WASHINGTON — In a historic vote Thursday, the U.S. House of Representatives approved a bipartisan measure to protect state cannabis programs against federal interference.
The amendment to the Commerce, Justice, Science, and Related Agencies Appropriations bill prohibits the Justice Department from using funds to prevent states, U.S. territories, and the District of Columbia from implementing laws authorizing the use, distribution, possession, and cultivation of marijuana. The measure, which was sponsored by Reps. Earl Blumenauer (D-OR), Eleanor Holmes Norton (D-DC), and Tom McClintock (R-CA), passed 267-165. A similar amendment approved by voice vote Wednesday prohibits the Justice Department from using funds to prevent Indian tribes from enacting or implementing their own cannabis laws.
Thursday’s vote marks the first time a chamber of Congress has declared that the federal government should defer to state cannabis laws. A similar appropriations rider specific to state medical cannabis programs, known as the Rohrabacher-Farr amendment and then the Leahy amendment, has been in effect since first passing in 2014.
Statement from Neal Levine, CEO of the Cannabis Trade Federation, a national coalition of cannabis-related businesses that lobbied in favor of the amendment:
“The historic nature of this vote cannot be overstated. For the first time, a chamber of Congress has declared that the federal government should defer to state cannabis laws.
“The bipartisan nature of this vote is a strong signal that there would be majority support in the House for the STATES Act, which could be considered a more permanent version of this amendment. We hope the full House will be given the opportunity to vote on the STATES Act in coming months so that we can move closer to the end of federal cannabis prohibition.”
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Should I Patent My Cannabis Plants?
The U.S. Patent and Trademark Office has been issuing both variety and utility patents for cannabis varieties.
During the days of full cannabis prohibition, there was essentially a free market at work. With a high-risk marketplace and an obscure market of producers and consumers, growers and breeders competed freely—resulting in the incredible variety of genetically diverse plants that a maturing marketplace now demands.
But because of the underground nature of it all, every business was run on unprotected trade secrets. Breeders were known by pseudonyms and the sometimes-ridiculous cultivar names used for marketing. As the industry emerged, websites like Leafly.com appeared to catalog them all. But as the industry matured, along came genetic sequencers to show that a lot of the plants were the same thing and the vast majority of the varieties on the market were neither new nor unique.
And, despite the newly emerging genomics and federal prohibition, the U.S. Patent and Trademark Office (USPTO) has been issuing both variety and utility patents for cannabis varieties, triggering industry groups and labs to begin open-sourcing genetic and chemical profiles of plants on legal markets in an attempt to prove prior art and prevent more broad utility patents on plants.
Variety patents, which are issued for all kinds of plants under the Plant Variety Protection Act of 1970 (PVPA), are issued only for plants that were asexually produced (clones) and are not found in nature, but rather the dedicated work of a breeder to create something new and unique. Variety patents last 25 years and allow breeders to have total control over their creation, including charging licensing fees and/or royalties if they enter into a contract with a producer.
Utility patents, on the other hand, usually apply to new methods of delivery (like vaporizers) or new processes (a new extraction device). But in 2015, a very controversial patent was issued to a biopharmaceutical firm, Biotech Institute LLC. The issued plant patent is so incredibly broad in scope that the vast majority of landrace varieties (or Type-II varieties) fit within their scope; plants that make both THC and CBD and are not dominant in the terpene myrcene.
The power of these patents lies in the cost of litigation. Oftentimes when a small company or similar-sized competitor infringes on the patent, whether knowingly or not, it is usually a lot cheaper to pay the patent holder a licensing fee than it is to go to court. If the patent is challenged and the defendant proves prior art, the patent could be invalidated.
Breeders derive all the value in their work from intellectual property (IP), so as the marketplace matures, investing in the appropriate protections is essential. Obtaining plant varieties and investing in an insurance plan that can cover costs of litigation— whether offensive of defensive— is key to protecting the core value of the business.
Protecting Genetic Assets
“The best way to protect your genetic assets is with plant patents, that is the safest thing to do, protect them strain by strain,” says Dale Hunt, a plant biologist and attorney specializing in cannabis patents.
According to Hunt, the standard that the USPTO applies to cannabis plant variety applications is no different than for any other plant; the cultivar must be new, useful and nonobvious, and the application must teach a person skilled in the art how to make the invention and how to use the invention. Plant patents are relatively inexpensive and easy to defend, and they are less likely to be invalidated by legal challenges—like a utility patent might.
Hunt says that the effects of utility patents like Biotech Institute’s remain to be seen because they have yet to be enforced or tested.
“With so little prior art there will always be a question mark over the utility patents. You will never know how valid they are until more literature is developed,” he says. “If you are worried about having people assert their broad utility patents against you, you need to be part of a coalition of people in the same boat who believe this and band together to defend yourself and each other against those patents.”
Hunt plans to release a new website, MJPatentsWeekly, that will be updated every Tuesday as the USPTO issues new patents. Visitors to the site can comment on patents and submit prior art, which he says is key to preventing more broad utility patents.
“The cannabis industry has been a pretty active industry with people doing a lot of innovative things, but have they created a body of literature?” he asks. “Of course not, they have hidden it pretty vigorously. There is a great void of any information that is printed that an examiner can look at. The examiner, their hands are kinda tied.”
Hunt says there are a lot of ways growers can protect their plants other than through patents. Growers can control their protections by only selling harvested material rather than clones or seeds. In countries with legalized cannabis but few legal IP protections, strong contracts are the best option for mitigating the risk.
Applying for a Patent
Hunt says the application process is relatively simple, although it is still standard for the patent examiner to reject the patent application on the first pass, particularly in the case of utility patents. He says the reason most applications are rejected on first submission is because it is important for the patent examiner to create a written record of the dialogue between the USPTO and the applicant in order to ensure the patent is valid. This creates a record that is open to the public over the review and analysis process.
He says for variety patents, the issue is usually because documentation provided to the USPTO examiner does not sufficiently describe the new variety.
Hunt details the other three primary reasons the application could be rejected at first submission in a post to his blog called “Three Rookie Mistakes Plant Patent Applicants Make,” (1) naming the variety in a way that is incompatible with trademark protection; (2) misunderstanding the flexibility of filing date and disclosure requirements and (3) incorrectly timing the filing of the application.
“What you don’t want to do is use your really cool, sexy trade name as your variety name when you apply for the patent, because you lose the ability to use that as a trademark,” he says. “You want a functional, non-appealing name, like an address or filing system kind of name. My clients have learned from making that mistake or others’ mistakes; they use some sort of code so they can track it, and an appealing name for the trademark.”
Enforcing a Patent
“It is one thing to get a patent, it is another thing to enforce one,” Hunt says.
With the average cost of litigation averaging $2.8 million for patent infringement lawsuits, according to Gil Shaheen with Intellectual Property Insurance Services Corporation (IPISC), a business could go bankrupt if its management tries to challenge the patent enforcer, even if they feel they have a case to challenge it. If a small business has an insurance policy that covers defensive and offensive litigation, they could potentially invalidate patents like Biotech’s.
“The interesting thing about cannabis patent landscape, and the utility patent, with so little printed prior art for the examiners to go on and so much black market prior art or hidden prior art that a defendant could use in their defense, when someone asserts the patent they are really risking having it invalidated,” Hunt says. “As soon as I sue someone for infringing a patent they get an army of lawyers, some experts and some patent searchers and they throw all kinds of resources at trying to prove my patent is invalid. They are going to do a more thorough search and any examiner would have ability to do.”
Hunt adds that everyone—whether longtime growers or experienced business professionals—is new to the legal industry, and, in many cases, there just isn’t precedent yet on cannabis industry intellectual property.
“Because everyone is new, be really careful in evaluating what qualifies the people you choose to work with—whether they are on the investment side or the business side or the lawyer’s side,” Hunt concludes.
Insurance policies that cover the cost of enforcing a company’s patent, or protecting them from an infringement suit, are the best defense of both the company and its most important assets.
A2LA Accredits Fouser Environmental Services LTD to ISO/IEC 17025
Fouser Environmental Services LTD is based in Versailles, Ky., and is the first cannabis testing laboratory accredited in the state.
June 17, 2019, Frederick, MD – PRESS RELEASE – A2LA has announced the accreditation of Fouser Environmental Services LTD to ISO/IEC 17025:2017 for cannabis testing. Fouser Environmental Services LTD is based in Versailles, Ky., and is the first cannabis testing laboratory accredited in the state.
“Fouser Environmental Services is extremely proud of this monumental achievement in the company’s history to have met the highest levels of standards set forth by A2LA”, said Ellen Fouser-Gormley on behalf of the entire Fouser family. “Fouser Environmental Services chose A2LA as its Accreditation body due to the quality of their assessors, and their stellar reputation as an industry leader in the field of accreditation. A2LA’s assessors have spent decades in their respective fields, which helps to ensure that Fouser Environmental Services is providing the best services possible to their clients.”
“We congratulate Fouser Environmental Services on becoming the first cannabis testing laboratory accredited in the state of Kentucky. Their completion of this milestone in such a timely manner through the A2LA accreditation process is a testament to their hard work and commitment to quality,” said Adam Gouker, A2LA general manager. “A2LA realizes the vital role that accreditation plays in the cannabis industry to support compliance with regulatory requirements, and we are thrilled to see that our service has been adopted in a new state. We look forward to our continued relationship with Fouser Environmental Services in the provision of their accreditation needs.”
Achieving ISO/IEC 17025 accreditation by A2LA is the pinnacle in third-party laboratory accreditation, as it confirms that laboratories have management, quality, and technical systems in place to ensure accurate and reliable analyses, as well as proper administrative processes to ensure that all aspects related to the sample, the analysis, and the reporting are standardized, measured and monitored.
RYAH Medtech Announces CE Mark for Its RYAH Vaporizer to Establish Plant-Based Dose Measuring and Data Analytics in the European Market
The certification is a critical part of RYAH’s expansion strategy in the European region.
NEW YORK, June 20, 2019 (GLOBE NEWSWIRE) -- PRESS RELEASE -- RYAH Medtech Inc. has announced that it has received a CE Mark for its dose measuring and data aggregator vaporizer. The certification is a critical part of RYAH’s expansion strategy in the European region for the RYAH dose-measuring plant-based vaporizer, RYAH proprietary dry herb cartridges and real-time data analytics solution.
“Countries around the world are embracing the health benefits of dry herb medicine, and we believe the RYAH vaporizer will be an essential tool to add legitimacy to the international market. The user-generated, HIPAA-compliant data that RYAH collects is expected to be instrumental in enabling physicians to make educated recommendations to help patients optimize their relief and avoid possible negative experiences from medicating with plant-based medicine. The CE mark of the RYAH vaporizer is an important milestone for RYAH's global aspirations and we expect to shortly initiate our launch in Europe,” says Jordan Medley, head of product operations at RYAH.
According to Prohibition Partners’ “The European Cannabis Report, 2019,” Europe’s cannabis market is estimated to be worth up to €123b by 2028, led by medicinal treatments. The report highlights that Europe will likely become the world’s largest legal plant-based treatment market over the next five years. RYAH plans to roll-out several other clinical delivery mechanisms for dose measuring and data collection, including an oil delivery capability, transdermal patch, tincture pen and multi-cartridge mechanisms--all using technologies in conjunction with RYAH’s data aggregators.
Syqe Medical Receives Regulatory Approval to Release Drug Delivery Device for Precise Dosing of Cannabis
The pharma-tech company is launching its pharmaceutical-grade cannabis inhaler in Israel, enabling physicians to prescribe cannabis as a standard medicine.
(Tel Aviv, Israel – June 20, 2019) – PRESS RELEASE – Syqe Medical, a pharma-tech company, has announced the launch of a pharmaceutical-grade metered-dose cannabis inhaler in Israel, empowering physicians to prescribe precise dosages meeting pharmaceutical standards. The debut of this drug delivery device reflects Syqe’s mission to transform medical cannabis into a mainstream medical treatment.
This news is the culmination of eight years of research and development – including rigorous testing through multiple clinical trials – including four years of paving a novel regulatory path. The Syqe Inhaler and supporting clinical research is poised to unlock the global medical cannabis market by eliminating uncertainty surrounding dosage administration and alleviating physician concerns with regards to adverse events and psychoactivity. In turn, this will enable greater physician adoption of medical cannabis. Syqe’s drug delivery technology introduces complex respiration technique automation, electronic selective dosing and remote clinical monitoring and dose control, significantly expanding the applicability of this platform well beyond cannabis.
“80 percent of cannabis patients inhale the plant. For too long, physicians who wish to treat these patients have been without the most basic clinical knowledge on dosing, efficacy and adverse events of cannabis,” says Perry Davidson, CEO and founder of Syqe Medical. “For eight years Syqe has been developing proprietary technologies for the administration of raw plants, and through our clinical trials we were able to determine the recommended dosage of inhaled cannabis down to the microgram. This launch marks the beginning of a new chapter in pain treatment, one in which physicians can confidently prescribe precise dosages of cannabis, and patients can reap the rewards, effectively and responsibly.”
The Syqe Inhaler, a non-combustion drug delivery device that operates with pre-loaded proprietary cartridges, has received the world’s first ever regulatory approval from the Israeli Ministry of Health as a medical device combined with cannabis, and will be available for purchase by licensed patients in Israel.
The devices will be marketed and distributed by Teva Israel. The cannabis in the Syqe inhaler is produced under controlled pharmaceutical conditions, complying with good manufacturing practices (GMP).
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