Tag Archives: application

Protecting Your Cannabis Plant IP

By Brian J. Amos, Ph.D, Charles R. Macedo, M.S
No Comments

You’ve bred a new strain of cannabis, or perhaps discovered an excellent new hybrid outgrowing the other plants in your cannabis plot. Can you claim the new plant as yours and legally protect it? The short answer is potentially yes. The long answer follows below:

Plant Patents


Since a 1930s’ Act passed by Congress, the US government has permitted a person land, and (ii) asexually reproduces that plant, to apply for a Plant Patent. If granted, the Plant Patent will protect the patent holder’s right to “exclude others from making, using, selling, offering for sale and importing the plant, or any of its parts.” In other words, if you have a Plant Patent, you have a monopoly on that particular plant and its progeny plants, as long as they are asexually reproduced (for example, from cuttings – i.e. a clone). There is a hole in the protection – once you’ve sold or given anyone the plant they can use the seed or pollen from it without your permission.

Originally this sort of coverage was thought to be useful for things like new apple varieties, which are often from spontaneous new mutants found by farmers in their orchards (i.e. “cultivated land”). But is it possible this coverage can be extended to cannabis plants? The answer is yes. Unlike the traditional refusal of the US Patent & Trademark Office (USPTO) to register “offensive” or “disparaging” trademarks on moral grounds, US patent law does not have any well-established “morality exception.” And, indeed, Plant Patents have already been issued for cannabis strains. In December 2016, US Plant Patent No. 27,475 was issued for a cannabis plant called “Ecuadorian Sativa.” This plant is said to be distinct in its exceptionally high level of a particular terpene (limonene) at levels of 10 to 20 times the usual range, and is a single variety of a cross between what are commonly named as Cannabis sativa and Cannabis indica.

How do you get a Plant Patent? Firstly – a Plant Patent is not automatically granted. The application has to be written correctly, and the USPTO will examine it to determine if your plant is new and distinct (non-obvious) from other known varieties, that it is described as completely as is reasonably possible, and that it has been asexually propagated. In addition, if the plant was “discovered” as opposed to “invented” then the USPTO will need to be shown that it was found in a cultivated area. A plant discovered simply growing wild cannot be patented. If you pass these hurdles, you will have a Plant Patent that lasts for 20 years.

Utility Patent
 

Another type of patent that can protect your new cannabis plant, and much more besides that, is a Utility Patent. Utility Patents have a longer history than Plant Patents in the US and, while they may be harder to obtain, a Utility Patent gives you broader protection than a Plant Patent. A Utility Patent can cover not only the plant itself, but if properly written can also cover parts of the plant, uses of the plant, methods used to create the plant, methods for processing the plant, and even edibles (like brownies) that contain an extract from that plant. If granted, the Utility Patent will protect your right, for 20 years from the date you filed the application, to “exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States.” An additional protection is that if the invention you claim in the patent is a “process,” you can assert the Utility Patent to exclude others from importing into the United States any products made by that process. Of course, given that present U.S. federal law regards cannabis as a DEA Schedule 1 drug, this importation blocking right is currently irrelevant. Nevertheless, it should be remembered that utility patents have a 20-year term, and Federal law may shift during that time.

Utility Patents are harder to obtain than Plant Patents. The USPTO will examine your application to determine whether what you are claiming protection on (for example: plants, cells, methods or processes) is new and non-obvious, does not cover a naturally occurring product or process, and is fully described. The simple description used in a Plant Patent is not enough for the more rigorous description needed in a Utility Patent. In addition, meeting the “enablement requirement” of a Utility Patent may require you to have the plant strain deposited with a recognized depository which will maintain that specimen plant – and you must agree that the public is permitted to access that deposit if a Utility Patent is granted to you.

So has the US government granted any patents on cannabis plants? Yes it has, multiple patents. A recent example is US Utility Patent No. 9,095,554 granted to Biotech Institute LLC (Los Angeles), which covers hybrid cannabis plants of a particular type with a CBD content of greater than 3%, as well as methods of breeding or producing them. Biotech Institute was also granted claims in the same Utility Patent for cannabis extracts from those plants, and edibles containing the extract. In this case, the plant samples were deposited with the NCIMB, which is a recognized depository in Aberdeen, Scotland. It should be noted that while the depository has to be internationally recognized, it does not have to be in the US. Another corporation, GW Pharma Ltd. (a UK firm), was early in the game and, according to USPTO records, has more than 40 U.S. Utility Patents issued relating to cannabis in some form or another, the earliest dating back to 2001.

Plant Variety Protection Act


A third type of protection is potentially available under the Plant Variety Protection Act (PVPA) if you breed a new cannabis plant by sexual reproduction. Colloquially, this protection is more often known as “breeder’s rights” and the USDA administers it. This right is not mutually exclusive with other protections – in 2001 the U.S. Supreme Court ruled that that sexually reproduced plants eligible for protection under the PVPA are also eligible for Utility Patents.

In theory, obtaining a PVPA certificate is a relatively straightforward procedure for seed reproduced plants, which are new, distinct, uniform and stable. If you are granted a PVP certificate it will last for 20 years from the grant date. You can bring a civil action against someone who sells, offers for sale, delivers, ships or reproduces the covered plant. So have any PVPA Certificates been issued for new cannabis strains? We have reviewed the USDA published certificates for the last two years and have not found any. Why is this? One obstacle may be what happens after you file your application. The US code governing these certificates states that a seed sample “will be deposited and replenished periodically in a public repository.” However, the government body that administers the PVPA, the USDA, specifically requires that all applicants submit a seed sample of at least 3,000 seeds with an 85% or more germination rate within 3 months of filing the application. Sending cannabis seeds in the mail to a federal agency – that’s a deterrent given current uncertainty. Ironically, the location that the seeds must be sent to is Fort Collins in Colorado, a state where cannabis has been decriminalized. The USDA’s published PVPA guidance describes courier delivery of the seed sample to the Fort Collins repository, but does not mention hand delivery of the seed samples. We contacted the seed depository and were informally told that seed samples can be deposited by hand delivery – but this still entails handing over to a federal agency actual seeds of a plant which is a DEA Schedule 1 drug. In any event, no PVPA Certificates that have yet been issued for new cannabis strains. It is possible that a new federal administration might deschedule cannabis, permitting an easier route to PVPA coverage. But for the present at least, PVPA protection may be hard to obtain.

Notice

The views expressed herein are those of the authors and do not necessarily represent those of Amster, Rothstein & Ebenstein, LLP, or its clients. Nothing in this article is to be construed as legal advice or as a substitute for legal advice.

California Releases Proposed Emergency Regulations

By Aaron G. Biros
No Comments

Last week, the California Bureau of Cannabis Control released their proposed emergency regulations for the industry. The Bureau, the government agency tasked with regulating California’s cannabis industry, announced the proposed emergency regulations ahead of the highly anticipated January 2018 start date.

The Bureau also published helpful fact sheets and overview documents, providing a good snapshot of the major requirements for different types of licenses. Here are some of the key takeaways:

Temporary licenses will allow businesses to operate for 120 days while their annual license application is being processed. Not surprisingly, local jurisdictions have considerable autonomy. Getting a license seems to be contingent on first getting local approval to operate. According to Josh Drayton, communications and outreach director at the California Cannabis Industry Association (CCIA), working with local governments will be crucial to making progress. “Now that the Brown Administration has created the framework for medical and adult use cannabis, the main challenge we face as an industry is getting local municipalities to move forward with regulations,” says Drayton. “California has a dual licensing process which means that cannabis operators must receive a local permit/license/authorization before being able to apply for a state license. A majority of California cities and counties have yet to finalize their regulations which will delay state licensing.”

The initial reactions to these proposed regulations seem positive, given that this is a culmination of efforts over several years. “The California Cannabis Industry Association welcomes the release of the emergency regulations,” says Drayton. “These regulations represent years of hard work and collaboration between the administration, the regulating departments, and the cannabis industry.”

License Distinctions

A-type licenses are for businesses in the adult-use market, while M-type licenses are for the medical market. Laboratory licenses don’t have this distinction, as they can test both medical and adult-use products.

The record keeping and security requirements seem relatively straightforward, requiring normal surveillance measures like 24-hour video, commercial-grade locks and alarm systems. The rules also lay out guidelines for disposing of waste, including securing it on the premises and not selling it.

Distributors

Distributor licenses appear to have a number of compliance documentation requirements, such as arranging for all product testing, quality assurance and packaging and label accuracy. “Cannabis and cannabis products must pass through a distributor prior to being sold to customers at a retail establishment,” reads the overview the Bureau published. There is also a transport-only distributor license option. Those regulations appear to be more comprehensive than others, with a number of regulations pertaining to appropriate transportation and security measures.

Everything has to be packaged before it gets to retail; Retailers are not allowed to package or label cannabis products on premises. Microbusiness licenses will be available, which should be an exciting new development to follow as the market matures.

Labs

The state will require ISO 17025 accreditation for testing labs. A provisional license is required for a lab to operate in the short term, expiring after 12 months. Laboratory personnel are required to go in the field and do the sampling. Documentation requirements, sample sizes, sampling procedures and storage and transportation rules are also laid out.

Testing labs are required to test for cannabinoids, foreign material, heavy metals, microbial impurities, mycotoxins, moisture content and water activity, residual pesticides, residual solvents and processing chemicals and terpenoids (terpenes). Infused and edible products are required to be tested for homogeneity in THC and CBD concentrations as well. Drayton and the CCIA welcome these new testing regulations, hoping it might improve overall public safety. “We believe that these regulations will address public health issues by mandating the testing of all cannabis products,” says Drayton. “The evolution of the cannabis industry will continue, and we will continue to advocate for good policy that creates solutions for the problems that arise. I believe that we will be visiting and revisiting cannabis regulations for many years to come.”

Certificates of analysis (COA) will be required, showing whether a batch passes or fails testing requirements. Harvest batches that fail testing can be processed for remediation. “Testing laboratories are required to develop and implement a quality assurance program that is sufficient to ensure the reliability and validity of the analytical data produced by the laboratory,” reads the statement on QA and QC.

The Bureau, at the end of their regulatory overview document, lays out some possible enforcement actions, disciplinary actions and citations that could come from noncompliance. “These emergency regulations create a framework for both medical and adult use consumers,” says Drayton.  “January 1, 2018 will be the first date that adults 21 years and older will be able to purchase cannabis without a medical card.”

In the coming weeks, we’ll be breaking down and analyzing the other proposed emergency regulations that the state released. Stay tuned for a breakdown of the California Department of Food & Agriculture (CDFA) regulations on cannabis cultivation, as well as The California Department of Public Health (CDPH) cannabis manufacturing regulations.

PA Approves First Two Cannabis Labs

By Aaron G. Biros
No Comments

According to a PennLive article, Pennsylvania’s Department of Health approved the first two cannabis laboratories for their medical cannabis program. ACT Laboratories of Pennsylvania LLC and Keystone State Testing LLC are the companies that were approved to perform analytical testing for safety and quality in cannabis products.

Both laboratories expect to be operational before the end of 2017, according to the PennLive article. Those labs are required to test for CBD and THC content, pesticides, moisture content, residual solvents and microbiological contaminants.

The temporary lab testing regulations are somewhat comprehensive, detailing lab reporting, licensing, sampling protocols and ownership stipulations, among other rules. ACT and Keystone, the labs that were approved by the Department of Health, have their approval for two years and can renew their license after.

While the state still expects the program to be fully implemented by 2018, Health Secretary and Physician General Dr. Rachel Levine said last week they are hoping to launch the program sometime next year, according to a press release. December 2017 will mark a full year since the state opened applications for licensing businesses.

January 2018 has long been the goal for the full implementation of the program. “We have made significant progress in getting this program off the ground since Governor Wolf signed the Medical Marijuana Act into law last year,” says Dr. Levine. “These proposed regulations for patients and caregivers to participate are one of the final pieces we need to have in place to launch the program sometime next year.”

Aaron_headshot
Biros' Blog

Should PA Revoke a Cannabis License For Their Parent Company’s Past?

By Aaron G. Biros
2 Comments
Aaron_headshot

Pennsylvania Medical Solutions, LLC (PAMS), won a license to grow medical cannabis in Pennsylvania, but some think the Pennsylvania Department of Health (PA DOH) should reconsider awarding that license. PAMS is a subsidiary of Vireo Health, which has medical cannabis licenses in New York and Minnesota, as well as quite the blemish on their business record. In December 2015, two former employees were accused of breaking state and federal laws by transporting cannabis oil from Minnesota to New York. Because of that history, some are questioning why exactly they were awarded the PA medical cannabis license.

A part of the PAMS application

In that school of thought is Chris Goldstein, a Philadelphia-based cannabis advocate and author of an article on Philly.com, which calls PAMS’ license into question. According to Goldstein, Vireo Health could lose their licenses in New York and Minnesota, and those former employees involved might even face federal prosecution. “On the surface it would seem that Vireo broke every rule in the book,” says Goldstein. “Not only could the company lose its permits in both of those states, but employees could face federal prosecution for interstate transport and distribution.” But does that previous wrongdoing by two former employees have any bearing on their application in PA? In Maryland, it did. According to The Baltimore Sun, concerns surrounding MaryMed’s parent company, Vireo Health, is the main reason why their permit to grow medical cannabis was revoked.

In response to some of those concerns about their PA license, Andrew Mangini, spokesman for Vireo Health, issued the following statement, which appeared in Goldstein’s article: “While we’re aware of allegations against two former employees of an affiliate, those individuals have never had a role in our application or in the management of PAMS,” says Mangini. “It’s also important to note that our Minnesota affiliate and our parent company Vireo Health have not been accused of any wrongdoing in connection with those allegations.”

Below is a timeline of events leading up to the PA DOH defending their decision to give PAMS a license:

  • December 2015: Two former employees of Minnesota Medical Solutions, a subsidiary of Vireo Health, transported a half-million dollars worth of cannabis oil from Minnesota to New York, violating state and federal laws.
  • February 9th, 2017: The two former employees were formally charged with crimes in Minnesota for illegally transporting cannabis across state lines.
  • February 20th-March 20th, 2017: PAMS submitted a license application to the PA DOH between these dates, listing their business state as Minnesota on the application.
  • May 2017: Maryland DOH suspended the licenses of MaryMed LLC, a subsidiary of Vireo Health, over concerns that the company did not provide information related to the Minnesota and New York licenses on their application, according to the Washington Post.
  • June 20th, 2017: PA DOH releases a list of license winners; PAMS was listed among winners for a cultivation license in Scranton.
  • June 26th, 2017: PA DOH officials defend their decision to award PAMS a license, according to a Philly.com article. That same day, The Baltimore Sun reported the Maryland Medical Cannabis Commission revoked MaryMed, LLC their license, citing concerns about Vireo Health.

April Hutcheson, spokeswoman for the PA DOH, told Philly.com in June, “Remember, the permits are given to business entities, not people.” The point she is making refers to the charges being filed against former employees, not any of the businesses who hold medical cannabis licenses.

Steve Schain, Esq. practicing at the Hoban law Group

Steve Schain, Esq., an attorney with Hoban Law Group in Pennsylvania, has seen no objective evidence of anything wrongful in either PAMS’ application or the DOH’s processing of it. “Marijuana related businesses often have distinct, affiliated components and the Department of Health faces two critical issues,” says Schain.

“First, whether grow applicant PA Medical Solutions, LLC (PAMS) had a duty to disclose alleged wrongdoing on its application, failed to fulfill this duty and, if so, whether PAMS’ application should be amended, re-scored or disqualified. Second, as part of its ongoing license reporting requirements, whether grow licensee PAMS has any duty to disclose the alleged wrongdoing. The answer to much of this hinges on whether criminal or administrative charges were leveled against just Vireo Health’s former employees or also included the entity and whether these individuals or enterprise fell within Pennsylvania Medical Marijuana Organization Permit Application definition of an “Applicant” (“individual or business applying for the permit”) or applicant’s “Principals, Financial Backers, Operators or Employees” of PAMS. Either way, it does not presently appear that the [PA] DOH missed anything.”

The list of permit winners in PA

This does raise the question of whether or not Vireo Health is under investigation, which is yet to be determined. According to Goldstein in his Philly.com article, the Minnesota DOH declined to comment on Vireo Health and the New York DOH says the department’s investigation is ongoing. “The selection of a Vireo Health affiliate to grow and process medical cannabis in Pennsylvania has cast a serious shadow over the integrity of the program even before it has started,” says Goldstein.

In Maryland, the DOH revoked their license as a direct result of those former employees in Minnesota committing crimes, according to The Baltimore Sun. Commissioner Eric Sterling said there is “a reasonable likelihood of diversion of medical cannabis by the applicant.” So should Pennsylvania do the same? Do those crimes by former employees have any bearing on their application? This story raises a number of questions regarding applications for state licenses that are largely left unanswered. One thing we know for certain: each state handles applications very differently.

PA Announces First 12 Grower/Processor Permit Winners

By Aaron G. Biros
No Comments

The Pennsylvania Department of Health announced today the first 12 winners of growing and processing permits for the state’s medical cannabis program. At first glance, it appears those who won the permits have teams with experience in successful cannabis operations elsewhere in the country. The permit winners now have six months to become operational, according to a press release.

The list of permit winners by region

According to that press release, John Collins, director of the Pennsylvania Office of Medical Marijuana, received 457 applications in total, with 177 prospective grower/processors and 280 for dispensaries. “With today’s announcement, we remain on track to fulfill the Wolf Administration’s commitment to deliver medical marijuana to patients in 2018,” says Collins. “The applications from the entities receiving permits were objectively reviewed by an evaluation team made up of members from across commonwealth agencies.”

A sample score card for the applicants

In the populous Southeast region of Pennsylvania, grower/processor permits were awarded to Prime Wellness of Pennsylvania, LLC, and Franklin Labs, LLC. Prime Wellness is a Connecticut-based enterprise. According to Steve Schain, Esq., attorney at the Hoban Law Group, Franklin Labs includes team members from Garden State Dispensary, a successful medical cannabis operation in New Jersey.

Two of the businesses that won permits are actually from Illinois, not Pennsylvania. GTI Pennsylvania, LLC (Green Thumb Industries), has a strong presence in Illinois and Nevada. AES Compassionate Care LLC lists their business state as Illinois as well.

Steve Schain, Esq. practicing at the Hoban law Group

“Based on the first phase award of grower/processor licensees both the strength and weakness of Pennsylvania’s program has been highlighted,” says Schain. “Many licensee recipients are affiliated with existing national marijuana-related businesses with excellent track records for operating in a transparent, compliant and profitable manner.” The applications were rated on a scorecard out of 1,000 points. “Unfortunately missing from this initial phase license winners are purely regional enterprises who may have been unable to compete with national concerns’ resources and checkbooks.” According to Schain, some of the more significant areas on the scorecard reflect a diversity plan, community impact statement, business history and capacity to operate, capital requirements and operational timetable. Capital requirements are the applicants’ demonstrable financial resources comprised of at least $2 million in capital and $500,000 in cash. All of the growers are required to grow indoors, not in a greenhouse or on an outdoor farm.

There is also a ten-day appeals process for scorecards that will undoubtedly be utilized by companies that were not successful in their bids. The next phase, according to Schain, of Pennsylvania’s Medical Marijuana Program regards “Clininical Registrants” in which grow/processor and dispensary licensure will be awarded to eight applicants, which, if able to satisfy requirements including demonstrating $15 million in capital, will be authorized to open up to six dispensary locations.

 

Pennsylvania Opens Cannabis Licensing Applications

By Aaron G. Biros
1 Comment

PA Secretary of Health Dr. Karen Murphy last week announced applications for growers and processors, while dispensary license applications will be available January 17, 2017. License applications will be accepted from February 20 through March 20, 2017. Governor Wolf signed the medical cannabis bill into law back in April of this year.

Philadelphia City Hall Photo: Michael Righi, Flickr
Philadelphia City Hall
Photo: Michael Righi, Flickr

“We’ve reached an important milestone in the program with the release of permit applications on January 17, 2017,” says Secretary Murphy. The PA Department of Health will issue 12 licenses for growers and processors and 27 dispensary licenses, according to Secretary Murphy’s statement. “The decision for which counties will be issued permits in this first phase was determined by using the department’s medical data, as well as comments from more than 5,000 patients and nearly 900 potential grower/processors and dispensary applicants.”

PA Capitol building in Harrisburg Photo: Harvey Barrison, Flickr
State Capitol building in Harrisburg
Photo: Harvey Barrison, Flickr

According to the Philly Voice, the highly populated Southeast region of Pennsylvania will get ten dispensary permits, including three in Philadelphia, two in Montgomery County and one in Bucks, Chester, Berks, Delaware and Lancaster counties each. The state will fully implement its medical cannabis program by 2018, but a temporary program with ‘Safe Harbor guidelines’ was effective in May of 2016, essentially allowing access for patients in the mean time, while establishing preliminary regulatory compliance guidelines.

In last week’s statement, Secretary Murphy also stressed the importance of their Physician Workgroup in developing the regulations. “We cannot underestimate the role of physicians in making sure that patients can access medical marijuana,” says Secretary Murphy. “That’s why the involvement of physicians and health care professionals through our Physician Workgroup is vital to the successful development and implementation of Pennsylvania’s Medical Marijuana Program.” The Workgroup’s recommendations include establishing quality monitoring, training for dosage recommendations while addressing rural and urban access, education and delivery.

Exploring Opportunities in Emerging Markets

By Aaron G. Biros
No Comments

This November 8th, voters in five states will head to the polls to decide on legalizing recreational cannabis and another three states have ballot initiatives that would legalize medical cannabis. If any of those five states pass a measure for recreational legalization, including Massachusetts, Maine, Nevada, Arizona and California, (which are all leading in the polls) they could potentially create massive new market opportunities for cannabis brands that have their eye on expansion.

Nancy Whiteman, co-owner of Wana Brands and chair of the Cannabis Business Alliance Infused Product Committee, sees great potential in capitalizing on those markets early. Whiteman has been working with Wana Brands since 2010 in Colorado, starting out in the young medical market there.

Nancy Whiteman holding a batch of cannabis gummies
Nancy Whiteman holding a batch of cannabis gummies

After expanding to the recreational market, Wana Brands saw its sales skyrocket. From January to August 2016, Wana had the best-selling candy brand in Colorado with 21% dollar share, according to BDS Analytics. Wana Brands has already expanded to Oregon and will launch in Nevada on November 15th, with agreements signed to expand in other states as well. “The model we are pursuing is a licensing agreement where we partner with existing or new license holders in their state,” says Whiteman. “In many ways they are doing the heavy lifting, but we are providing an enormous lift by licensing our intellectual property to them.” That model for growth is becoming increasingly common in some of the more established brands, like Steep Hill Laboratories, GFarma Labs, Dixie and others. Whiteman says that Wana Brands also has a partner in Illinois, Massachusetts and a number of other states they hope to reach.

Mark Slaugh, CEO of iComply
Mark Slaugh, CEO of iComply

According to Mark Slaugh, executive director of the Cannabis Business Alliance and chief executive officer of iComply, a compliance services provider, brands from Colorado expanding to other states need to ask themselves if their reputation is on the line with these new operators. “If you are licensing to companies that are not compliant, the penalties could be huge and they vary state to state- that could potentially hurt the overall brand image nationally,” says Slaugh. “People doing the licensing that are operating with full compliance really need to look at controlling that risk and mitigating that as much as possible.” With brand trust on the line, there are substantial risks that come with expansion. “We help clients ensure quality is consistent so, for example, an edible product would taste the same in Colorado as it would in Nevada or Arizona. They need to follow the intellectual property consistently but more importantly follow those specific regulations in that state to stay afloat.” Managing ongoing compliance in different states requires monitoring regulatory updates across multiple markets, which can get incredibly complex.

rsz_unspecified-3
Processing SOPs vary widely stae to state

“Six years ago, it was much easier to get into the market in Colorado,” says Whiteman. “There were no capital requirements, no limits on the number of licenses, but there was still a lengthy application and vetting process- as long as you met those minimum requirements you could get a license.” Other new states put stringent limits on the number of licenses granted and some have extraordinarily cost-prohibitive capital requirements, up to a million dollars, as is the case for New York. “Anyone who becomes a license holder in Massachusetts has to be prepared to embark on three separate business models, which is a massive undertaking,” says Whiteman. Massachusetts requires license holders to cultivate, process and dispense in a vertically integrated model.

In other states, Wana Brands is working with exclusive partners who will have the capabilities to manufacture and distribute throughout the entire state, but in Massachusetts that won’t be the case. “To cover the state, we need several partnerships; the partner we are working with is a little south of Boston,” says Whiteman. But all that could change if voters in Massachusetts legalize it recreationally, opening a much larger market than the current medical program. “With no legislation drafted yet, the regulatory environment is still up in the air in Massachusetts so there is no way of telling what the recreational market will look like.” In terms of ongoing regulatory compliance, Whiteman believes that Colorado still has some of the most stringent rules. The universal symbol printed on every individual edible product serving is one example. “Every state has different lab testing and licensing requirements, but Colorado looks like the most stringent currently,” says Whiteman. “Colorado requires a full gamut of lab testing including homogeneity, potency, residual solvents, contaminants and soon pesticides too.” According to Mark Slaugh, Nevada’s lab testing regulations are fundamentally different from Colorado’s with regard to sampling procedures, but the broader inconsistencies in lab standards need to be addressed. “The lack of laboratory standardization state to state with regard to methods creates a big challenge to get consistent, proficient lab testing across the board,” says Slaugh.

Wana's edibles come stamped with the universal symbol (THC!)
Wana’s edibles come stamped with the universal symbol (THC!) in Colorado, as required by law.

A big differentiator between Colorado and other states is that it was a first mover. “When Colorado came online there were not any established brands to speak of anywhere in the country- we were all pioneers,” says Whiteman. “Because it is so difficult to get a license in another state, either the organization or investor groups are looking to partner with established brands.” The advantages to this business model are many. Expediting your entry to market gets you the advantage of being a first mover. Working with an established brand also minimizes risks and the learning curve. “Bigger players understand that building a brand from scratch is time consuming and expensive so I think we will see a lot of these partnerships.”

As those new states come online, similarities in their regulations might appear in the form of standard operating procedures (SOPs) or good manufacturing practices (GMPs). “We might start to see a standardization from state to state that models FDA GMPs or USDA GAPs, [good agricultural practices] moving toward a framework that is more consistent with the possibility of federal regulation,” says Slaugh. Another commonality among a number of states is the implementation of a statewide tracking system. According to Slaugh, California has no such mandated system in place yet. “They will probably have one eventually but the market is so localized there- we will see if California will be ready with a statewide compliance system for tracking by 2018,” says Slaugh. “With such a weird patchwork of local governments allowing or not allowing certain operations to exist, it is a tough business to be in and it’s getting tougher every day.”

Pennsylvania Temporary Rules for Growers & Processors Released

By Aaron G. Biros
No Comments

Last week, Pennsylvania Department of Health Secretary Dr. Karen Murphy announced the formation of temporary regulations for cannabis growers and processors in the state, according to a press release. Those temporary rules were published on Saturday, October 29. Secretary Murphy asked for public comment on developing regulations for dispensaries as well.padeptofhealthlogo-768x186

The PA Department of Health published the new set of temporary regulations this past Saturday, outlining “the financial, legal and operational requirements needed by an individual to be considered for a grower/processor permit, as well as where the facilities can be located.” The regulations also discuss tracking systems, equipment maintenance, safety issues, disposal of cannabis, tax reporting, pesticides, recalls and insurance requirements. “One of our biggest accomplishments to date is the development of temporary regulations for marijuana growers and processors,” says Secretary Murphy. “We received nearly 1,000 comments from members of the community, the industry and our legislative partners.”

The general provisions published on Saturday outline the details of the application process, fees, inspections, reporting, advertising and issues surrounding locations and zoning. The temporary regulations for growers and processors delve into the minutia of regulatory compliance for a variety of issues: including security, storage, maintenance, transportation, tracking, disposal, recall, pesticides and packaging and safety requirements. A list of pesticides permitted for use can also be found at the bottom of the rules.

PA Department of Health Secretary Dr. Karen Murphy
PA Department of Health Secretary Dr. Karen Murphy

The document discusses the regulations for performing voluntary and mandatory recalls in great detail. It requires thorough documentation and standard operating procedures for the disposal of contaminated products, cooperation with the Department of Health and appropriate communications with those affected by the recall.

The department has yet to release temporary regulations for laboratories and dispensaries, but hopes to do so before the end of the year. “I am encouraging the public – and specifically the dispensary community – to review the temporary regulations and provide us with their feedback,” says Secretary Murphy. “The final temporary regulations for dispensaries will be published in the Pennsylvania Bulletin by the end of the year.”

Since Governor Tom Wolf signed the medical cannabis program bill into law in April 2016, the state has made considerable progress to develop the program, including setting up a physician workgroup, public surveys for developing temporary rules and a request for information for electronic tracking IT solutions. The PA Department of Health expects to implement the program fully in the next 18 to 24 months.

Soapbox

Best Practices for Submitting a Winning Application

By Leif Olsen
No Comments

Even though half of U.S. states and the District of Colombia now permit the possession of medical or recreational cannabis, state regulatory bodies differ greatly in their approaches to managing our industry. In Washington, anyone over the age of 21 can legally possess one ounce of usable cannabis and/or seven grams of concentrate. In Minnesota, patients are only allowed to purchase non-smokable cannabis in pill, liquid or oil form.

Given these substantial differences, it is no surprise that the application process to open a dispensary or cultivation facility also varies from state to state. The question I am most often asked (and catch myself mulling over late at night) is what can applicants do to ensure their success, regardless of where they are applying?

Recently we helped a client secure one of the first 15 licenses issued to grow medical cannabis in Maryland. The Maryland application process was particularly unique because most of the applicants had political or law-enforcement ties, or were connected to successful out-of-state growers. That experience, along with our work in places like Arizona, Colorado and Florida, has shown me the importance of teamwork, diversity and security in developing a winning application.

So here are my suggestions for ensuring a successful submission, regardless of which state you are operating in:

  1. Build the Right Team. My dad likes to say, “Use the right tool for the right job.” I think the same is true about creating the team for your application. Do not assume one or two people will be able to fill all of the required roles. You will need experts in a range of different areas including medicine, pharmacology, capital investment, cultivation, real estate, security and law.
  2. Focus on Diversity. I think one of the reasons we have been successful in helping clients secure applications (we are six for six, in six different states) is our commitment to gender, racial and even geographic diversity. For example, we recently helped a client secure a license in an economically underdeveloped area. I think our choice to headquarter the new business outside of the metropolitan corridor was at least partially responsible for our success.
  3. The Devil is in the Details. According to ArcView Market Research, the cannabis industry is expected to be worth $23 billion by 2020. If you want to be one of the organizations selected by your state to sell cannabis, you need to have your act together. Most applications ask incredibly detailed questions. Therefore it is essential that you answer them thoroughly and accurately. All answers should be in compliance with your state’s regulations.
  4. Put Safety First. You will need a comprehensive plan that takes all aspects of security into account. This includes everything from hiring security guards to purchasing cameras, and implementing internal anti-theft procedures. Regardless of the size of your operation, safety should be a primary consideration.
  5. Secure Funding. Successful cannabis businesses require capital. It’s important to be realistic about the amount of money you will need to have on hand. Application costs typically range from $500,000 to $1 million. This will cover things like hiring an architect or leasing land. Ideally, your organization will have another $5 to $10 million or more available to start your project once you’ve been approved so that you can quickly become operational.
  6. Connect With Your Community. It is essential to consider the impact of your business on the community. Being a good corporate citizen means being transparent and engaging in a two-way dialogue with neighbors, government officials and patients. I strongly recommend that my clients develop a comprehensive community outreach plan that designates which organizations they plan to work with, (hospitals or universities, for example) and what the nature of those partnerships will be.