Biotech Institute's Growing Patent Portfolio -- U.S. Patent No. 9,095,554 and the Path Forward

As with any billion dollar market, patents are an important consideration for the cannabis industry.  Despite its current classification as a Schedule I drug under the Controlled Substances Act, however, the U.S. Patent and Trademark Office has issued hundreds of patents on cannabis to date.  These patents cover a range of cannabis-related inventions, including methods of treatment with cannabinoids, cannabis-infused edible products, cannabis consumption methods and devices, and methods of growing Cannabis plants.  Even the Cannabis plant itself is fair game for patenting via both utility and plant patents.[1]

However, one family of utility patents, in particular, entitled "Breeding, Production, Processing, and Use of Specialty Cannabis" (collectively, the "Biotech cannabis patents"), has many in the cannabis industry concerned.  This patent family is owned by Biotech Institute LLC of Westlake, California, and provides, according to the abstract:  "compositions and methods for the breeding, production, processing and use of specialty cannabis."  The over-250-page specification (as filed) contains 43 examples directed to a host of embodiments including:

• chemical analysis of cannabinoids and terpenes of the Cannabis plants described in the specification (Examples 1, 7, 13, and 17);
• parental classes of Cannabis varieties (Example 2);
Cannabis varieties with high THC content or non-THC content and terpene profiles to meet specific aroma/flavor or medicinal needs (Examples 3 and 4);
• breeding programs (Example 5);
• strains producing both THC and CBD or CBD alone (Example 6);
• tracking the Cannabis plants during production, processing, and use (Example 21);
• feedback-based cultivation systems (Example 23);
• packaging single-dose units in a bubble pack (Example 25);
• use as a vaporized expectorant (Example 26);
• use of specialty cannabis in edibles (Example 29);
• use of multiplexed cannabis mixtures to treat brachial plexus avulsion, arthritis, motion sickness, seizures, neuropathic pain, depression, irritable bowel syndrome, pain from cancer, psychosis-related diseases (g., schizophrenia) as well as to aid in weight loss and improve cholesterol levels (Examples 31-41); and
• zero-point delivery devices and doses (Examples 42 and 43).

Although the specification contains extensive tables showing cannabinoid and terpene profiles of the Cannabis varieties described in the specification, as well as actual data from volunteer trials using the Cannabis plants, many of the examples are prophetic and aspirational.

Claiming priority to U.S. provisional applications that were filed on March 15, 2013, and October 29, 2013, this family currently contains three granted U.S. patents and two pending continuation applications.  The first patent in this family was granted as U.S. Patent No. 9,095,554 ("the '554 patent") on August 4, 2015.

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:
    a) a BT/Bgenotype;
    b) a terpene profile in which myrcene is not the dominant terpene;
    c) a terpene oil content greater than about 1.0% by weight; and
    d) a CBD content greater than 3%;
    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.

The dependent claims of the '554 patent cover methods of breeding and producing chemotype II Cannabis plants with a non-myrcene dominant terpene profile, a cannabis extract, and an edible product using the Cannabis plant described in claim 1.

The next to issue in the Biotech cannabis patents was U.S. Patent No. 9,370,164 ("the '164 patent") on June 21, 2016.  Like the '554 patent, the '164 patent covers Cannabis plants with particular cannabinoid content and terpene profile.

Claim 1 of the '164 patent recites:

1.  A Cannabis plant, or an asexual clone of said Cannabis plant, or a plant part, tissue, or cell thereof, which produces a female inflorescence, said inflorescence comprising:
    a) a tetrahydrocannabinol (THC) content that is at least 3%;
    b) a cannabidiol (CBD) content that is at least 3%;
    c) a terpene profile in which myrcene is not the dominant terpene; and
    d) a terpene oil content greater than about 1%;
    wherein the contents of THC and CBD comprise acidic and decarboxylated cannabinoids as measured by high performance liquid chromatography (HPLC) and calculated based on dry weight of the inflorescence; wherein the terpene profile is defined as terpinolene, alpha phellandrene, beta ocimene, carene, limonene, gamma terpinene, alpha pinene, alpha terpinene, beta pinene, fenchol, camphene, alpha terpineol, alpha humulene, beta caryophyllene, linalool, caryophyllene oxide, and myrcene, and wherein the terpene oil content is the additive content of the terpenes in the terpene profile;
    wherein the terpene contents 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. 42254, 42255, 42256, and 42258.

More recently, the third of the Biotech cannabis patents issued on May 9, 2017, as U.S. Patent No. 9,642,317 ("the '317 patent").  Like the '554 and '164 patents, the '317 patent has an independent claim directed to a Cannabis plant with particular cannabinoid and terpene characteristics, but further claims strains containing specific content ratios of THC:CBD (see claims 18 and 19).

Currently, there is one published pending continuation application in this family -- U.S. Patent Application No. 15/400,277, which was filed on January 6, 2017, and published as US 2017/0202170 on July 20, 2017.  This case has not yet been picked up for examination, but the pending claims appear to be directed to additional Cannabis varieties.  Another application in this family was recently filed and assigned U.S. Patent Application No. 15/795,904; however, this application is currently unpublished.  Thus, given the plethora of embodiments disclosed in the specification, Biotech Institute will almost certainly continue to file continuation applications to pursue additional subject matter and to keep an application in the family pending.

Additionally, Biotech Institute has also sought international protection of this family.  International Application PCT/US2014/030267 was filed in parallel with the U.S. application that led to the '554 patent and has entered national stage in Mexico.  Furthermore, International Application PCT/US2014/046694 was filed on July 15, 2014, and claims priority to the same family.  This application entered national phase in Europe and Canada.

So, considering the reach of the Biotech cannabis patents so far, why has this family caused such a stir in the cannabis industry?  At first glance, the independent claims of the '554, '164, and '317 patents seem limited in that they require that the Cannabis plants to contain certain percentages of THC and/or CBD and a terpene profile of more than 15 specific terpenes.  Some of the independent claims additionally require that myrcene is not the dominant terpene.  The independent claims also recite specific deposit numbers of seeds that are representative of the strains described by the independent claims.

However, despite these limitations, commentators have speculated that Biotech Institute's patents may cover anywhere from 50-70% of all Cannabis plants that are currently on the market, which could pose a serious threat to many Cannabis growers.[2]  Unlike plant patents, which are narrow and cover a particular, well-defined new plant variety, utility patents directed to plants have the potential to claim a much broader range of varieties.

Further, the potential sweeping scope of these patents, specifically, highlights a couple of issues with prosecuting and challenging patents on Cannabis plants, generally.  For example, there would seem to be a lack of prior art available showing the particular chemotypes of strains that are currently in use.  Without this information, Examiners are unable to accurately determine whether a Cannabis plant with a particular chemotype is novel and nonobvious.  Moreover, the lack of publications or information on the Cannabis varieties currently available to the public may pose similar challenges for third parties seeking to initiate certain post-grant review proceedings before the USPTO of patents covering Cannabis plants.  Indeed, perhaps unsurprisingly, none of the patents in this family have yet been subjected to an IPR proceeding.

Regardless of this lack of post-grant challenges or proceedings for the Biotech cannabis patents, however, these concerns have become apparent by other market reactions in the industry.  For example, in direct response to these issues and Biotech Institute's patents in particular, groups such as the Open Cannabis Project ("OCP")[3] are working to catalog and publish the chemotype data of cannabis strains that are currently in the public domain.  OCP's mission, in part, is to prevent broad utility patent protection of Cannabis plants.  Having such a database will help ensure that patents on Cannabis plants are properly limited in scope to cover novel and nonobvious varieties.

For now, it is uncertain whether Biotech Institute's patents are enforceable given the current federal climate.  However, as this family of patents is not set to expire until March 2034, the cannabis industry will have to remain careful, diligent, and concerned over Biotech Institute's growing patent family.

[1] Importantly, the USPTO recently issued the first plant patent on December 20, 2016, PP27,475, entitled "Cannabis plant named 'Ecuadorian Sativa.'"
[2] See, e.g., https://hightimes.com/business/patented-pot-a-multimillion-dollar-battle-looms/.
[3] http://opencannabisproject.org/

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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