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Who’s Afraid of Biotech Institute LLC?

By Brett Schuman, Daniel Mello, Nicholas Costanza, Olivia Uitto
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While cannabis patenting activity is still in its infancy, relatively speaking, a lot has been written already about the cannabis patenting activity of an entity called Biotech Institute LLC (BI) of Westlake Village, California.1 BI is building a sizable portfolio of utility and plant patents covering various aspects of the cannabis plant. According to some commentators, BI’s patents have “many in the cannabis industry concerned.”2

But how concerned should members of the cannabis industry really be about BI’s patents? Generally, patents are susceptible to numerous challenges in multiple fora. From 2012-2016, approximately 80% of challenged patents were invalidated by the Patent Trial and Appeal Board (PTAB) each year.3 The PTAB was created in 2011 by the Leahy-Smith America Invents Act, 35 U.S.C. § 6, to create a process for eliminating improvidently issued patents. And the statistics suggest that the process may be working as intended by Congress.

BI may be building its portfolio by taking advantage of some unique challenges in the cannabis patenting area. First, even though cannabis has been cultivated and consumed by humans for thousands of years, there is a relative lack of published prior art available to patentees and patent examiners examining patent applications.4 Second, patent examiners are not as familiar with cannabis patent applications as they may be with other types of patent applications.

So, we examined carefully BI’s earliest and arguably broadest utility patent, U.S. Patent No. 9,095,554, and concluded that maybe the cannabis industry need not be so concerned about this and some of BI’s other utility patents. Although the ’554 patent is lengthy – 247 columns of text and over an inch thick when printed in hardcopy – there appears to be little if any novelty to the claimed invention. Alternatively, the patent appears to be obvious in light of the available prior art.

In a patent, the claims define the metes and bounds of the patentee’s intellectual property. Claim 1 of the ’554 patent recites:

  1. A hybrid cannabis plant, or an asexual clone of said hybrid cannabis plant, or a plant part, tissue, or cell thereof, which produces a female inflorescence, said inflorescence comprising:
  1. a BT/BD genotype;
  2. a terpene profile in which myrcene is not the dominant terpene;
  3. a terpene oil content greater than about 1.0% by weight; and
  4. a CBD content greater than 3%;
  5. wherein the terpene profile is defined as terpinolene, alpha phelladrene, beta ocimene, careen, limonene, gamma terpinene, alpha pinene, alpha terpinene, beta pinene, fenchol, camphene, alpha terpineol, alpha humulene, beta caryophyllene, linalool, cary oxide, and myrcene, and wherein the terpene oil content is determined by the additive content of the terpenes in the terpene profile; and wherein the terpene contents and CBD content are measured by gas chromatography-flame ionization detection (GC-FID) and calculated based on dry weight of the inflorescence; wherein a representative sample of seed producing said plants has been deposited under NCIMB Nos. 42246, 42247, 42248, 42249, 42250, and 42254.

While claim elements define the metes and bounds of the invention, typically only certain claim elements are intended to distinguish the claimed invention from the prior art. Other claim elements merely help to describe the invention. For example, the preamble in the ‘554 patent, or the part of the claim before subpart (a), describes the flowering part of the cannabis plant. This is not intended to describe anything novel about the claimed invention, but rather it simply describes the part of the cannabis plant that is relevant to the invention.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

Before the priority date of the ’554 patent, it was known in the prior art that BT/Bgenotypes produce nearly equal amounts of THC and CBD (both are dominant; one is not recessive).5 Thus, it is not unexpected to have a CBD content greater than 3% in a genotype that can produce large amounts of CBD (known references state as high as 21% in CBD-dominant strains and 3%-15% in BT/Bgenotypes).6 Further, it was known in the prior art that terpenes generally constitute more than 1.0% percent by weight (usually between 2-4%) of the flower.7

As these databases continue to grow and studies of cannabis are publicly disclosed, cannabis patents like BI’s ’554 patent will become more and more susceptible to patent challenges and invalidation.Claim element (b), reciting a terpene profile in which myrcene is not the dominant terpene, appears to be one of – if not the only – claimed element of novelty of the BI invention. Terpenes are aromatic compounds produced in plants, and the cannabis plant has more than 100 different terpenes. Claim element (e) simply lists the most abundant terpenes in the cannabis plant. A majority of cannabis strains express high levels of myrcene; however, there are known prior art strains that express high levels of other terpenes, such as caryophyllene, limonene, pinene, etc. Additionally, it is well known in the art that terpenes have different therapeutic effects. For example, pinene and linalool are known to have antidepressant activity.8 Thus, a prior disclosure of a BT/Bgenotype that has a terpene profile where myrcene is not the dominate terpene very likely invalidates this claim. And even assuming there is any novelty to a high-CBD strain where myrcene is not the dominant terpene, there is a motivation to breed for a dominant terpene besides myrcene.

Because cannabis has been and remains a Schedule I drug under the Controlled Substances Act, previously known and used strains generally have not been chemically characterized, studied, researched, and the subject of publications that can be used as prior art for purposes of challenging cannabis patents. But that is changing. For example, the Open Cannabis Project (OCP) attempted to characterize and publish chemical details of cannabis plants. Even though OCP closed as of May 31, 2019, is database is still publicly available. Another example is CANNA, a non-profit initiative of the CANNA Espana Fertilizantes SL company, which carries out studies and conducts research on cannabis and its active compounds.9 In one study,10 CANNA found that some strains have terpene profiles where myrcene is not the dominant terpene, which could be relevant to a novelty-based or obviousness challenge to claim 1 of the ‘554 patent. As these databases continue to grow and studies of cannabis are publicly disclosed, cannabis patents like BI’s ’554 patent will become more and more susceptible to patent challenges and invalidation.


References

  1. See, e.g.,Amanda Chicago Lewis, The Great Pot Monopoly Mystery, GQ (August 23, 2017), https://www.gq.com/story/the-great-pot-monopoly-mystery;  Brian Wroblewski, Utility Patents on Marijuana? Who is BioTech Institute LLC?, The National Marijuana News, https://thenationalmarijuananews.com/utility-patents-marijuana-biotech-institute-llc/; Eric Sandy, Biotech Institute Has Applied for Patents on 8 Individual Cannabis Cultivars, Cannabis Business Times(June 24, 2019), https://www.cannabisbusinesstimes.com/article/biotech-institute-cannabis-patent-applications/.
  2. Nicole Grimm, George Lyons III, and Brett Scott, Biotech Institute’s Growing Patent Portfolio — U.S. Patent No. 9,095,554 and the Path Forward, JD Supra (November 17, 2017), https://www.jdsupra.com/legalnews/biotech-institute-s-growing-patent-17433/.
  3. World Intellectual Property Organization, An overview of patent litigation systems across jurisdictions,World Intellectual Property Indicators 2018, https://www.wipo.int/edocs/pubdocs/en/wipo_pub_941_2018-chapter1.pdf.
  4. Brett Schuman et al., Emerging Patent Issues In The Cannabis Industry, Law360(February 20, 2018), https://www.goodwinlaw.com/-/media/files/publications/emerging-patent-issues-in-the-cannabis-industry.pdf.
  5. Chandra, et al. Cannabis sativa L. – Botany and Biotechnology, pages 142-144, Springer, 2017 (citing de Meijer, Genetics163: 225-346 (2003)). See alsoMolecular Breeding (2006) 17:257-268, doi/10.1007/s11032-005-5681-x. 
  6. American Journal of Botany 91(6): 966:975 (2004). doi.org/10.3732/ajb.91.6.966; See e.g., Jikomes, Peak THC: The Limits on THC and CBD Levels for Cannabis Strainshttps://www.leafly.com/news/science-tech/peak-thc-cbd-levels-for-cannabis-strains.
  7. PLoS One. 2017; 12(3): e0173911. doi: 10.1371/journal.pone.0173911.  See also, Fischedick J. T., Hazekamp A., Erkelens T., Choi Y. H., Verpoorte R. (2010). Phytochemistry712058–2073 (2010). 10.1016/j.phytochem.2010.10.001
  8. J Ethnopharmacol. 2012 Sep 28;143(2):673-9. doi: 10.1016/j.jep.2012.07.026. Epub 2012 Jul 31.
  9. Retrieved from https://www.fundacion-canna.es/en/about-us, on August 6, 2019.
  10. Retrieved from https://www.fundacion-canna.es/en/variations-terpene-profiles-different-strains-cannabis-sativa-l, on August 6, 2019.

Tips for Finding the Perfect Cannabis Packaging Partner for Your Business

By Danielle Antos
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Whether your cannabis business is a start-up in its infancy, or established with a loyal customer following, the product packaging you use is essential to building and maintaining your brand. The packaging is the first thing a potential customer sees, and it creates that critical first impression. While the primary function is to contain, protect, and market your products, your packaging is a reflection of your company to the customer. In many ways, the package is the product. Partnering with a quality plastic packaging manufacturer for your cannabis products will increase your success.

Bottles made of high-density polyethylene (HDPE), low density polyethylene (LDPE), polypropylene (PP), and polyethylene terephthalate (PET) have become widely-accepted packaging options within the cannabis industry. There are many plastic bottle manufacturers, but how do you find the right one? In short, seek a manufacturer who makes quality products that are unlikely to present downstream problems for your company, provides services and options that align with things you feel are important, and wants to build a long-term relationship with you so both of your businesses grow faster through strategic partnership.

What to Look for in a Plastic Bottle Manufacturer

Excess Bottom Flash creates a poor printing surface.

As you search for a packaging partner for your cannabis business, here are a few key things to look for:

Bottles That Visually Support Your Brand

It’s essential to partner with a manufacturer who understands the importance of defect-free plastic bottles. Does everything about your packaging convey a sense of trust for your customers? Defects in plastic bottles typically occur during the manufacturing process.

Excessive Side Taper results in uneven, wrinkled labels.

For instance, excessive side taper on the bottles can result in uneven, wrinkled labels that are hard to read and make your product look unprofessional. If flashing on the bottle bottom is not removed, it creates a poor printing surface and results in a poor brand impression.

Partnering with a manufacturer who understands that plastic bottle defects diminish brand presence and who continually strives to remove defect-producing problems out of their manufacturing process is of utmost importance. This avoids many downstream quality problems and helps to keep the focus on growth and off of damage control.

Bottles That Minimize Risk and Waste

Product recalls or safety concerns can be a result of cloudy bottles or material trapped in the resin that makes the plastic packaging look dirty or contaminated. These situations can erode consumer confidence in your brand or expose the customer to risk.

Foreign material trapped in the resin results in reduced customer confidence.

Sub-par plastic bottles can lead to inefficiencies on your filling lines, lost production time, and product that cannot be sold. These situations lead to reduced profitability and negatively impact your bottom line. It’s never good when filled packaging or product has to be thrown away because problems are identified on the filling line.

Uneven Sealing Surface results in poor closure seal and increased risk of product spoilage or contamination.

Worse yet is when your product reaches the point of sale and the problems are identified at the dispensary or by a consumer. For example, over time, an improper seal between the plastic bottle and cap can cause flower to be excessively dry. In turn, when this flower is dispensed to the consumer it can lead to overfilling to make up for weight loss. And some consumers just don’t like their flower to be too dry, resulting in lost sales. Does the defective product get shipped back or trashed at the point of sale location? In either case, this results in the dilemma of wasted product that can’t be used and extra costs that eat into your profitability. 

Closures That Work With The Bottle

The closures for the bottles are also an important part of your cannabis packaging. Can your packaging partner manufacture and supply plastic closures that assure complete functionality to protect your product? Closures produced by the same manufacturer as the bottles ensures that the closure and bottle function correctly together. A one-stop-shop approach will save you time and money.

The cannabis industry is growing quickly and faces many complex regulatory challenges, including regulations for child-resistant packaging. Many states have their own unique cannabis packaging requirements which must be strictly adhered to. Are their bottle and closure pairings compliant with current regulations and those that are under legislation for the future? 

Customization for Your Brand

Can the cannabis packaging manufacturer customize their products to your exact design and specifications? Your product is unique, and your packaging should reflect that. Make sure your brand stands out with the exact image you want to project. There should be “depth” in your supplier: can they do more than just sell you packaging that already exists?

A Safe Resin Source

Another important aspect of safety is country of origin. Plastic bottles and closures manufactured overseas may have impurities in the resin or colorant that could leach or bleed into your products. They may not have documentation of origin or comply with FDA regulations. Your plastic packaging partner should be able to provide this documentation so you can rest assured that your bottles are manufactured under strict guidelines for the safety of your consumers and that your product won’t be affected.

Commitment to Sustainability

To many consumers, packaging made from recycled materials is important. Does your packaging supplier have a strong commitment to environmental sustainability? There is strong market support for carbon-friendly alternatives. Progressive plastic packaging manufacturers are actively working to provide alternatives to plastics made from fossil fuels and instead, using resins produced from renewable resources (i.e. sugarcane). By partnering with a supplier that provides alternative and recycled materials, you enhance your brand by appealing to a growing segment of environmentally concerned consumers.the best cannabis packaging suppliers understand that consistency in the manufacturing process is essential.

Scalable Growth

As your business grows, can your packaging partner grow with you? It’s important that they are able to keep up with the demand for your product and that their supply chain can match your manufacturing needs. As you add to your product line, are they capable of continuing to offer new and innovative packaging? A manufacturer that has a strong business model for growth will benefit you now and for the future.

A Real Cannabis Packaging Partner

Your cannabis business should develop a true partnership with your packaging supplier. They should invest in your success and care about your business. Businesses depend on one another for continued growth – look for a knowledgeable partner that is responsive, courteous and dependable now and for years to come. The best suppliers realize that there is more to a relationship than just the financial transaction of buying packaging.

Additionally, the best cannabis packaging suppliers understand that consistency in the manufacturing process is essential. Using virtually perfect bottles time after time not only reduces waste but helps build consumers’ trust in your brand. Consistency saves you three precious commodities – time, hassle and money.

Remember, a brand consists of more than just a logo and company name. It identifies who you are, what your company stands for and the integrity of your product. Quality cannabis packaging will reinforce your company standards and attract consumers to your product – consistently defining you as a quality provider with integrity in the marketplace. Improving your bottom line and meeting your company’s financial goals is at stake. Is your cannabis packaging partner going to help you grow?

Organic Cannabis Association & Ethical Cannabis Alliance Announce Merger

By Aaron G. Biros
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The Organic Cannabis Association and Ethical Cannabis Alliance announced today they are merging into one organization, the Cannabis Certification Council (CCC), according to a press release. The new third-party certifications include “Organically Grown” and “Fairly Produced”, granting producers a seal for marketing if they achieve the certifications.

Ashley Preece, executive director of the Cannabis Certification Council

According to Ashley Preece of the Ethical Cannabis Alliance, now executive director at CCC, they plan on starting with the “Organically Grown” certification as first certification to market. “We are launching with Organically which will include robust labor standards as well as standards that go beyond [USDA] Organic,” says Preece. “The USDA Organic standard is watered down and we want to expand on proper horticulture practices so it relates directly to cannabis producers.” The process of designing that certification involves using that USDA Organic certification as a building block to draw from but not directly adopt.

“We will start by pulling from Organic and Fair Trade standards, then we will have a technical advisory committee (TAC), made up of multi-stakeholder agricultural industry and cannabis industry professionals to give input and adjust the standard accordingly,” says Preece. “From there we will have a pilot program, engaging with producers abiding by the standards’ requirements. After the pilot phase, we make final adjustments before bringing it to market.” In order to make sure their certification works across the board, Preece says they are engaging with stakeholders around the country and eventually globally. “We need to engage each different community to make sure this is applicable on a national level.” Preece also says they plan staying abreast of other standards, such as ASTM International’s, but those are geared more towards production safety. “We are looking towards more robust Organic and Fair Trade standards, and ‘cannabinizing’ them,” says Preece.

Photo courtesy of L’Eagle Services

David Bronner, a prominent advocate of drug policy reform and CEO of Dr. Bronner’s, a top-selling soap brand in the US market place, will be providing seed funding and a matching grant to the CCC. “We are committed to making socially and environmentally responsible products of the highest value, and we are excited for the CCC to begin driving that ethos in the cannabis industry,” says Bronner. “The Cannabis Certification Council (CCC), with its unique mission, is a perfect vessel for us to support our values in the cannabis space.”

Preece says the “Fairly Produced” labor certification is going to be based off of Fair Trade practices. “That will include living wages per community and taking options of ownership into consideration, including different business models where employees might have shares or partial ownership,” says Preece. “As we know, this industry has come from the illicit market, where we saw a lot of inappropriate working environments, gender relations and pay schedules. So we want to ensure that workers have contracts in place, they are treated fairly just as any other industry and we want to mitigate any strange encounters that might have seeped into this regulated market.” Founding board members include Laura Rivero of Yerba Buena Farms; Amy Andrle of L’Eagle Services Denver; Nick Richards of Dill and Dill and Vicente Sederberg; and Ben Gelt of Par, with Ashley Preece as executive director. “This is a huge step for the cannabis industry,” says Preece. “Our collaboration reflects the priority of the mission ingrained in both parties, and together we will immediately be greater than the sum of our parts.”