Tag: Cannabis

USPTO Issues Examination Guide on Trademark Applications for Cannabis and Cannabis-Related Goods and Services

On May 2, 2019, the United States Patent and Trademark Office (“USPTO”) issued Examination Guide 1-19 (“Examination Guide”), which outlines the path to registration for trademark applications covering hemp-based goods and services.  The issuance of the Examination Guide serves as a departure from the USPTO’s longstanding bar to the registration of cannabis-related marks, and signals the potential for further relaxation of the USPTO’s prohibition on federal registration of trademarks and service marks for cannabis and cannabis-related goods and services as state legalization of cannabis continues to crop up across the country.

To obtain federal registration for a mark, a mark’s use in commerce must be lawful under federal law.  See generally Trademark Manual of Examining Procedure §907.  The USPTO will not issue registrations for marks covering goods or services that violate federal law – even if such goods or services are legal at the state level.  Despite the legalization of cannabis for medical use in 33 states and the legalization of cannabis for recreational use in 10 states, cannabis has been deemed illegal by the federal government under the Controlled Substances Act (“CSA”)1.  Cannabis-related marks have therefore been ineligible for federal trademark registration.

On December 20, 2018, the Agricultural Improvement Act of 2018, better known as the 2018 Farm Bill, was signed into law.  In relevant part, the 2018 Farm Bill removed “hemp”2from the CSA’s definition of marijuana, thus removing “hemp” from the list of controlled substances under the CSA and creating an avenue for federal registration of marks covering some goods and services derived from hemp.  Now, marks covering certain hemp-derived goods and services with less than 0.3% tetrahydrocannabinol (“THC”)3 may be eligible for federal registration.  However, the USPTO will continue to refuse registration when the identified goods or services in an application involve cannabis that meets the definition of marijuana and encompass activities still prohibited under the CSA.

To assist in the prosecution of trademark applications for these newly registerable goods and services, the USPTO outlined the requirements an application must meet before it may be eligible for registration for hemp-derived goods and related services.  First, the USPTO advises that only applications covering hemp-derived goods and services with less than 0.3% THC are registerable.  Second, an application’s identification of goods for all goods derived from hemp must explicitly state that the hemp-derived goods contain less than 0.3% THC.  Third, only applications for marks covering hemp-based products and related services filed after December 20, 2018, are eligible for federal registration.  Any applications filed prior to December 20, 2018, must be amended or refiled.4.  Specifically, applicants must request the USPTO amend their filing date to December 20, 2018, or withdraw their application and submit a new one.   Notably, the USPTO will also examine applications to register service marks for compliance with the CSA and the 2018 Farm Bill; and, as such, an application’s identification of services must also specify that the involved cannabis contains less than 0.3% THC on a dry weight basis.  Moreover, there are additional requirements for applications that include services involving the cultivation or production of hemp.

Restrictions still remain on the registrability of marks for hemp and hemp-derived goods.  For example, applications to register marks covering hemp-derived foods, beverages, dietary supplements, or pet treats will still be refused as unlawful because the use of hemp in items for human or animal consumption has not yet been approved by the Food and Drug Administration (“FDA”)5.

While Examination Guide 1-19 signals the budding federal registrability of marks for certain hemp-derived goods and services, applicants should consider the stringent requirements placed on the same.  Mark owners should think critically about whether their trademarks for cannabis and cannabis-related products and services are potentially eligible for federal protection, as we expect to see a significant influx of applications covering these types of offerings in the near future.  Filing applications for eligible products and services now may help mark owners gain a foothold in what will likely be a competitive business field going forward.

1 Under the Controlled Substances Act the drug class “Marihuana” (also referred to as “cannabis” or “marijuana”) is defined as “all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.”  21 U.S.C. §802(16).  Cannabidiol (“CBD”), a chemical constituent of the marijuana plant is included in the Controlled Substances Act’s definition of “Marihuana.”  See id.

2 Hemp is defined as “the plant Cannabis sativa L., and any other part of that plant, including the seeds thereof an all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol (“THC”) concentration of not more than 0.3% on a dry weight basis.”  Agricultural Improvement Act §297A

3 THC is the main psychoactive ingredient of cannabis.

4 The USPTO takes the position that any applications filed before December 20, 2018 lacked a valid basis to support registration at the time of filing because the applied-for goods violated federal law.  See Examination Guide 1-19: Examination of Marks for Cannabis and Cannabis Related Goods and Services after Enactment of the 2018 Farm Bill.

5 The 2018 Farm Bill specifies that the FDA retains its authority to regulate goods containing cannabis and cannabis-derived compounds, and the FDA has taken the position that cannabis-infused items for human or animal consumption require the FDA’s approval before they may be sold to consumers. The FDA is conducting clinical investigations into the safety and efficacy of such products for human and animal consumption.

© 2019 Brinks Gilson Lione. All Rights Reserved.
This post was written by Virginia Wolk Marino and Emily Kappers of  Brinks Gilson & Lione
Read more USPTO & Trademark news on the National Law Review Intellectual Property page

Cannabis Prop 65 Liability: Lessons Learned from the Dietary Supplement Industry

The cannabis industry appears to be next on the liability “hit list” under California’s notorious Proposition 65 statute. In June 2017, more than 700 Prop 65 notices were served on California cannabis businesses. Companies in this emerging market should start mitigating risk under Prop 65 now. Fortunately, lessons can be learned from the dietary supplement industry’s expensive Prop 65 battles over the past decade.

California’s Prop 65, also known as the Safe Drinking Water and Toxic Enforcement Act, requires a warning on all products that contain chemicals known to cause cancer or reproductive harm, even in amounts a fraction of what is deemed safe by federal standards. Prop 65 has caused havoc within the dietary supplement and herbal product markets over the past decade, led by a cottage industry of “bounty hunter” attorneys who have weaponized the statute, ostensibly in the public interest but in reality as a lucrative for-profit business. These bounty hunters are now turning their attention to cannabis. Though amendments to the statute were adopted in 2016 for the purpose of reducing this abuse, Prop 65 litigation will continue and cannabis companies must stay vigilant.

Many businesses faced with the necessity of using a Prop 65 warning have no concern with the impact that a warning may have on sales or with consumer confidence in the product. After all, who would look twice at a Prop 65 warning on motor oil or insect repellent? Like the dietary supplement industry before them, however, many cannabis businesses will resist including a warning that the product contains a chemical known to cause cancer or reproductive harm. Many cannabis products rely on the consumers’ belief that the product is harmless and even therapeutic. For many, this will be an important business decision that may give rise to expensive mistakes − a decision should be made with an understanding of the basis for Prop 65 liability and exposure.

What Is Prop 65 and What Does It Require?

Prop 65 was passed by California voters in 1986 after an aggressive lobbying campaign by environmental and public health activists. The stated purpose of Prop 65 was to improve public health. The general consensus, however, is that Prop 65 has placed an undue burden on California businesses while achieving no significant impact on public health over the past 30 years.

As noted above, Prop 65 requires a warning on all products that contain chemicals known to cause cancer or reproductive harm. There are more than 900 such chemicals listed, and marijuana smoke has been included on the list since 2009.

For a warning to be acceptable under Prop 65, it must (1) clearly make known that the chemical involved is known to cause cancer and/or birth defects and/or other reproductive harm and (2) be given in such a way that it will effectively reach the person before he or she is exposed. The warnings must be “clear and reasonable,” meaning that the warning may not be diluted by other language. Various means of communicating the warning are allowed, including product-specific warnings on a posted sign or shelf, warnings on the product label or electronic warnings for internet purchases.

Important Exemptions

There are several important exemptions to Prop 65 that make a warning unnecessary. Businesses with nine or fewer employees are exempt from the statute. There also is an exemption involving chemicals that occur naturally in food. Lead, for example, will be considered naturally occurring only if it “is a natural constituent of a food” and is not added as a result of human activity such as pollution or poor manufacturing processes. The burden is on the company to prove the exemption, however, which is typically time-consuming and expensive.

Another important exemption is provided by “safe harbor” exposure levels for many chemicals on the Prop 65 list, below which no warning is required. The listed chemicals include additives or ingredients in pesticides, food, drugs and common household products. Most food contains at least some level of one or more of these substances. Prop 65 safe-harbor levels, however, are in many cases around 1,000 times lower than levels set by the Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and World Health Organization (WHO). The exposure levels established by Prop 65 are often lower than what occurs naturally in fruits, vegetables, grains and even drinking water.

For example, the Prop 65 limit for lead is 0.5 mcg / day, which is below the amount of lead naturally found in many fruits, vegetables and herbs grown in non-contaminated soil. By comparison, the FDA allows 75 mcg / day and the European Union allows 250 mcg / day for lead. The European Food Safety Authority estimates the average adult consumes around 50 micrograms per day, which is 100 times the Prop 65 limit. It is nearly impossible to manufacture herbal products, including cannabis, without trace amounts of lead. Therefore, despite the “naturally occurring” exemption, discussed above, it can be dangerous to simply assume that an herbal product, including cannabis, complies with safe-harbor levels.

Only about 300 of the more than 900 Prop 65 chemicals have specific safe-harbor levels. For those chemicals without a safe-harbor limit, the burden will be on the cannabis business to establish that the subject chemical is within a safe range. This typically requires expensive testing, the results of which may be open to multiple interpretations as to whether a warning is required.

Determining the Exposure Level

Determination of the “exposure level” also is an important consideration. Prop 65 focuses on the level of a chemical to which the consumer is actually exposed. Although a product may have a very low amount of a chemical on the Prop 65 schedule that is below the safe-harbor level, liability under the statute may nevertheless be triggered based on the recommended serving size. It is advisable for companies to work with a laboratory that specializes in Prop 65 testing to determine the cumulative exposure level in order to verify the recommended serving size.

Enforcement of Prop 65

Prop 65 is enforced through litigation brought by the government or by private attorneys that “act in the public interest.” It is the threat of these private lawsuits that causes such consternation among those targeted with Prop 65 liability. After a 60-day notice period, the attorney may file a civil suit against the offending company. Typically, the plaintiff will demand that the defendant provide warnings compliant with Prop 65, pay a penalty, and either recall products already sold or attempt to provide health hazard warnings to those who purchased the products.

Though purportedly brought in the public interest, it is the collection of penalties and attorneys’ fees that in reality drives this litigation. Prop 65 allows individuals who bring suit to recover 25 percent of the penalties awarded, which by statute is calculated at $2,500 per violation per day. Amendments made to Prop 65 in 2016 allow for certain voluntary actions by the defendant – reformulation of the product, for example – in lieu of penalties. The threat of paying the plaintiff’s attorney’s fees makes litigating Prop 65 cases potentially very expensive. The attorney is incentivized to drag out the litigation, and the longer the case goes on, the more difficult it becomes to resolve because of the mounting fees.

This framework has created a cottage industry of Prop 65 “bounty hunter” lawyers who affiliate with “public interest” organizations that bring these cases for profit. According to the California Attorney General, 760 settlements were reported in 2016 with total settlement payments of more than $30 million. Attorneys’ fees accounted for 72 percent of that amount. The 2016 amendments to the statute have attempted to address these abuses to some extent by requiring a showing that the public benefits derived from the settlement are “significant” and by requiring contemporaneous record keeping for fees and costs sought to be recovered. Prop 65 litigation nevertheless continues to burden many industries in California, now including the cannabis industry. For Prop 65 liability, prevention is certainly less costly than a cure.

 

This post was written by Ian A. Stewart of Wilson Elser © 2017

For more legal analysis go to The National Law Review

Oklahoma and Nebraska Challenge Colorado’s Amendment 64: Legalized Marijuana

In 2012, Colorado was the first state to legalize recreational marijuana with Amendment 64.  While this has made Pizza Franchisors happy and sent snack sales through the roof, it has also created controversy and unintended consequences.  The entire country has watched Colorado sort through these issues, curious to see how things will land, how much people really want to get high, and most of all, exactly how much money is there to be made?  Along with these practical issues and enforcement questions, several legal issues have come into play as marijuana legalization—and its conflict with federal law—has changed the landscape.  Perhaps most significantly are the legal challenges to Colorado’s statute in front of the Supreme Court.

Colorado’s Amendment 64 changed the State Constitution to allow for recreational use of marijuana. According to the law, Adults 21 or older can grow up to six cannabis plants, with 3 being mature at a time, and legally possess all the cannabis from those plants.  Adults may also travel with up to one ounce of marijuana while traveling, and gift up to one ounce to other adults 21 or over.  Consumption is regulated like alcohol.  The sale and growth of marijuana is regulated by the state, with licenses available for both growers and retail outlets.

The Attorney Generals’ of neighboring states Oklahoma and Nebraska, Scott Pruitt and Jon Bruning, respectively, have sued Colorado.  The complaint cites Colorado for creating a “scheme” that “frustrates the federal interest in eliminating commercial transactions in the interstate controlled-substances market, and is particularly burdensome for neighboring states [Oklahoma and Nebraska] . . . States where law enforcement agencies and the citizens have endured the substantial expansion of Colorado marijuana.”  Colorado’s Attorney General, John Suthers, was against marijuana legalization when it was being debated, but now he is tasked with defending the state’s controversial measure.

Oklahoma and Nebraska take issue with Colorado’s failure to take steps to prevent the drug from leaving the state.  In particular, the complaint takes issue with Colorado not requiring patrons to smoke or eat the marijuana where they purchase it, or tracking marijuana once it is sold, or requiring a background check on purchasers.  The law, in fact, only requires a driver’s license that says you are 21 to purchase the drug.  Colorado has no effective way, according to the complaint, to stop “criminal enterprises, gangs and cartels from acquiring marijuana inventory directly from retail marijuana stores.”

Concerns about a black market exist, and how the law might be creating gray areas in how pot is sold and cultivated.  A CNBC documentary “Marijuana Country: The Cannabis Boom” examines some of these issues.  Cameras follow two pot dealers as they show how loopholes in the law allow them to profit from their excess marijuana, grown legally, in a gray market heavy with craigslist postings and terminology—he is a caregiver, not a dealer, and he gifts the marijuana and receives gifts of cash in return.  It’s easy to see how this gray area doesn’t stop at the state line.

In fact, law enforcement officials from counties neighboring the Colorado border say they are seeing more Colorado marijuana, some of it still in the retail packaging, flow into their counties.  The strained jail budgets in these counties are a result of the increased enforcement costs—more impounded vehicles, more arrests and higher costs all around because of the pot coming down the highway.  Colorado AG John Suthers says 40 states have contacted his office regarding marijuana seized within their borders, and the Washington Post has gone so far as to call Colorado “the nation’s giant cannabis cookie jar.”

It is for these reasons that Oklahoma and Nebraska have filed their complaint.  Invoking the Constitutional provision that gives the Supreme Court original jurisdiction on disputes between the states, basing their complaint on the claim to the right to have federal laws prevail over contradictory state laws under the Supremacy Clause of Article VI of the Constitution.  Nebraska and Oklahoma v. Coloradohas not received permission to be filed by the court.   It should be interesting to see how the case develops.  But with over 130 metric tons of marijuana sold, legally, in Colorado last year, the demand is not going away.

The court documents and the complaint are here.

ARTICLE BY

Eilene Spear
OF
The National Law Review / The National Law Forum LLC