly trained in operation, trouble-shooting and response. Failure to do so can be catastrophic.
Standard operating procedures should identify and then address any area that might expose a company to internal or external threats. This must, at the very least, include public access protocol, visitor procedures, internal monitoring, alarm testing and response and perimeter controls.
The last piece of the security puzzle for pharmaceutical companies and cannabis is equipment. The Code of Federal Regulations, 21 CFR 1301.72 specifically dictates storage in a precisely defined vault/safe for controlled substances or DEA Schedule I-II. Subsequently, the vault or safe is indeed the cornerstone of physical security for many pharmaceutical companies and all cannabis operations.
This is complemented by other physical security elements including safes, mantraps, safe entry portals and bullet resistance. And, prompted by regulatory requirements, electronic security components include video surveillance, access control and alarm. All equipment ultimately works together to support optimal compliance and business success.
Scientists have conducted over 140 controlled clinical trials since 1975 assessing the safety and efficacy of whole-plant cannabis or specific cannabinoids, according to a new literature review published in the journal Critical Reviews in Plant Sciences.
A pair of German researchers identified 140 clinical trials involving an estimated 8,000 participants. Of these, the largest body of literature focused on the use of cannabis or cannabinoids in the treatment of chronic or neuropathic pain. Authors identified 35 controlled studies, involving 2,046 subjects, assessing the use of marijuana or cannabinoids in pain management. In January, the National Academy of Sciences acknowledged that “conclusive or substantial evidence” exists for cannabis’ efficacy in patients suffering from chronic pain.
Cannabinoids have also been well studied as anti-emetic agents and as appetite stimulants. Researchers identified 43 trials evaluating marijuana or its components for these purposes, involving total 2,498 patients. They also identified an additional 14 trials examining the role of cannabis or cannabis-derived extracts in the treatment of multiple sclerosis.
Researchers also identified several additional trials evaluating the use of cannabis or cannabinoids for Crohn’s disease, Tourette’s syndrome, Parkinson’s disease, glaucoma, epilepsy, and various other indications.
A 2014 study published in the Journal of the American Medical Association reported that new drugs typically gain FDA approval on the basis of one or two pivotal clinical trials.
Full text of the study, “Medicinal uses of marijuana and cannabinoids,” appears online here.